Case Law from the Contracting States to the EPC
I. PATENTABILITY
A. Patentable inventions
1. Technical character of an invention
FR France
Paris Court of Appeal of 15 March 2006 (05/14785) - Cotranex v Directeur Général de l'INPI
Keyword: patentability - business method - technical character
Company C's patent application related to a method and system of compensation in kind for insurance policyholders. The Director General of INPI had refused the application, holding that its subject-matter could not be considered a patentable invention in the legal sense. Company C objected that the application had been refused by the Director General on the grounds that it concerned a method of doing business, whereas in its view the patent's claims applied technical means.
The Court considered that, in order to determine whether a patent application related to an invention patentable under Art. L. 611-10 French Intellectual Property Code or, on the contrary, a non-patentable mental act or business method, the nature of the problem to be solved by the patent and the solution offered by the invention had to be examined. The patent application enabled insurance companies to check how policyholders used the compensation paid out in order to avoid the misappropriation thereof, and enabled policyholders to obtain a replacement for lost or damaged property rather than receiving a sum of money. The Court upheld the Director General's assessment that the solution to both of these problems was business-related rather than technical.
The solution proposed in claim 1 related to a management centre, a server, and a network linking the centre, the policyholders and the insurance companies. This system had an economic character given the way it brought together different economic operators (management centre, traders, policyholders and insurance companies). According to the Court, the mention in claim 1 of the use of a "server" did not confer technical character on the system, as the server itself was not described and was not claimed in terms of how it was configured or used or how it interacted with the system. Dependent claims 2 to 8 did not contain any additional features that might suggest that a technical problem was being solved.
Thus while claim 8, in particular, specified how the server was used within claim 1, said device was not described from a technical perspective, but merely by reference to the processing of business data. So the use of these technical means did not confer upon the claimed invention a technical content that it did not in itself possess.
The Court concluded that the Director General of INPI had been quite right in his assertion that this method could not be considered an invention and so was not patentable within the meaning of Art. L. 611-10 French Intellectual Property Code. The Court consequently dismissed company C's appeal.
FR France
Paris Court of Appeal of 5 June 2009 (07/20589) - Kone v A
Keyword: technical character
The claimed invention related to a system for remotely managing the maintenance of a set of facilities installed in buildings, such as lifts, ventilation systems, district heating systems or automatic car park gates.
By decision of 23 October 2007, the Paris District Court had dismissed company K's request for revocation of French patent 2 814 901, owned by Mr A., for lack of novelty and, on an auxiliary basis, lack of inventive step.
On appeal, company K (appellant) requested revocation of the patent, mainly on the grounds that it did not constitute an invention but simply a non-technical solution to an economic problem. On the validity of claim 1, the appellant essentially submitted that the subject-matter of this invention concerned a management system for the economic sector because it enabled facility managers to verify the fulfilment of obligations agreed upon in a maintenance contract. The problem to be resolved was thus economic rather than technical because the transmission of information on facility malfunctions detected by local monitoring units to two computers had been known at the time of filing. Thus, the invention had merely resolved an economic problem by sending both parties to a maintenance contract identical information on the performance of that contract.
On the existence of an invention within the meaning of Art. L. 611-10 French Intellectual Property Code, the Paris Court of Appeal stated that company K had misconstrued both the definition of the problem that the invention purported to resolve and the result it achieved. As the respondent noted, a claim had to be considered in its entirety to determine whether the field to which the subject-matter related was excluded from patentability and whether or not it had technical character. In the case in question, the problem to be resolved related to the lack of information available to the facility manager on facility operation and the maintenance company's response to malfunctions.
The invention forming the subject-matter of claim 1 aimed to provide a facility manager with means to verify the operation of facilities and monitor the activities of the maintenance company. This involved giving the manager the technical means of information needed to perform these tasks, at which stage it was irrelevant whether or not those means were known, either individually or in combination, when the patent was filed. The result of combining the claimed means was that the local monitoring units sent the fullest possible technical information to the facility manager, this being the same as the information sent to the maintenance company. While the facility manager could use this information, among other things, to check the fulfilment of obligations agreed upon in a maintenance contract, this was only one possible use of the result and did not alter its nature. The Court of Appeal therefore held that the invention as claimed was indeed an invention within the meaning of Art. L. 611-10 French Intellectual Property Code.
The Court of Appeal rejected the pleas of insufficiency of disclosure and lack of novelty but revoked claim 1 for lack of inventive step.
FR France
Court of Cassation of 10 November 2009 (08-18218) - Syrdrec v Groupement Carte Bleue
Keyword: technical character
According to the Toulouse Court of Appeal's contested judgment of 28 May 2008, company S was the proprietor of French patent no. 9 107 639 relating to a "cashing system"; company O had subsequently obtained a European patent for a "credit card system and method"; said patent had been sub-licensed by company G for use in an e-Carte Bleue payment service for online shopping; and company S had sued G for patent infringement.
Company S objected, in particular, to the judgment's revocation of claims 1 and 7 of French patent no. 9 107 639, arguing that while business methods were not patentable as such, the technical application of such methods was patentable, and that the Court of Appeal had violated Art. 455 French Code of Civil Procedure by nevertheless declaring, according to company S, that its patent merely set forth principles and did not specify the technical means for carrying them out. The Court had not responded to its arguments demonstrating that the patent did specify the technical means to be used (card with clearly specified characteristics, online communication facilities, a computing and control unit, a transaction processing routine and accept/reject signals).
According to the Court of Cassation, however, the Court of Appeal had observed in its judgment that though the patent specified the expected outcome it never explained how to achieve it, so it merely set out the principles without specifying the technical means for carrying them out. The judgment of the Court of Appeal had also noted that the description was merely a list of constraints common to the envisaged transactions, and that for the electronic management of these logical constraints a system designer would have to use a non-redundant database of buyers. Given the above, and especially the fact that the claimant (company S) had failed in its submissions to claim either the use of online communication facilities or the principle of a computing and control unit, the Court of Cassation found that the Court of Appeal had indeed responded to the allegedly overlooked submissions and had not ruled out the patentability of a technical application in principle, but had noted the omission of such an application in the case in question. The Court of Appeal had therefore justified its decision to revoke the contested claims.
SE Sweden
Stockholm Court of Patent Appeals (Patentbesvärsrätten) of 6 February 2009 - case No. 04-329
Keyword: technical character - card games
In the case at issue, the claimed invention constituted an aid specially adapted for people with difficulties in reading, spelling and word recognition by helping them to achieve a phonological awareness by dividing words into parts in a special manner. For this purpose, the aid encompassed a number of card games with multiple cards, each of which had a word written on one side.
The Swedish Patent Office had rejected the application on the grounds that the claimed invention was merely a presentation of information and therefore not patentable. Upon appeal against this decision, the applicant argued that the claimed invention involved a learning aid in the form of a plurality of cards with words written on them in order to serve educational purposes and not - as considered by the Patent Office - as a mere presentation of information. In support of its case, the applicant cited the example of a similar invention which had been granted by the EPO (see EP 1 007 168 B1 "Apparatus for playing a game").
In the Court's view, claim 1 related to an aid which consisted of "a number of card games comprising a plurality of cards, each of which has a word [written] on one side of the card". The features "card games" and "cards", as these were to be understood on the basis of the description, were physical and thus technical in nature. The fact that each of the cards had a word written on it should also be regarded as technical in nature. Whereas the other features of the claim were not technical and, according to the Court, did not appear to contain any technical effects, the aid as defined in claim 1 involved technical features and, taken as a whole, should be deemed to have a technical character, irrespective of whether the technical features helped the skilled person distinguish the aid from the prior art or not. The claimed aid was therefore considered an invention within the meaning of Art. 52(1) EPC.
However, the technical features of the aid did not go beyond those known in the prior art, which equally described a card game designed, and therefore suitable, to be used for educational purposes, and more particularly for helping children learn to read, spell and think logically. The patent application was rejected for lack of novelty.
2. Computer-implemented inventions
DE Germany
Federal Court of Justice of 24 May 2004 (X ZB 20/03) - Online banking
Keyword: technical character - computer-implemented inventions
The invention concerned a secure method of performing transactions by online banking. It could be gathered from the application that online banking via an internet connection between clients and their banks used encryption methods largely resistant to unlawful attacks to secure the transferred data, whilst only data relevant to the order and comparatively worthless to third parties was transmitted between the provider and client computer.
At the lower instance, the Federal Patents Court had taken the view that the method in question was primarily concerned with a model for commercial payment and not a technical teaching. By contrast, the Federal Court of Justice found that it was of the requisite technical nature because the claimed teaching related to the problem of transferring from one place to another specific data requiring protection which, in the absence of the proposed solution, would have to be forwarded via an insecure connection. However, a computer-based method of completing a transaction in the course of commercial activity was patentable only if, beyond the proposal to use a computer as a means of processing the data needed to complete the transaction, the claim contained other instructions based on a specific technical problem making it possible to establish as part of the assessment of inventive step whether there was any technical contribution justifying patentability.
The Federal Court of Justice thus followed its decision of 17.10.2001 - Suche fehlerhafter Zeichenketten ("search for incorrect strings"). A problem arising as part of a commercial activity to be completed is not sufficient by itself - even if it must be solved as a precursor to any technical measures. That followed from the purpose of patent law, which was to promote only inventive technical solutions through a temporally limited exclusive right. It was not relevant here whether or not "online banking" was known as a solution, that being a question relating to the conditions for patentability and not a question relating to the exceptions to patentability. Even in the case of computer-related teachings or those using computers, the decision whether a concrete technical problem existed and had been solved or whether, in the absence of such a problem, an exception to patentability applied could not depend on whether the claimed subject-matter was new and inventive.
DE Germany
Federal Court of Justice of 19 October 2004 (X ZB 34/03) - Profitability calculation
Keyword: technical character - computer-implemented inventions
The Federal Court of Justice held that a method for determining the economic feasibility of acquiring a new medical technical apparatus by automatically collecting and transmitting to a central database data on the use of an existing apparatus and determining remuneration data and operational costs was not patentable as such.
According to the Court's case law, a method which, in order to achieve the desired effect, used a program as an aid to controlling a computer in such a way that the desired effect is achieved could not be patented solely on the basis of the computer-based process. Rather, since the law excluded computer programs as such from patentability (§ 1(2), No. 4, and § (3) German Patents Act), the claimed teaching had to provide instructions on how to solve a specific technical problem by technical means (Federal Court of Justice of 24.5.2004 - Elektronischer Zahlungsverkehr; Federal Court of Justice of 17.10.2001 - Suche fehlerhafter Zeichenketten).
In the case at issue, the Court made it clear that the technical character of the apparatus whose profitability was to be calculated and the technical nature of the computer system components were beyond doubt. However, this did not by itself constitute a technical problem solved by the features of the claimed method. The automatic data calculation and transfer did not lend technical character to the claimed method. These measures could only be attributed to the general problem of automatically determining and transferring the data relevant for the desired business result using electronic data processing, but that was not a specific technical problem as defined in the case law. It did not go beyond the general objective of using electronic data processing and transfer to achieve a non-technical effect, which objective was precisely not sufficient. Accordingly, the claim did not contain any solution going beyond the guidance that the skilled person should calculate the data "automatically".
DE Germany
Federal Patents Court of 10 February 2005 (17 W (pat) 46/02) - Online banking transaction II
Keyword: technical character - computer-implemented inventions
The patent application at issue concerned a secure method of performing transactions online based on an instruction to use an electronic banking system to transmit the transfer data. In a previous judgment, the Federal Patents Court had taken the view that the method in question was primarily concerned with a model for commercial payment and not a technical teaching. The Federal Court of Justice overturned the judgment of the Federal Patents Court and referred the case back to it on the ground that the claimed teaching had to be deemed technical (see summary of the Federal Court of Justice's decision of 24.05.2004 - Online banking decision in the present report).
In its subsequent judgment Online banking transaction II, the Federal Patents Court confirmed that the method was technical, but held that its technical contribution consisted solely of the instruction to use an electronic banking system to transmit the transfer data.
Nevertheless, it concluded that the method was not based on an inventive step. It was obvious to the skilled person to use a per se known electronic banking system. In its reasons, it found, having regard to the Federal Court of Justice's findings in its Online banking judgment, that the question whether a computer-implemented method was technical could be assessed only on the basis of those (other) instructions in a claim which supported a finding of a technical contribution. This was intended to ensure that inventive step was established on the same basis as rendered the claimed subject matter a practical technical teaching. Since, in this case, only the "use of per se known electronic banking" to transmit the (full) set of transfer data from the client's to the bank's computer specified in feature (b) of the claim was based on a specific technical problem, only the instruction to do so could be taken as the basis for assessing inventive step. The other aspects of the method, which concerned the sequence of payment steps activating a neutral channel using key information and automatically generated data, were based on business considerations and therefore irrelevant for assessing inventive step (with reference to T 258/03, OJ EPO 2004, 575).
DE Germany
Federal Court of Justice of 19 May 2005 (X ZR 188/01) - Recording medium
Keyword: technical character - computer-implemented inventions
Claim 1 of the patent in suit concerned a method of encoding a stream of data bits into a stream of channel bits and claim 11 a recording medium with an information structure generated according to the method in claim 1. The claimant took the view that claim 1 (and so claim 11) concerned the presentation of information and therefore could not be considered an invention under § 1(2), No. 4, German Patents Act. The Federal Court of Justice rejected that view, holding that both the problem solved by the patent and the means of solving it were technical. Those means consisted of an encoding method leading to a recording structure with physical properties which allowed for better visual evaluation of the information saved using that structure. This also meant that claim 11 was directed to a practical technical teaching and so to an invention within the meaning of § 1 German Patents Act.
That a method or apparatus concerned the presentation of information did not preclude its patentability. Rather, the key issue was whether the claimed teaching provided guidance on how to solve a specific technical problem by technical means. If so, it did not matter whether the patent claim also related to the use of an algorithm, a business use or the informative nature of the outcome of the process or claimed object (see also T 517/97, OJ EPO 2000, 515). In this respect, the same applied as to methods using a computer program to achieve the desired effect.
DE Germany
Federal Court of Justice of 20 January 2009 (X ZB 22/07) - Equipment for selecting medical examination methods
Keyword: exceptions to patentability - computer-implemented inventions - technical and non-technical features
The subject-matter of the application at issue was a method for processing medically relevant data for patient examinations. It was characterised by a program installed in a data-processing device which, on the basis of entered symptom-specific and/or diagnosis-specific information and using a symptom-based and/or diagnosis-based database, selected one or more modalities for patient examinations. These modalities were then communicated to an output device, with the database selecting and communicating one or more examination or measurement protocols defining the manner in which a particular examination was to be conducted. The German Patent Office had refused the application. The Federal Patents Court had likewise dismissed the ensuing appeal on the ground of non-patentability. It took the view that the claimed method was excluded from patentability in so far as it related to the correct choice of examination modalities (e.g. X-ray, computer tomography, magnet resonance) and, as the case might be, their purpose-related order of application on the patient by means of a program using a symptom-specific and/or diagnosis-specific database.
The Federal Court of Justice granted the applicant's appeal and remitted the case to the Federal Patents Court. For the requirement of technical character, the Court regarded it as irrelevant whether the subject-matter of an application had non-technical features in addition to its technical ones, as had been found in this case. The case law that based the delimitation of non-patentable combinations on the so-called "core theory", which the Federal Patents Court had cited in support of its contrary approach, was already obsolete. Whether combinations of technical and non-technical features were patentable in a specific case depended solely on whether they involved an inventive step.
According to the case law of the Federal Court of Justice, an application for a computer program or method performed by software had to contain, in addition to technical character, instructions defining the method and solving a specific technical problem by technical means. Since computer programs as such were excluded from patentability, generally only instructions dealing with the solution of a problem by such means could render a method patentable. Having regard to the exceptions to patentability, it was not the use of a computer program itself, but rather the solution of such a problem with the aid of a (programmed) computer which could render an invention patentable. In any case, wherever the method using data-processing apparatus was embedded in the process carried out by technical equipment (e.g. setting the image resolution for computer tomography), it was not the outcome of weighing up the technical and non-technical elements which determined patentability. Rather, the decisive point was whether, taking the requisite overall view, the teaching served to solve a specific technical problem consisting of more than just data processing.
DE Germany
Federal Court of Justice of 22 April 2010 (Xa ZB 20/08) - Dynamic document generation
Keyword: exceptions to patentability - non-technical features
The German patent application claimed a method for dynamically generating structured documents (e.g. in HTML format) in a client-server system which enabled a structured document requested by the client to be generated dynamically also in servers with limited resources. The Federal Patents Court had held that the claimed method was not technical, but rather was based on "conceptual considerations". On appeal to the Federal Court of Justice, it was argued that the denial of technicity was an unrealistic fiction and that computer programs were technical per se.
The Federal Court of Justice set aside the judgment of the Federal Patents Court and remitted the case back to it for a decision on novelty and degree of inventiveness. On the question whether the method was technical, the Federal Court of Justice applied its settled case law that it was irrelevant whether the subject-matter of an application comprised non-technical features in addition to its technical ones and which of those features characterised the claimed teaching. Accordingly, in the case of a method claim, it did not matter whether the invention taught (fundamental) deviations in the operation of the components of a data processing system. Rather, it sufficed that it taught the use of such components and so provided practical technical guidance. A method concerning the direct interaction of the elements of a data processing system (here: a server with a client for dynamic generation of structured documents) was therefore always technical, irrespective of whether the form it took in the patent application was characterised by technical instructions.
Such a method was not a non-patentable computer program for a data processing system. The Court cited its settled case law establishing that an application whose subject-matter was a computer program or a method carried out by a data processing program, in addition to the technical character essential for patentability, had to contain guidance on carrying out the invention which provided the solution to a specific technical problem by technical means. In the case at hand, the Court added that a problem could be considered solved by technical means not only where system components had been modified or addressed in a novel way. Instead, it sufficed that operation of the data program used to solve the problem was determined by technical factors external to the computer or that the solution itself lay in structuring the program in such a way that it took account of the technical features.
FR France
Paris District Court of 20 November 2007 (01/11641) - Infomil v Atos
Keyword: patentability - computer-implemented inventions - inventive step - skilled person
French patent No. 97 08712 related to a computer-implemented business method and specifically to a "device, method and computerised cashing system for automatic delivery of commercial advantage coupons". The company holding the patent manufactured and sold computer systems which allowed supermarkets to provide their customers with discount coupons printed on sales receipts. On learning that competitor companies were selling a similar system, the patent proprietor sued them for infringement.
The allegedly infringing companies responded by filing for revocation of the French patent. Their initial case was that the invention was not patentable (Art. L. 611-10 French Intellectual Property Code) because it was purely economic and commercial in nature and lacked any technical character. They maintained that the patent concerned the protection of the content of stores' client, criteria and advantage files.
The petition for revocation on the basis of lack of patentability was, however, dismissed by the Paris District Court, which considered that the patent protected a process and a device that described a computer system. This structure, integrated in a cashing system, allowed, by comparing the data in various predefined files, discount coupons to be printed on customers' sales receipts. The judges held that this structure was not excluded from the scope of patentability, even though the result of the invention was to provide "a commercial advantage and to play a role in a store's marketing".
The allegedly infringing companies then maintained that the patent was invalid for lack of industrial application, lack of novelty and insufficiency of disclosure. The District Court held that these conditions were met, and summarily dismissed these petitions.
Finally, the defendants argued that there was a lack of inventive step. The prior art taken into consideration was the European patent Catalina (EP 0 512 509), filed on 6 May 1992. The District Court considered that the structure protected by the French patent was the same as that of the European patent Catalina. The innovation contained in the French patent, i.e. to "allow the personalisation of different kinds of coupons, by registering the payment and the commercial advantages and by then issuing several kinds of coupons" involved no inventive effort. This solution was evident to the skilled person, who would only have to "program this characteristic in the content of one of the existing files to bring about this improvement". The prior art suggested the invention and the French patent was therefore revoked in its entirety for lack of inventive step.
FR France
Paris District Court of 19 March 2010 (08/01998) - Exalead v Sinequa
Keyword: exceptions to patentability - computer-implemented inventions - search tool
Company E was the proprietor of a European patent for a search tool and process allowing the user to navigate freely between categories and keywords in a user-friendly and transparent way. It brought an infringement action against company S in respect of the French part of the European patent. Company S asked the Court in particular to declare the invention in question to be non-patentable.
Company E submitted that there were basically two approaches when it came to existing search tools: as set out in the patent, there was the keyword approach and the fundamentally different approach of predefined categories.
Company S on the other hand argued that the patent in suit related to a search process devoid of all technical character, since it was implementable by wholly intellectual means, without requiring the implementation of any technical means whatsoever. It added that there was no technical difference between the notions of "category" and "keywords".
Putting the case for the patentability of what it considered to be an invention, company E explained that it solved a technical problem, namely how to obtain more relevant search results from a database. Company E also cited a communication from the EPO on the basis of which it had concluded that the EPO was inviting it to formulate a technical problem.
The Court held, contrary to what company E maintained, that the EPO had not raised objections solely with regard to novelty or inventive step but also with regard to the technical character of the invention presented to it, and therefore to its patentability.
The process consisted of a set of theoretical and abstract steps, without specifying the function and technical means allowing it to confer technical character. Since the search server did not suffice in the present case to confer a technical character on the subject-matter of the application, that subject-matter, as defined in claims 1 to 16, concerned a method of performing intellectual activities as such, despite the heading to claims 14 to 16.
The description of the claimed process merely set out the subject-matter, without specifying the technical means required for implementation. It only detailed the results and possibilities offered for the user, without mentioning the technical characteristics of the search engine itself. The process did not therefore constitute a patentable invention in the Court's view.
Consequently, and without there being a need to examine the arguments relating to the extension of the patent and lack of inventive step, all the requests were rejected and the French part of the patent was revoked.
GB United Kingdom
Court of Appeal of 27 October 2006 - Aerotel Ltd v Telco Holdings/Re Macrossan's Application [2006] EWCA Civ 1371
Keyword: computer programs - excluded subject-matter - methods for doing business
Two appeals concerning categories excluded from patentability under Art. 52 EPC, specifically computer-implemented inventions and business methods, were heard together before the Court of Appeal. Both inventions had been held to involve excluded subject-matter and so not to be patentable.
Aerotel's patent concerned a telephone system which enabled customers to pay in advance for calls that could later be made from any available telephone station. The patent was revoked in infringement proceedings. Macrossan's application concerned an automated system for acquiring the documents necessary to incorporate a company. The application was rejected by the Patent Office. The Court of Appeal allowed Aerotel's appeal but dismissed Macrossan's.
The Court of Appeal was bound by its previous decision in Merrill Lynch and so the 'technical effect' approach given there, albeit reformulated on the suggestion of the Patent Office, was applied. This consists of four steps: 1. properly construe the claim; 2. identify the actual contribution; 3. ask whether the contribution falls within the excluded subject-matter; 4. check whether the actual or alleged contribution is technical in nature.
Applying this test to the Aerotel patent, the Court identified the contribution as a new system, which was a physical device consisting of various components combined in a new way. This amounted to more than just a method of doing business as such and was clearly technical in nature.
The Macrossan patent application, on the other hand, was held to a be a method of doing business as such, being concerned with the business of advising upon and creating business documents which would otherwise have been dealt with by a solicitor or company formation agent. Moreover, it was for the running of a computer program and there was nothing technical about it beyond that.
The Court of Appeal considered the case law of the boards of appeal of the EPO and national courts in other European countries, but found the decisions of the boards of appeal mutually contradictory, revealing at least four different approaches:
1. the "contribution approach" (for which the Court of Appeal actually expressed a preference);
2. the "technical effect approach" (applied by the Court of Appeal in Merrill Lynch and thus binding in the absence of clear persuasive authority from the case law of the EPO);
3. the "any hardware approach"; and
4. the variations on the "any hardware approach".
The Court of Appeal considered a referral of this point of law by the President of the EPO to the Enlarged Board of Appeal to be desirable and even formulated possible referral questions.
Editor's note: see also Opinion G 3/08 of the Enlarged Board of Appeal dated 12.05.2010, OJ EPO 2011, 10.
GB United Kingdom
Patents Court of 25 January 2008 - Astron Clinica Ltd v Comptroller General of Patents, Designs and Trade Marks [2008] EWHC 85 (Pat)
Keyword: patentability - excluded subject matter - computer-implemented inventions
The appellant, Astron Clinica, had made a number of patent applications. In each case the examiner found method and apparatus claims allowable but reported that corresponding claims to computer programs were not allowable on the basis that they were prohibited by Art. 52 EPC.
Astron Clinica appealed against a decision of the hearing officer upholding the refusal to grant their patent applications relating to computer programs. The hearing officer found that the program claims were not allowable and that the patent applications could not be accepted in their current form. It fell to be determined whether patent claims could ever be granted for computer programs.
The appeal was allowed. The hearing officer's approach was considered wrong and the cases were remitted for further consideration.
According to Kitchin J, the approach to be adopted by the Patent Office and the Court was to:
(a) properly construe the claim;
(b) identify the actual contribution;
(c) ask whether it fell solely within the excluded subject-matter;
(d) check whether the contribution was actually technical in nature, Aerotel Ltd v Telco Holdings Ltd applied.
Claims to computer programs were not necessarily excluded by Art. 52 EPC. In a case where claims to a method performed by running a suitably programmed computer or to a computer programmed to carry out the method were allowable, then in principle a claim to the program itself should also be allowable. The claim would have to be drawn to reflect the features of the invention, which would ensure the patentability of the method that the program was intended to carry out when it was run, Oneida Indian Nation's Application considered.
GB United Kingdom
Court of Appeal of 8 October 2008 - Symbian Ltd v Comptroller General of Patents [2008] EWCA Civ 1066
Keyword: exclusion from patentability - computer-implemented inventions
The application at issue, entitled "Mapping dynamic link libraries in a computer device", had been refused by the Comptroller on the ground that it was excluded from patentability, being related to "a program for a computer ... as such". The Comptroller's decision was overturned by the High Court and the Comptroller appealed.
The Court of Appeal considered the general approach taken by the boards of appeal and the UK in cases in which it was contended that a patent application should be rejected on one or more of the grounds contained in Art. 52(2) EPC. Despite the deprecatory tone adopted in T 154/04 and Aerotel Ltd v Telco Ltd [2006] EWCA Civ 1371, concerning the approach adopted by the other tribunal, it seemed to the Court of Appeal that the approaches in the two cases, and indeed the majority of cases in the two jurisdictions, were capable of reconciliation. The third stage mandated in Aerotel ("whether the contribution falls solely within the excluded subject-matter") could amount to the same as that identified in T 154/04 (''whether the contribution cannot be characterised as technical"). The approach in T 1543/06 was also consistent with both Aerotel and T 154/04.
In the case before the Court of Appeal, the only real issue was whether the claimed technical contribution to the state of the art could be said to be the excluded subject-matter itself, or, to invoke the Aerotel approach, whether the claim failed at stage 3 or 4. Whichever way that issue was expressed, it was necessary first to identify the ambit of the exclusion of "programs for computers … as such" in Art. 52 EPC, an inherently problematic issue.
The Comptroller pointed out that there was no reference to any "technical" requirement in Art. 52 EPC and that the meaning and effect had never been explained by the boards. The Court of Appeal agreed that the stipulation of a requirement for a technical contribution could lead to a potentially dangerous exercise of asking whether an application satisfied that stipulation rather than whether it satisfied the statutory requirement itself - the danger being greater as the concept of a "technical" contribution was imprecise. But that did not mean the test was unhelpful or inappropriate. Given the lack of clarity in the concept of "programs for computers … as such", it was understandable, indeed desirable, that tribunals charged with applying that expression gave guidance as to its meaning. However, it was essential that such guidance should be clear: otherwise, it had all the disadvantages of the original obscure wording, with the added disadvantage of not even providing the actual legislative test.
Evaluating UK and EPO authorities to see if there was a consistent or predominant view of the scope of the computer program exclusion, the Court of Appeal found that recent decisions of the boards of appeal appeared to have adopted an analysis which appeared substantially more restrictive of the exclusion (T 931/95, T 258/03 and T 424/03). These decisions were rejected by the Court of Appeal in Aerotel. Three board of appeal decisions subsequent to Aerotel also appeared to support the approach disapproved of there (T 154/04, T 1188/04, and T 1351/04). This was no reason for the Court now to adopt this approach of the boards of appeal disapproved of in Aerotel.
Firstly, there was no decision of the Enlarged Board. Not only did this mean that the view of the boards was not as authoritative as it could be, it also suggested that the boards did not consider that the time had arrived for the point to be conclusively determined. Secondly, the approaches in the four decisions since Aerotel were not identical, one appearing more consistent with the view in Aerotel. Thirdly, if the passage in T 1351/04, "the claimed method requires the use of a computer. It is therefore technical in character and therefore constitutes an invention ..." represented the boards' view, the computer program exclusion might have lost all meaning. Fourthly, the English courts were not alone in their concern about the approach of the boards, as shown by the extra-curial remarks made by Judge Mellulis of the German Federal Court of Justice at a Symposium of European Patent Judges (Sept. 2006): "software is not patentable merely by virtue of being used in conjunction with a general-purpose computer". He also deprecated the use of the word "technical"; not least because, "when assessing software, as such, the program's interdependence with the technical device makes the technical content hard to deny". Fifthly, if the Court of Appeal were seen to depart too readily from its previous approach, it would risk throwing the law into disarray.
Applying these principles to the case at issue, the Court of Appeal found that, in deciding whether the application revealed a "technical" contribution, the most reliable guidance was to be found in T 6/83, T 208/84 and T 115/85 and Merrill Lynch's Appn [1989] RPC 561, and Gale's Application [1991] RPC 305, 323. It would be dangerous to suggest that there was a clear rule available to determine whether or not a program was excluded by Art. 52(2)(c) EPC. Each case had to be determined on its particular facts and features.
The Court thus dismissed the appeal, finding that the claimed invention did indeed make a technical contribution. It did not embody any of the items specifically excluded by other categories in Art. 52 EPC. More positively, the instructions could be said to "solve a 'technical' problem lying within the computer itself". The fact that the improvement might be to software programmed into the computer rather than hardware forming part of the computer could not make a difference. A computer with this program operated better than a prior-art computer. Nor was there a basis for holding the contribution not to be technical, given that the contribution in the two claimed inventions in T 6/83 and T 115/85 was held to be technical.
B. Exceptions to patentability
1. Breaches of "ordre public" or morality
DE Germany
Federal Patents Court of 5 December 2006 (3 Ni 42/04) - Neural progenitor cells
Keyword: patentability - exceptions - "ordre public" or morality - stem cells
The defendant Brüstle, a stem cell researcher, was the proprietor of a German patent for "neural progenitor cells, methods for producing them and their use in the therapy of neural defects". Claim 1 of the patent covered isolated, purified progenitor cells with neuronal or glial properties of embryonic stem ("ES") cells comprising no more than 15% primitive embryonic cells and non-neuronal cells and obtained in several stages: cultivation of ES cells into neural progenitor cells, proliferation of those latter cells in a serum-free medium containing a growth factor, purification and isolation. The ES cells were derived from germ cells of the group comprising mice, rats, hamsters, pigs, cows, primates and humans. The claimant Greenpeace contended that the patent was invalid because it constituted a breach of ordre public and morality in so far as the claims were directed to neural progenitor cells derived from human ES cells.
Whilst, as a general rule, the review of a patent's validity in revocation proceedings was based on the law applicable at the time of grant, which was generally that in force on the date of filing or date of priority, this did not apply where revocation was sought on the ground of non-patentability due to a breach of ordre public or morality. In the Court's view, this followed from the spirit and purpose of this exception to patentability. Unlike the other grounds for revocation, it did not relate to the invention itself or its technical examination under the law applicable at the filing or priority date, but rather to its use after grant.
In the Court's view, the patent in question expressly claimed human embryos as starting material for ES cells. Therefore, this was not merely a hypothetically possible use of the invention, which could not be imputed to a defendant to his detriment, but rather an intended use specifically mentioned by the defendant himself. It would run counter to the spirit and purpose of the exception to patentability under § 2 German Patents Act to disregard the patent proprietor's stated intention as to use and, in view of the permissible use with animal ES cells or human embryonic cells, deem the invention patentable in its entirety, including that part not in keeping with ordre public and morality.
§ 8(1) German Act on the Protection of Embryos defined embryo for the purposes of that legislation as, inter alia, any totipotent cell derived from an embryo which was capable of dividing and developing into an individual if the additional conditions were met. The Court stated that, according to the information in the patent specification, pluripotent stem cells were progenitor cells which could differentiate into a wide variety of mature cell types. It was already doubtful whether the claims even met the requirement of original disclosure and whether, at the date of filing, the skilled person would have understood the exclusive reference in the patent to totipotent stem cells to include pluripotent stem cells. Not only were the stem cells in question described exclusively as totipotent throughout the patent, but the wording used in the patent to set out the underlying definitions also distinguished expressly between pluripotent and totipotent. A way of producing human ES cells on the basis of which the skilled person at the date of filing could have identified which stem cells might have been intended for use according to the patent was not indicated.
However, the Federal Patents Court found that this question could remain unanswered for the purposes of ruling on the action for revocation because, irrespective of whether the stem cells were totipotent or pluripotent or whether ES cell lines were used, embryos always had to be used to derive them at the date of filing. The defendant had failed to persuade the Court, and it was not otherwise apparent, that there had been any fundamental change in this respect at the time of ruling. The Brüstle patent was therefore revoked.
Editor's note: On appeal, the German Federal Court of Justice decided on 17 December 2009 to refer questions to the Court of Justice of the European Union concerning the interpretation of, in particular, the concept of "human embryo" which was not defined in Directive 98/44/EC on the legal protection of biotechnological inventions. The question was whether the exclusion from patentability of the human embryo covered all stages of life from fertilisation of the ovum or whether other conditions had to be met, for example that a certain stage of development be reached.
On 18 October 2011, the Court of Justice of the European Union issued its decision in Oliver Brüstle v Greenpeace e.V. - Case C-34/10, thereby establishing the exclusion from patentability of the human embryo at all stages of life from fertilisation of the ovum. In interpreting the concept of "human embryo" very broadly, the Court referred to the aim of Directive 98/44/EC, which was, according to the Court, to exclude the possibility of patentability in all cases where respect for human dignity could be affected. Accordingly, the term "human embryo" comprised any human ovum as soon as fertilised and totipotent, as well as a non-fertilized human ovum, which had been rendered totipotent by artificial means. As regards stem cells obtained from a human embryo at the blastocyst stage, the Court stated that it was for the referring court to ascertain, in the light of scientific developments, whether they were capable of commencing the process of development of a human being and therefore fell within the scope of the term "human embryo". Moreover, the Court refused patent protection for scientific research. Although the aim of scientific research should be distinguished from industrial or commercial purposes, when research using human embryos was the subject matter of a patent application, it was intrinsically linked with that patent. However, the Court made one exception: where therapeutic or diagnostic purposes useful to the human embryo were applied to it, for example to correct a malformation, the use of human embryos should not be excluded from patentability.
2. Medical methods
DE Germany
Federal Court of Justice of 19 December 2006 (X ZR 236/01) - Carvedilol II
Keyword: patentability - exceptions - method for treatment - administration of a substance
This case concerned patent claims containing, in addition to features of the drug to be administered (Carvedilol) and the indication (congestive heart failure), instructions on the manner of administration (incl. once daily for 7 to 28 days with increases in dosage up to a maximum). The Federal Patents Court had granted an application for revocation. On appeal to the Federal Court of Justice, the patent proprietor defended the patent in an admissible limited form.
However, the Federal Court of Justice held that the subject-matter of the patent as defended was not patentable. The administration of a medicinal product designed to treat a particular illness was, as such, a treatment of the human body by therapy. It was not part of preparing a substance for use in treating an illness. Determining a suitable individual plan for a patient's therapy, including the prescription and dosage of medicine, was a typical feature of a doctor's activities and therefore a process excluded from patentability under Art. 52(4) EPC and § 5(2) German Patents Act. Although a use claim might be granted for the preparation of a particular substance to treat an illness in accordance with instructions inserted as a patient information leaflet or printed on the packaging, that did not mean that a mere recommendation as to the dosage was patentable in isolation from the substance preparation. The Court held that, where a non-patentable dosage recommendation was one of several features of a patent claim, it could not at any rate be taken into account for the purposes of assessing novelty and inventive step, but it left open whether a patent claim including such a recommendation was non-patentable in its entirety (in contrast to EPO case law).
However, there was no doubt about the admissibility of the patent claims according to auxiliary request 2, directed to the protection of the use of a chemical substance (suitable pill sizes) for the treatment of the human body by therapy. These claims were not precluded by the exception to patentability for methods of treating humans or animals by surgery or therapy.
Novelty:
In the circumstances of the case, patentability could only be based on the specific purpose of reducing mortality by using the substance known as a medicinal product (Carvedilol) in combination with the likewise known standard therapy using the three other named medicinal products in the known field of application (treatment of heart insufficiency). The Court already doubted whether the teaching could be considered novel on the basis of that intended purpose. Also, novelty was a normative term of patent law. It was thus irrelevant whether, in medical jargon, the term "medical indication", which did not appear in the EPC, was also defined by the therapeutic aim of a particular course of treatment and not only by the illness and that treatment. In accordance with the spirit of Art. 54(5) EPC, the decisive factor was whether the use of the substance in a method referred to in Art. 52(4) EPC was not comprised in the prior art. Having regard also to the purpose of that provision, there was no immediately apparent reason to consider that this requirement could have been met by other, as yet unknown, further therapeutic uses to treat the same illness.
Inventive step:
Numerous publications showed that the use of Carvedilol had been discussed as a promising course of therapy in treating heart insufficiency with beta blockers, precisely because of its vasodilatory properties. In any event, the proposal to prepare the medicine for administration according to the dosage plan in the claims of auxiliary request 2 did not involve an inventive step. A gradual increase in the dosage of beta blockers, and especially Carvedilol, to treat heart insufficiency in doses and periods differing at most slightly and at any rate obviously from the defendant's dosage plan was also established in the prior art.
DE Germany
Federal Patents Court of 6 March 2008 (21 W (pat) 45/05) - Method for evaluating state of health
Keyword: exceptions to patentability - diagnostic method
The technical problem to be solved by the invention in question was to provide a method and device enabling a person to evaluate his state of health and a computer program enabling a user to examine his state of health and make at least a preliminary diagnosis with a view to preventing illness or detecting it at an early stage. The applicant for the patent took the view that the method claims according to the main request and auxiliary request 1 did not concern a method of diagnosis and that, as a whole, the subject-matter of those claims was new and inventive. He therefore sought annulment of the German Patent Office examination section's decision.
The Federal Patents Court ruled that the action failed on the merits because the methods claimed were non-patentable diagnostic methods:
Diagnostics involved methods carried out on the living bodies of humans or animals for medical purposes to help identify, localise or exclude pathological conditions, the results of which methods could provide a basis for subsequent therapy. Given that many illnesses only manifested themselves in the form of non-specific symptoms, doctors attempted to limit the number of possible diagnoses by a process of elimination through further tests, the first step being to try to exclude those illnesses posing an acute threat to the patient's life. This meant that, where there were only few or unclear results, the evaluation of those results or of the symptoms could only provide a very general picture of the condition or else lead to several potential diagnoses. Attributing results to a specific disease by way of diagnosis therefore ranged from clearly identifying a particular condition and ruling out some conditions to ascertaining that a patient was not healthy without being able to attribute the result to a particular disease. Developing on the case law of the Enlarged Board of Appeal, the Federal Patents Court therefore divided the process of diagnosis into the following steps:
(i) testing coupled with collection of data, (ii) comparing that data with standard values, (iii) ascertaining, on the basis of that comparison, any deviation, (iv) interpreting the deviation as a pathological condition. A method for health evaluation claiming the above steps fell within the scope of the exception to patentability in § 5(2) German Patents Act (old version).
There was already a pathological condition within the meaning of step (iv) if, on the basis of the data gathered, the method showed an abnormal condition in the sense of "not healthy" as compared with the standard values. A doctor did not have to be involved, and so even automated methods or methods of self diagnosis might fall within the scope of the exception to patentability. The requirement that the diagnostic method be carried out on the "body of humans or animals" could already be regarded as met if step (i) alone was performed in this way.
DE Germany
Federal Court of Justice of 31 August 2010 (X ZB 9/09) - Image supported catheter navigation
Keyword: exceptions to patentability - surgical methods
The invention concerned a method for image-supported, selective navigation of a medical instrument invasively inserted as a catheter into a hollow organ of a human or animal body to a pathological site in that organ. The Federal Patents Court had classed the insertion of a catheter as a method for treatment of the human or animal body by surgery and so excluded it from patentability under § 2a(1), No. 2, sentence 1, German Patents Act.
The Federal Court of Justice held that the method was not subject to that exception to patentability because the selective navigation of a medical instrument invasively inserted as a catheter to a pathological site in a hollow human organ was not a feature of the claimed teaching. Neither the claims as worded nor the application as a whole were in any way dedicated to the procedure of the catheter examination itself, but rather depended on prior conduct of that examination as a step outside the scope of the claimed subject matter. The imaging method was closely linked medically and technically to the prior catheter navigation, but that did not alter the fact that the claim objectively distinguished between it and the navigation procedure.
In this, the method at issue differed from that concerned in the first head note of the EPO Enlarged Board of Appeal's decision of 15 February 2010 in G 1/07. That decision dealt with a magnetic resonance method for imaging the pulmonary and/or cardiac vasculature which entailed the delivery of polarised Xenon, inter alia by injection to a region of the heart. This measure, which the Enlarged Board of Appeal deemed a method of treatment of the human body by surgery, was an element forming part of the claimed imaging method and not, as in this case, a process outside the scope of such a method. The Court shared the view taken by the Enlarged Board of Appeal in G 1/07 that Art. 53(c) EPC precluded the patenting of surgical methods but not the patenting of processes which might be conducted in connection with such a method.
FR France
Paris Court of Appeal of 28 June 2006 (05/07852) - Lely v Delaval
Keyword: methods for treatment by therapy
By decision of 10 December 2004, the Paris District Court had rejected a request for revocation the French part of European patent EP 0 535 754, entitled "An implement for milking animals and a method of after-treating the teats of a milked animal". By decision of 21 February 2002, the EPO board of appeal had rejected company D's opposition to this patent.
Claim 11 protected a method of treating an animal's teats after milking using automatic milking apparatus. Company D sought revocation of this claim for lack of industrial applicability pursuant to Art. L. 611-15 and L. 611-16 French Intellectual Property Code on the grounds that the claimed process constituted a method for treatment by therapy.
However, the Court of Appeal considered that company L had rightly maintained that, even though the invention involved spraying a disinfectant agent to prevent disease, it was not a method for treatment of animals by therapy but an industrially applicable process allowing the animal to be milked in accordance with hygienic standards. This process therefore did not fall within the scope of Art. L. 611-16 French Intellectual Property Code.
FR France
Paris Court of Appeal of 13 June 2008 (07/12143) - K v. MTEC
Keyword: method for treatment by therapy
The European patent in suit concerned an electronic device for adrenergic stimulation of the sympathetic nervous system with respect to the venous media, and more particularly that of the smooth muscles of the vascular tissue, allowing flexible but reliable monitoring of the effectiveness of the treatment at the time of its administration.
Company M considered that the invention was not patentable as it had no industrial application within the meaning of Art. L. 611-10 French Intellectual Property Code, having regard to the exclusion of methods of treating the human body provided for in Art. L. 611-16 of that Code.
The Court held that the patent did not concern a method for treatment by therapy but a device which, though certainly intended to improve a form of treatment, defined the means of achieving said objective using a technical method, and that, irrespective of the likely benefit, the device did indeed have an industrial application.
FR France
Paris District Court of 6 October 2009 (07/16446) - Teva v Sepracor
Keyword: medicament - therapeutic application - sufficiency of disclosure - therapeutic effect
Company T brought an action before the Paris District Court against company S for revocation of the French part of EP 0 663 828 for insufficiency of disclosure; it did not disclose any experiment or plausible explanation that might demonstrate the alleged effects. Company S countered that company T's arguments were irrelevant in view of the absence of a requirement to prove or demonstrate a therapeutic result.
The patent concerned the use of levocetirizine in the manufacture of a medicament for the treatment of allergic rhinitis or allergic asthma. The Court noted that cetirizine was a chiral molecule that could exist in the form of two enantiomers. A chemical solution featuring two enantiomers of the same molecule in equal quantities was known as a racemic form (or racemate) and, as indicated in the patent description, the use of cetirizine in its racemic form as a medicament for the treatment of allergic symptoms had been known at the priority date. The patent therefore claimed to be based on the discovery that levocetirizine possessed better properties than the racemic form, and the patented invention lay in using levocetirizine at least as efficaciously as cetirizine to treat allergic rhinitis and allergic asthma, while significantly reducing a number of cetirizine-related side-effects.
On insufficiency of disclosure, the Court stated with regard to Art. 138 EPC that in the pharmaceutical field, sufficiency of disclosure for an invention relating to a medicament required the indication of pharmacological properties and one or more therapeutic applications.
In this case, the description disclosed the technical problem to be solved and the summary of the invention described the solution applied.
According to company S, the patent taught the use of levocetirizine for the preparation of a medicament intended for treating allergic rhinitis or allergic asthma. The Court held that the description did not provide any technical information in support of the statements made in the application. In particular, there were no experiments or plausible explanations to demonstrate the alleged effects establishing an actual inventive step on the part of company S. Moreover, company S had clearly not, at the filing date, performed any experiments or tests to demonstrate that levocetirizine was more efficacious (or caused fewer side effects) than cetirizine in its racemic form.
According to the Court, company S had therefore merely speculated on the pharmaceutical usefulness of one of the two enantiomers. Where sufficiency of disclosure was required by law, an inventor in the field of pharmacology was not obliged to demonstrate the result but had to indicate that the result had been researched into and did exist. The absence of any mention of research or a result was indicative of the application's speculative nature and concealed a lack of inventive step.
That was why company S had subsequently attempted to demonstrate the presence of an inventive step, stating that the skilled person thought that the enantiomers had the same disadvantages in terms of sedative effects as the racemate; it would thus not have been obvious for him to focus his research on the enantiomers of cetirizine instead of on the modification of the structure of cetirizine. The mere fact that company S's application taught the use of levocetirizine, an enantiomer of cetirizine, to treat allergies while reducing the latter's side-effects was proof of inventive step. The Court, however, found that the presence of an inventive step was not demonstrated by merely stating that the skilled person's most logical line of reasoning was not that which had been followed: there had to be a real invention, that is, a concrete technical solution had to be provided for a given technical problem, and that required at least a minimum of experimentation and testing, which was absent in the case in point.
Furthermore, the existence of WO-A-94/06429 - the disputed patent's "sister" application - indicated that, at the date these applications were filed, company S had no information that enabled it to determine which of the two enantiomers was the more efficacious (or caused fewer side-effects) or even if one of the two enantiomers was more efficacious (or caused fewer side-effects) than the racemic form.
The subsequent filing of experimental evidence could not remedy this deficiency. To decide otherwise would imply, on the one hand, that an idea or intuition could be patented and, on the other, that the recognition of subject-matter claimed as a solution to a particular problem could vary over time. This would contradict the principle that inventive step, like all other patentability criteria, had to be verified at the effective date of the patent.
Consequently, even if supplementary post-published evidence could also be taken into consideration, it could not serve as the sole basis for demonstrating the reality of the claimed inventive step. Finally, the Court pointed out that the tests submitted in substantiation of the two applications and those submitted in substantiation of the "sister" application were tests contained in a subsequent patent application for US 5,478,894, filed by a third party.
For all of these reasons, the Court granted the request for patent EP 0 663 828 in respect of all claims for insufficiency of disclosure.
C. Novelty
1. Defining the state of the art
AT Austria
Supreme Patent and Trademark Chamber of 28 April 2010 (OBp 2/09)
Keyword: novelty - availability to the public - public prior use
The invention in this case related to a free-flowing self-compacting drainage filling material. Prior to the application the material had been described in two test reports and submitted to various departments of the Municipality of Vienna. It had also been used on a number of test building sites. The claimant contested the novelty of the invention.
On the test reports:
Citing various commentaries as well as the case law of the German Federal Court of Justice and of the boards of appeal of the EPO, the Supreme Patent and Trademark Chamber clarified that knowledge was not deemed to be available to the public if it was known only to a restricted group of people by whom it was kept secret. The mere existence of an obligation to maintain secrecy was not in itself sufficient; crucially, the obligation also had to be respected. This usually had to be assumed, however, in the absence of any indications that the secrecy obligation had in fact been breached. An obligation to maintain secrecy could also stem from an implicit agreement. As a rule, such an agreement had to be assumed when several people or companies were involved in the development and testing of a new technical process because, in that case, all those involved had a shared interest in keeping the invention secret from third parties. The Supreme Patent and Trademark Chamber concluded that this was such a case.
On the test building sites:
A patent was made available to the public by use if said use gave an unrestricted group of people more than just a theoretical possibility of gaining knowledge of it. If the patent related to the composition of a product, a disclosure was novelty-destroying if the product as such was available to the public and could be analysed and reproduced by the skilled person. In contrast, the possibility of observing the new product made it available to the public (only) if a skilled person could identify the technical correlations from a mere visual inspection. The Supreme Patent and Trademark Chamber concluded that only a theoretical possibility of gaining knowledge existed in the case of filling material used on the building sites of a public contracting authority.
BE Belgium
Brussels Court of First Instance of 19 December 2008 – Lefebvre v Bogaert
Keyword: novelty – prior art disclosed on internet
L was the proprietor of a Belgian patent for a "thermodermal massaging and slimming device". This patent concerned a device which applied a procedure intended for physiotherapy that involved drawing up the skin while at the same time injecting into it a high-power red and infrared beam to bring about the lipolysis of fat in adipose tissue.
With regard to novelty, the Court noted that B asserted that the invention was not novel because several slimming applications based on the power of infrared rays were already in existence. In support of this assertion, B cited submission 13 of its file, comprising various web pages. The Court held, however, that these pages bearing the date of the printout – 9 May 2007 – did not allow the date of the invention and the date on which the machines were put on the market to be established with all certainty, so that anticipation of the patented invention was not proven.
Regarding industrial application, the Court noted that B further asserted that the patent was not valid because the invention as per L's patent application "concerned a machine for firming up the skin, improving the dermal blood circulation and reducing fatty deposits", while Art. 7 Belgian Patents Act ruled that methods of surgery or therapy could not be considered as being inventions susceptible of industrial application. In doing so, B had manifestly lost sight in the Court's view of the fact that the patent concerned the device and not the treatment that the device enabled.
DE Germany
Federal Court of Justice of 29 June 2010 (X ZR 49/09) - Traction unit for a drawing machine II
Keyword: state of the art - long stagnation of technology
The patent in suit concerned a traction unit for a drawing machine used for continuous metal drawing. To generate the high perpendicular pressure needed, the drive chains co-operated with (rigid) guides fitted along the traction segment within the oval formed by the surrounding roller chains. According to the description, various ways of preventing friction between the rigid guides and the surrounding roller chains were known, but were mainly designed to replace sliding friction with a revolving friction of a much lower value. To overcome this, the patent provided for load-bearing idle rollers between the chains and the (rigid) guides which, being linked to form a continuous (ring-shaped) chain, followed the movements of the drive chains and were interposed between the inner surface of the links and the rigid guides. At the lower instance, the Federal Patents Court had revoked the patent.
The Federal Court of Justice likewise held that the claimed subject-matter was not patentable, because it was not based on an inventive step. The Court did not share the defendant's view that the skilled person would not have consulted an application dated 1949 at the priority date if only because he would never have expected to find inspiration for a development in a document as old as that. Where the state of the art had stagnated for a long time before the priority date of a new invention, it depended on the specific circumstances of the individual case (here: long development cycles in the relevant technical field) whether or not that indicated that the new invention had been obvious to the skilled person in the light of the prior art.
Even if the steps introduced to the method stemmed from the prior art in a different technical field, the skilled person seeking to improve traction units for drawing machines at the priority date would have taken them into consideration. In view of his training and qualifications, he could be expected to take a systematic approach and not limit his research to the prior art in the directly related technical field but rather include prior art from a different field which, given the problems arising in that field, was likely to provide the kind of solutions he required, even if his requirements might indeed differ significantly in detail.
FR France
Paris District Court of 13 October 2006 (04/07666) - Asahi v General Electric
Keyword: novelty - implicit features
Company G was the proprietor of European patent EP 0 685 527 entitled "Thermoplastic composition comprising a compatibilized polyphenylene ether-polyamide base resin and electroconductive carbon black". Company A applied for revocation of the French part of the patent (all claims) owing to insufficiency of disclosure along with lack of novelty and inventive step. With regard to novelty, company A maintained that claim 1 was invalid for lack of novelty with respect to the teachings of the Japanese ISHIDA patent entitled "Electroconductive resin composition".
The Court pointed out that to impact on the novelty of an invention, the prior art had to be definite and complete, i.e. disclose all the invention's constituent parts, form, arrangement and functioning, with respect to the same technical outcome so that it could be implemented by the skilled person. It should not require interpretation. The Court added that if lack of novelty could be derived from something implicit in a prior-art document, the characteristics not expressly claimed should result unambiguously from the implementation of the document's teachings.
To show that this patent implicitly comprised the other characteristics of the claim of the contested patent, and in particular the volume resistivity and shock resistance, company A had various tests conducted. The Court held, however, that none of the tests conducted on the ISHIDA composition and process demonstrated the properties of company G's patent.
The Court consequently concluded that company A's claim that the ISHIDA patent destroyed the novelty of patent G, be it by elements implicit in the prior art document, was unfounded. However, the Court went on to revoke the French part of the contested patent in its entirety for lack of inventive step.
FR France
Court of Cassation of 7 October 2008 (07-17518) - SMCA v SAT
Keyword: novelty – state of the art – confidentiality clause
Company S, proprietor of a French patent, brought an infringement action against company T, which applied for revocation of the patent by way of counterclaim. The Court of Appeal had revoked the patent.
The Court of Cassation held that the Court of Appeal had established that, whilst the plans transmitted by company T were all marked as being confidential, the proposal of 21 October 1998, including the installation specifications, carried only a proprietorship clause, so the proposal could be taken into account as prior art in an assessment of the inventiveness of company S's patent. The Court of Appeal had thus made an independent assessment of the parties' intention, but without distorting Art. 1 of the general conditions of sale annexed to the proposal.
The Court of Cassation dismissed the appeal of company S.
IT Italy
Florence District Court of 29 December 2005 (17178/2005) - Barbieri v Bacci
Keyword: novelty – co-ordination of known elements - "translation" inventions
The novelty requirement does not involve originality and creativity to an absolute degree with respect to the state of the art. Novelty can also be present in an original and clever co-ordination of known elements and means resulting in a technically new and economically useful achievement (known as a combination invention), in a different and less expensive solution to technical problems previously resolved otherwise (improvement inventions) and in transferring a known principle or a prior invention to a different field or with a different end result (known as translation inventions). A translation invention is where the application of a known product or process to different products or processes produces new and unpredictable results, different from those which the prior invention involved.
The evaluation of a translation invention is based on an analysis of whether the combination of known elements and means consists in an original and clever contribution for the purpose of obtaining a new and economically useful result which had not been achieved before. The invention should contain quality features, i.e. an original step forward in technology, both with respect to the time of the intellectual creation and to the time of the practical transfer into an economic-industrial result. The translation of an inventive idea, a method or a product from its original technical field may lead to a patentable invention only if and to the extent that it results in a new and different achievement as compared with the one which can be achieved directly by applying the principles inferred from the prior art. It should therefore involve an inventive step for the purpose of overcoming technical problems implied in the transfer itself.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 9 December 2009 - Intervet v Merial
Keyword: inventive step - prior-art document
Merial's European patents (EP 1 281 760, EP 1 386 617) in the case at issue concerned the isolation of a new type of virus responsible for the breakout of the (by the 1997 priority date already known) weaning disease (Postweaning Multisystemic Wasting Syndrome, PMWS) in pigs. Intervet challenged the validity of the invention by reference to a prior-art document which allegedly disclosed the same insight.
Recognising the cited document as part of the state of the art, the Court held that the isolation of that new virus type lacked an inventive step. Although the requirements for the qualification for a new virus type as set out in the prior-art document were not clear-cut, the skilled person would feel stimulated to aim his research at the isolation of new variants instead of the known ones. Moreover, the Court could not share the view of the patentee that the isolation of a new virus as such was inventive. In support of its argument, the patentee relied on T 1231/01, which concerned a similar invention with a 1992 priority date. In that decision, the Board of Appeal had held the isolation of a specific virus strain as a component of a vaccine to protect pigs against the reproductive and respiratory syndrome to be inventive.
According to the Court, however, it could not be deduced from this decision that the isolation of a virus was unreservedly inventive. Rather, the assessment depended on the knowledge and the competence of the skilled person at the priority date. Due to the time difference of five years between the priority dates in the two cases and in view of the rapid development in the particular field, the skilled person in 1997 had significantly more knowledge and competence. In the present case, the prior-art document provided sufficient information and therefore enabled the isolation of the new virus type. This was also supported by the fact that, around the priority date, three other research teams had succeeded in establishing the DNA sequence of the virus.
NL Netherlands
The Hague Court of Appeal (Gerechtshof te's Gravenhage) of 13 July 2010 - Clyde Bergemann v Magaldi
Keyword: novelty - prior art - availability to the public - inspection of files
In appeal proceedings against the District Court's decision to dismiss an action for revocation of the patent, the patentee argued that a novelty-destroying letter in the grant file of another, previous application at the EPO was not prior art, because such grant files had not been digitally accessible at the 1990 priority date.
The Court of Appeal rejected this argument and revoked the patent. Grant files had been accessible at the priority date inasmuch as they could be requested or inspected by the public under Art. 128(4) EPC. The fact that the public could not know in advance what was in a grant file did not alter the fact that its content was publicly accessible. The situation was not comparable to that in T 314/99, in which the Technical Board of Appeal had held that an unpublished and not yet catalogued dissertation in a library was not prior art. Whilst the public could not be expected to go through the entire contents of a library for potentially relevant material, searching a grant file for relevant documents did not entail an insurmountable effort.
NO Norway
Board of Appeal of the Patent Office of 7 January 2010 (case no. 7886) - Laminaria hyperborea
Keyword: novelty standard - harmonisation with EPO standard
The case concerned an appeal from a decision of the Examining Division of the Norwegian Patent Office, by which a patent application had been refused for lack of novelty. The application concerned a soil fertilizer containing the giant kelp laminaria hyperborea. The closest prior art, D1, only disclosed the use of kelp in general, without disclosing any particular species. The question was whether the selection of one species of giant kelp could confer novelty on the application. The answer to this question would depend on the concept of novelty to be applied.
In Norwegian law, the novelty requirement has traditionally been understood as a requirement for a "reasonable technical difference" between the closest prior art and the invention. This is a stricter standard than that applied by the EPO, according to which an invention is only anticipated if all its features are directly and unambiguously derivable from a single citation.
The Board of Appeal stated that in previous times the application of a stricter novelty standard in Norway had been regarded as justified, but now two circumstances made it difficult to maintain this view. Firstly, Norway had acceded to the EPC on 1 January 2008. Secondly, reference was made to the judgment by the German Federal Supreme Court dated 16 December 2008 in the olanzapine case, in which the German concept of novelty had been brought into line with the standard applied by the EPO. Hence, if Norway were still to apply a stricter standard, this would deviate from a more or less generally accepted European practice. This would, in the Board's view, be contrary to the objective of Europe-wide harmonisation in patent law.
Therefore, the Board of Appeal abandoned the old concept of novelty and adhered to the EPO standard. As the selection of a certain species of giant kelp was not directly and unambiguously derivable from the closest prior art, the novelty requirement was regarded as fulfilled.
Editor's note: See chapter V. 2. on the olanzapine case.
2. Chemical inventions and selection inventions
CH Switzerland
Federal Court of 28 February 2007 (4C.403/2005) – Citalopram
Keyword: novelty – chemical invention – greater purity
The patent concerned the manufacture of citalopram – a substance used to treat depression – as a crystalline base with an extremely high degree of purity (over 99.8%). In the lower instance, the Zurich Commercial Court had found that claims defining the purity of citalopram, a known substance, did not disclose a new invention or achieve a previously unknown technical effect. The patent therefore lacked novelty and inventive step.
On appeal, the Swiss Federal Court noted first of all that the case law of the EPO boards of appeal could be drawn on where appropriate. The defendant (patent proprietor) therefore had no grounds for objecting to the lower court's reference to such case law, as long as it related to the interpretation of the EPC and was relevant to the case in point.
On novelty, it was common ground that citalopram, the chemical substance claimed in the patent as a crystalline base, was known as such to the public and could be carried out by the skilled person. The Federal Court held that persons skilled in the art of preparative organic chemistry viewed the further purification of compounds produced in chemical processes as common practice and would be aware of the methods conventionally used to achieve it. That was why, in the case law of the EPO boards of appeal, the manufacture of a known substance in an especially pure form was patentable only exceptionally, if conventional purification methods did not enable the skilled person to manufacture the substance with the degree of purity claimed (see T 990/96, OJ EPO 1998, 489). Only then could that degree of purity be considered to provide a new element over the prior art (see T 803/01).
In the present case, the chemical compound claimed was part of the state of the art and therefore, in view of general experience, already known in all degrees of purity. So the Federal Court ruled that the patentee had to prove in particular that the claimed degree of purity constituted a new element in the art, e.g. by showing that a special process was necessary to achieve that specific degree of purity because it could not be achieved by conventional means.
GB United Kingdom
House of Lords of 20 October 2005 - Synthon BV v Smithkline Beecham plc [2005] UKHL 59
Keyword: novelty - state of the art - chemical inventions - anticipation of chemical compounds
The House of Lords allowed the appeal from the Court of Appeal, thus restoring the decision of the High Court. This had found SB's patent (UK Patent no. 2 336 364) for a compound with improved characteristics used to treat depression invalid; matter contained in a prior patent application filed by Synthon had disclosed the existence of the very product which was the subject of the SB patent and the making of that product was enabled.
Lord Hoffmann, who gave the leading judgment, stated that, according to the law, there were two requirements for anticipation: prior disclosure and enablement. These were distinct concepts, each of which had to be satisfied and each of which had its own rules.
The matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That might be because the prior art disclosed the same invention. In that case there would be no question that performance of the earlier invention would infringe and usually it would be apparent to someone who was aware of both the prior art and the patent that it would do so. But patent infringement did not require that one should be aware that one was infringing. The prior disclosure had to be construed as it would have been understood by the skilled person at the date of the disclosure and not in the light of the subsequent patent (see T 396/89). It was the requirement that performance of an invention disclosed in the prior art had necessarily to infringe the patent which distinguished novelty from obviousness.
Enablement meant that the ordinary skilled person would have been able to perform the invention, which satisfied the requirement of disclosure. This applied whether the disclosure was in matter which formed part of the state of the art by virtue of s. 2(2) or, as in this case, s. 2(3) Patents Act 1977 (i. e. contained in another patent application subject to certain conditions).
Lord Hoffmann thus asked, "Did the Synthon application disclose an invention, which, if performed, would infringe the SB patent? Because it covered a class of chemicals defined by reference to a formula, it disclosed a myriad of compounds, each of which may be regarded as an invention. Was one of those the crystalline PMS claimed in the patent?" Lord Hoffmann found that, yes, the existence of PMS crystals of sufficient purity and their advantages for pharmaceutical use were clearly disclosed. Whether they could be made was a question of enablement, and also a question of fact. The judge at first instance had held that there was an enabling disclosure, a finding of fact with which an appellate court should be reluctant to interfere.
ES Spain
Barcelona Court of Appeal (Audiencia Provincial) of 18 October 2007 (appeal no. 116/2007) - LEK Pharmaceuticals v Warner-Lambert Company
Keyword: novelty - selection invention - technical opinion under Art. 25 EPC - atorvastatin
In the nineteen-eighties, the respondent WL developed new inhibitors of the enzyme involved in the initial stages of the biosynthesis of cholesterol, creating a series of compounds of a general formula I, protected in the USA and Europe. Later, WL devised a new improved process for obtaining the compounds of the general formula I, filing inter alia, on 22 February 1989, a European patent application, identified as D1, which led to the grant of European patent EP 0 330 172, published in Spain as ES 2 058 356. Finally, the respondent selected and developed from amongst these options atorvastatin calcium, protected by European patent EP 0 409 281 ('281), validated in Spain as ES 2 167 306. The appellant considered European patent EP '281 to be partially invalid for lack of novelty since the subject-matter of the claims in question already formed part of the state of the art at the date of priority of EP '281 (which was 21 July 1989), the earlier document being precisely WL's European patent application of 22 February 1989, described as D1.
Section 15 of the Barcelona Court of Appeal held that selection patent EP '281 was novel and did not depart from the general criteria on novelty developed by the EPO boards of appeal but rather gave specific form to them in what has come to be known as the "two-lists principle". Indeed, if the information conveyed by the earlier document to a person skilled in the art had to be sufficient to enable the latter, on the relevant date, to put into practice the technical teaching of the document, and in order that the implicit novelty-destroying teachings could be determined, it was essential that the later invention be immediately apparent to the skilled person, in other words that it could be inferred directly and unequivocally from the description as something of a certainty and an inevitable deduction. (According to T 677/91, "it is not sufficient for a finding of lack of novelty of claimed features that such features could have been derived from a prior document. There must have been a clear and unmistakable teaching of the claimed features"). The existence then of a significant number of options and alternatives for the skilled person did not imply that the selection made was not novel, since the product obtained was not derived in a clear and unmistakable way from the document but from the particular selection made a posteriori, given concrete form in something new that had not been described before. The more complicated the options for the skilled person encountering the earlier document, the less unequivocal and inevitable would be the conclusions reached.
The Court made it clear in its judgment that the complexity and extent of the range of options were at the heart of the double-list principle: the formal existence of two starting lists was not enough in itself. The more complicated the options for the skilled person confronted with the earlier document, the less unequivocal and inevitable the conclusions reached. The general principles with regard to sufficiency of description, with the focus on the complexity of the selection options, were also given concrete form by the EPO boards of appeal and in the Guidelines for Examination, which dealt specifically with selection patents (see T 12/81, followed by T 7/86). Board of appeal case law had already indicated that the later selection of a calcium salt of atorvastatin was novel. This view was shared by the EPO examining division in its opinion dated 19 October 2006, applying precisely the teachings of decision T 12/81. In the Court's opinion, there was no explicit description in D1 of either atorvastatin calcium or any salt of this compound. With regard to the possibility of an implicit description, meanwhile, the complexity of the options for the skilled person was, at the relevant date, sufficient to allow it to be said that obtaining a calcium salt of atorvastatin was not an inevitable deduction, a teaching that was immediately apparent, unequivocal and 100% certain. The Court pointed out that the concept of novelty had been dealt with in detail by the boards of appeal of the EPO. The criteria established, which were of course not binding on the judicial authorities of the EPC contracting states, since of a purely administrative nature, were nevertheless capable of illustrating, and providing guidelines for the interpretation of, key concepts in the EPC, which had proven to be undeniably useful for legal disputes like the present one, in which the validity of a European patent was under discussion.
Editor's note: see also judgments of 17 March 2008 (Laboratorios Cinfa, S.A. et al. v Warner-Lambert Company) and 30 October 2009 (Laboratorios Ranbaxy, S.A. et al. v Warner-Lambert Company), in which the Court declared the selection invention to be novel in the same terms.
FR France
Paris District Court of 20 February 2009 (05/12994) - Glaxo v Merck
Keyword: novelty – compound disclosed in prior art – "novel" degree of purity
The invention concerned an amorphous form of cefuroxime axetil, a procedure for its preparation, a composition containing it and its use in medicine. Company M contested the novelty of company G's impugned French patent with respect to the UK patent GB 1 571 683.
The Court took it as given that cefuroxime axetil and its use as the active ingredient in a pharmaceutical compound had been in the public domain since 15 February 2004. The description of the patent in question itself indicated that the processes involved in preparing cefuroxime axetil, cited by way of example in the UK patent, "produced [the matter] in relatively impure amorphous form or in the form of purer crystalline matter". The Court held that a new degree of purity could not confer new character on a known product once it had become accessible to the skilled person through the implementation of classic purification techniques.
Moreover, the Court stated that the US decisions obtained by company G in other proceedings did not support the novelty of claim 1 at issue in the present case.
As to whether the patent was valid as regards novelty, the Court therefore decided that claim 1 of the French patent, disclosing amorphous cefuroxime axetil, as contained in the prior art and differing only in terms of its degree of purity, should be revoked for lack of novelty on the basis that a new degree of purity did not make a known product patentable.
NL Netherlands
The Hague Court of Appeal (Gerechtshof te's Gravenhage) of 16 March 2010 - Aventis v Apothecon
Keyword: novelty - selection inventions - fexofenadine
The patentee filed an appeal against the District Court's decision that had declared its patent invalid. The European patent EP 0 639 976 at issue concerned the use of fexofenadine as a hay-fever inhibitor also for the treatment of hay-fever patients who also suffered from a liver condition. The use of chemical substances for the treatment of hay fever was already known. However, the claimed invention sought to avoid the side-effects of another hay-fever inhibitor, terfenadine, which induced heart failure in hay-fever patients with a liver condition. The patentee argued that the novelty of the claimed substance was based on a selection, the selection being the specific group of hay-fever patients with a liver condition.
The Court pointed out that, in accordance with established European case law, for a selection invention to be valid the selection could not be arbitrary. In this case, it was considered arbitrary because neither a surprisingly better therapeutic effect nor lack of a serious side-effect had been demonstrated. Given that the administration of fexofenadine did not cause heart failure either to hay-fever patients who suffered from a liver condition or to hay-fever patients without such a condition, the prevention of heart failure itself could not be regarded as a surprising technical effect of the claimed invention.
3. Novelty of use
AT Austria
Supreme Patent and Trademark Chamber of 28 September 2005 (Op 3/04) - Omeprazol III
Keyword: substance protection - Swiss-type claims
The contested patent concerned the use of new benzimidazoles (common name "omeprazole") to produce pharmaceutical preparations to treat gastric and duodenal ulcers and was drawn up in the form of a Swiss-type claim. In earlier decisions, the Supreme Court had held the patent to be invalid in infringement proceedings because the wording of the claims did not describe a specific process and so the claims fell under the substance protection ban for pharmaceutical products that existed at the time and was valid on the basis of an Austrian reservation (Austrian Supreme Court of 21.12.2004 - Omeprazol II; Austrian Supreme Court of 28.09.2004 - Omeprazol I).
In the present revocation proceedings, the Supreme Patent and Trademark Chamber decided that, as process claims for a specific use, Swiss-type claims were compatible with the substance protection ban. Such claims did not protect the pharmaceutical product as such, but rather a process for preparing a product, defined by the use of a specific active substance for a specific medical indication. The limitation to a specific medical indication precluded any monopolisation of the pharmaceutical product such as the substance protection ban sought to prevent.
According to the case law of the Austrian courts, the process for preparing a pharmaceutical product had to be "specific" to prevent any circumvention of the substance protection ban. A process which merely involved mixing would constitute such circumvention. However, the present Swiss-type claims did not concern a mere mixing process. This was because the measures necessary to prepare a pharmaceutical product for use in the treatment of illness (which have been called in German the "augenfällige Herrichtung"), such as formulation and dosage of the active substance and appropriate packaging of the product, could not be equated to a mere mixing process. Such measures were not trivial, but derived from the relevant medical indication and served to implement the consequent limitation of the scope of protection. The fact that they were not set out in detail in the patent claim did not mean that the method was not specific; there was no need to include them because they were already known to the skilled person.
AT Austria
Supreme Court of 9 February 2010 (17 Ob 35/09k) - Isoflavone
Keyword: substance protection - Swiss-type claims
The patent contained a use claim (Swiss-type claim), namely for the use of an isoflavone phyto-oestrogen extract for the manufacture of a pharmaceutical product for the treatment of specific illnesses and complaints. The patent proprietor alleged that the defendant distributed a food supplement which, according to the description, was intended to alleviate similar complaints owing to the isoflavone content.
The Court considered that the claim at issue concerned purpose-limited substance protection for use in a method of therapy (Art. 54(5) in conjunction with Art. 52(4) EPC 1973). As novelty was established here by the effect of the substance (indication of medical purpose), patent protection extended only to products suitable for the stated purpose. The intended use ultimately restricted the scope of the patent such that the proprietor's monopoly was limited to acts relating to the manufacture and use of substances of the same composition and intended purpose as pharmaceutical products in the area of the claimed indication.
A reasonable yardstick was needed in practice to assess whether the purpose pursued and achieved was the one specified in the patent or something else. The mere fact that a drug was - also - suitable for the purpose stated in the patent in suit did not mean that it was also geared to such a use (in terms of dosage, formulation, preparation and packaging). Use of the teaching protected in the "purpose-related claim" also meant that the purpose inherent in the invention had to have been achieved to a practically significant extent in terms of the actual aim of the patented teaching.
GB United Kingdom
Patents Court of 12 October 2007 - Teva Pharmaceutical Industries Ltd & Teva UK Ltd v Merrell Pharmaceuticals Inc, Aventis Inc & Sepracor [2007] EWHC 2276 (Ch)
Keyword: novelty of use - second medical use - Swiss-type claims - fexofenadine
Merrell held a patent for terfenadine, an antihistaminic drug with the generic name fexofenadine which, when administered through the stomach, produced an acid metabolite inside the human body without causing the usual drowsiness or cardiovascular side-effects.
Aventis and Sepracor owned two other patents which related to the use of fexofenadine rather than terfenadine to make a medicament for use as an antihistamine to treat allergic symptoms.
The generic pharmaceutical manufacturer Teva, which wanted to sell fexofenadine in the UK, sought declarations of invalidity before the Patents Court. Most of the claims in issue were Swiss-type claims.
Warren J granted Teva the declarations it sought, the patents being neither novel nor inventive. It was common general knowledge at the priority date that fexofenadine provided most, if not all, the pharmaceutical effect in its use as an antihistamine. There was nothing to prevent the testing of fexofenadine as being something worth trying with a good prospect of success. Therefore, the fexofenadine medicaments could not be said to be novel and belonged to the state of the art.
In his decision, Warren J performed a close analysis and evaluation of technical evidence and helpfully summarised the current status of Swiss-type claims in the EPO and UK practice as follows:
- It is possible to obtain a patent for the first medical use of a known substance or composition, where this substance or composition was not previously known to have any medical application.
- The EPO practice has accepted, on policy grounds, the practice of the Swiss Federal Intellectual Property Office, according to which a European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application. This gave rise to the now widely used form of the second medical use, or so-called "Swiss form" claim (see G 1/83). Accordingly, a claim in the form: "Use of [X] for treatment of [Y]" would not be accepted, whereas a claim "Use of [X] for the manufacture of a medicament for treatment of [Y]" would be accepted. It might be noted that the feature supporting novelty and inventive step is the new treatment; nonetheless the Swiss-form claim itself covers the use in preparation of the medicament in question, not the use of the medicament for the novel therapy.
- The leading case under English law in relation to claims in the Swiss form is the decision of the Court of Appeal in Bristol-Myers Squibb v Baker Norman concerning a novel dosing regime rather than a new therapeutic application. In summary, the Court of Appeal held that, in so far as Swiss-type claims were permissible at all, they must be limited to a therapeutic application which was not only inventive but new; novelty must reside in the new second, or subsequent, therapeutic use. In other words, the novelty must lie in a new application (i. e. the known compound is to treat an additional disorder or prevent a disease rather than cure) not in an improved use in the method of administering an existing treatment.
Warren J took into consideration the defendants' observations that the EPO technical board of appeal had recently interpreted G 1/83 differently from the Court of Appeal in Bristol-Myers and expressly declined to follow it. They argued before Court that the English law was now out of step with the EPO and suggested departing from the previous case law, in the light of the observations of the House of Lords to the effect that even decisions of the EPO, and a fortiori of the technical boards of appeal, were to be regarded as of great persuasive authority.
However, Warren J did not consider that it was open to him to depart from the decision in Bristol-Myers, this being a carefully considered and argued decision of the Court of Appeal. It was for that Court to consider whether its earlier decision should be departed from in the light of developing case law in the EPO.
GB United Kingdom
Patents Court of 30 June 2008 - Actavis Ltd v Janssen [2008] EWHC 1422 (Pat)
Keyword: novelty - second medical use
The defendant, Janssen, was the proprietor of European patent EP 0 334 429 concerning an invention relating to a medicament potentiating the effects of blood pressure reducing agents. Actavis attacked, largely successfully, the patent's validity on the grounds of, inter alia, lack of novelty.
The Court found that an earlier patent of the patentee anticipated several of the claims in the patent at issue. Referring to the recent review of the law of novelty in Synthon v SmithKline Beecham [2006] RPC 10, the Court applied the principle that the matter relied upon as prior art had to disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. The Court interpreted that as meaning that it should be concerned to establish what, on the balance of probabilities, would in fact occur. That led to the conclusion in this case that such an infringement would necessarily occur.
The patentee, relying on G 2/88, had argued that a claim could validly cover the use of a known compound so as to produce a hitherto undiscovered technical effect and that for claims of this kind it did not matter that the technical effect was inherent in the use of the compound to produce the known technical effect. In G 2/88 the technical feature of the claim (actually achieving friction reduction) was inherent in the old use and an inevitable result of pouring the additive into the engine. Yet this technical feature was held not to have been made available to the public. Janssen claimed that this was no different from the new medical treatment cases. No doubt when an old medicine (known for disease X) is found to treat a new disease, Y, it could be said that it was inevitable that some of the patients treated to date with this medicine for X might have had disease Y, and inherently been treated for it. Yet the novelty of purpose, using it for making a medicine for Y, was enough. That principle was now definitely part of UK law (see G 5/83; Wyeth v Schering [1985] RPC 545).
G 2/88 concerned the fate of claims directed to the use of a known compound for a new purpose based on new, undisclosed (yet actually achieved) technical effects. The claimed new purpose, friction reduction, was undoubtedly a different purpose from rust prevention, made possible by the new and different technical effect. The case before the Court was not easy to fit into that category.
According to the Court, if G 2/88 were correctly decided, then unadvertised technical effects which underlay new uses of known material would be an exception to the rule about inevitable results. However, there were signs that courts in the EPO and the UK were taking a limited view of what G 2/88 had decided. Cases T 958/90 and T 279/93 also showed that the EPO had come to appreciate the distinction between true new uses and cases of mere more information about old uses. In the former, the board of appeal concluded that the new information in the patent merely provided "an additional reason to use the known mixture in the known way for the known purpose" and thus made no contribution to the state of the art.
The Court concluded that merely explaining the mechanism which underlay a use already described in the prior art could not, without more, give rise to novelty. In G 2/88, the technical effects which underlay the new and old uses were different and distinct. It was not the case that every discovery about the mode of action of a drug could be translated into a new purpose and claimed as such.
It was also shown that the subject-matter of several claims had been anticipated by being shown at a scientific conference. Thus, the majority of the claims in the patent were held void for lack of novelty, only one remaining valid.
D. Inventive step
1. Assessment of inventive step
CH Switzerland
Berne Commercial Court of 6 July 2005 (HG 03 9024) – Stop element holder III
Keyword: inventive step - significant technical progress
In a case involving a dependent licence and alleged infringement of an older patent through use of a later one, the Court ruled that the later invention had to constitute significant technical progress over the earlier one. Quite what that meant was not clear from either the Swiss Patents Act or the historical documentation, but legal doctrine suggested that the later invention must give rise to a considerable technical improvement and thus significantly enhance the technical field. It did not however have to involve an actual technological leap. In line with German practice, a new teaching might be regarded as constituting technical progress if, for example, it provided a better way of doing something – in particular by making a process simpler, faster or just more reliable. Another possible criterion was that it solved a technical problem in an equivalent but different way – in which case however it could be regarded as a technical enhancement only if, in the art, there was a perceived need for an alternative solution.
DE Germany
Federal Court of Justice of 12 October 2004 (X ZR 190/00) - Panel elements
Keyword: assessment of inventive step - skilled person - functional improvement of known elements
The patent concerned panel elements for wall and ceiling cladding and clamps used to fasten those panels together. In particular, it concerned the problem of how to achieve, as simply and cheaply as possible, varying widths of visible joints between such panel elements. Before the Federal Patents Court, the claimant had argued that the subject-matter of the patent was not novel and, in any event, lacked inventive step. The action was dismissed, but the patent was revoked in part, in so far as the defendant had failed to defend it broadly. On appeal to the Federal Court of Justice, the claimant maintained its claim for revocation of the patent in its entirety.
Like the Federal Patents Court, the Federal Court of Justice was not persuaded that the subject-matter as defended in the appeal proceedings was obvious to the skilled person in the light of the prior art and that no inventive step was therefore required to arrive at it. In particular, the known solutions in the prior art did not convey the idea of equipping the panels with a clamp - be it in addition to a tongue-and-groove joint, as in the patent, or in combination with a double-groove joint. As the name suggested, clamps were always described as a fastening component used to fix the panel elements to the underlying construction and not as a means of ensuring distance, i.e. as a component which the skilled person would have used only to set the width of the visible joint between two adjoining elements.
To arrive at the solution according to the invention, the skilled person therefore had to rethink the functions of the tongue-and-groove joint and the clamp. The former, in particular, lost its conventional purpose because the tongue was no longer inserted into the groove as it had hitherto been (albeit only approximately, in view of the expected wood swelling). In the absence of a specific suggestion to that effect, it could not be established that such a modified concept would have been obvious to the skilled person. Rather, an inventive step was involved if the skilled person had to modify the functions of known product components to produce a simpler structure and so save money, and there was nothing in the prior art to prompt such a modification.
DE Germany
Federal Court of Justice of 15 May 2007 (X ZR 273/02) - Papermaker's fabric
Keyword: inventive step - partial problems
The defendant was the proprietor of the German part of European patent EP 0 532 510. The invention was directed to a low-permeability papermaker's fabric consisting of woven, flat all-monofilament machine direction ("MD") yarns which did not use stuffer yarns or sacrifice strength or stability. The Federal Patents Court had partly revoked the patent. On appeal to the Federal Court of Justice, the defendant maintained its defence of the patent only as limited to claiming "a papermaker's fabric". The appeal was granted.
The Federal Patents Court had based the partial revocation of the patent on the view that the prior publication of a European patent application had disclosed that the proposed use of MD-yarn pairs resulted in a high level of lateral stability, which was identical to feature group 3 of the patent at issue, which group solved the "partial problem" ("Teilaufgabe") of sufficient strength and stability. In addition, the second prior-art document (a US patent application) had disclosed that fluttering of the paper sheet on the fabric with a low fabric permeability could be achieved using the weaving technique described, which solved the "remaining problem" ("Restaufgabe") in feature group 4 of the patent in question.
The Federal Court of Justice took a different view. It was not permissible, for the purposes of examining inventive step, to divide the subject-matter of the invention into separate groups of features forming "partial problems", so as to assess whether individual features or feature groups had, in themselves, ever been obvious to the skilled person in the light of the prior art. Rather, the legal question of whether the subject-matter was obvious in the light of the prior art at the patent's priority date had to be answered by reference to all of the solution features contained in the subject-matter as a whole and in terms of their technical relationship. As was the case in interpreting patent claims, it was also impermissible for the examination of inventive step to entail isolated comparisons of individual features or feature groups with the prior art, even where the inventive subject-matter could be divided up into "partial problems". Even then, therefore, the content of the teaching had to be considered as a whole.
DE Germany
Federal Court of Justice of 18 June 2009 (Xa ZR 138/05) - Fish-bite indicator
Keyword: inventive step - closest prior art
The patent concerned a fish-bite indicator, a device through which the line of a fixed fishing rod was fed and which indicated by means of a sensor signal that a fish had bitten. Devices were known in the prior art which could indicate the length of line which had been drawn out after a fish bite. According to the description, a shortcoming of such devices was that their sensitivity could not be adjusted to the fishing line's movements. At the lower instance, the Federal Patents Court had revoked the patent.
The Federal Court of Justice upheld that decision on appeal. The "closest" prior art could not always be taken as the sole basis for deciding whether patented subject-matter was obvious. Rather, the choice of starting point (or starting points) had to be specially justified, the basis generally being the skilled person's efforts to find a better or even simply different solution to a particular problem than that existing in the prior art. There was likewise no basis in the EPC for basing the assessment on the "closest" prior art alone.
DK - Denmark
Eastern High Court (Østre Landsret) of 29 August 2008 (B-3527-03) - Ranbaxy v Pfizer
Keyword: novelty - inventive step - prior art - atorvastatin
In the infringement proceedings pertaining to European patent EP 0 409 281 diveded to atorvastatin calcium ("salt patent"), the Court dealt with the validity arguments raised by the plaintiff with regard to novelty and inventive step. As background information to the case, it should be noted that the Danish Court had requested a technical opinion from the EPO on the basis of Art. 25 EPC in which the examining division confirmed both the novelty and the inventive step of the European patent at issue after comparing it to the prior art. The inventive step was equally confirmed by the board of appeal when examining the application for the salt patent.
On the question of novelty, the Court stated that the prior art, i.e. a Danish application for a process patent comprising the same salt, failed to emphasise certain salts as being particularly advantageous or to include instructions for the production of salts. Moreover, according to the information provided, there was no standard procedure for salt screening at the date of priority. For these reasons, the skilled person would have to make several selections and would not inevitably arrive at the atorvastatin salt. The fact that the enantiomer of atorvastatin was mentioned in the prior-art document did not lead to a different conclusion.
As to the aspect of inventive step, the Court observed several deficits in the prior-art document, i.e. the defendant's patent which was published at the time: it did not deal with the question of handling properties, including hygroscopicity and solubility; it provided no directions as to how the racemate of atorvastatin was to be modified to improve the handling properties; it included no information as to how any handling difficulties in respect of the compounds (sodium salt of the racemate of atorvastatin) were to be solved; and it included no incentive to modify the compounds comprised by the prior art. Furthermore, the document did not emphasise the calcium salt as particularly advantageous compared to other salts. Against that background, the salt patent was held to be inventive and valid. The fact that it was obvious to the skilled person at the date of priority to test the biological effect of the enantiomer compared to the racemate described in the prior art had no impact on the outcome.
FR France
Court of Cassation of 15 May 2007 (06-12487) - Lesaffre v Puratos
Keyword: inventive step - prior art - definition of precise proportions
Company P sought revocation of a patent held by company L relating to a "bread improver and process for use of same".
The appellate court had dismissed the revocation petition for lack of novelty on the grounds that the analysis conducted by the Spanish health ministry prior to authorisation, while setting out parts of the subject-matter of claim 1, did not constitute prior art because it was not accessible to the public. The appellate court revoked the eight claims for lack of inventive step. Company L lodged an appeal before the Court of Cassation against the judgment of the appellate court on the basis that the grounds were contradictory.
The Court of Cassation ruled as follows: Although the appellate court had established that the document setting out the analysis of a product already on the market was not part of the known state of the art at the time of filing of the patent application, it concluded that because the product itself was accessible, an analysis of it as conducted at the time, while not disclosed, would allow the skilled person to identify the constituent parts, and in particular to establish that fatty monoglyceride acids featured in its composition.
Furthermore, it was no contradiction that while a product known from the prior art did not teach the use of precise constituents (in this case saturated fatty monoglycerides), it did, however, disclose the use of fatty monoglycerides identifiable through analysis.
Finally, the appellate court had not ruled out in principle that the definition of suitable proportions of product constituents could constitute an inventive step but had established, with respect to claim 1 of the patent, that determining these proportions was just a question of technical skill, and, with respect to claim 2, that after some tests, the skilled person would clearly choose the most appropriate dosages to achieve a maximum technical result, from which the court had deduced that this definition was derived from execution operations alone, and excluded any inventive step.
The Court of Cassation dismissed the appeal lodged by company L against the judgment of the appellate court.
FR France
Paris District Court of 7 May 2010 (08/12537) - Hexal, Sandoz v Boehringer
Keyword: inventive step - additional effect
Company H initiated proceedings against company B for revocation of the claims in the French part of European patent EP 0 589 874 for lack of novelty and in any case of inventive step.
The Court began by noting various fundamental principles and definitions from the field of chemistry, in particular that enantiomers were a sub-category of stereoisomers and that a racemate was a mixture of equimolecular amounts of two enantiomers. The pharmaceutical properties of two enantiomers could differ significantly.
The patent indicated that a surprising therapeutic benefit had been found.
On the novelty of claim 1, the Court, after noting the conditions under which prior art is novelty-destroying, said it was common ground that one of the two cited items of prior art (two patents) disclosed the active ingredient as well as its use as a medicament for treating diabetes mellitus. The claimant companies argued that this citation also disclosed the means of obtaining the enantiomers of the racemates that it disclosed.
The Court pointed out, however, that neither of the two patents cited as prior art had examined the specific effect of enantiomer S(+) in relation to the racemate. It decided that since the invention had thus not been fully anticipated, the two citations were not novelty-destroying.
On inventive step in claim 1, the Court started by defining the skilled person in this case as one of a team of specialists and then went on to examine the prior art submitted for discussion. It stated that a study of the submitted literature available at the time the patent application was filed showed that the skilled person had been encouraged to study the action of each enantiomer of a chiral molecule used as a medicament; accordingly, the skilled person had no prejudice to overcome, as rather than dissuading him from studying every enantiomer the literature submitted by the defendant company had in fact urged him to do so.
Company B maintained that the use of repaglinide as an active ingredient suitable for the preparation of a drug for long-term antidiabetic therapy on account of its unexpected pharmacological properties was inventive.
The Court noted that an effect said to be unexpected could be regarded as an indication of inventive step. However, if, having regard to the state of the art, something falling within the terms of a claim would have been obvious to a person skilled in the art because the combined teaching of the prior-art documents could be expected to produce an advantageous effect, such a claim lacked inventive step, regardless of the fact that an additional effect (possibly unexpected) was obtained.
The Court held the additional and unexpected effect to be a mere "bonus" that occurred independently in the course of the studies suggested by the state of the art and as such did not confer an inventive character. Consequently, claim 1 of the contested patent was revoked for lack of inventive step.
GB United Kingdom
House of Lords of 14 October 2004 - Sabaf SpA v MFI Furniture Centres Ltd et al. [2004] UKHL 45
Keyword: inventive step - obviousness - Windsurfing approach - EPO Guidelines - more than one invention - aggregation of features
Sabaf SpA was the proprietor of patent GB 2 100 411 for a burner for gas cookers and hobs. The object of the invention was to provide a gas burner of very low height which could be used in hobs which had to be flat. This was done by enabling both the air intake and the Venturi effect - the conversion of kinetic into potential energy by virtue of slowing down a stream of gas in a specially designed tube - to take place above instead of below the hob.
The patent had expired in June 2001. Sabaf alleged that Meneghetti SpA had infringed the patent during its term by importing infringing products into the United Kingdom. Meneghetti counterclaimed for a declaration that the patent was invalid because the invention was obvious. The judge at first instance held that Meneghetti had imported the products but that the patent was invalid. The Court of Appeal held that the patent was valid but that Meneghetti had not imported the products.
The House of Lords held that the patent had always been invalid and that infringement was not established.
In its view, when establishing whether an invention is not obvious to the person skilled in the art (s. 3 Patents Act 1977), the Court first had to ask what the invention was, and in particular whether there was one invention or two or more inventions. The House of Lords referred to the EPO Guidelines (C-IV, 9.5 and Annex 2.1 of the December 2003 edition), which stated the principle upon which it was decided whether a single invention was being dealt with or not. Thus, if the two integers interacted upon each other, if there was synergy between them, they constituted a single invention having a combined effect and s. 3 Patents Act 1977 was applied to the idea of combining them. If each integer performed its own proper function independently of any of the others, then each was, for the purposes of s. 3 Patents Act 1977, a separate invention and the section had to be applied to each one separately.
The House of Lords held that the judge at first instance had applied the relevant principles correctly at each stage. He had found that the two features of the invention, namely taking the air above the hob and having a radial Venturi, had no effect upon each other and that he was therefore dealing with two alleged inventions, each of which had to pass the test laid down in s. 3 Patents Act 1977. He had identified the inventive step in each. He had asked himself what in each case were the differences between the relevant prior art and the invention and he had found that there were virtually none. He had concluded that it would have required no invention on the part of the skilled man armed with common general knowledge in the art to design a product in accordance with the alleged invention. In other words, the judge had applied s. 3 Patents Act 1977 according to the Windsurfing structure to each of the features alleged to constitute the invention.
GB United Kingdom
Court of Appeal of 20 May 2009 - Aerotel Ltd v Wavecrest Group Enterprises Ltd [2009] EWCA Civ 408
Keyword: inventive step - commercial use
The appeal was from a judgment of the Patents Court holding Aerotel's patent invalid. The patent had already expired and came from a different and seemingly long-gone era of telephone technology, the priority date being in 1985. The patent claimed a method of making a (prepaid) call.
It was not in dispute that the structured Windsurfing test as set out in Pozzoli v BDMO was helpful. It was also acknowledged that "when the application of a legal standard such as negligence or obviousness does not involve a question of principle but is a matter of degree, an appellate court should be very cautious in differing from the judge's evaluation" (Lord Hoffmann in Biogen v Medeva).
The appellant alleged four errors of principle by the trial judge; trivialising the problem of the prior art, misstating the inventive concept, disregarding the evidence of the experts, and using hindsight. There was also a general theme running through these - that the alleged invention had led to commercial success. The judge agreed that this could be a powerful indication of non-obviousness, but, referring to Haberman v Jackal, disagreed that this was so in the case before him. The priority date was in 1985 and the application was published in Europe in 1986 and yet no one was said to have used the invention until 1994, and then not by virtue of anything said or done by Aerotel. The judge found that Aerotel made money from the patent by litigation or the threat of litigation against users, principally in the US. This was unimpressive, for it was notorious that the US patent litigation scene had become immensely pro-plaintiff. Nor did the increasing business from 1994 in pre-payment telephone cards prove that the invention as disclosed in the patent was the cause of this business. Here the burden of proof lay with the appellant. If a patentee sought to rebut an allegation of obviousness by an assertion of commercial success of his invention, it was down to him to prove that the success was due to the invention. Where a number of other factors might explain the success, as here, unless he could show they were irrelevant, or largely so, he would not have proved what he needed.
Here that was particularly pertinent, given the long, otherwise unexplained, delay in any use of the invention. The adoption of pre-payment from the mid-90s was entirely ascribable to factors other than the invention - or rather, was not shown to be ascribable to the invention given the existence of other factors.
The judge also pointed out that all but one of the so-called problems of the prior art set out in the patent were not problems at all, but had either been solved by WATS (Wide Area Telephone Service), a system in use in the USA and forming part of the prior art, or were not proven and seemed improbable. The only problem unsolved was that of the difficulty of obtaining credit.
With that in mind, Jacob LJ considered the difference between the inventive concept and WATS (Windsurfing step 3) and the alleged errors of principle made by the trial judge. He found that the patent did indeed significantly overstate the problem of the prior art, it hardly being inventive to propose running a business by requiring cash up front for the services rendered. Nor had the trial judge misstated the inventive concept (he had taken it from the appellant's own expert). No error had been made in failing to conclude inventiveness having regard to the evidence as a whole. A different view might have been taken of this evidence if the invention had been shown to be commercially worthwhile in 1985. Finally, the submission that the skilled worker was being asked to improve WATS was hindsight had built within it the notion that the idea of pre-payment was inventive, which was not the case.
There had therefore been no error of principle by the trial judge and the appeal was dismissed.
GB United Kingdom
Court of Appeal of 31 July 2009 - Wake Forest University v Smith & Nephew [2009] EWCA Civ 848
Keyword: obviousness
The patent concerned a medical device described as an "apparatus for treating tissue damage" which related to the treatment of wounds that were unlikely to heal completely under conventional methods. The invention resided in the application of a pump creating a negative pressure. The Patents Court found the claim 1 relating to an apparatus comprising vacuum means for creating a negative pressure to be anticipated by Russian prior art, Bagautdinov. Wake Forest, the patent owner, appealed against this finding. Moreover, in the same judgment the Court considered as not obvious claim 4 relating to an apparatus that included flexible polymer sheet, claim 16 relating to cyclically operating vacuum means and claim 19 relating to cyclically operating vacuum means in particular ratio of duration.
The Court of Appeal found that the judge at first instance had been correct to hold that claim 1 was anticipated by the prior art. By contrast, the Court did not agree with the findings on the question of obviousness and found claims 4, 16 and 19 to be obvious.
The Court expressed the need for exercising caution before overturning a judge's finding. However, if a judge had adopted the wrong approach to obviousness, then the appellate court would have to form its own evaluation based on facts found by the judge at first instance or which appeared clearly in the documents or other evidence having been expressly mentioned in the judgment.
Although the Court did not find the application of the Windsurfing test - as restated in case Pozzoli - compulsory, it considered it to be a helpful approach. In the framework of this test, four steps had to be taken:
Step 1 included the assessment of the nature of the skilled person and common general knowledge. Step 2 required the definition of an inventive concept of the claim in question. Step 3 included the identification of the differences from the prior art. Finally, the aim of step 4 was to assess whether the differences required invention.
Anticipation:
The respondent, Wake Forest, suggested that claim 1 should have been taken in a rather less broad view and regarded it as contemplating only the means of maintaining negative pressure for a long time. The Court of Appeal found this construction not relevant to reverse the judgment of the first instance.
Obviousness:
One of the defences raised against the obviousness attack was the alleged risk of the Bagautdinov method. In particular, it was argued that Western doctors would consider it contrary to good practice.
In considering this question, the appellate court applied the Pozzoli test. Upon step 3, the difference from the prior art was defined as the use of adhesive film instead of Vaseline and a film. With regard to the question as to whether the above-mentioned replacement was obvious (step 4), Wake Forest argued that the use of an adhesive film would cause more pain upon removal than a film held down only by Vaseline.
Given that by 1991, the priority date of the patent, it would have been difficult to find non-adhesive films, the Court stated that claim 4 should be regarded as obvious.
This consideration was supported by the findings on the removal of an adhesive film. The Court found that there was nothing to suggest that an adhesive film would have any disadvantage in terms of ease of removal and comfort as compared with the alternative treatment of Bagautdinov. Moreover, there was nothing in the teaching of Bagautdinov that an adhesive film could not be used. Also, the judge at first instance had not considered the application of treatment for a certain group of patients for whom the use of adhesive film would not create more skin damage or patient discomfort. Finally, the judge at first instance had not taken into consideration the fact that the skilled person was already used to changing dressing facilitating the healing of a wound many times a day often causing some degree of pain. That meant that a skilled person would consider the use of adhesive film.
Moreover, the Court of Appeal recalled that the question at stake was not whether the methods of the patent were novel, but whether the change to the apparatus was obvious. Thus, the Court found irrelevant the fact that the patent was designed to apply negative pressure for a period of time longer than the one described in the prior art. In particular, this was irrelevant for the question of whether it would be obvious to use an adhesive film for precisely the same purpose and in the same conditions.
Finally, the court did not agree with the claim of Wake Forest that the skilled person would be deterred from implementing Bagautdinov because of the questionable quality of his paper. In particular, a skilled person would have seen 100% success in relation to the 170 patients referred to in the paper.
Although Bagautdinov did not teach using the negative pressure cyclically, the Court regarded both claims 16 and 19 as obvious. According to the judge, nothing prevented the use of an apparatus which as well as a perfectly conventional "on/off" switch had a cyclical function even if that function was not used in implementing Bagautdinov.
ES Spain
Barcelona Court of Appeal (Audiencia Provincial) of 30 October 2009 (appeal no. 56/2008) - Laboratorios Ranbaxy, S.A. et al. v Warner-Lambert Company
Keyword: inventive step - could-would approach
After the issue of the novelty of patent ES 2 167 306 (EP 0 409 281) (hereinafter "P 306"), the subject-matter of the proceedings before the Barcelona Court of Appeal was the invalidity of claims R1, R2 and R3 of patent P 306 due to lack of inventive step. The appellant pointed out the legal precedents of other states which had recognised the lack of inventive step of P 306.
The objective technical problem that P 306 sought to solve was that of obtaining hypercholesterolemic and hyperlipidemic compounds with improved handling properties, in particular improved solubility and hygroscopicity. The Court pointed out that the objective technical problem had not come up in P 633 (the document representing the closest prior art according to the application) nor was it mentioned at all in the prior art documents cited by the appellant's expert, which turned out to be relevant for determining the extent to which the skilled person would, when making a selection, be incited or prompted to arrive at the calcium salt of enantiopure atorvastatin. In principle, there was no doubt that the person skilled in the art would have been able to choose or select, from amongst all of the compounds protected generically by P 633, the atorvastatin racemate and then opt for the R-(R*,R*) isomer, but no certain proof had been provided that the skilled person would have opted for that alternative, from amongst all the possibilities from P 633 and the general knowledge available at the relevant date, as being the obvious solution to the technical problem presented.
An important element of the last step of the "problem-solution approach" was what was known in English as the "could-would approach", which meant that it was not enough that the average person skilled in the art could or might have opted for the solution proposed by the applicant for the patent; rather what mattered was that he actually would have made that choice. In any case, since the requirement of inventive step had to be assessed at the date of priority of the patent under examination, an ex post facto analysis of the state of the art, examining the latter by taking account of and with foreknowledge of the solution proposed by the invention, was inappropriate (the Guidelines for Examination C-IV, 9.10.2). It was also indicated that P 633 did not contain any information or teaching on possible problems relating to formulation or to the handling properties of the compounds it protected, nor on possible problems with the compound closest to the hemicalcium salt of atorvastatin, i.e. the sodium salt of racemic atorvastatin. Thus, said P 633 did not guide the skilled person towards solving a technical problem. The improved solubility and hygroscopicity of the hemicalcium salt of atorvastatin had already been demonstrated during the patent grant proceedings (see decision T 229/97). The advantages of the compound claimed by the patent had to be taken into account when stating the technical problem that was to be solved, according to EPO case law, which allowed consideration to be given to additional advantageous effects not mentioned in the application provided that they did not "change the nature of the invention", which would be the case if there were a technical link between the advantages and the original problem mentioned in the application (T 440/91 and T 1062/93).
The Court diverged from the criteria adopted by the judicial authorities of other states, which had not recognised inventive step for the patent in question – a situation still tolerated by the European patent system in its original and current configuration.
Editor's note: see also judgments of the same court of 18 October 2007 (LEK Pharmaceuticals v Warner-Lambert Company) and 17 March 2008 (Laboratorios Cinfa, S.A. et al. and Warner-Lambert Company).
IT Italy
Venice District Court of 14 July 2005 (7064/2004) - Stelplast v La Brenta
Keyword: inventive step - combination of prior inventions
Whereas the novelty requirement is deemed fulfilled whenever a product does not form part of the state of art at the filing date, the assessment of inventive step involves a different approach: the product can be distinguished from the state of the art insofar as it represents an "evident" development in the relevant field with respect either to the product structure or to the function to be performed by it (the two parameters – structure or function – on which the decision on the evidence is to be based are alternative and capable of supporting, by themselves, the evaluation of inventive step). Moreover, an inventive step cannot be established through the mere fact that a product combining the individual features of patents already granted has not yet been the object of a patent application; the combination of prior inventions does not preclude the risk that the invention may still be regarded as obvious. In fact, the prior art, when taken into account for the assessment of inventive step (and unlike what happens in the evaluation of novelty), should not be considered individually and separately but in the overall technical context at issue. This requires the expert who is called upon to assess the inventive step to be skilled in the technical fields of the combined inventions, so as to exclude obviousness in cases where the combination is, with regard to each component, the result of an intuitive activity at which no one would have arrived on the basis of reason alone.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 13 May 2009 - ratiopharm v Sepracor
Keyword: inventive step - enantiomers
The European patent in issue (EP 0 663 828) concerned the use of levocetirizine for treating allergic disorders such as hay fever, levocetirizine being one of the two enantiomers that composed the known hay-fever inhibitor cetirizine. According to the patentee, the use of the pure enantiomer should be regarded as inventive in the particular case because it was surprisingly as effective as the racemic mixture while producing fewer side-effects. The Court held that the skilled person had sufficient incentive to investigate the properties of the enantiomers. In this respect, the Court cited T 296/87 (OJ EPO 1990, 195), according to which the testing of the individual enantiomers was in general the obvious first step of research into the improvement of a drug consisting of enantiomers. The therapeutic application of an enantiomer as such was therefore obvious and the claimed invention lacked inventive step, irrespective of whether the application brought unexpected benefits.
2. Problem-solution approach
AT Austria
Supreme Patent and Trademark Chamber of 29 March 2006 (Op 5/05)
Keyword: inventive step - problem-solution approach
In this decision, the Supreme Patent and Trademark Chamber set out the fundamental criteria for examining inventive step. It pointed out that in considering inventive step, as distinct from novelty, it was fair to construe any published document in the light of subsequent knowledge and to bear in mind all the knowledge generally available to the person skilled in the art at the filing or priority date valid for the claimed invention. Assessment of whether the solution involved an inventive step had to be based on the specialist's knowledge and ability.
As a rule, in order to assess inventive step in an objective and predictable manner, the so-called "problem-solution approach" had to be applied. In this approach, there were three main stages: (a) determining the closest prior art, (b) establishing the objective technical problem to be solved, and (c) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person. "Obvious" meant that which did not go beyond the normal progress of technology but merely followed plainly or logically from the prior art, i.e. something which did not involve the exercise of any skill or ability beyond that to be expected of the person skilled in the art.
In this case, the objective problem was not what the applicant had originally identified as the problem in his application. The Supreme Patent and Trademark Chamber noted that such a reformulation of the technical problem on the basis of facts objectively established in the patent granting procedure at the EPO was admissible because any effect of the invention could be used as a basis for the reformulation of the technical problem, as long as said effect was derivable from the application as filed. The Supreme Patent and Trademark Chamber observed that this was in full accord with the practice of the Austrian authorities.
AT Austria
Supreme Patent and Trademark Chamber of 25 February 2009 (Op 6/08)
Keyword: inventive step - problem-solution approach
In this decision the Supreme Patent and Trademark Chamber summarised its case law on the assessment of inventive step.
An invention involved an inventive step if it solved a technical problem in a way that was not obvious to an average skilled person in the light of the closest prior art. "Obvious" meant that which did not go beyond the normal progress of technology but followed plainly or logically from the prior art (see above Supreme Patent and Trademark Chamber of 29.03.2006).
In order to assess the invention in an objective manner with a view to avoiding ex post facto analysis, the question of inventive step was assessed, in particular, on the basis of the problem-solution approach used by the EPO. According to this approach, when assessing inventive step, it was irrelevant whether or not a person skilled in the art would in principle be able to implement the measures described in the patent. The crucial question, rather, was whether or not he actually had reason to do so.
NL Netherlands
Supreme Court (Hoge Raad) of 15 February 2008 - Rockwool v Saint-Gobain
Keyword: inventive step - problem-solution approach - could-would approach
Rockwool's patent concerned a method for applying a wetting agent to stone wool in order to make it suitable for use as a substrate for breeding plants. The patentee appealed in cassation against the revocation of its patent by the Court of Appeal. The Supreme Court held that the Court of Appeal had correctly assessed inventive step by applying the problem-solution approach and dismissed the appeal.
The Supreme Court dealt with the question whether the claimed use was relevant for the assessment of novelty and inventive step. According to the Court, the starting point for the assessment of the validity of a process patent was the invention as described in the patent. The novelty and inventiveness of the product obtained by the process or its application were normally not decisive for that assessment, if only because a patent could be granted for a new method of obtaining an existing product in a more advantageous way. However, the novelty and inventiveness of the product or its application, provided they could be inferred from the patent, might, in some cases, be taken into account as a potential indication that the method was novel and inventive.
The Supreme Court also held that the degree of inventiveness could not be determined by searching retrospectively, with the knowledge of the patented process, for earlier disclosures to which that method could have been traced. In this respect, three questions had to be considered when assessing inventive step. First, whether the average skilled person would have identified the problem solved by the patented method. Second, whether he would have consulted the prior art publications with a view to solving that problem. Third, whether, using common general knowledge, he would (as opposed to could) have gone on to derive the patented method as an obvious solution from the then prior Art.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 26 January 2011 - Sandoz v Glaxo
Keyword: inventive step - problem-solution approach - could-would approach - bonus effect
Glaxo held a European patent (EP 0 416 951) pertaining to a combination of salmeterol and fluticason for the treatment of asthma and other respiratory disorders. Following the corresponding opinions of the English, German and Irish courts, the The Hague District Court invalidated the patent due to lack of inventive step, in the process elaborating on the application of the problem-solution approach.
During the proceedings, Glaxo advocated a different approach to assessing inventive step, not based on taking a single statement as the closest prior art, but rather on a consideration of the entire prior art, including synergistic effects and negative pointers towards fluticason and the combination. The Court dismissed that approach and aligned itself with the established case law in the Netherlands and the common practice at the EPO that, as a rule, applied the problem-solution approach in the assessment of inventive step. The Court made no exception here, the case being well-suited for the structured approach of the problem-solution approach. Therefore, in this case as well, a single statement should apply as the closest prior art. Any other prior art could be addressed when assessing the inventive step, firstly, to the extent that it could be considered as part of the common general knowledge and, secondly, to indicate the progress of the categories of patented asthma medicines. According to the Court, it remained to be seen whether the various approaches used in Europe for determining inventive step would still lead to different outcomes. To the extent that the method of assessment advocated by Glaxo conformed to the English state-of-the-art approach of Pozzoli/Windsurfing, the Dutch Court pointed out that the English judges repeatedly indicated that the "English" inventive-step assessment was not, in essence, different from the EPO approach and should not lead to different outcomes.
In endorsing the problem-solution approach, the Dutch Court supported the grounds of its judgment by making reference to the publication "Case Law of the Boards of Appeal of the EPO", 6th ed. 2010, the relevant decisions reported in it as well as the EPO Guidelines. In particular with regard to the third step of the problem-solution approach, the Court highlighted the importance of the could-would distinction and of avoiding an assessment affected by hindsight as endorsed in the Dutch case law.
As to the patentee's key argument that the patent contained a synergistic and therefore surprising effect due to the mutual interaction between the two components which resulted in a pioneering invention in asthma treatment, the Court refused to take such a "bonus effect" into account when assessing inventive step, because it arose effortlessly as soon as the average skilled person followed the clear path indicated in the closest prior-art document.
3. Skilled person
BE Belgium
Liège Court of First Instance of 6 December 2007 - Joskin Machines Agricoles v Veenhuis Machines
Keyword: definition of skilled person
The two parties to the case were companies which manufactured agricultural machinery, including machines for spreading and injecting liquid manure.
Company J brought an infringement action against company V and requested revocation of the Belgian part of its European patent EP 1 044 592.
Company V filed counterclaims, the main petition being that J's patent EP 0 520 974 be revoked. On an auxiliary basis it requested that the Court ask for an expert technical opinion from the EPO under Art. 25 EPC. In particular, the defendant (company V) refuted the inventive nature of the plaintiff's (company J's) patent.
The Court pointed out that an invention was inventive if it was not obvious to a person skilled in the art. That person was a normally qualified practitioner, i.e. of average intelligence, capable of solving problems that arose regularly in the technical field. In a ruling handed down on 10 February 1999, the same Court had defined the person skilled in the art as being "a notional person who must be a technician in the sector concerned, have a good knowledge of the technical field (i.e. be familiar with all the existing prior art), be sufficiently intelligent to arrive at certain developments that correspond to current problems in his sector, but not overly so; he would need no creative ingenuity, but sufficient insight to confront the current necessities not solved by a mechanical or stereotypical application of the usual techniques". The state of the art comprised everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the patent application (Art. 5(2) Belgian Patents Act).
The Court held that the documents filed in the present case led to the conclusion that the professional circles concerned had, for many years, been trying to solve the problem identified in all of these patents, including J's patent and V's patent in suit, namely that of cutting the fibrous material in liquid manure. This was an indication of inventive activity. Contrary to what the defendant was asserting, it was not so much the "scissor" technique which was being claimed by J as the inventive part of its machine, but rather the device put in place to obtain the cutting effect, which was in itself inventive and innovative. This effect was clearly described in the main claim of the patent. According to the Court, the conclusion had to be that although the previous patents were concerned with finding a solution for dealing with fibrous material in liquid manure, including a cutting effect, the technique used by J's invention to achieve this cutting effect was inventive. The Court held that the technique used by J was not obvious to a skilled person since it called for reflection on how best to obtain a scissor effect, what form that should take, etc.
As an auxiliary request, company V petitioned the Court to seek an expert technical opinion from the EPO. The Court regarded this petition as of little relevance to the settlement of the dispute. It also noted that the EPO had recognised the inventive step of J's invention and had granted it the patent sought.
CH Switzerland
Federal Court of 18 May 2005 (4C.52/2005) – Insert for a drywall
Keyword: inventive step – skilled person – problem-solution approach
With this judgment, the Federal Court confirmed its case law on obviousness:
Under Art. 1(2) Swiss Patents Act – corresponding to Art. 56 EPC – the patentability criterion of inventive step presupposed "non-obviousness". Inventiveness thus began beyond the area that lay between the known prior art and what the average skilled person in the relevant field, on the basis of his knowledge and expertise, could find and develop further. The crux of the matter was whether this skilled person, given all the part-solutions and individual contributions which make up the prior art, could reach the solution according to the patent with little intellectual effort or only with additional creative effort. The average skilled person was neither an expert in the technical field concerned nor a specialist with outstanding knowledge, mastering the entire state of the art, but a person with sound qualifications and sufficient practical experience in the relevant field.
Inventive step had to be assessed on the starting basis of the prior art objectively available at the relevant time. That had to be viewed as a whole - a "mosaic" as it were - but not as its individual parts. The usual starting point was the closest prior art, with more distant prior-art citations coming into play only if they suggested going in the direction of the claimed solution. All the publicly available teaching and prior art citations formed together the trove of technical expertise to be drawn on by a skilled person or team equipped with average talent to combine them into a solution. However, there was a limit to such combination of individual prior-art elements, i.e. where it would be an artificial ex post facto analysis in the knowledge of the claimed invention. Citations could be combined only if the prior art hinted at doing so.
The Cantonal Court had not defined the criteria for the skilled person, and its approach to inventive step was unclear. The Federal Court therefore set the impugned decision of the Cantonal Court aside and sent the case back for further processing, commenting that although the problem-solution approach used by the EPO boards of appeal was not the only admissible method, contestable decisions should include statements with regard to the prior art, the skilled person and whether or not the solution disclosed in the patent was obvious, because otherwise they could not be reviewed.
DE Germany
Federal Court of Justice of 7 March 2006 (X ZR 213/01) - Prepaid phone calls
Keyword: inventive step - skilled person
The patent concerned a method of processing prepaid phone calls. The specification referred to a method and system of such processing described in an earlier US patent specification which was based on special certifiable codes allocated to the caller on purchase of credits. The credits were stored in special central computers, allowing calls to be made from any private telephone. The specification of the patent at issue criticised as a drawback of that system the fact that those interested in using it had to go through a series of preparatory steps - usually via credit-card companies - to obtain user rights. According to the patent, the object of the invention was therefore to overcome the drawbacks of coin- and card-operated public payphones, whilst at the same time obviating the need first to contact phone and/or credit-card companies. In the Federal Patents Court the patent had been revoked.
The Federal Court of Justice, however, held that the patent was novel and inventive. Whether the subject-matter of an invention was obvious to the skilled person in the light of the prior art was a question of law to be answered by way of a critical assessment of the facts apt - be it directly or indirectly - to provide information on the prerequisites for arriving at the solution according to the invention.
The skilled person in question could not be equated with any real person. Indeed, inventions could not be assessed in a uniform manner so as to meet the requirements of legal certainty on the basis of an individual's knowledge and skills. Therefore, the courts used the thought processes, understanding and imagination of the skilled person to provide a reliable basis for reaching decisions in the light of the specialist knowledge usual in the relevant technical field, the average knowledge, experience and skills of experts in that field and the resulting understanding of the content of a technical teaching.
The skilled person (in this case, a trained telecommunications and/or IT technician with several years' professional experience in the telecommunications sector) approaching the problem of finding the simplest and cheapest solution possible for processing prepaid calls knew of two ways of storing the data needed to make such calls: one whereby all the data was stored in a chip or magnetic strip on the card and another whereby it was stored in a database, with particular credit being allocated to a particular ID number.
If the skilled person had wished to avoid the drawback of distribution requiring the transmission of data from the sales points to the database, he could only have dispensed with this if he had provided the customer with the ID number in another way. The Court, however, could find no evidence that this would have made it obvious to the skilled person to adopt the solution of standardising certain sums, as was usual in the case of chip cards in particular, which would then have enabled him to allocate the ID number to credit even before the customer had bought that credit. This step would only simplify distribution if, at the same time, the skilled person identified a solution to the problem of how to inform customers of their ID number. The chip-card system could not serve as an example as the problem did not arise there. Accordingly, it was not enough to move from individually set credit to standard credit amounts fixed from the outset; rather such a move required further steps, i.e. the advance allocation of credit and ID number in the database and issue of the ID number to the customer.
FR France
Paris Court of Appeal of 22 February 2008 (06/08776) - Thermohauser v Matfer
Keyword: inventive step - skilled person - neighbouring field
The patent related in a general manner to kitchen utensils, and more specifically to whisks used to beat mixtures and comprising several open loops of steel wire gathered and joined at a handle, enabling the whisk to be held for use.
On the petition for revocation:
Apart from the prior art previously analysed by the trial judges, company T, the petitioner seeking revocation, referred to documents relating to screwdrivers and knives which were dismissed by those judges. Company M, the patent proprietor, submitted that there was no need to take into account all the prior art cited because the prior art concerning screwdrivers and knives was not part of the standard technical knowledge of the skilled person in that field, i.e. that of kitchen whisks.
The Court did not concur with company M on this point, the skilled person being someone possessing normal knowledge of the technology in question (problem of attaching a tool to a handle), which was not limited to the field of the patent, i.e. in this case kitchen whisks, but rather someone with more general knowledge in the field of small hand-held utensils having a handle attached to an active part of the tool used to various ends, such as knives (in the culinary field) and, in a broader context, screwdrivers. Moreover, the Court held that this field of technical expertise had been referred to in two prior patents submitted for discussion, which, while related more specifically to screwdrivers, referred in a broader context to handles for utensils for domestic use such as kitchen whisks and spatulas. The question of lack of inventive step had therefore to be examined with respect to all the documents cited in the appeal.
The Court ruled that in view of the problems for which the skilled person sought a solution (ensuring the tightness and high-level stability of the whole implement), none of the prior-art teachings would lead the skilled person to regard it as obvious for there to be co-operation between the handle and the sub-assembly comprising attachment means each guaranteeing distinct functions; on the contrary, the prior art would lead him to think that fixing by duplicate moulding, i.e. introducing material resulting in a clasping of the wires, thereby preventing them from moving longitudinally and from rotating, was enough to achieve the desired result, a result which proved to be imperfect in practice.
FR France
Court of Cassation of 26 February 2008 (06-19149) - Newmat v Normalu
Keyword: inventive step - skilled person - neighbouring field
In revoking claim 1 of a patent relating to "a shaped part to affix to a stretch ceiling" for lack of inventive step, the appellate court held that a document ("Pelleix") did not relate directly to stretch ceilings. Nevertheless, it did concern connections between walls and ceilings that were designed to ensure tautness, such connections serving to eliminate any gaps between the other parts, and since the person skilled in the art of false ceilings could not be unaware of the different structures envisaged for connecting walls and ceilings, the argument that it was not possible to refer to the teaching of the Peillex document had to be dismissed.
The Court of Cassation ruled that the skilled person was someone who had a normal knowledge of the technology in question and was able, relying solely on his professional knowledge, to conceive of the solution to the problem that the invention proposed to resolve.
The Court held that by assuming that the skilled person – in this case a specialist in stretch ceilings – had professional knowledge in a specialist area other than his own (tautness), the appellate Court had contravened the wording of Art. L. 611-14 French Intellectual Property Code.
FR France
Paris District Court of 28 January 2009 (07/06328) - Technip France v ITP
Keyword: definition of skilled person
Company I was an engineering firm specialising in the manufacture of offshore pipelines for the transportation of oil and was the proprietor of French patent no. 2 746 891. It was also the proprietor of European patent EP 0 890 056, claiming priority from the above patent and not designating France. Board of appeal decision T 1013/02 dated 17 February 2004 had revoked this European patent for lack of inventive step.
Companies I and T had been on opposing sides in various proceedings before foreign courts on the subject of the invention claimed in the above patents. Company T had initiated proceedings against company I for revocation of claims 1 to 16 of the French patent for lack of inventive step.
Company T claimed that the invention was obvious for the person skilled in the art, who in its view was a pipeline insulation engineer, in the light of prior-art teachings.
For company I, the skilled person was a pipeline engineer involved in the design and manufacture of offshore pipelines, commonly known as an "offshore pipeline engineer". The problem facing this expert was to improve the thermal performance of existing pipelines under the usual constraints. There was nothing in the prior art that would lead him to the features of the invention. Microporous products had existed since the early 1960s and had not been used in pipelines prior to the invention.
For company I, company T's reasoning was based upon an ex post facto approach which could not be followed.
On the definition of the skilled person, the Court held it to be common ground that the person skilled in the art was an ordinary practitioner possessing general knowledge of the field at the date of filing of the relevant patent application.
In the light of the elements featuring in the description, the court considered the field in question to be the design and manufacture of pipes with a double casing for assembly into pipelines for the conveyance of fluids that had to be kept at a constant temperature and subject to specific installation constraints (for example on the ocean bed). Though the wording of claim 1 did not actually limit the field of the invention to pipelines for oil products, the fact remained that the whole description related to pipelines subject to major constraints in terms of fluids conveyed, geographical location and length (several kilometres). Also, contrary to the position of company T, the court considered the skilled person to be an engineer specialising in pipeline design and manufacture, not a "pipeline insulation technician".
According to the Court, company I had rightly pointed out that company T's definition of the skilled person conflicted with the type of witnesses it had relied on within the framework of the Scottish proceedings, who had all had extensive experience in pipeline engineering but did not match the profile of a "pipeline insulation technician".
As held by Lord Smith in the Scottish proceedings between the same parties on the validity of the European patent, the pipeline engineer had extensive knowledge but was not a specialist in the various insulation products.
On the problem in question: In the description, the proprietor of the patent stated that his main objective was to reduce the cost of laying the prior-art double-casing pipes in which a high vacuum was created in the annular space between the two tubes (page 2, lines 16 et seq. of the translation) and to improve their heat insulation for the fluid conveyed while satisfying the constraints placed on this type of equipment at all stages of production, transport, assembly and utilisation.
The Court held the problem defined by the EPO board of appeal to be of no relevance; the board had used the results of the invention (simplified assembly operations, reduced space requirement) to define the problem for which the skilled person sought a solution, while it was clear from the description that the proprietor of the patent sought to cut expenses and improve the standard and durability of heat insulation, not to simplify assembly operations or reduce the size of double-jacketed tube sections.
On the closest prior art: The parties agreed that the Preussag patent was the closest prior art. The Preussag invention related to a pipeline for the conveyance of gaseous or liquid media whose temperature differed from the ambient temperature, with a double casing, the inner tube being encased in heat insulating material.
The Court held that the Preussag invention differed from company I's in two respects and, on the basis of these two differences, the Preussag invention was divergent from company I's in terms of both the problem raised (elimination of the spacers or rings which, by creating heat bridges, had a negative impact on heat insulation) and the solution adopted (respective position of the inner and outer pipes, type of insulating material).
Endorsing Lord Smith's judgment, the Court concluded that the invention to which claim 1 of company I's patent related was not suggested by any combination of the Preussag patent's teaching with the prior-art documents cited by company T. This position was confirmed by the following evidence of inventive step: – a confidential document showed that, at the date in question, company T's successor was not using open-pore microporous materials, despite the benefits now described by the company as obvious and the enormous pressure on oil companies to improve the cost of their installation; – company M, in the form of its former president, Mr H, had dubbed company I staff "crazy Frenchmen" in response to their suggestion that he should consider using Microtherm products for pipeline insulation; – the delay between the market launch of its Microtherm products in 1967 and their use in 1996 in pipeline systems developed in 1982 clearly demonstrated that this use was anything but obvious.
In these circumstances, the Court rejected company T's request for revocation of the claims of company I's patent, the validity of claim 1 entailing the validity of the dependent claims.
Editor's note: The Paris Court of Appeal of 22 September 2010 (09/02379) confirmed the above judgment.
GB United Kingdom
Court of Appeal of 1 April 2004 - Rockwater v Technip France SA [2004] EWCA Civ 381
Keyword: inventive step - skilled person - expert witness
In this judgment, Jacob LJ discussed the attributes of the skilled person.
According to Jacob LJ, the "man skilled in the art" was invoked at many critical points of patent law. The claims of a patent had to be understood as if read by that notional man. Likewise, many questions of validity (obviousness and sufficiency, for instance) depended upon trying to view matters as he would see them. He had statutory recognition – Articles 56, 83 and 100 EPC expressly referred to "the person skilled in the art".
It was settled that this man, if real, would be very boring – a nerd. Lord Reid put it this way in Technograph v Mills & Rockley [1972] RPC 346 at 355: the hypothetical addressee is a skilled technician who is well acquainted with workshop technique and who has carefully read the relevant literature. He is supposed to have an unlimited capacity to assimilate the contents of, it may be, scores of specifications but to be incapable of scintilla of invention. When dealing with obviousness, unlike novelty, it is permissible to make a "mosaic" out of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity".
The no-mosaic rule also made him very forgetful. He read all the prior art, but unless it formed part of his background technical knowledge, having read (or learnt about) one piece of prior art, he forgot it before reading the next unless it could form an uninventive mosaic or there was a sufficient cross-reference to make it justified to read the documents as one.
He did, on the other hand, have a very good background technical knowledge – the so-called common general knowledge. The courts in the UK had long set a standard for this which was set out in the oft-quoted passage from General Tire v Firestone Tire & Rubber [1972] RPC 457 at 482, which in turn approved what was said by Luxmoore J in British Acoustic Films 53 RPC 221 at 250. Luxmoore J's happy phrase "common stock of knowledge" conveyed the flavour of what this notional man knew. Other countries within the EPC applied essentially the same standard.
The man could, in appropriate cases, be a team – an assembly of nerds of different basic skills, all unimaginative. But the skilled man was not a complete android, for it was also settled that he would share the common prejudices or conservatism which prevailed in the art concerned.
None of this was controversial. However, sometimes the requirement that the skilled man be uninventive was used by counsel for a patentee in an attempt to downgrade or dismiss the evidence of an expert called to say that a patent was obvious – "my witness is more nerdlike than his" was the general theme. Jacob LJ did not find this a helpful approach for reasons connected with the function of expert witnesses in patent actions. Their primary function was to educate the court in the technology. It was also permissible for an expert witness to opine on an "ultimate question" which was not one of law. But just because the opinion was admissible, it by no means followed that the court had to follow it.
In fact, the expert's conclusion (e.g. obvious or not), as such, although admissible, was of little value and so it did not really matter what the actual attributes of the real expert witness were. What mattered were the reasons for his or her opinion. And those reasons did not depend on how closely the expert approximated to the skilled man.
GB United Kingdom
Patents Court of 12 October 2005 - Ranbaxy and Arrow Generics v Warner Lambert [2005] EWHC 2142 (Pat)
Keyword: inventive step - skilled person - selection invention - atorvastatin
The two patents at issue (Warner-Lambert's EP (UK) 0 409 281 ("281") and Ranbaxy's EP (UK) 0 247 633 ("633") concerned atorvastatin, a cholesterol synthesis inhibitor of great commercial importance. There was a dispute between the parties as to the right approach to obviousness. The question was examined both on a problem-solution basis and following the approach set out in Windsurfing International Inc v Tabur Marine (GB) Ltd [1985] RPC 59.
The judge cited Lord Wilberforce in E I Du Pont de Nemours (Witsiepe's) Application [1982] FSR 303:
"The inventive step in a selection patent lies in the discovery that one or more members of a previously known class of products possess some special advantage for a particular purpose, which could not be predicted before the discovery was made (in re I. G. Farbenindustrie A.G.'s Patents (1930) 47 RPC. 283, per Maugham J). The quid pro quo for the monopoly granted to the inventor is the public disclosure by him in his specification of the special advantages that the selected members of the class possess (Beecham Group Ltd v Bristol Laboratories International S.A. [1978] RPC 521, at 579).
The selected class might be obvious, but the nature of the advantage was one of the factors to be taken into account in assessing obviousness. Witsiepe was a case under the 1949 Act, but the same principles were accepted by the Court of Appeal in a 1977 Act case, Hallen v Brabantia [1991] RPC 195. Unless the later patent stated what the advantage possessed by the selected class was, it was merely an arbitrary selection among things already disclosed, and would lack novelty.
The judge thought that the belief that the law of selection was concerned with obviousness to be a misconception. Obviousness only became relevant if the later patent was not anticipated, and the obviousness of the selected class would be decided according to the normal principles. It would no doubt help the patentee to repel an allegation of obviousness if he could point to a statement of the advantage possessed by the selected class, but this was not essential.
The EPO view was stricter. As expressed in T 198/84 (OJ EPO 1985, 209), it seemed to be to the effect that a newly discovered effect could never add novelty to a narrower class if the class was otherwise old. However, the real difficulty was caused by certain aspects of the problem-solution approach. There were two possible difficulties with this approach. The first was its concentration on the closest prior art, which had to stem from a belief that if an invention was not obvious in the light of the closest prior art it could not be obvious in the light of anything further away. This ran the risk of offending against the principle that a skilled man had to be permitted to do that which was obvious in the light of each individual item of prior art seen in the light of the common general knowledge. The second was that the reformulation of the problem could obscure that which was objectively obvious.
The judge could not see this approach producing a different result from that produced by a Windsurfing analysis in the vast majority of cases. Where results differed, that would generally be because of the importance that a judge following the Windsurfing approach would give to the common general knowledge.
The judge went on to say that if redefinition of the problem were permitted on the basis of any advantage which was known to the patentee before the priority date but not referred to in the specification or which was discovered after the priority date then there was a substantial risk that the reformulation would result in a finding of non-obviousness: how could one solve an (objective) problem that one did not know existed?
It was for this reason that in this jurisdiction after-discovered advantages were highly unlikely to be capable of supporting inventiveness, for the reasons given by Jacob J in Richardson-Vicks [1995] RPC 568 and T 867/95. The latter decision emphasised that reformulation of the problem could be allowed "provided the skilled man could recognise the same as implied in or related to the problem initially suggested".
Pumfrey J did not detect any real difference in the substantive law between the jurisdictions. It was true that the problem-solving techniques might be different, but he did not see either in this case or in others differences that could not be attributed to differences of appreciation, rather than principle.
Patent 281 was held invalid for lack of novelty and obviousness and Ranbaxy were refused a declaration of non-infringement of patent 633. Both parties appealed to the Court of Appeal, which did not hear the case on obviousness and which dismissed both appeals (Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA Civ 876).
GB United Kingdom
Court of Appeal of 22 June 2007 - Pozzoli v BDMO & Moulage Industriel de Perseigne [2007] EWCA Civ 588
Keyword: inventive step - skilled person
The patentee, Pozzoli SpA, appealed the decision of the Patents Court holding its patent, a double push tray for CD packages accommodating overlapping CDs, invalid on the ground of obviousness (lack of inventive step).
The Court of Appeal restated and elaborated the well-known (four-step) Windsurfing test, which had been the test generally applied to assess obviousness. It held that the first two steps should be conducted in the opposite order - first the Court should assume the mantle of the normally skilled but unimaginative addressee in the art and impute to him the common general knowledge at the priority date, and only then identify the inventive concept. For it was only through the eyes of the skilled man that one could properly understand what such a man would have understood the patentee to have meant and thereby set about identifying the concept. Moreover, the new first step actually comprised two steps: identification of the attributes of the notional "person skilled in the art" and identification of the common general knowledge.
In identifying the inventive concept, it was the inventive concept of the claim in question which had to be considered, not some generalised concept to be derived from the specification as a whole. The first stage of identification of the concept was likely to be construction of the claim, trying to identify the essence of the claim, stripping out unnecessary verbiage. What mattered was/were the difference(s) between what was claimed and the prior art - these formed the "step" to be considered at stage 4.
In some cases one did not need to go into the finer points of construction, the concept being fairly apparent without. In yet other cases it was not even practicable to try to identify a concept, for example a chemical class claim. Identification of the concept was not the place to take into account the prior art.
The revised test for obviousness was thus:
1. (a) Identify the notional "person skilled in the art";
1. (b) Identify the relevant common general knowledge of that person;
2. Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it;
3. Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or claim as construed;
4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
The patentee sought to defend his invention from a charge of obviousness by saying that there was a technical prejudice against it ("a lion in the path"). The Court of Appeal reasoned that:
- A patentee who contributed something new by showing that, contrary to the mistaken prejudice, the idea would work or was practical had shown something new. In this case the lion in the path was merely a paper tiger.
- A patentee who merely patented an old idea thought not to work or to be practical and did not explain how or why, contrary to the prejudice, that it did work or was practical, contributed nothing to human knowledge. The lion remained apparent and the patent could not be justified.
The Court of Appeal found that the latter applied to the case at issue and the patent was found invalid for obviousness, the appeal thus being dismissed.
GB United Kingdom
Court of Appeal of 17 February 2010 - Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82
Keyword: inventive step - skilled person - fluvastatin
Novartis appealed the decision of the Patents Court that its EP (UK) 0 948 320 was invalid for obviousness. The patent was for a sustained-release formulation of fluvastatin. At the priority date, fluvastatin was a well-known statin available in an immediate-release formulation and there was extensive knowledge of sustained-release formulations generally. The patent argued that there was a need for a sustained-release formulation of fluvastatin but its solubility was so high that there was at least a perception that any of the conventional methods would not work. The patent then disclosed that sustained-release formulations of fluvastatin could in fact be made by using any of the three conventional techniques already acknowledged.
According to the Court of Appeal, which dismissed the appeal, the question was simply whether the invention was obvious. The UK courts had found a structure helpful to approach – not answer - this question. In its latest refinement it ran as set out in Pozzoli v BDMO [2007] FSR 37 (see above).
This structured process was not - as some thought - something peculiarly British. It merely made explicit that which was implicit in all other approaches. Step 4, for example, merely posed the question. It did not attempt to provide any structure for answering it. Depending on the facts, various approaches might assist - e.g. "obvious to try", or the "problem-solution approach". Although there was nothing like step 1 of the problem-solution approach (identify the closest prior art) in the Pozzoli/Windsurfing approach, this was because practitioners before the English Patents Court had learned to confine themselves to their best cases, especially by the time of trial. English patent judges were simply not faced with profligate citations.
While the problem-solution approach had its limitations, it was apt to work very well when there was no need to reformulate the problem. This was such a case.
The patent stated that the skilled man would think the solubility of fluvastatin was so high that a sustained-release form could not be made. The Court disagreed. The skilled man would not think that, based on his common general knowledge alone. The problem presented in the patent was illusory – it was in reality a non-problem because fluvastatin was not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained-release form. Once the obstacle put forward in the patent against being able to make a sustained formulation was shown to be illusory, then a sustained-release formulation was obvious. In Pozzoli terms, the only difference between the prior art and the claim was the idea of making a sustained-release formulation. For that there was a technical motivation and no difficulty, real or apparent.
The problem-solution approach gave the same answer. The problem was to produce a sustained-release form of fluvastatin. The solution was obvious, because any of the standard methods for such formulations would clearly work. There was no need and it would be wrong to re-formulate the problem. This was not a case where some prior art unknown to the patentee had turned up. Nor was it right to reformulate the problem as one of looking for better medical effects when that was not the problem as seen by the patentee or to reformulate the solution as having found such effects when the patentee had not promised any. In this respect this case differed from that recently considered by the Court of Appeal, Napp v ratiopharm [2009] EWCA Civ 252, [2009] RPC 539, concerning a sustained-release form of oxycodone. Oxycodone was, until the patent, known as a minor weak opiod generally administered, to the extent that it was administered at all, as a co-drug. The slow-release form transformed it, as the patent said, into a serious alternative to morphine – something that was wholly unexpected. Clearly the invention in Napp v ratiopharm was non-obvious.
The appellant also submitted that even though it was conceded that the idea of a slow-release formulation of fluvastatin would occur to the skilled person, that was not enough to make a claim to it obvious. It was necessary to show that the skilled person would implement it. In support of this argument it relied upon the Guidelines (and two board of appeal cases, T 632/91 and T 116/90). Jacob LJ did not read the Guidelines as involving a requirement that the notional skilled person would actually physically implement the idea - what was meant was that it was not enough that the skilled man could have arrived at the invention from the prior art; it had to be shown that he would have done. Whether he would actually press ahead and implement the idea depended on a host of other, commercial, considerations.
GB United Kingdom
Court of Appeal of 28 July 2010 - Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819
Keyword: inventive step - skilled person
The Patents Court had revoked two of Electromagnetic Geoservices' ("EMGS") patents relating to the use of controlled source electromagnetic ("CSEM") surveying to detect oil and gas deposits under the sea. The invention could detect whether an underwater geological formation contained oil or water without the need for costly drilling, which, prior to the invention, was the only way of finding out. As it was agreed that the two patents stood or fell together, only one was the subject of the proceedings and it was held to be obvious on the basis of three pieces of prior art, although the attack alleging lack of novelty was rejected. EMGS appealed.
The Court of Appeal allowed the appeal. The question addressed by Jacob LJ, who gave the leading judgment, concerned the person skilled in the art, to whom reference was made three times in the EPC (Articles 69, 83 and 56), Jacob LJ acknowledged that it had long been settled in general terms, both in UK and EPO case law, that the "person skilled in the art" could, where necessary, be a notional team of people having different skills. However, the point of law at issue in the case before the Court was whether the notional team was by law to be the same for all purposes. In none of the cases before the EPO or the UK courts had it been said that there was some sort of universal rule about the nature of the team.
The correct approach was to start with the real problem faced by exploration geophysicists. Did they appreciate that their problem - determining whether a layer of porous rock identified as potentially hydrocarbon-bearing was so, or just contained water - was a solvable problem? Would the notional exploration geophysicist appreciate that CSEM had a real prospect of being useful?
The problem had also to be approached from the point of view of the CSEM expert. Would he know of the geophysicist's problem, and if so, would he appreciate that CSEM had a real prospect of being useful?
In short: was the marriage obvious to either notional partner? Jacob LJ found that the answer was "no", and therefore, because there had been a non-obvious marriage of skills (citing with approval Haberman v Jackel [1999] FSR 683), the invention involved an inventive step.
The approach that Jacob LJ found not necessary was to ask whether the notional team including both types of expert would see that CSEM could solve the problem. He also pointed out that there was a danger to be avoided: there were cases where, even though you could, in retrospect, clearly see that there was a problem and articulate what it was, workers at the time did not do that - they put up with things as they were. Then the essence of the invention was the insight that there was a solvable problem at all.
It was argued that the same phrase ("person skilled in the art") used three times in the EPC, could not have different meanings, but by all known canons of construction had to have the same meaning in all three places. Jacob LJ thought that the flaw in that was to assume that "the art" was necessarily the same before and after the invention was made. The assumption might be correct in most cases, but some inventions were themselves art-changing. If a patentee said, "marry the skills of two different arts to solve a problem", marrying might be obvious or it might not. If it was not, and doing so resulted in a real technical advance, then the patentee deserved a patent.
This was not because a different construction was being given to the phrase "person skilled in the art" in the different articles. It was because the phrase was being applied to different situations.
4. Inventive step in patents and utility models
AT Austria
Supreme Patent and Trademark Chamber of 22 December 2010 (OGM 1/10)
Keyword: inventive step - relationship between the inventiveness of a patent and that of a utility model
In this case, the Supreme Patent and Trademark Chamber dealt with the legal issue of whether or not the inventiveness required under patent law differed from that required under utility-model law.
According to Austrian case law and legal doctrine, an invention was obvious not simply because the skilled person could have arrived at it on the basis of the prior art; it was obvious only if the skilled person would actually have proposed it, given sufficient reason, in expectation of some improvement or advantage. One test for this was the problem-solution approach used by the EPO. The substantive conditions for utility model protection were lower by comparison, according to the case law of the Supreme Court and the current case law of the Supreme Patent and Trademark Chamber; the requirement there was (only) an inventive step involving a lesser degree of inventiveness than that necessary for patenting.
The Supreme Patent and Trademark Chamber also cited the Demonstrationsschrank decision of the German Federal Court of Justice (see next summary in this report), according to which the principles elaborated in patent law had to be applied in assessing inventive step in utility-model law. It was wrong to assess obviousness as if it were based on inventive step. This was because when Germany adopted the definition of inventive step as laid down in Art. 56 EPC, the requirements for patentability were lowered in patent law such that they now covered all above-average achievements. The Supreme Patent and Trademark Chamber agreed that the old view, whereby the requirements applicable to inventiveness had to be set lower in utility-model law than in patent law, could not be maintained.
Neither legal doctrine nor case law had succeeded in providing an independent definition of "inventive step". While the undefined legal concept of "invention" in patent law was amplified using the problem-solution approach, it was striking that "inventive step" was defined chiefly in negative terms. For instance, arguments based on solutions that were "not too remote" were used to identify an achievement protectable under utility model law. The adoption of the problem-solution approach developed by the EPO had lowered the patent-law requirements that hitherto had had to be fulfilled by an invention. According to the problem-solution approach, to confirm the obviousness of subject-matter it was no longer sufficient for the skilled person to be aware of two prior-art documents which, in combination, produced the subject-matter to be examined. The "invention" was considered obvious only if the skilled person also had specific reason to actually combine the prior art. Novelty and non-obviousness were thus so close that there was no room in between for the concrete definition of inventive step for a utility model. The attempt to introduce the category "not entirely obvious solution" between "new" and "non-obvious" had to be considered unsuccessful because even a solution that was not "entirely obvious" was ultimately obvious in the sense that the skilled person had to have some reason for proposing it (as otherwise the solution was in any case non-obvious according to the problem-solution approach). The inventive-step criterion in utility model law was qualitative, not quantitative.
DE Germany
Federal Court of Justice of 20 June 2006 (X ZB 27/05) - Display Case
Keyword: inventive step - closest prior art - utility model
In this decision, the Federal Court of Justice discussed the degree of inventive step required under patent and utility-model law:
In patent law, any invention which is novel, capable of industrial application and not obvious to the skilled person is patentable, without any differentiation. The requirements for patentability have thus been relaxed in such a way that they are met by all above-average innovations. Generally applicable criteria for relaxing them further still, whilst nevertheless preventing the monopolisation of trivial innovations which, having regard also to higher-ranking law, third parties could not justifiably be excluded from using, have not yet been developed; nor could such criteria provide sufficient certainty. Moreover, the fact that patents and utility models have - at least essentially - the same protective effect precluded a different assessment of the requisite inventive act. Although a utility model cannot be obtained in all areas for which patents are available, in those areas in which such a right may be granted, it is not inferior, except for its shorter maximum term. Account has also been taken of the legislator's interest in distinguishing the two rights inasmuch as the prior art to be considered, not only in examining novelty but also in assessing the inventive act, has a different definition from that in patent law.
Like the patentability requirement of inventive step to be met in patent law, the requirement for an inventive act foreseen in utility-model law under Art. 1 German Utility Model Act is not quantitative but qualitative in nature; as in the examination of inventive step, whether or not an act is inventive under utility-model law has to be established by way of an assessment of the circumstances. Moreover, the assessment criteria applicable to patents differ only marginally from those applicable to utility models. For that reason alone, the German Federal Court of Justice considered the idea that an exclusive right could be obtained on the basis of a "lesser" inventive act than that required for a patent, or ultimately even on the basis of an obvious element, to constitute a breach of the system.
Whilst account has to be taken of the differences arising from the specific utility-model-law definition of prior art under § 3 German Utility Model Act with respect to oral descriptions and uses outside the scope of the Act, it is permissible for the purposes of assessing the inventive act to have recourse to the principles developed in patent law. However, obvious developments cannot be regarded as involving an inventive act, for example on the basis that the skilled person could not have arrived at them purely on the basis of his general expertise and routine consultation of the prior art.
E. Industrial applicability
GB United Kingdom
Supreme Court of 2 November 2011 - Human Genome Sciences Inc v Eli Lilly [2011] UKSC 51
Keyword: biotechnology - industrial applicability
The case concerned the patentability or otherwise of a protein called by HGS Neutrokine-α, antibodies to it and the polynucleotide sequence encoding for it. HGS were the first to discover its existence, doing so by "bioinformatics".
The judge at first instance held that all the claims of the patent (EP (UK) 0 939 804) were invalid on three grounds: they were not susceptible of industrial application, they were insufficient and they were obvious because of a lack of technical contribution. HGS challenged all these findings.
The Court of Appeal dismissed the appeal on the ground of lack of industrial applicability, upholding the judgment of the lower court in this respect, so the other grounds did not need to be considered. The patent proprietor, HGS, appealed. The Supreme Court allowed the appeal, dismissed the cross-appeal on the issue of insufficiency and remitted the case to the Court of Appeal to deal with outstanding issues.
Despite the patent's very wide-ranging and generalised suggestions as to the uses to which Neutrokine-α and its antibodies might be put, its only relevant teaching ultimately arose concerning the tissue distribution of Neutrokine-α, its expression in T-cell and B-cell lymphomas, and the fact that it was a member of the TNF ligand superfamily. Accordingly, the question was whether the judge at first instance had been right to conclude that the inferences which would have been drawn from this in 1996 would not have been enough to satisfy Art. 57 EPC. He had considered that the functions of Neutrokine-α "were, at best, a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project".
The Supreme Court acknowledged that there was very little authority in the UK on the topic of industrial applicability and so the applicable principles were to be found in the jurisprudence of the boards of appeal of the EPO. The judge's approach was not consistent with that of the boards concerning the requirements of Art. 57 EPC in relation to biological material, which could be summarised in the following general principles:
(i) The patent must disclose "a practical application" and "some profitable use" for the claimed substance, so that the ensuing monopoly "can be expected [to lead to] some … commercial benefit" (T 870/04, T 898/05);
(ii) A "concrete benefit", namely the invention's "use … in industrial practice" must be "derivable directly from the description", coupled with common general knowledge (T 898/05, T 604/04);
(iii) A merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do (T 870/04 and T 898/05);
(iv) The patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden", or having to carry out "a research programme" (T 604/04, T 898/05);
Further specific principles were also set out, concerning new proteins and their encoding genes, as well as family or superfamily members.
The judge at first instance had found that the patent disclosed Neutrokine-α as a new member of the TNF ligand superfamily. In the light of the principles set out by the boards of appeal, this should have been sufficient, taking into account the common general knowledge, to satisfy the requirements of Art. 57 EPC. The Supreme Court derived considerable assistance from the approach set out in T 18/09 (the decision of the board of appeal on the same patent). Here the board had concluded that the disclosure of what was accepted to be a new member of the TNF ligand superfamily (coupled with details of its tissue distribution) satisfied Art. 57 EPC, because all known members were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function.
The judge had held that the disclosure in the patent as to the uses of Neutrokine-α, even when taken together with common general knowledge, was no more than "speculative" and did not give rise to an "immediate concrete benefit". However, this argument proceeded on the implicit assumption that the disclosure of the patent was not sufficient in itself to satisfy the requirements of Art. 57 EPC. If, in the light of the boards' approach, the known activities of the TNF ligand superfamily were enough to justify patentability for the disclosure of a novel molecule (and its encoding gene) which was plausibly identified as a member of that family, the fact that further work was required to see whether the disclosure actually had therapeutic benefits did not, at least without more, undermine the validity of a patent. For the same reasons, the cross-appeal alleging insufficiency had also to be dismissed.
The standard set by the judge at first instance for susceptibility to industrial application was a more exacting one than that used by the boards of appeal. He had looked for a description that showed that a particular use for the product had actually been demonstrated rather than that the product had plausibly been shown to be "usable", which included the use of the molecule for research. The board in T 18/09 had to be taken to have regarded this in itself as an industrial activity.
The decision of the Patents Court that the claimed inventions were not susceptible of industrial application at the date of the patent was therefore set aside.
II. SUFFICIENCY OF DISCLOSURE
AT Austria
Supreme Court of 9 November 2004 (4 Ob 214/04f) - Paroxat
Keyword: novelty - sufficiency of disclosure
The defendant in this case submitted that the patent lacked novelty, citing a patent application with an earlier priority published in the UK. The claimant argued that as the substance described in claim 4 could not be reproduced on the basis of the information in the UK patent application, the patent specification was not a novelty-destroying disclosure.
The Supreme Court examined which requirements had to be met for a prior publication to be novelty-destroying, i.e. whether the UK patent application with the earlier priority met the requirements for a disclosure. Under older Austrian case law, a document was novelty-destroying only if the essential inventive concept was readily derivable by a skilled person; the inventive concept had to be described in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art purely on the basis of the information contained in the document, without reference to other sources.
The Supreme Court made a detailed analysis of German case law and EPC jurisprudence and came to the basic conclusion that Austria's national patent law had to be interpreted in harmony with the EPC to determine the circumstances under which a product disclosed in a patent specification could be considered prior art at the priority date, not least because § 87a(1) Austrian Patents Act and Art. 83 EPC were identical in terms of content. What had to be assessed was whether the information contained in the application enabled the average skilled person to put the technical teaching into practice reliably, repeatably and directly, and without either undue burden or an unreasonable number of initial failures, using the skill and information expected of him and common general knowledge and following the approach described by the applicant. What the skilled person considered reasonable always depended on the circumstances of the individual case, particularly the progress associated with the invention and the relevant technical field. These criteria also affected the failure rate that the skilled person was willing to accept.
Editor's note: This ruling was upheld in Supreme Patent and Trademark Chamber decision Op 3/06 (N 21/2000) of 27.09.2006, Österreichisches Patentblatt (Austrian Patent Gazette), 2006, 151.
FR France
Paris District Court of 19 January 2005 (04/17466) - CEA v Samsung
Keyword: sufficiency of disclosure
The French Atomic Energy Commission, a public body active in the area of scientific, technological and industrial research, hereinafter referred to as CEA, is the proprietor of European patent EP 0 162 775 and French patent no. 2 595 156. When CEA learnt that LCD televisions and computer monitors which, it believed, implemented the features of some of the claims of the European and of the French patent were being marketed in France by company S, it had a television purchased on 10 December 2003 [...] and a computer monitor on 30 March 2004 (...).
The invention concerned a liquid crystal cell presenting a homeotropic structure, with birefringence compensation for said structure. According to the patent, it applied more particularly to the production of data display means, such as watches or electronic pocket calculators. The cells known from the prior art suffered from a disadvantage: when observed obliquely in their homeotropic structure, their contrast deteriorated, with this deterioration increasing as the observation angle increased; said contrast could even be reversed. The main object of the invention was to obviate this disadvantage, thereby maintaining a high contrast during oblique observation. According to the invention, the thickness of the liquid crystal layer was taken to be double the particular thickness e0, which could be determined by the skilled person (using data processing simulation or by experiment).
In a counterclaim against the infringement action brought by CEA, company S requested in particular that the Court revoke the French part of claim 1 of European patent EP 0 162 775 for insufficiency of disclosure under Art. 138(1)(b) EPC, arguing that the patent did not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
In reply, CEA pointed out that the person skilled in the art had had simulation software at his disposal at the patent's filing date and moreover, as an expert in the field of optics, he could have chosen to write his own program. He could also have used the experimental method and created multiple prototypes with different liquid crystal layer thicknesses. He then would have only had to choose the thickness that offered the best attenuation during oblique observation, and thus the best contrast.
The Court, however, held that the skilled person (in this case, a research engineer specialising in liquid crystal optics) could not, at the time of the patent's filing, have carried out the invention from reading claim 1 and the description without exercising inventive skill. In an attempt to prove infringement, CEA had commissioned Dr S to determine the value e0 for the optical properties of the device implemented in the television acquired as described above. To do this, Dr S had had to use a software package named Dimos LCD Workbench which did not come onto the market until 1987, three years after the patent's priority date.
So, without providing further information, CEA could not rely on the use of the experimental method or the development of a computerised simulation program to demonstrate that it had indeed disclosed in its patent all the means necessary to allow the skilled person (who, although a high-level researcher, could not be expected to have the same computerised simulation tools as a body such as CEA) to implement the invention without exercising inventive skill. The Court thus revoked claim 1 of European patent EP 0 165 775 under Art. L. 614-12 French Intellectual Property Code and Art. 138(1)(b) EPC.
Editor's note: The Paris Court of Appeal on 2 July 2008 (08/09712) noted that both parties had withdrawn their claims by mutual agreement.
SE Sweden
Stockholm Court of Patent Appeals (Patentbesvärsrätten) of 31 January 2007 - case no. 04-139
Keyword: sufficiency of disclosure - desideratum - parameters
The invention related to a new quality of uncoated paper or board product with a top layer of bleached chemical pulp that allowed for improved printability. The latter was achieved by means of a process wherein calendering was performed in a specific manner in an extended soft nip calender with the aim of obtaining an uncoated paper or board product with specific surface properties indicated by values for the parameters gloss, coefficient of gloss variation and surface roughness.
According to the Court, however, claim 1 referred merely to what was to be achieved and not to how it was to be achieved, therefore constituting a type of claim generally known as a "desideratum": the claim included all the products referred to in the preamble of the claim that had the specified surface properties, irrespective of how those properties had been achieved.
The Court clarified that, as a rule, a claim specified generalisations of one or more examples of embodiments covered by the description, with the degree of generalisation being determined with reference to the state of the art and the experimental evidence. For an invention in a new field, the degree of generalisation could be permitted to be greater than the degree usually required for an invention which related to the further development of the prior art.
In the case in hand, the product according to claim 1 included specified intervals for the three parameters gloss, coefficient of gloss variation and surface roughness, all of which, according to the prior art, were well-known measurement variables for calendered paper and board products and associated with the achievement of good printability for such products, including uncoated ones. In the Court's view, characterisation of an invented product by means of parameter intervals could only be allowed if it was known how these were to be achieved and if the invention encompassed additional information on this. However, claims 1 and 4 (claim 4 related to the use of the product specified in claim 1) specified an invention which assumed that the surface properties of the claimed product were already defined. Moreover, the description did not state that the invention related to such a definition.
It was a well-established principle that a patent applicant must be granted protection that corresponds to the inventor's contribution. The scope of protection must be sufficiently specified and in reasonable proportion to the contribution to the prior art. The definitions in the claim must correspond to the scope of the invention specified in the description. With regard to claims containing parameters, the information specified in the description must allow the person skilled in the art to achieve the result determined by these parameters without undue burden across the whole scope of the claim (reference to T 409/91, reasons 3.5, last paragraph). The Court could not regard the invention at issue - characterised by wide ranges and a broad scope - as sufficiently described so as to ensure that the skilled person could carry it out on the basis of the description (Articles 8 and 25(1), sub-paragraph 2, Swedish Patents Act). Consequently, the patent was revoked.
SE Sweden
Stockholm Court of Patent Appeals (Patentbesvärsrätten) of 19 December 2008 - case no. 05-217
Keyword: sufficiency of disclosure - therapeutic method
In this case, the invention comprised methods and compositions for the prevention and treatment of vascular occlusive conditions including, but not limited to, neointimal hyperplasia. Preferred embodiments of the invention included methods and compositions for measuring the induction of HSPG (heparan sulfate proteoglycans) including, but not limited to, syndecan, glypican and perlecan. The invention also comprised assays for detecting compounds that have specific biological effects and may be useful as therapeutic agents. The description used the term "compound" in such a way as to include any single entity or combined entities whose activity can be measured in the assays of the present invention. Such entities included, but were not limited to, chemical elements, molecules, compounds, mixtures, emulsions, chemotherapeutic agents, pharmacological agents, hormones, antibodies, growth factors, cellular factors, nucleic acids, proteins, peptides, peptidomimetics, nucleotides, carbohydrates and combinations, fragments, analogs or derivatives of such entities. The compound's effects and therapeutic uses in the assays of the invention under consideration were not determined in the patent specification so that any agent that caused the cells or compounds of the assay to respond in a measurable manner was covered by the scope of protection of the invention.
In addition, claim 5 related to the use of a composition including one or more compounds for the manufacture of a medicament for treatment of vascular occlusive conditions. The essential features of the claim consisted of the information on the treatment, i.e. the medical indication, and the information on which compounds are included. The active ingredient was not specified as such but encompassed one or more compounds "determined" by means of a three-step method specified in the claim.
According to Art. 8(2) Swedish Patents Act, a patent application must contain a description of the invention, including drawings where required, and precise information regarding the scope of protection as defined in the claims. The description of the invention must also be sufficiently clear to allow a person skilled in the art to carry out the invention on the basis of the description. The Court clarified that the said requirement was intended to ensure that the relevant information corresponded to the invention described in the application. The claims should therefore be supported by the description and could not relate to a different invention. The fact that a claim in itself was free of ambiguities and could be understood without the help of the application's description did not necessarily mean that the requirement of sufficient disclosure had been fulfilled (see Supreme Administrative Court records for 1991 (RÅ 1991), Note 17, in particular the Court of Patent Appeals' judgment in case P 87-226, and EPO board of appeal decision T 409/91).
In the case in hand, claim 5 included the use of all compounds which, having been "determined" by means of a method specified in the claim, met the specified criterion of inducing HSPG synthesis, irrespective of whether the compounds already existed at the filing date, were produced thereafter or would be produced in the future - a so-called "reach-through claim", according to the Court. In its view, claim 5 was not able to provide clear information on what the patent application was intended to protect. Neither the feature in the claim that the compounds had been determined by means of a method nor the feature that the use according to the claim related to a compound or compounds with unknown cell growth activity could sufficiently delimit the scope of protection with respect to the compounds.
SE Sweden
Stockholm Court of Patent Appeals (Patentbesvärsrätten) of 26 February 2010 - case no. 07-161
Keyword: sufficiency of disclosure - chemical inventions - parameters
The invention related to a gas-liquid mixture, a fire-extinguishing agent, a fire-extinguishing unit comprising a container for a fire-extinguishing agent, and a method for controlling the spreading of a fire or embers. One object of the present invention was to provide a gas-liquid mixture which could be used in existing fire-extinguishing systems, thereby replacing known agents such as halons. Halons are effective as fire-extinguishing agents but not ozone-friendly. According to the invention, the claimed agent appeared to be essentially as effective as the halons, but had a substantially lower negative effect on the environment than the halons. For this purpose, the gas-liquid mixture should combine three components: an extinguishing basis, a dispersing agent and a propellant. The preferred contents of the three components were defined by ranges related to steam pressure, the boiling point of the additives and the solubility of the chemical compounds.
In its decision, the Court stated that, with regard to claims encompassing characteristic values such as parameters, the information in the description had to be sufficiently clear and complete to allow the person skilled in the art to manufacture the product in a reliable manner and without undue effort across the whole scope of the claim. In this respect, the Court cited the EPO board of appeal decision T 12/81, which allowed a more precise definition of a chemical substance through the use of specific product parameters, e.g. physico-chemical properties such as melting point or hydrophilic properties, in cases where the chemical compound could not be defined by a sufficiently accurate generic formula. If a product parameter was to be allowed, it was required that a parameter specified as essential in the description could be construed from the latter or that the skilled person could determine it without undue effort and experimentation and that this applied to the entire scope of the claim (see T 965/01).
Applying the above to the case in hand, the Court held that the applicant had to specify in the description how the skilled person should select a combination of the three components in order to obtain the desired gas-liquid mixture. In the Court's opinion, the general part of the description and the examples of mixtures given in the description did not disclose the invention in a manner sufficiently clear and complete so as to enable the skilled person to carry it out based on instructions across the entire scope covered by the attributes and the broad compound definitions of the components in the claim.
III. CLAIMS
A. Form of the claims
GB United Kingdom
House of Lords of 21 October 2004 - Kirin-Amgen Inc et al. v Hoechst Marion Roussel Ltd et al. [2004] UKHL 46
Keyword: novelty - product-by-process claims - DNA sequences - erythropoietin
The proceedings concerned European patent EP 0 148 605 B2, relating to the production of erythropoietin ("EPO") by recombinant DNA technology. The owner of the patent, Kirin-Amgen Inc ("Amgen") had alleged that Transkaryotic Therapies Inc ("TKT") had infringed the claims of the patent. It was held at first instance that the claims were infringed but were bad for insufficiency. The Court of Appeal held that the claims were valid but not infringed. Amgen appealed against the finding that the claims were not infringed and TKT and others claimed a declaration of non-infringement and revocation of the patent. The House of Lords held that TKT did not infringe any of the claims. Amgen's patent was revoked on the basis that one of the claims was invalid on the ground of anticipation and another one was invalid for insufficiency.
When considering novelty of the claim to EPO produced by recombinant DNA technology, Lord Hoffmann, who gave the leading opinion in the case, revisited the general approach to product-by-process claims. The practice in the United Kingdom under the Patents Act 1949 and earlier had been to treat the fact that a product was made by a new process as sufficient to distinguish it from an identical product which had already been part of the state of the art. A product-by-process claim had the advantage of enabling the inventor of a new process to pursue not only the manufacturer who infringed his claim to the process but also anyone who dealt in a product which had been made by that process. This had been particularly useful in the case of the importation of a product made by someone outside the jurisdiction by a process which would have infringed the process claim if it had been made in the United Kingdom.
The EPC, however, by virtue of Art. 64(2), contained a provision which allowed a patentee to rely directly on his process claim to allege infringement of a product made by the patented process. This provision, which was given effect in UK domestic law by virtue of the Patents Act 1977, would largely remove the practical argument for allowing product-by-process claims. The EPO had thus been able to accept the logical argument that a new process was not enough to make the product new and would not ordinarily accept product-by-process claims (see, for example, T 150/82, OJ EPO 1984, 309). The same approach had been taken in other member states. It was important for the United Kingdom to apply the same law as the EPO and the other member states when deciding what is new for the purposes of the EPC. Applying these principles to the facts of the case, Lord Hoffmann concluded that the claim to EPO produced by recombinant DNA technology was invalid on the ground of anticipation.
ES Spain
Barcelona Court of Appeal (Audiencia Provincial) of 17 March 2008 (appeal no. 184/2007) - Laboratorios Cinfa, S.A. et al. v Warner-Lambert
Keyword: chemical and pharmaceutical products - revocation action - use claims - scope of the Spanish reservation under Art. 167(2)(a) EPC
The claimants and then appellants requested a declaration of partial invalidity in respect of claims R1, R2 and R3 of the European patent EP 0 409 281 (ES 2 167 306), a process patent for obtaining atorvastatin calcium. As grounds for seeking invalidity in respect of the claims, they stated that the latter conferred protection on a pharmaceutical chemical product and, at the time when the patent application was filed, Spain expressly prohibited chemical and pharmaceutical products from being patented, as a consequence of the reservation made by Spain in its instrument of accession to the European Patent Convention (Art. 167(2)(a) EPC).
The Barcelona Court of Appeal stated in its judgment that the use claims were, apart from being admissible, distinct from the product claims in their conception, effects and in particular with regard to the scope of protection conferred. Product claims provided absolute protection, since they protected the product, whatever the production process and whatever the use of the product, whereas claims for an activity (manufacturing process and use claims) conferred relative protection, limited to the activity claimed, but not for the product or device per se when used other than for the activity claimed. The Court stated that the prohibitive effect of the reservation made by Spain, interpreted literally, was limited to European patents "in so far as they confer protection on chemical or pharmaceutical products as such" (Spain's instrument of accession to the EPC), i.e. to patents for a chemical or pharmaceutical product, which "shall be ineffective in Spain". However, it did not extend to patents that referred to a process of manufacture or, as here, of use of a chemical product. This is why the invalidity invoked had to be examined solely with regard to the first two claims, which actually were product claims, but not to the third (R3).
On the other hand, the Court stated that by its instrument of accession to the EPC of 10 July 1986, Spain did not in any way reserve the right to annul European patents for inventions of chemical or pharmaceutical products, but made a reservation with regard to their effectiveness. Patents for products therefore were not revoked in accordance with Art. 138 EPC, but rather, if products had been introduced amongst the claims, had become "petrified" or "frozen", and without any effect in Spain. Thus, of the two options offered to the contracting states by Art. 167(2)(a) EPC, to reserve the right to provide that chemical or pharmaceutical patents be either ineffective or revocable, Spain had opted solely for the former, that they be ineffective in Spain. The Court was of the opinion that if Spain had opted for them to be revocable, it would have done the same as Austria and specified this when making its reservation. It was therefore clear to the Court that the reservation, as worded by Spain in its instrument of accession and expressed later in the transitional provisions of Royal Decree-Law No. 2424/1986, did not admit any legal actions for the revocation in Spain of European patents for chemical or pharmaceutical products, but rather only those aimed at ensuring that such patents were ineffective in Spain. Consequently, it was ruled that the objection made by the respondent raised no cause of action and that to this end the contested decision was confirmed.
Editor's note: see also judgments of the Madrid Court of Appeal (Audiencia Provincial) of 26 October 2006; Barcelona Court of Appeal (Audiencia Provincial) of 24 January 2008; and Barcelona Court of Appeal (Audiencia Provincial) of 30 June 2008.
GR Greece
Athens Single Member Court of First Instance (Monomeles Protodikeion Athinon) of 23 December 2010 (decision no. 9908/2010)
Keyword: Swiss-type claims - scope of the Greek reservation under Art. 167(2)(a) EPC - TRIPS
The invention related to ophthalmic compositions of a β-adrenergic antagonist and a topical carbonic anhydrase inhibitor, particularly useful in the treatment of ocular hypertension, especially for patients insufficiently responsive to β-adrenergic antagonists (EP 0 509 752). The relevant claims were drafted in the form of Swiss-type claims. Within its scope of application in Greece, the European patent encompassed the use of dorzolamide and timolol for the treatment of glaucoma, the relevant pharmaceutical composition as well as the method of its manufacturing. As the owner of an exclusive licence to manufacture and distribute the said product under the name "Cosopt" on the Greek market, the claimant launched injunction proceedings before the Athens Single Member Court of First Instance against a company aiming to market a generic version of the same product and for the same therapeutic use. The defendant raised objections by referring to the Greek reservation to the EPC (former Art. 167(2)(a) EPC), according to which European patents for which the application was filed before 7 October 1992 would not have effect in Greece as long as they protected chemical or pharmaceutical products as such. It argued that Swiss-type claims fell under the reservation.
The Court dismissed the defendant's objections and held that the Greek reservation to the EPC regarding pharmaceutical patents should be strictly interpreted to cover product claims only. Following the established case law in Greece, the Court distinguished three types of claims, namely product, process and use claims, and acknowledged the validity of Swiss-type claims as a particular category of use claims. It further clarified that, whereas protection attributed to product claims was considered absolute - irrespective of its production method and use of the product - process and use claims were subject to a relative protection which was restricted to the claimed process or use of the specific product without extending to the product itself. Hence Swiss-type claims did not fall under the scope of the Greek reservation.
This conclusion was regarded by the Court to be in accord with the spirit of EPC and the flexibility provided by the TRIPS Agreement. With regard to TRIPS, the Court departed from the established case law by rejecting the direct applicability of the relevant provisions (Articles 27 and 70 TRIPS) in Greece due to their lack of clarity on the matter.
Editor's note: In a landmark decision rendered on 3 February 2009 (decision no. 728/2009), the Athens Full Bench Court of First Instance ("Polymeles Protodikeion Athinon", specialised IP and Commercial Law Division) held that pre-1992 claims of pharmaceutical products that fell under the Greek reservation were valid in view of the TRIPS Agreement, which took effect in Greece on 9 February 1995 and prevailed as of that date over the reservation.
B. Amendments to claims
AT Austria
Supreme Court of 19 November 2009 (17 Ob 24/09t) - Nebivolol
Keyword: amendments to patent claims - deletion of features
Regarding amendments to a patent, the Supreme Court stated that according to Art. 123(2) EPC the European patent application or European patent could not be amended in such a way that it contained subject-matter which extended beyond the content of the application as filed. Under Art. 123(3) EPC the European patent could not be amended in such a way as to extend the protection it conferred. Corresponding grounds for revocation were established in Art. 138(1)(c) and (d) EPC. According to Art. 105a(1) EPC the European patent could, at the request of the proprietor, be limited by an amendment of the claims.
Although the provisions specified related to the procedure before the EPO, they were nevertheless an expression of a general principle. On grounds of legal certainty alone, a granted patent could not be arbitrarily amended at a subsequent point. Thus if the patent was defended with amended claims, its validity could stand only if said patent was also admissible under patent law with the new content. An amendment was not allowed to replace the protected invention with a different invention and extend the subject-matter or the protection conferred. In principle, it was therefore inadmissible to delete features because this did not, as a general rule, limit the scope of a claim; in fact it often resulted in broadening the scope of protection. A limitation was admissible as long as it actually reduced the scope of protection and did not extend beyond the original disclosure.
BE Belgium
Brussels Court of Appeal of 20 June 2008 – GSK v Sanofi
Keyword: amendments – infringement of a confidentiality agreement
At the time in question, the company GlaxoSmithKline Biologicals (hereinafter: GSK) was working on the development and marketing of a new vaccine to prevent pneumococcal infections. In a bid to prevent its plans from being compromised by the existence of European patent EP 0 983 087, held by Sanofi Pasteur (hereinafter: Sanofi), a company under French law, GSK had asked the Brussels Court of First Instance to revoke the Belgian part of the patent.
Sanofi had originally asked to be informed of the composition of the vaccine that GSK was planning to market to establish whether it needed to take action. GSK had agreed only on the strict understanding that Sanofi needed this information to support its arguments in any counterclaim for infringement.
In an initial judgment dated 20 June 2007, the Brussels Court of First Instance had ruled that Sanofi was not in breach of its obligation to observe confidentiality, and had deemed the amended claims proposed by Sanofi to be admissible.
In its second judgment – Brussels Court of First Instance of 17 October 2007, GSK v Sanofi – the Court had deemed GSK's petition to be allowable and had revoked the Belgian part of the patent. It had also found that, in the absence of any legal basis, only reasons of expediency could lead a national jurisdiction to defer taking a decision on the validity of a patent/on acts of infringement until the EPO had taken its decision, and judged that this was not justified in the case in question.
On the merits, assuming that the invention was novel and involved an inventive step, it still had to be sufficiently developed to be susceptible of application and therefore had to be disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Art. 49(1) No. 2 Belgian Patents Act). Yet in the case in question there had been too many unknowns for the development of a safe and effective vaccine to overcome the described phenomenon of negative interference. In the Court's view, the plaintiff had quite rightly argued that it was a patent on an idea or concept.
GSK therefore appealed the judgment of 20 June 2007, and Sanofi appealed that of 17 October 2007. GSK requested the Court of Appeal in particular to declare that in submitting amended claims for the patent, Sanofi had abused its rights, as a result of which the amended claims could not be admitted into the present proceedings. The two appeals having been filed against two successive judgments handed down on the same issue, the Court held that there was good reason to join them.
On the scope of the obligation of confidentiality, the Court of Appeal held that the confidential information transmitted by GSK to Sanofi could be used by Sanofi only to assess whether to bring an infringement case in all of the states designated in the European patent. The terms of the agreement were unambiguous and reflected the joint intention of the parties, and thus required no interpretation. The agreement did not authorise Sanofi to use confidential information to amend its patent in such a way as to overcome potential grounds for revocation. The agreement was strictly confined to assessment in connection with an infringement action. Contrary to what Sanofi maintained, validity and infringement of a patent were two totally distinct issues. While a defendant in a revocation case could remedy the invalidity of his patent by amending his claims, no such action could be taken in connection with infringement per se.
At no time had it been agreed that Sanofi could use confidential information to restrict its patent to the point of customising its invention to such an extent that the claims were virtually limited to a particular variant of GSK's vaccine. Furthermore, Sanofi wrongly asserted that the parties had agreed that the confidential information had the same effect as a "saisie-description", meaning that it could be used without restrictions other than those attached to this type of measure for securing evidence. No interpretation of that kind could be made on the basis of any document in the file. The fact that the EPO opposition division regarded the amendments to the patent as admissible had no impact on the settlement of the present dispute.
On the question of breach of the confidentiality obligation, Sanofi did not dispute that it had taken the confidential information into account when drafting the additional claims. A close link between the confidential information and the amendments was therefore established. Contrary to Sanofi's assertion, it had gone beyond merely checking whether the amendments it intended to make prejudiced the infringement case, i.e. by removing the allegedly infringing subject-matter from the scope of the patent, and in fact had done the opposite, i.e. it had used the confidential information to amend its patent in an attempt to eliminate potential grounds for revocation. Moreover, Sanofi did not really defend itself on this question, because it was claiming the very right to be able to do so, wrongly maintaining that revocation and infringement procedures were intimately linked.
The Court ruled that Sanofi had used confidential information relating to GSK's vaccine in breach of its contractual obligations. It held that Sanofi could not invoke the amended claims of patent EP 0 983 087 and that these could not be admitted into the present proceedings.
DE Germany
Federal Court of Justice of 16 October 2007 (X ZR 226/02) - Saddle stitcher II
Keyword: claims - amendments - admissibility - intermediate generalisation - embodiment
The patent in question concerned a saddle stitcher for gathering and then, in the same machine, stitching printed and folded sheets (printed sheets) to produce multiple-page printed matter such as magazines, brochures, etc. The claimant, which had been found to have infringed the patent in a final judgment, contested it in an action for revocation, asserting that the subject-matter of the current patent claim 1 went beyond the content of the application as filed and that the protection conferred by that claim had been extended beyond the patent as granted. Having found that the omission of a feature of patent claim 1 constituted an inadmissible extension, the Federal Patents Court had revoked the patent in part and maintained the claim in amended form. In its reasons, the Court had stated that the protection conferred by the claim as currently in force could also cover saddle stitchers not transported up to the gathering section with the open side to the fore, but for example sideways on to that section, as was known from the published European patent application.
The claimant appealed against that decision, seeking revocation of the patent and revision of the contested judgment. The Federal Court of Justice dismissed the appeal.
In the Court's view, it was true that amendments to the claims could not extend the subject-matter of the application or substitute a different invention for that originally claimed. Accordingly, claims could not be directed to subject-matter which, based on the original application, the skilled person would not have recognised as falling within the scope of protection sought at the outset. In this context, applicants or patent proprietors seeking protection only for a particular embodiment of the invention as filed were not required to include all the embodiment features in the claim.
Where only one of several features describing an embodiment of the invention was included in the patent claim, thereby disclosing the technical effect achieved by the embodiment, this did not constitute an inadmissible extension even if no other way of achieving the same effect was disclosed.
FR France
Paris Court of Appeal of 31 January 2007 (05/22227) - Nergeco v Mavil
Keyword: amendments
The invention claimed by the patent related to a lifting curtain door comprising two vertical side uprights, each constituting or including a slideway.
Company N sued company G for infringement of European patent EP 0 476 788. Company G counterclaimed by filing for revocation of claim 5 under Art. L. 613-25(c) French Intellectual Property Code and Art. 138(1)(c) EPC, claiming that it related to doors that did not implement the features of claims 1 and 6 of the European patent application as filed.
The Court held that the deletion of a feature in a claim in the course of European patent grant proceedings contravened the provisions of Articles 123(2) and 138(1)(c) EPC if said feature was presented as essential to the invention and its implementation in relation to the technical problem to be solved.
In the Court's opinion, company N was wrong to claim that the deleted features were not essential to the solution of the problem. The invention purported to resolve a technical problem relating to the reinsertion of a curtain following its dislodgement from the lateral slideways as a result of excessive force or wind. Both the patent application and the granted patent stated that the object of the invention was to stop the side parts of the curtain from escaping via the openings or apertures provided to allow reinsertion when the shutter was being lowered.
The only solution to this technical problem was provided by the flexible wall element specified in the original version of claim 1, which stated that said element was designed to prevent the curtain from shifting from inside to outside. Company N had failed to show that this object had been achieved simply through the design of the guide rails which, in the patent application, were added to the flexible wall element. This feature was essential to the execution of the invention, and its deletion in claim 5 had caused the subject-matter to extend beyond the content of the application as filed in contravention of the provisions of Art. 123(2) EPC. This claim therefore was to be revoked with effect for France pursuant to Art. 138(1)(c) EPC.
Further, the flexible wall feature by no means appeared to be secondary to achieving the desired result in this particular configuration, such that claim 9 was to be revoked with effect for France on the same grounds as claim 5, in accordance with Art. 138(1)(c) EPC.
The Court concluded that as company N had based its infringement case on claims 5 and 9 alone, company G could not request revocation of the European patent in its entirety.
FR France
Paris District Court of 27 January 2009 (06/07287) - ADA Cosmetic v Emicela
Keyword: amendments
Company C was granted European patent EP 0 530 789, designating France. This patent related to a dispenser for liquid soap, hair shampoo or similar fluids, and pursued two objectives, namely, to satisfy hygiene requirements by preventing cross-contamination of the liquid during hand-washing and to make replenishing the dispenser easy while minimising the risk of theft.
On 13 April 2006, company C initiated proceedings before the Paris District Court against company E, in particular for the infringement of claims 1, 2, 4, 5, 6, 8, 11 and 13 of its patent.
In its latest submissions of 8 December 2008, company E requested revocation of the patent for insufficiency of disclosure and extension of the subject-matter beyond the content of the application as filed, in accordance with Art. 138(1)(b) and (c) EPC.
In its latest submissions of 5 December 2008, company C pointed out that according to its patent, the soap was dispensed not by means of a pump but simply by the application of pressure to the flexible wall of the storage vessel. This storage vessel was connected to a holder by a detachable holding sleeve and was secured by an anti-theft mechanism.
Company C disputed that the subject-matter of the patent extended beyond the content of the application as filed; it explained that it had amended claim 1 at the request of the EPO, but argued that the technical features mentioned by company E clearly came from the original application documents. It also asserted that the two embodiments of claim 1 were sufficiently disclosed, and sought rejection of company E's request for revocation.
The patent was particularly characterised in that: (i) the holder featured a holding sleeve at one of its two free end zones, (j) the holding sleeve locally embraced the storage vessel, (k) was detachably connected to the holder, and (l) was secured thereto by an anti-theft mechanism.
Company E pointed out that characteristics (i) and (j) showed that two embodiments were envisaged: (1) the holding sleeve embraced the neck of the soap storage vessel and was connected to the lower end of the holder; (2) the holding sleeve embraced a different part of the storage vessel, notably the base, and was connected to the upper end of the holder. It maintained that the second embodiment had not been envisaged in the application as filed.
The Court stated that claim 8 added that the holding sleeve embraced the storage vessel in the area of the vessel neck or bottle neck. These were the only positions specified for the holding sleeve and the neck, and no alternative was provided. The patent application as a whole did not indicate any other possible arrangement of the holding sleeve and the soap storage vessel. Thus, even if the term preferably gave reason to consider that another embodiment was envisaged, the rest of the claim relating to the position of the storage vessel's neck in the holding sleeve clearly excluded any arrangement other than that of a holding sleeve situated in the lower part of the holder. Claim 1 of the patent which, in (j), indicated that the holding sleeve locally embraced the storage holder, was thus not consistent with the application in that the new wording gave reason to consider an embodiment that had not previously been covered.
Pursuant to Art. 138(1)(c) EPC and Art. L. 614-12 French Intellectual Property Code, the Court revoked patent claim 1. Claims 2, 4, 5, 6, 8, 11 and 13, being dependent on claim 1, were also revoked. Company C's requests relating to infringement of these claims were therefore rejected.
GB United Kingdom
Patents Court of 25 June 2008 - Zipher Ltd v Markem Systems Ltd, Markem Technologies Ltd [2008] EWHC 1379 (Pat)
Keyword: amendments to claims - added subject-matter
One of the issues considered in this decision was the exercise of any discretion retained by the Court to allow a patentee to amend its patent, provided such amendments did not offend against any grounds of objection under the Patents Act.
Prior to the UK's ratification of the EPC the UK courts and tribunals had exercised a very wide discretion over whether to allow a party to amend the scope of the monopoly granted by a patent following its grant. Such a discretion had involved, for example, inquiry into the timeliness of the patentee's conduct, the patentee's state of mind about the need for amendment, or the effect of the patent in its unamended state on third parties.
Since legislative changes had brought about the need to have regard to any relevant principles applicable under the EPC, a judge should now turn to the EPC to see what principles were applied to considering whether or not to allow amendments.
The judge noted that there was little by way of express guidance in the EPC. The case law of the boards of appeal showed that appropriateness of the amendments to the proceedings, their necessity and procedural fairness were the main, perhaps only, factors considered relevant to the discretion to allow amendment in opposition proceedings. The EPC 2000 had introduced a new procedure in Art. 105a which enabled a patentee to limit a granted European patent by an amendment of the claims outside the context of opposition proceedings and by a central request to the EPO. In these proceedings, compliance with the procedural requirements gave the right to have the patent limited in accordance with the request.
Consequently, if a proper amendment was now brought forward in opposition proceedings in good time and was necessary and appropriate to meeting the opposition, it seemed inescapable that it would be allowed. It would seem to be an odd result if an amendment which would be available as of right under the central limitation procedure was refused simply because the patent was under opposition. Such a result could only be justified if either (a) the amendments would have no effect on the opposition and could accordingly be made after the conclusion of the opposition procedure if the patent survived or (b) procedural fairness to the opponents meant that it could not be considered.
In conclusion, the discretion of a judge to refuse amendments which complied with the Patents Act had been limited. Considerations formerly considered relevant to the discretion, such as the conduct of the patentee, were no longer relevant.
ES Spain
Supreme Court of 4 November 2010 (appeal No. 6669/2009) - Pfizer v Medichem
Keyword: revision of the translation of the European patent - scope - insertion of new product claims
The Spanish Supreme Court gave a ruling on a legal question regarding the possibility of using the revision of a translation to incorporate claims not included in an original translation. The basic underlying question concerned the scope of the procedure for revising a translation and that of the possible protection following the TRIPS Agreement of the product claims not included in the translations published at the time in accordance with the reservation made by Spain to the EPC under Art. 167 thereof. The company Pfizer Inc had appealed against the judgment of 26 March 2009 of the Chamber for Administrative Disputes (Second Section) of the High Court of Madrid dismissing the administrative appeal filed by the appellant against the decision of the Spanish Patent and Trademarks Office (OEPM) of 27 October 2006 to refuse publication of the revision of the translation of European patent EP 0 463 756, as requested by the appellant, and maintaining the wording of the patent as validated for Spain in accordance with the initial translation filed within three months following the mention of the grant of the patent by the EPO.
In its judgment, the Supreme Court rejected the proposition that reduced the OEPM's role to that of a mere register, which had to receive and publish any translation of a European patent, verifying only that it was the translation of a European patent. It pointed out that the official publication of the translation of a patent on the part of the OEPM had some important legal consequences, such as the right of the proprietor to exploit it commercially, for which reason said act of publication had to provide legal certainty for third parties. This in itself justified giving the Spanish OEPM a qualifying function. This applied, for the same reasons, not only to translations, but also to revisions of translations.
A second question for examination was whether it was possible to use the procedure for revising a translation of a European patent to extend the scope of protection of the original translation, up to the limits marked by the European patent. The Supreme Court observed in its judgment that the anticipation in the EPC of the fact that the contracting states had to contemplate the possibility that the applicant for or proprietor of the patent might file a revised translation and make the legal effects thereof conditional upon compliance with the corresponding requirements, as well as its recognition of the possibility for the states to safeguard protection of the rights acquired by third parties in the terms of Art. 70(4)(b) EPC, had unequivocally led to the conclusion that revision of the translation had a much further-reaching objective than that put forward by the OEPM and the court of first instance. The purpose of a revision to a translation could not be other than precisely that of incorporating claims contained in the European patent but for some reason not incorporated in the translation filed in another contracting state. There were undoubtedly a variety of reasons why an initial translation had not incorporated all the claims of a European patent, such as, in its day, the reservation made by Spain under the EPC with regard to pharmaceutical product claims, but also perhaps purely commercial agreements with other pharmaceutical companies or reasons of a strictly economic or commercial nature. In all of those cases, once such reasons were removed, the proprietor of the patent could opt to incorporate the claims initially omitted. The Supreme Court also came to the conclusion that the option offered by Art. 70(4)(b) EPC and expressed in Art. 12 of Royal Decree-Law 2424/1986 remained open, without time limits, to the patent proprietor.
The Supreme Court held that the entry into force in Spain of the TRIPS Agreement had removed any doubt that might have remained with regard to the possible effects of the reservation on patents affected by it, given that the express recognition on the part of the TRIPS Agreement of the possibility not just of admitting pharmaceutical product claims but of doing so also for those cases in which it had not been possible beforehand as a result of national decisions – such as reservations – had to prevail over the EPC. At the date that the TRIPS Agreement came fully into force, 1 January 1996, the disputed patent was already granted, and the reservation with regard to product patents under the EPC was no longer valid.
IT - Italy
Milan District Court of 23 September 2010 (14437/10) - Giellepi Chemicals v Meda Pharma
Keyword: novelty - disclaimer
Meda Pharma was the holder of European patent EP 0 994 705 relating to the mixture of two chemical compounds aimed at limiting the complications of diabetes. During the proceedings before the District Court, the plaintiff argued that the patent lacked any new technical teaching when compared with the relevant prior art. In its defence, the patentee pointed out that the mixture claimed in the prior art was different from the core compound of Meda Pharma's patent. The synergic co-application of the two compounds in the prior-art document was purely coincidental. Moreover, the document did not provide enough information about an effective mixture of the two compounds owing to the lack of experimental data. However, since the mixture claimed in the prior art was among the mixtures claimed in the patent at issue, the patentee proposed the use of a disclaimer as a precautionary measure.
The proposed disclaimer was held to be admissible and effective. As to its admissibility, the Court cited the relevant Italian and European provisions. With respect to the case at issue, Italian law allowed amendments after grant when (a) the limitation of its subject-matter, upon request by the patentee, was allowed (Art. 79 Italian Patents Act) and (b) the limitation of the patent could also be the consequence of a judgment stating its partial invalidity (Art. 76(2) Italian Patents Act). The conversion of an invalid patent into another patent which met the validity requirements and would have been sought by the applicant had he been aware of the invalidity (Art. 76(3) Italian Patents Act) was equally allowable. The only common limit to such amendments was that the subject-matter of the patent was not extended, by virtue of the amendment, beyond the contents of the application as filed.
According to the Court, if the amendment consisted of a disclaimer that was a limitation or an instrument to delete part of the subject-matter deemed not deserving of protection, this should be allowed and was in line with the decisions of the boards of appeal of the EPO (T 583/93) and the Enlarged Board of Appeal (G 1/03). In particular, the EPO had made it clear that the introduction of disclaimers was permissible in order to avoid a conflict with prior art. Indeed, in the case at issue, the proposed disclaimer effectively removed the overlap with the prior art.
C. Interpretation of claims - relevance of Article 69 EPC
AT Austria
Supreme Patent and Trademark Chamber of 26 May 2010 (Op 3/09)
Keyword: interpretation of claims - extent of protection - Art. 69 EPC
In this decision, the Supreme Patent and Trademark Chamber summarised Austrian case law on the extent of the protection conferred by a patent. According to § 22a Austrian Patents Act, the extent of the protection conferred by the patent and the published application is determined by the terms of the claims. Nevertheless, the description and drawings are to be used to interpret the claims. The Protocol on the Interpretation of Art. 69 EPC is to be applied mutatis mutandis. According to this Protocol, the provision in question should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should Art. 69 EPC be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a sufficient degree of legal certainty for third parties.
Accordingly, the Supreme Patent and Trademark Chamber took the view that to determine the extent of protection conferred by a patent it was crucial to strike a balance between that which was defined by the strict, literal meaning of the wording used in the claims and that which was shown in the description and drawings as the solution to the technical problem. Also, to guarantee legal certainty for the proprietor and the public, the wording of the claims should be required to limit the extent of protection; it should not be necessary to rely on interpretation of the description and drawings to determine the extent of protection. This was fully in keeping with § 22 Austrian Patents Act in conjunction with the Protocol on the Interpretation of Art. 69 EPC, which likewise stipulated that the extent of the protection conferred could not be what a person skilled in the art, only after considering the description and drawings, deemed the patent proprietor to have contemplated.
BE Belgium
Liège Commercial Court of 8 July 2010 - Core, Urban v Germeau Carrière
Keyword: interpretation of claims
The plaintiffs were co-proprietors of European patent EP 1 448 865 granted on 10 January 2007, having a priority date of 2 August 2002, for an extending ladder and associated manufacturing methods. This patent was not opposed. The plaintiffs asserted that Germeau Carrière was marketing ladders which in their view matched – and thereby infringed – claim 1 of their patent.
The invention concerned an extending ladder and a method for assembling such a ladder. Claim 1 defined the essential object of the invention. The validity of the plaintiffs' patent was not questioned.
Referring to Figures 6 and 7, Germeau argued that since the ladders it marketed had circular-section guiding surfaces with no flattened parts, the patent had not been infringed. It claimed that since no other guiding-surface shape was shown in the EP 865 drawings, it was legitimate to conclude that the shape shown there constituted an essential element of the claimed ladder. The plaintiffs maintained that the shape or section of the guiding surface was not part of the claim, so it did not constitute an essential feature requiring protection.
The President of the Court pointed out that under Art. 26 Belgian Patents Act the subject-matter of the patent and hence the protection conferred by law were defined by the claims alone. The description and any accompanying drawings were simply aids to interpreting the claims. He went on to make several references to French law and case law, pointing out in particular that elements not actually contained in a claim could not be introduced into it by interpretation; that interpreting was not the same as adding, as the Paris Court of Appeal had held in a ruling handed down on 10 May 1994; and that while Art. 84 EPC specified that the claims had to be supported by the description, the description and claims did not have to match exactly.
The President held that, as the plaintiffs had rightly argued, the claim did not specify the shape (section) of the columns. He found that the shape represented was not therefore a protected element, and that asserting that the drawings should allow the claim to be interpreted with a view to establishing its content conflicted with the fact that the claim's wording was perfectly clear and precise. Nowhere in claim 1 of the patent was there a reference to columns or rungs having a particular shape or section.
He concluded that under the doctrine of equivalents the patent had been infringed.
FR France
Paris Court of Appeal of 4 March 2009 (07/08437) - Institut Pasteur v Chiron
Keyword: scope of protection – Art. 69 EPC
The Institute Pasteur is a foundation for research in microbiology. The Chiron group, incorporated under US law, specialises in biotechnology, manufacturing and marketing vaccines, therapeutic products and blood tests.
The Institute Pasteur sued Chiron for infringement before the Paris District Court, alleging that since September 1999 the group had been marketing HIV tests which used claims 8 to 11 of its patent. The Paris District Court dismissed the case by decision of 7 February 2007, and the Institute Pasteur appealed.
The Paris Court of Appeal noted that European patent EP 0 178 978, filed by the Institute Pasteur on 17 September 1985 and claiming a UK priority of 19 September 1984, had been granted on 6 February 1991, opposed by Chiron before the EPO, and maintained with amended claims by EPO board of appeal decision T 824/94 of 18 November 1999.
At issue was the scope of claims 8 and 11. The Court cited Art. 69 EPC, stipulating that the extent of protection conferred by a European patent or application is determined by the wording of the claims, with the description and any drawings being used to interpret the claims.
The Institute Pasteur argued that EP 0 178 978 was such an outstanding innovation that it broke new ground. That conferred on its claims 8 to 11 a scope beyond their literal meaning.
The Court however held that even though a patent for a ground-breaking invention might describe one way of carrying it out and claim all other possible ways, it did not confer a broad scope of protection if its claims were drafted in restrictive terms. An unambiguous claim framed narrowly could not be interpreted to give it a broad scope, especially if the patentee had been obliged to restrict it during grant and opposition proceedings in order to delimit it against the prior art. The Court noted that the application as originally filed had 24 claims, and that following Chiron's opposition and an appeal (T 824/94), the patent was maintained with 11 – narrower – claims.
On claim 11, the Court held that the patentee who amended his claims to narrow their scope acted to the detriment of legal certainty for third parties if he then asserted that the amendments were not necessary, that the narrower claims had the same scope as the original – broader – ones and that the prior art giving rise to the amendments was not relevant.
It further held that the Institute Pasteur could not argue that claim 8 covered any diagnostic method, whatever probe was used, simply on the basis that it referred indirectly to claim 1, which used the words "corresponding to" and therefore still covered any DNA fragment.
The EPO board of appeal had pointed out that claim 1 seemed to use "corresponding to" in the narrow sense of base to base correspondence, subject to the allowable variations which would not substantially alter their capability of hybridising with the LAV retroviral genomes, as understood by a person skilled in the art. It could therefore not be argued, without misrepresenting that decision, that the protection of the allowable variations covered all equivalent DNA fragments as well.
Claim 8 could not cover any diagnostic method, regardless of the type of probe used. Its scope was therefore limited to a test method involving the use of probes composed of clone fragments and comprising a DNA fragment corresponding to the retroviral genome contained in λJ19. Lastly, once the scope of claims 8 and 11 were thus defined, there was no need to examine the Chiron group's auxiliary request for their revocation, as Chiron did not dispute their validity as amended after opposition and as interpreted.
The Court upheld the Paris District Court's decision of 7 February 2007 in all points, including its dismissal of the Institute Pasteur's infringement suit. In a judgment of 23 November 2010 (09-15668), the commercial chamber of the Court of cassation dismissed the Institute Pasteur's appeal against that decision (see below).
FR France
Court of Cassation of 23 November 2010 (09-15668) - Chiron v Institut Pasteur
Keyword: scope of protection - Art. 69 EPC
The Institute Pasteur, proprietor of European patent EP 0 178 978, appealed against the Paris Court of Appeal's decision of 4 March 2009 (q.v.).
Citing Art. 69 EPC, it challenged the Court of Appeal's dismissal of its suit alleging infringement of claims 8 and 11 of its patent; when determining the extent of protection conferred by the claims as finally worded, the Court should have taken no account of amendments made to the application during EPO proceedings, as the final wording formed a self-contained whole.
The Court of Cassation found that the Court of Appeal had not confined itself to a literal interpretation of the two patent claims, but had assessed their scope on the basis of the applicable versions. In so doing, it had borne two things in mind. Firstly, claim 8 did not cover all diagnostic methods, irrespective of the probe used; it was limited to a detection method using the probes defined in claims 1 to 6, i.e. formed from one of the cloned DNA fragments defined by their restriction sites and corresponding to the retroviral genome of the LAV virus contained in λJ19. Secondly, claim 11 protected only the specific character of the purified RNA claimed – i.e. having a size from 9.1 to 9.2 kb and hybridisable with the cDNA contained in λJ19 – and not any sequence of purified RNA of the LAV (or HIV-1) virus, whatever its size.
Furthermore, under Art. 69 EPC and Art. L. 613-2 French Intellectual Property Code the extent of the protection conferred by a patent was determined by the claims as amended after opposition proceedings, and the description and drawings were used to interpret the claims. According to the Court of Cassation, the Court of Appeal had considered the scope of the claims only in their final wording, noting that the application, originally filed with 24 claims, had been maintained after opposition proceedings with 11 claims of narrower scope.
On the Institute Pasteur's further objections that the Court of Appeal had ruled on claims 8 and 11 in their narrower scope, the Court of Cassation held that in determining the scope of claim 11 the Court of Appeal had been under no obligation to comment on amendments made during grant proceedings. It further held that in declining to determine the scope of claim 8 on the basis of the grant proceedings, and merely noting that it had been amended in the course of them, the Court of Appeal had assessed the claim on the basis of its final wording. Lastly, the Court of Cassation noted that determining the scope of a claim was not the same thing as deciding whether it had been infringed.
GB United Kingdom
House of Lords of 21 October 2004 - Kirin-Amgen Inc et al. v Hoechst Marion Roussel Ltd et al. [2004] UKHL 46
Keyword: extent of protection - interpretation of claims - equivalents - Protocol on the Interpretation of Art. 69 EPC - Protocol questions - DNA sequences - erythropoietin
The proceedings concerned European patent EP 0 148 605 B2, relating to the production of erythropoietin ("EPO") by recombinant DNA technology. The owner of the patent, Kirin-Amgen Inc ("Amgen") had alleged that Transkaryotic Therapies Inc ("TKT") had infringed the claims of the patent. It was held at first instance that the claims were infringed but were bad for insufficiency. The Court of Appeal held that the claims were valid but not infringed. Amgen appealed against the finding that the claims were not infringed and TKT and others claimed a declaration of non-infringement and revocation of the patent. The House of Lords held that TKT did not infringe any of the claims. Amgen's patent was revoked on the basis that one of the claims was invalid on the ground of anticipation and that another one was invalid for insufficiency.
Construction of claims:
Lord Hoffmann, who gave the leading opinion in the case, elaborated on the principles of construction of claims when considering the issue of infringement. He noted that Art. 84 EPC specified the role of the claims in an application to the EPO. The claims defined the matter for which protection was sought. The extent of protection was governed by Art. 69 EPC and the Protocol on the Interpretation of Art. 69 EPC ("the Protocol"). Lord Hoffmann concluded that the Protocol was intended to reject the artificial English rules for the construction of patent claims, also referred to as "literalism", which had been developed by common law prior to the Patents Act 1977, and turned to the principles of construction to be applied at present.
A court had to apply the same rules of construction for a patent as it applied for any other document. It had to pose the central question what the notional addressee would have understood the author to mean by using the words. The answer to this question would be highly sensitive to the context of and background to the particular utterance.
In the case of a patent specification, the notional addressee was the person skilled in the art. He would come to a reading of the specification with common general knowledge of the art. He would read the specification on the assumption that its purpose was both to describe and to demarcate an invention - a practical idea which the patentee has had for a new product or process.
In the context of patent claims the essential question that the court had to answer was, "What would a person skilled in the art have understood the patentee to have used the language of the claim to mean?" This principle of purposive construction meant that the language chosen by the applicant was usually of critical importance. The skilled man would ordinarily assume that the patentee had chosen the language to express his invention with great accuracy. Furthermore, the words were usually chosen upon skilled advice. Nevertheless, there would be some occasions where it would be obvious to the skilled man that the patentee must in some respect have departed from conventional use of language or included in his description of the invention some element which he did not mean to be essential. Those occasions would not happen very often.
The doctrine of equivalents and the Catnic approach:
"Literalism", according to Lord Hoffmann's assessment, could stand in the way of construing patent claims so as to give fair protection to the patentee. Two things could be done. One was to adhere to literalism in construing claims and evolve a doctrine which supplements the claims by extending protection to equivalents (this is what the Americans had done). The other was to abandon literalism. This is what the House of Lords had done in the Catnic case (Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183), where it adopted a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming. Since the Catnic case, one had Art. 69 EPC, which firmly shut the door on any doctrine which extended protection outside the claims.
Lord Hoffmann stressed that the Catnic approach accorded with the Protocol. The Protocol was a protocol for the construction of Art. 69 EPC and did not expressly lay down any principle for the construction of claims. The Protocol said what principles should not be followed, namely the old English literalism, but otherwise it said only that one should not go outside the claims. It also said that the object was to combine a fair protection for the patentee with a reasonable degree of certainty for third parties. A principle of interpretation which gave a fair protection to the patentee would be one that gave the patentee the full extent of the monopoly which the person skilled in the art would think he was intending to claim. A principle which provided a reasonable degree of protection for third parties would be one that did not give the patentee more than the full extent of the monopoly which the person skilled in the art would think that he was intending to claim. The Catnic approach was thus in accordance with the Protocol. It was intended to give the patentee the full extent, but not more than the full extent, of the monopoly which a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim.
Although Art. 69 EPC prevented equivalence from extending protection outside the claims, there was no reason why it could not be an important part of the background of facts known to the skilled man which would affect what he understood the claims to mean. When speaking of the "Catnic principle" it was important to distinguish between, on the one hand, the principle of purposive construction which gave effect to the requirements of the Protocol, and, on the other hand, the guidelines for applying that principle to equivalents, which were encapsulated in the "Protocol questions". These questions had been used by English courts for the past fifteen years as a framework for deciding whether equivalents fell within the scope of the claims.
GB United Kingdom
Patents Court of 21 July 2005 - Halliburton Energy Services Inc v Smith International (North Sea) Ltd [2005] EWHC 1623 (Pat)
Keyword: interpretation of claims - Art. 69 EPC
The judge noted that the principles to be applied to the construction of claims had been set out in Lord Hoffmann's speech in Kirin-Amgen v Hoechst Marion Roussel [2004] UKHL 46. In view of the approval that was given in that speech to the observations of Jacob L.J. in Rockwater v Technip France SA [2004] EWCA Civ 381, the judge set out this list with the modification he thought necessary to take into account the single criticism that Lord Hoffmann had made of this list:
(a) The overarching principle is contained in Art. 69 EPC.
(b) Art. 69 EPC says that the extent of protection is determined by the terms of the claims. It goes on to say that the description and the drawings shall be used to interpret the claims. In short, the claims are to be construed in context.
(c) The claims are to be construed purposively - the inventor's purpose being ascertained from the description and drawings.
(d) The claims must not be construed as if they stood alone - the drawings and description only being used to resolve ambiguity. Purpose is vital to the construction of claims.
(e) When ascertaining the inventor's purpose, it must be remembered that he may have several purposes depending on the level of generality of his invention. Typically, for instance, an inventor may have one, generally more than one, specific embodiment as well as a generalised concept. But there is no presumption that the patentee necessarily intended the widest possible meaning consistent with his purpose be given to the words he used: purpose and meaning are different.
(f) Purpose is not the be-all and end-all. One is still at the end of the day concerned with the meaning of the language used. Hence the other extreme of the Protocol - a mere guideline - is also ruled out by Art. 69 EPC itself. It is the terms of the claims which delineate the patentee's territory.
(g) It follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements.
Editor's note: Whilst Halliburton lodged an appeal with the Court of Appeal, this did not concern the construction of some of the claims. Halliburton accepted the findings of the trial judge in this respect.
GB United Kingdom
Court of Appeal of 22. October 2009 - Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062
Keyword: Interpretation of claims - skilled reader
Virgin had sued Premium Aircraft Interiors ("Contour") for infringement of the UK part of its European patent (derived from a European divisional application), which related to a seating system for a passenger vehicle, particularly an aircraft, and a seating unit for a passenger system. The case was dismissed in the Patents Court inter alia because the scope of claim 1 of the patent was construed to be limited to a system using flip-over bed/seats, such that it did not encompass Contour's reclining seating system. Virgin appealed this part of the judgment, with Contour filing a cross-appeal for revocation of the patent contingent on the Court of Appeal finding the patent to be wide enough to cover its system.
Reversing the decision of the lower court, the Court of Appeal found that Contour's counter-claim failed on all objections, including that regarding scope of protection. Some observations on the matter of claim construction for the purpose of determining the scope of protection of a patent were made by Jacob LJ.
After reiterating the general principles for applying Art. 69 EPC as previously approved by the House of Lords in Kirin-Amgen v Hoechst Marion Roussel [2005] RPC 9 and refined in Halliburton v Smith International [2005] EWHC 1623 (Pat), Jacob LJ identified three further matters arising from Contour's case. These involved the question of how much of the law and practice of the patent system the skilled reader was supposed to know and thus take into account when trying to work out what, by the words of his claim, the patentee was intending to mean. Following Kirin-Amgen, the skilled reader was taken to suppose that the patentee would know some patent law - that his claim was for the purpose of defining the monopoly and that it should be for something new. Knowledge of that could well affect how the claim was read. The aspects to be considered here were the explicit drafting conventions by which the patent and its claims were framed and, where there was a reference to the patent being a divisional application, knowledge of the divisional system.
As the first point, therefore, the use of numerals should not influence the construction of the claim. Patentees were told by R. 29(7) EPC 1973 that numerals in the claim would not be used to limit it. If a court subsequently paid attention to these to limit the claim, that would not be fair, and patentees would wisely refrain from inserting numbers in case these were used against them. Numbers helped a reader orient himself at the stage when he was trying to get the general notion of what the patent was about, but the claim must be construed as if the numbers were not part of it. The Court thus rejected Contour's argument that a numeral referring to the only specific embodiment, which was a flip-over bed/seat, also indicated a limitation to this type of seat.
Secondly, on the question whether, in view of R. 29(1) EPC 1973, the skilled reader at least expected the pre-characterising portion of a two-part claim to describe matter which was prior art, Jacob LJ stated that, even without a two-part structure, because the skilled reader knew that the patentee was trying to claim something which he, the patentee, considered to be new, he would be strongly averse to ascribe to the claim a meaning which covered that which the patentee acknowledged was old. And if the patentee not only acknowledged that a piece of prior art was old but then had a pre-characterising clause which was fairly obviously based on it, the skilled reader would be even more strongly inclined to read that clause as intended to describe that old art. Accordingly, in the instant case, since flip-over seats were not old, the skilled reader would not expect the language used (in the pre-characterising portion) to be limited to this type of seat. Indeed, there was nothing in the claim at all about flip-over seats.
Thirdly, as a more general issue, for cases where there was a reference to the patent being a divisional application, the skilled reader would know about the practice of divisional applications (cf. Art. 76, R. 25 EPC 1973). This could affect his understanding of a claim because he would know that there were, or could be, aspects of what was described in the patent which were actually claimed in some other patent(s) divided out from the original application. The skilled reader would expect the flip-over bed/seat of the only specific embodiment to be patented somewhere, but, knowing that what was in the contested patent had been divided out, he would not necessarily expect it to be done there.
Focusing on the problem of the lost space behind the bed/seat and on the space-packing idea of using the bed to extend into it (as set out in the characterising part of claim 1), Jacob LJ stated that this was self-evidently unrelated to whether the bed flipped over or not. So the skilled reader would have no reason to suppose that the patentee intended to limit his claim to flip-over bed/seats.
In conclusion, claim 1 was held not to be limited to this type of seat.
IT Italy
Milan District Court of 22 October 2005 (22222/05) - Assograph v Termozeta
Keyword: interpretation of claims
The description and claims of a patent are complementary: the description has the function of showing the technical aspects and disclosing the invention itself, whereas the claims are the manifestation of the will to customise the specific protection claimed, so anything that is not described and, at the same time, claimed cannot be patented. Even though the limits of the protection granted by a patent are defined by the language of the claims, the description and drawings are useful for interpreting the claims according to the principle expressed in Art. 8 Strasbourg Convention dated 11 November 1963 and ratified by Law No. 260/1978. Such an interpretation allows for an appropriate balance between the public interest, as ensured by the main function attributed to the claims, on the one hand, and the adequate protection of the applicant, on the other. The latter should not be excessively penalised just because the addressee of the patent application has difficulty in understanding the claimed subject-matter, as long as this difficulty is easily overcome by consulting the patent text as a whole.
NL Netherlands
Supreme Court (Hoge Raad) of 22 December 2006 - Dijkstra v Saier
Keyword: interpretation of claims - use of prosecution history file
In the infringement proceedings before the Court of Appeal, the patentee had reclaimed part of European patent EP 0 565 967 (synthetic bucket with a lid) which had previously been excluded from protection during the opposition proceedings before the EPO in order for the patent to meet the requirements of patentability. To prevent the patentee from recovering the surrendered part of the patent, the defendant had invoked the prosecution history file, in particular the patent as originally granted as well as the opinion of the technical board of appeal in its decision on the opposition filed against the patent. However, the Court of Appeal dismissed these references as it saw no reason to consult the grant file; the claim was sufficiently clear on its own and did not provide cause for that kind of consultation.
On appeal in cassation against this judgment, the Supreme Court set aside the Court of Appeal's decision and remitted the case for further prosecution. The Supreme Court stated in its grounds that there was no common understanding among the EPC member states as to whether the grant file might be relevant for interpreting a patent, and if so, when and to what extent. The Court confirmed its previous ruling laid down in the decision of 13 January 1995, Ciba Geigy v Oté Optics. The latter had followed a complaint directed against the position of the Court of Appeal that the publicly accessible part of the prosecution history file could - to a certain extent - be invoked against the patentee, but could under no circumstance be used in favour of an interpretation of the patent defended by the patentee and disputed by a third party being sued for infringement. By reference to that landmark decision, the Supreme Court clarified in the instant case that the Court could only make use of elucidating information in the grant file if it took the view that, even after studying the description and drawings, the average skilled person would still have reasonable doubts as to how to understand the claims' content, related to the use of such information in support of the patentee's interpretation of the patent. That restrictive rule was conducive to ensuring reasonable legal certainty for third parties when interpreting the patent. However, if a party other than the patentee invoked the grant file in support of its interpretation of the patent, the Supreme Court could not see any reason why such requirement should entail any restriction with respect to the use of publicly accessible information found in the grant file.
NL Netherlands
Supreme Court (Hoge Raad) of 7 September 2007 - Lely v Delaval
Keyword: interpretation of claims
With reference to Art. 69 EPC and the Protocol on its interpretation, the Supreme Court reaffirmed the ruling laid down in its landmark decision of 13 January 1995, Ciba Geigy v Oté Optics, which provides guidance on the interpretation of claims. In this respect, the Court clarified that, when determining the scope of patent protection, the essence of the invention for which protection is sought, i.e. the inventive concept underlying the wording of the claims, was not a starting point for the interpretation of those claims, but merely a viewpoint opposite to the literal wording of the claims (the two "extremes" in the wording of the Protocol on Art. 69 EPC).
Editor's note: In its decision of 13 January 1995 - Ciba Geigy v Oté Optics, the Supreme Court introduced a series of steps for defining the scope of protection. The court has (i) to determine the essence of the invention, (ii) assess whether an interpretation of the claims by considering the essence of the invention gives reasonable protection to third parties, (iii) use the public parts of the grant file, an interpretation in favour of the patentee necessarily being be restrictive and (iv) take into account the specific circumstances of the case, including the scope of the invention. For a summary of this decision see European National Patent Decisions Report, 1st ed. 2004, p. 210.
IV. PRIORITY
AT Austria
Supreme Patent and Trademark Chamber of 27 June 2007 (Op 7/06)
Keyword: priority - same invention - numerical values
Citing Art. 4C(4) Paris Convention, the petitioner asserted in this case that priority had not been validly claimed. The patent in suit concerned a diagnostic agent for use as a contrast agent in diagnostics. The Supreme Patent and Trademark Chamber referred to the relevant jurisprudence of the EPO boards of appeal and concluded that the scope of the right to priority extended to the same invention. Under Art. 88 EPC, priority for a claim in a European patent application was to be acknowledged only if the person skilled in the art could derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole. The disclosed subject-matter of the first application and the claim of the subsequent application were not identical if the latter displayed additional features. Subject-matter defined by multiple features in a patent application could claim only one priority. If individual features of the subject-matter had different priorities, the subject-matter as a whole enjoyed the priority only of the prior application in which the entire range of features was first disclosed. A claim with a number of different features giving rise to a right of priority had, as a whole, only the priority assigned to the most recent feature.
Indications of numerical values in patent claims had always been binding and essential; they could not be changed in any way without significantly modifying the technical meaning of the values. An application that cited a previous application as giving rise to a right of priority could thus specify as a mandatory feature in the claims only ranges that were the same as or narrower - but not broader - than those specified in the previous application. The Supreme Patent and Trademark Chamber took the view that in the case in question the deviation (of two-and-a-half powers of ten) from the concentration range's lower limit was no longer within the standard tolerance range. The concentration range in the contested patent's claim (1 µmol - 0.5 nmol) went beyond the range specified in the priority document and was thus an additional feature in this claim.
GB United Kingdom
Patents Court of 12 June 2009 - Edwards Lifesciences AG v Cook Biotech Inc [2009] EWHC 1304 (Pat)
Keyword: priority - entitlement - joint applicants
The international application on which the contested patent (European patent EP (UK) 1 255 510) was based claimed priority from a US application filed in the names of three joint inventors, one of whom was an employee of the defendant/patent proprietor, Cook, at the time the invention was made. The international application was filed in the name of Cook but at that time the only interest it had in the invention was via the employment contract of the aforementioned employee. The interests of the other two inventor-applicants were assigned to Cook 21 months after the filing of the international application but before the grant of the patent. Cook's entitlement to claim the priority was challenged by Edwards in view of a document published in the priority interval.
The proprietor's case that its claim to priority was good because it had acquired all the rights in the invention before the date of grant of the patent-in-suit and in any event had always owned the interest of its employee was rejected by the judge, who said that the effect of the relevant provisions on entitlement to priority, namely s. 5 Patents Act 1977 and Art. 4 Paris Convention (cf Art. 8 PCT), was clear. A person who filed a patent was afforded the privilege of claiming priority only if he himself had filed the earlier application from which priority was claimed or if he was the successor in title to the person who had filed it. Moreover, his position was not improved if he subsequently acquired title to the invention. It remained the case that he was not entitled to the privilege when he filed the later application and made his claim. Any other interpretation would introduce uncertainty and the risk of unfairness to third parties. The boards of appeal of the EPO had adopted the same approach to the interpretation of Art. 87 EPC in J 19/87 and T 62/05.
Accordingly, the judge disposed of Cook's submission (based on s. 7 Patents Act 1977) that because it was entitled to file the application and, as the successor in title to all the inventors as a result of the later assignment, was also entitled to the grant of the patent, the position must be the same in relation to priority. section 7 Patents Act 1977 dealt with the separate issue of the right to the grant of a patent and it was not permissible to interpret the Paris Convention in the light of it.
Cook's further argument that it was sufficient that it had always owned its employee's interest in the invention also failed. The US application had been filed in the names of all three joint inventors, not by the employee alone. Therefore he was not "a person" who had "duly filed an application for a patent" within the meaning of Art. 4A(1) Paris Convention. Once again, this approach was consistent with that adopted by the board of appeal of the EPO in T 788/05.
In sum, Cook's acquisition of all the rights in the invention at a later date did not permit it to claim the priority and the patent was entitled only to the international filing date.
Editor's note: The validity of the priority date did not become relevant in the subsequent appeal proceedings (see Cook Biotech Inc v Edwards Lifesciences AG [2010] EWCA Civ 718).
GB United Kingdom
Patents Court of 23 June 2010 - KCI Licensing Inc et al. v Smith & Nephew plc et al. [2010] EWHC 1487 (Pat)
Keyword: priority - entitlement - joint applicants
This case concerned the entitlement to priority of two European (UK) patents, derived respectively from a European parent and a European divisional application originating from an international application. Applicants for the international application were a Mr Lina for the US, KC Inc (parent company of all the claimants) for all PCT designated states except the US, and Mediscus, a wholly-owned subsidiary of KC Inc, for "GB only". The US priority application, however, had been filed in the name of Mr Lina as sole inventor and applicant. It was not disputed that for the patents in suit KC Inc only had the right to claim priority if, at the time the PCT application was filed, KC Inc was Mr Lina's successor in title. Therefore the judge had to decide, inter alia, whether the terms of an earlier confidentiality agreement entered into by Mr Lina in favour of his employer, KC Inc, were sufficient to transfer to it his rights in the future invention.
For this purpose the judge followed the relevant rules of English law, which were taken to correspond to the applicable law. In particular, s. 7(2)(b) Patents Act 1977 proceeded on the basis that it was possible for a person other than the inventor to acquire the whole of the property in an invention by means of an agreement entered into with the inventor before the making of the invention. In the judge's view, this meant that it was possible to assign the legal title (and not just the beneficial interest) in an invention before it was made. Accordingly, the terms of the confidentiality agreement were effective to assign to KC Inc legal title to the invention, such that KC Inc was Mr Lina's successor in title at the date of the international application and hence entitled to claim priority, in accordance with Art. 4A(1) Paris Convention, from the priority document. Referring to decision J 19/87 of the Legal Board of Appeal, the judge further held that even if the agreement was not effective to convey the legal title to the invention, it was effective to transfer the entire beneficial interest in it. When determining whether a person was a "successor in title" for the purposes of Art. 4(A)(1) Paris Convention (also Art. 87(1) EPC), it must be the substantive rights of that person, and not his compliance with legal formalities, that mattered.
A further question was whether the validity of the priority claim would be adversely affected if Mediscus, designated for GB only, was co-applicant with KC Inc, which the judge decided it was not for the purpose of the European part of the international application, this being the only part material to the entitlement of the patents in suit to priority. The judge accepted the proprietor's submission that, contrary to the position in Edwards v Cook [2009] EWHC 1304 (Pat) (see above) and board of appeal decision T 788/05 (in both cases priority claimed by only one of joint applicants of an earlier application), in the instant case the priority application had been filed by a single applicant and that it was possible for a single priority applicant to share its rights to the invention with another person so as to entitle both to claim priority for a later joint application.
In conclusion, the judge held that the patents were entitled to the claimed priority date.
V. EUROPEAN PATENTS SUBJECT TO LITIGATION IN MULTIPLE JURISDICTIONS
1. Extended-wear ophthalmic lens (EP 0819 258)
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 11 February 2009 - Novartis v Johnson & Johnson
Keyword: interpretation of claims - parameters
European patent EP 0 819 258 owned by Novartis concerned an ophthalmic lens suitable for prolonged use without causing significant damage to the eye. When sued by the patent proprietor for infringement, Johnson & Johnson filed a counterclaim for invalidity on the grounds that the patent was non-reproducible and lacked novelty. In particular, one of the arguments was that the main claim did not involve any essential technical features of the underlying invention, but merely addressed a desired outcome.
Whilst The Hague District Court agreed that the main claim lacked clarity contrary to Art. 84 EPC, it decided that this did not constitute grounds for revoking the patent. In the Court's view, the patent was reproducible because the specification gave several examples of extended-wear contact lenses, thereby enabling the skilled person to carry out the invention. The parameter thresholds described in the patent were good predictors of the lens's suitability for wearing over an extended period of time. Moreover, the actual suitability could easily be determined through routine clinical tests which, if carried out by the skilled person in compliance with the parameter requirements, would - in most cases - result in a product with technical features such as those specified in the patent at issue. Thus, the defendant's argument that the claimed invention was only obtainable with undue burden to the skilled person could not be upheld.
The Court upheld the patent, additionally granting an injunction against Johnson & Johnson to block further sales of the related Acuvue Oasys product in the Netherlands.
GB United Kingdom
Court of Appeal of 29 September 2010 - Novartis AG v Johnson & Johnson Medical Ltd [2010] EWCA Civ 1039
Keyword: sufficiency of disclosure - undue burden - predictability of success - burden of proof
Novartis (N), having sued Johnson & Johnson (J&J) for infringement, appealed the decision of the Patents Court which revoked its patent for extended wear contact lenses (EP (UK) 0 819 258) on the ground of insufficiency. N contended that:
- the burden of proof lay with J&J to show that the instructions in the patent could not be used to produce the lens claimed and that J&J had, by not conducting any experiments, failed to discharge this burden;
- predictability of success in producing a lens which "worked" was not a relevant consideration for insufficiency;
- the judge at first instance had applied the wrong test for sufficiency, mixing in irrelevant considerations of obviousness or anticipation.
- the judge at first instance had overlooked the fact that J&J were running two inconsistent cases, one of obviousness and the other of sufficiency. There was evidence from J&J's witnesses that a lens falling within the claim could be made and tested and accordingly the case of insufficiency had to fail.
The appeal was dismissed. The patent was insufficiently disclosed; its teachings were either matters of common general knowledge which did not enable the skilled person to produce an extended wear silicone hydrogel lens without needing inventive skill or were not such as to provide any general teaching as to how such lenses could be made without undue effort.
According to Jacob LJ, the patentees had even admitted that they did not know whether the examples given in their own patent actually "worked". This did not appear to have been made clear in the parallel proceedings in Holland, France and Germany, nor before the EPO (in T 246/04), in all of which the courts assumed that the examples worked. None of the parallel decisions recognised just how devoid of meaningful limitations the claim at issue was. This was perhaps explicable on the basis that the courts concerned assumed that the examples worked and they did not have the benefit of the intensive probing of facts and expert evidence afforded by cross-examination which was provided by English procedure. It was irrelevant that J&J had not done experiments to prove that the instructions in the patent could not be used to produce a lens complying with the claim. Of course a skilled man could make a lens falling within the very wide physical limitations of the claim and he could test it to see whether it "worked". It might or might not - the patent gave no clue as to whether he would be successful. It was manifestly not enabling across the range claimed.
Moreover, predictability could be relevant to sufficiency, as here, where the functional limitation of the claim to ophthalmic compatibility was so crucial. The patent gave no indication as to the predictability of success. The skilled person would have to do his own research, requiring the making and testing of many pairs of polymers, various proportions and also perhaps surface treatments.
The skilled reader would thus not be able to discern from the patent that any of the examples "worked". Once it came to sufficiency, this mattered. For, without any guidance from the examples, what was the skilled person to do? The skilled person was to select two polymerisable materials from two vast classes. The reader was given little guidance as to the respective proportions of the polymers. Although informed that ion permeability was an unexpected predictor of the important on-eye movement, he was not told how to use this. The only way the patent offered to find out whether you had got everything right was to test it - if it "worked", well and good, but this would tell you nothing about the remainder of the vast ambit of the claim. If it did not "work", the patent did not help you with what to do next.
This was a long way off from satisfying the sufficiency test and Jacob LJ referred with approval to the principles laid down in T 435/09 (Reasons 2.2.1), as well as to T 494/92, where the board explained how Art. 83 EPC could interplay with Art. 84 EPC considerations. The heart of the test for sufficiency was, "Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?"
J&J submitted that T 1743/06 was closely analogous to the case at issue. Here, the board of appeal had held that the skilled person was confronted (for part of the claimed patent) with a lot of process variables affecting the claimed parameters, but once he had encountered failure in one parameter value, there was no clear guidance enabling him to adjust the multitude of process steps in order to arrive with certitude at the claimed invention. Although a reasonable amount of trial and error was permissible, the broad definition of the claim at suit was no more than an invitation to perform a research program, and the requirement of Art. 83 EPC that the skilled person be given sufficient guidance for performing the invention without due burden over the whole range claimed was not fulfilled.
Jacob LJ agreed that this also applied to the case before the Court of Appeal. The judge at first instance had had the correct test in mind. The patent was manifestly not enabling across the range claimed. It was revoked in its entirety.
FR France
Paris Court of Appeal of 27 October 2010 (09/08135) - Johnson & Johnson v Novartis
Keyword: sufficiency of disclosure - skilled person - definition - team
Novartis instituted proceedings against group Johnson & Johnson for infringing European patent EP 0 819 258 by marketing ophthalmic lenses which it considered reproduced the characteristics protected by claim 1 of its patent.
In its judgment of 25 March 2009, the Paris District Court had rejected J&J's request for revocation of the French part of the European patent.
Group J&J, the appellant, had requested that the Court of Appeal revoke claim 1 of the French part of the European patent for insufficiency of disclosure, lack of novelty and, on an auxiliary basis, lack of inventive step.
Insufficiency of disclosure:
The parties agreed on the relevance in the case at issue of the principle that, to be regarded as sufficient within the meaning of Art. 138(1)(b) EPC, the disclosure had to be such that the invention could be carried out over the whole range claimed without undue burden by the person skilled in the art. They did not contest the definition of the person skilled in the art as specified in the judgment, i.e. a team consisting of a polymer chemist, to develop appropriate materials, a physicist, to determine the physical properties of the lenses, and an ophthalmologist specialising in contact lenses.
The Court of Appeal closely examined each of J&J's submissions in relation to materials and ion permeability values and concluded that the contradiction alleged by the appellant had not been proven. In submissions relating to the examples, J&J had maintained that the person skilled in the art would not have been able to tell from the description which of the examples in the long but meaningless list provided would ensure the effective implementation of claim 1; nor would the description have helped the skilled person in any way to look beyond these examples or seek improvements. In any event, J&J had argued that evaluating the examples would have required undue burden, given the significant number of tests and particularly clinical trials this involved. The Court ruled, however, that company N had been right to consider the operations as routine and the high number of operations that had to be performed as failing to constitute an undue burden implying insufficiency of disclosure.
Measuring the oxygen transmissibility parameter:
The appellant insisted that the disclosure was insufficient because the DK 1000 instrument and accessories needed to measure oxygen transmissibility were no longer available and the measuring method itself was insufficiently explained. The Court, however, ruled that N's assertion that the skilled person would have no major difficulty building an instrument similar to the DK 1000 or having one built, given its use of laws of chemistry that had been around for over a century, had not been seriously refuted. The Court stated furthermore that J&J was wrong to claim that the patent disclosed two contradictory methods for wet measurement, leading to confusion for the skilled person.
In short, the Court upheld the judgment insofar as it rejected the request for revocation of claim 1 of the patent for an alleged insufficiency of disclosure which would prevent a skilled person from reproducing the invention over the whole range claimed without undue burden.
Novelty:
In seeking to demonstrate that the European patent in suit (EP 0 819 258) was not novel, the appellant did not deny that for prior art to be novelty-destroying it had to be definite (i.e. there could be no doubt whatsoever about its existence or content), sufficient (i.e. it had to include enough information for the skilled person to understand and reproduce the claimed invention without undue burden on the basis of the disclosure as it stood) and complete (i.e. it had to disclose all features of the invention in the same form, arrangement and action with a view to achieving the same technical result).
The appellant did not claim that the prior art it cited met these criteria because it disclosed, explicitly and under the conditions already described, the teachings of the patent in suit, but maintained that implementing the art described in the earlier patents cited nevertheless destroyed the novelty of the claim because they implicitly disclosed its content, clearly enabling lenses with the claimed features to be manufactured.
The Court examined the priority claims in advance and pointed out that the prior art to be used for assessing the novelty of an invention was that which was contemporaneous with the patent application whose priority had been validly claimed when the application for the contested patent was filed. Art. 88(2) EPC allowed multiple priorities to be claimed.
The parties accepted that a later application could not validly claim the priority of an earlier one except insofar as the invention claimed in the later application was the same invention as that described in the earlier one. This was the case only if the person skilled in the art could derive the subject-matter of the claimed invention directly and unambiguously, using common general knowledge, from the earlier application. Thus on this point the Court of Appeal agreed with the conclusions of the Paris District Court. It then did a thorough examination for lack of novelty in the light of the various earlier patent applications, and concluded that novelty had been established, echoing the Paris District Court ruling on this point too.
Similarly for inventive step, following a thorough examination, the Court upheld the ruling dismissing the plea for revocation for alleged lack of inventive step, given that the definition of the person skilled in the art as specified in the judgment, i.e. a team consisting of a polymer chemist, to develop appropriate materials, a physicist, to determine the physical properties of the lenses, and an ophthalmologist specialising in contact lenses, had not been contested by the parties.
2. Olanzapine (EP 0 454 436)
ES Spain
Barcelona Court of Appeal (Audiencia Provincial) of 17 January 2008 (appeal no. 368/2007) - Laboratorios Cinfa et al. v Eli Lilly and Company Ltd
Keyword: product claim - reservation under Art. 167 EPC - valid and enforceable - TRIPS
In this dispute the appellants had applied for, inter alia, a declaration of invalidity in respect of claim R5 of patent ES 2 078 440 (EP 0 454 436), the product in itself of olanzapine, on the grounds that this was a product patent filed prior to 7 October 1992 and ineffective because of the reservation made by Spain to the EPC.
The Chamber of the Barcelona Court of Appeal refused the application just as the court of first instance had done. In this respect, the Court made it clear in its judgment that reservations to the EPC (Art. 167 EPC) were maintained or withdrawn within the framework of the Munich Convention, without prejudice to the fact that all contracting states had signed other international agreements that imposed binding obligations on them in respect of patents. It was up to each state's national judicial authorities to determine the extent to which rights granted to individuals by international agreements signed by that state, including the EPC, had to be protected. And with regard to TRIPS, the Court emphasised how the right to patent without discrimination undoubtedly extended to chemical and pharmaceutical products as such and how the Agreement affected patents granted prior to 1 January 1996, as this is what was established by the transitional provisions under the TRIPS Agreement.
The Court explained in its judgment that if the signing by Spain of the Agreement Establishing the World Trade Organization and its Annex 1C, TRIPS, were disregarded, the appellants' claims would obviously be supported by the law because, before the Agreement was signed, it was clear that patents for chemical or pharmaceutical products were ineffective prior to 7 October 1992, although any declaration of invalidity had to be ruled out. However, the signing of the TRIPS Agreement, in force since 1 January 1995, had changed the legal context significantly. The Chamber held that Spain could not get around the provisions of Articles 27(1) and 70(2) of the TRIPS Agreement, as they directly affected patents granted prior to that Agreement's entry into force and had since then conferred protection on patents for chemical or pharmaceutical products. And it concluded that claim 5 contained in the European patent, while certainly a product claim, was not to be declared invalid for that reason alone since, on the contrary, thanks to the direct application of the TRIPS Agreement, it had to have all the corresponding effects.
Editor's note: for similar reasoning see also Madrid Court of Appeal (Audiencia Provincial) of 26 October 2006; Barcelona Court of Appeal (Audiencia Provincial) of 30 June 2008; and Barcelona Court of Appeal (Audiencia Provincial) of 27 March 2009.
NO Norway
Oslo District Court (Tingrett) of 2 December 2008 - Actavis Norway AS v Eli Lilly and Co. Ltd
Keyword: novelty - inventive step - problem-solution approach
The case concerned the validity of the Norwegian part of Eli Lilly's patent NO 178 766 relating to olanzapine, a drug for the treatment of schizophrenia marketed by Eli Lilly under the trade mark Zyprexa. Actavis filed an invalidity action and claimed that the requirements for novelty and inventive step were not met. The prior art cited was an article by Chakrabarti (1980), which did not make direct reference to olanzapine but disclosed compounds similar in structure, and Eli Lilly's UK patent GB 1 533 235, which encompassed olanzapine among other molecules of the general formula defined in claim 1. Actavis argued that olanzapine was not novel, as it could be derived directly from Chakrabarti. In any event, the selection of olanzapine did not involve an inventive step, as the testing of compounds based on Chakrabarti would be limited and involve only purely routine work.
The District Court upheld the patent as valid and dismissed Actavis' action. The Court held that the novelty requirement was met, as it could not be derived from the cited prior art that olanzapine would treat schizophrenia while causing substantially less severe side-effects than known treatments.
Applying the problem-solution approach, the Court held that the patent involved an inventive step. Specifically, it solved the problem of producing a drug to treat schizophrenia with less severe side-effects than known treatments. The Court pointed out that even though the chemical solution claimed in the patent was not very different from what had previously been described in Chakrabarti, earlier research groups, with skills exceeding those of the ordinary practitioner, did not achieve this solution. It was only with hindsight that the selection of olanzapine could be regarded as routine. In addition, the commercial success of the drug Zyprexa provided a strong indication that the solution was not obvious.
Editor's note: Decisions from England and Germany in parallel proceedings at the time pointed in different directions, and little weight was ascribed to them by the Norwegian judge.
DE Germany
Federal Court of Justice of 16 December 2008 (X ZR 89/07) - Olanzapine
Keyword: novelty - selection inventions - prior art
The defendant was the registered proprietor of a European patent for a chemical compound with the generic name "olanzapine", its use as a drug, in particular as an anti-psychotic agent to treat schizophrenia and severe mania, and a process for producing the compound. In the proceedings at previous instance, the Patent Court had upheld the claimants' challenge to patentability on the grounds of a lack of novelty and inventive step and so revoked the patent.
The Federal Court of Justice found that the Patent Court had been wrong to revoke the patent and dismissed the admissible action as unfounded. In line with its previous case law, the Court first of all endorsed the uniform interpretation of disclosure:
Determining whether a prior document was prejudicial to the novelty of patent subject-matter required an examination of its entire content. The decisive factor was what technical information was disclosed to the skilled person. The relevant definition of disclosure was no different from that otherwise applied in patent law. The Court found that there was no need to establish how the skilled person, using for example his specialist knowledge, could implement, or might modify, an existing general teaching, but only what that person would gather from the prior document as the content of that (general) teaching. As worded in the case law of the Federal Court of Justice and the EPO boards of appeal, the relevant question was what a skilled person could "directly and unambiguously" gather from a document. This did not contradict the Court's previous view that, having regard especially to the aim of avoiding double patenting underlying the (separate) examination of novelty, it was essential to extend the scope of disclosure prejudicial to novelty beyond the "mere wording".
Matter not expressly mentioned in the patent claim or description could also be deemed disclosed if the skilled person would consider it part of implementing the protected teaching as a matter of course, so that it did not require special disclosure, but was "taken as read". The inclusion of such obvious matter did not, however, make it permissible to supplement the disclosure with specialist knowledge; rather, just as with interpreting the wording of a patent claim, it merely served to ascertain the full scope of the content, i.e. the technical information gathered from the source by readers skilled in the art in the light of their expert knowledge. The Court considered that this general assessment of the disclosed content of chemical formulas was largely in line with the case law of the EPO boards of appeal cited by the High Court of England and Wales in proceedings for revocation of the patent. According to that case law, technical teachings were prejudicial to novelty only where they disclosed a substance either as the inevitable result of a previously described method or in specific, i.e. individualised, form.
GB United Kingdom
Court of Appeal of 18 December 2009 - Dr Reddy's Laboratory (UK) Ltd v Eli Lilly & Co. Ltd [2009] EWCA Civ 1362
Keyword: novelty - selection inventions
Dr Reddy's Laboratory("DRL") appealed against a judgment dismissing DRL's application for revocation of Eli Lilly's, the respondent patentee's, EP (UK) 0 454 436 on the grounds of lack of novelty, lack of inventive step and insufficiency. The patent related to a single chemical entity called olanzapine.
DRL contended that olanzapine formed part of the state of the art, having been disclosed in a document, where, whilst it was not mentioned specifically, it was one of the 1019 compounds of formula (I) and one of the 86,000 compounds of the "preferred" class, having a useful nervous system activity. The contention amounted to this: that every chemical class disclosure discloses each and every member of the class.
The Court, dismissing the appeal, rejected this for two reasons: firstly as a matter of a priori reasoning and secondly because it was inconsistent with settled EPO board of appeal case law. Logic dictated rejection of the argument that a disclosure of a large class was a disclosure of each and every member of it, as did EPO case law (see T 296/87, which effectively summed up earlier cases). According to this, what one had to look for by way of an anticipation was an "individualised description" of the later claimed compound or class of compounds. The case at issue was miles from that. This view of the law accorded with the decision of the House of Lords in Synthon's Patent [2006] RPC 10. When a patented product or class of products falls within a greater class, the boards deploy the objection of obviousness where the patentee has made no real technical advance.
Thus, where you have a patent for a particular chemical compound and a prior-art general disclosure, performance of the general disclosure (which means no more than using anything within it) does not necessarily result in infringement of the patent. The Court of Appeal was pleased to note that the approach it adopted was not only the same as that in the EPO but also the same as that in Germany (see STADApharm case no. 1-2W 47/07, 29 May 2008).
FI Finland
Helsinki District Court of 19 February 2010 (decision no. 3641) - Eli Lilly v Oy Leiras Finland AB
Keyword: analogous process patent - doctrine of equivalence
In this infringement case, the Finnish court had to determine whether the defendant's generic olanzapine products which were sold and marketed in Finland infringed the Finnish patent FI 101 379 and the supplementary protection certificate based upon it, concerning the novel pharmaceutical substance olanzapine.
Due to the fact that, in Finland, product protection for pharmaceutical products was not available prior to 1 January 1995, the novel pharmaceutical substance olanzapine was protected by a so-called analogous process patent, i.e. the patentability of the patent in suit was based on the novelty and inventiveness of the end product while the patent claims described known processes for the manufacturing of the said product.
While taking into consideration Art. 57a Finnish Patents Act concerning the reversed burden of proof in the case of analogous process patents, the District Court found for the defendant and concluded that Leiras had established that its generic olanzapine products were manufactured by means of a process described in the European patents EP 1 513 845 and EP 1 814 886 ("Adamed Process").
However, in assessing whether the Adamed Process fell within the scope of protection of the patent in suit, the Court concluded that the scope of protection of an analogous process patent covered not only literally infringing manufacturing processes but also processes that were essentially identical to the process described in the patent claims. The Court found that (i) in the Adamed Process and in the process described in claim 1a of the patent in suit ("Lilly Process") the end product (olanzapine) and one of the starting compounds (benzodiazepine derivate) were the same; (ii) the most essential step was chemically the same in both syntheses; and (iii) the subsequent methylation step of the Adamed Process was a minor and routine-like supplementary step to obtain olanzapine.
Consequently, the Court found that the Adamed Process represented an obvious alternative to the Lilly Process and that the two processes were chemically equivalent. Moreover, the Court found that the patents granted for the Adamed Process did not bear any significance for the assessment whether the Adamed Process was equivalent to the Lilly Process. Applying the doctrine of equivalence, the Court concluded that the process used to manufacture olanzapine for Leiras' products infringed the patent in suit and ordered a permanent injunction.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 24 March 2010 - ratiopharm v Eli Lilly
Keyword: novelty - inventive step - error in the prior art
Eli Lilly was the proprietor of European patent EP 0 454 436 concerning olanzapine, the active ingredient of the drug Zyprexa. The latter was used for disorders of the central nervous system, in particular schizophrenia and schizophrenia-like ailments, and for the treatment of mild anxiety disorders. The advantage of olanzapine lay in the reduction of very serious side-effects such as uncontrollable movements of face, tongue, arms and legs caused by previous medicaments.
ratiopharm sought the revocation of the Dutch part of the patent and the related SPC before The Hague District Court. It argued that olanzapine was already directly and unambiguously disclosed in the studies Schauzu (1983) and Chakrabarti (1980). Eli Lilly denied that olanzapine had been previously disclosed. In particular, the basic molecule in Schauzu was not similar to the basic molecule of olanzapine; and olanzapine had a nitrogen atom, not a carbon atom as in the prior-art document. ratiopharm acknowledged that difference, but alleged that it was due to a readily recognisable error in the structure disclosed by Schauzu. The defendant questioned this, arguing that the skilled person would neither recognise the error nor be in a position to correct it.
The Court based its examination mainly on the alleged anticipation of olanzapine in the Schauzu prior-art document, which refers to Chakrabarti in one of its two footnotes. Citing the case law of the EPO boards of appeal, the Court distinguished between two scenarios: either the document included an error prima facie or the skilled reader would readily discover the error when studying source documents.
According to the Court, a disclosure might include a prima facie error that would mislead the skilled person regarding the prior art, but the relevant document should not be disregarded on these grounds. If the necessary correction was just as obvious – directly and unambiguously – as the existence of the error, then there was good reason to accept the corrected disclosure. If the skilled person did not immediately notice an error in the disclosure, he would consider that the publication solved a technical problem as disclosed. However, this principle did not apply if the disclosure as such included a reference to another document which the skilled person would undoubtedly consult and in which he would immediately discover that the information in question was not correct (T 591/90). In that case, the skilled person would again correct the error on the basis of the document consulted. At this point, the Court emphasised that the skilled person would be likely to consult the document, either because of doubts about the correctness of the disclosed information (T 412/91) or because the document was merely an abstract of the underlying document (T 77/87) or because he was confronted with entirely unknown prior art (T 591/90).
The Court concluded that the Schauzu document contained an error obvious to the skilled person without any further reference. Equally recognisable was the correction of that error. Olanzapine was directly and unambiguously disclosed in that single document. For that reason, there was no need for the skilled person to consult Chakrabarti. Should the skilled person still do so, the said reference would confirm his first assumption that Schauzu included an error. The patent was accordingly revoked.
Editor's note: At the end of its decision, the Court provided a brief overview of the outcome in the parallel cases in the UK, Germany, Austria and Canada.
3. Alendronate (EP 1 175 904)
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 13 February 2008 - Merck v Generics, ratiopharm et al.
Keyword: inventive step - dosage regime - double patenting
Merck was the proprietor of European patent EP 1 175 904 for the use of alendronate in the treatment of osteoporosis, which was granted pursuant to a divisional application. Oral alendronate preparations, which act against bone diseases such as osteoporosis, were already known before the oldest priority date and were marketed by Merck under the drug brand Fosamax with a daily standard dosage unit of 10 mg. Strict precautions were necessary to avoid serious gastrointestinal side-effects when oral preparations of alendronate were administered. In particular, the medicament had to be taken in the morning on an empty stomach and with a considerable amount of water; the patient must be standing or sitting upright and was not allowed to eat or drink anything for 30 - 60 minutes. Before the first priority date, no clinical trials had concluded that the side-effects of alendronate were dose-related. Moreover, the weekly total dose effect of alendronate at 70 mg had already been known before the first priority date, so the skilled person knew that daily or weekly administration would not have a significantly different impact on the absorption of alendronate in the body.
Generics marketed oral alendronate preparations for the treatment of osteoporosis in a once-weekly unit dose of 70 mg. Merck sued Generics for infringement of its patent. In its counterclaim action, Generics requested the revocation of the patent and a ruling that Merck had been guilty of multiple patenting.
The Court revoked the patent for lack of inventive step. The patent proprietor had failed to demonstrate that a once-weekly dose of 70 mg resulted in fewer side-effects than a daily dose of 10 mg. Moreover, it had failed to substantiate its assertion that a once-weekly dose of 70 mg was therapeutically more advantageous than a once-weekly dose of 40 or 80 mg as suggested in the closest prior art. Clinical studies did not provide any relevant support as they did not go beyond a comparison between 10 mg per day and 70 mg per week. In view of the above, the Court concluded that dosage regimes of alendronate preparations for the treatment of osteoporosis with a once-weekly dose of 70 mg should be deemed a non-inventive variation of the prior art at the time of the earliest priority date invoked in the case at issue.
As to the defendant's double-patenting arguments, the District Court disagreed, on the grounds that the patent granted on the basis of the parent application had previously been revoked. It observed that the EPO had nevertheless proceeded with the divisional application after - in the court's view, wrongfully - dismissing several third-party observations indicating unlawful double patenting. The Court referred to its earlier Medinol v Cordis judgment on the same subject in which it demonstrated how double patenting contradicted the principles of patent law. In this respect, the Court pointed out in the case at issue that the nullity grounds represented a closed system which ought not be opened through a back door, however undesirable the consequences might be.
CH Switzerland
Federal Court of 4 March 2011 (4A_435/2010) – Alendronic acid (Fosamax)
Keyword: patentability of a substance for treatment by therapy – dosage regime – Swiss-type claim
Merck held a European patent (EP 1 175 904) for the use of alendronic acid to treat osteoporosis. It was already marketing the drug Fosamax, which contained alendronic acid as its active agent and was taken in doses of 10 mg daily. Meanwhile, it put on the market a new form of Fosamax, to be taken in doses of 70 mg weekly. The Zurich Commercial Court ruled that the claimed new dosage was a method for treatment by therapy under Art. 2(2)(a) Swiss Patents Act and Art. 52(4) EPC 1973, and therefore not patentable. Devising the treatment plan best suited to the individual patient – including the prescription and dosage of medicines – was the task of the treating physician and thus a non-patentable method.
The Federal Court set this decision aside and sent the case back for retrial. With a view to a uniform interpretation of European patent law, its ruling cited the case law of the EPO boards of appeal and relevant decisions taken by other national courts (UK Court of Appeal of 21 May 2008, Actavis v Merck, and Paris District Court of 28 September 2010). The Court also dwelt at some length on G 2/08 (OJ EPO 2010, 456) and the relevant provisions of Articles 53(c) and 54(4) EPC (formerly Articles 52(4) and 54(5) EPC 1973):
Art. 53(c) EPC – like Art. 52(4) EPC 1973 before it – drew a distinction between non-admissible method claims directed to a treatment by therapy (first sentence) and grantable claims relating to products for use in such methods (second sentence). Both provisions carried equal weight; hence, method claims for treatment by therapy were absolutely excluded from patent protection, whereas claims directed to products for use in such methods were granted if their subject-matter was new and inventive. So Art. 53(c), second sentence, and Art. 54(4) EPC were not exceptions to the absolute exclusion of methods for treatment by therapy from patentability (Art. 53(c), first sentence, EPC), subject to a narrow interpretation; rather, they were provisions of equal rank whose purpose was to allow patent protection for pharmaceuticals.
Thus a product for use in a method for treatment by therapy might be patentable not only if it was new in itself and matter for which product protection could be sought; it was also patentable as a substance or composition under Art. 54(4) EPC even if it was already known per se but had not been used in a method for treatment by therapy. Under the EPC 1973, no provision had existed comparable to Art. 54(5) EPC 2000 expressly providing that products (substances or compositions) already known as pharmaceuticals could be patented. At the time, that gap was filled by "Swiss-type" claims for second or further medical uses. Since G 2/08, Swiss-type claims were no longer allowed, although Art. 54(5) EPC with its new claim category for substance protection limited to a specific use did not affect patents already granted. In these cases, the requirements of novelty and inventive step derived not from the substance or composition as such but from its intended therapeutic use.
Summing up, the Federal Court saw no reason to exclude patentability simply because the only claim feature not already part of the state of the art was a new dosage regime for a known medicament. But that regime had to be new and inventive. So the claim had to do more than merely define the dosage regime differently; it had to contain a technical teaching which departed from the prior art.
4. Finasteride (EP 0 724 444)
GB United Kingdom
Court of Appeal of 21 May 2008 - Actavis Ltd v Merck and Co Inc [2008] EWCA Civ 444
Keyword: novelty - second medical use - Swiss-type claims
The appellant, Merck, appealed against the decision holding its EP (UK) 0 724 444 invalid for lack of novelty pursuant to Art. 54 EPC (enacted as s. 2 Patents Act 1977) and the subject-matter unpatentable as a method of treatment pursuant to Art. 54(5) EPC (enacted as s. 2(6) Patents Act 1977). The respondent, Actavis, cross-appealed the judge's finding of non-obviousness.
The patent concerned the use of a drug called finasteride for the treatment of a condition known as androgenic alopecia that included male pattern baldness. The conventional therapeutic dose for that condition was 1 mg of finasteride daily. Under an earlier patent Merck had marketed finasteride under a different name for the treatment of benign prostatic hyperplasia. The conventional therapeutic dose for that condition was 5 mg of finasteride daily. The specification for the earlier patent disclosed that finasteride was beneficial in the treatment of androgenic alopecia but referred to a much larger dosage for that use than the dosage of from 0.5 mg to 1 mg referred to in the patent in suit.
The Court of Appeal upheld the finding on obviousness, but on novelty and method of treatment, it followed the settled view of European patent law of the boards of appeal and reversed the findings of the judge.
On the basis of G 5/83, the Court of Appeal held that Swiss form claims were allowable where the novelty was conferred by a new dosage regime or other form of administration of a substance. This was far from saying that in general just specifying a new dosage regime in a Swiss form claim could give rise to a valid patent. Such dosage regimes would nearly always be obvious. Only in an unusual case such as this (where treatment for the condition with the substance had ceased to be worth investigating with any dosage regime) could specifying a dosage regime as part of the therapeutic use confer validity on an otherwise invalid claim. Importantly, there was also now clear board of appeal authority holding that a novel dosage regime could confer novelty on a Swiss form claim.
The Court of Appeal decision of Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] RPC 253, did not contain a clear ratio that a Swiss form claim lacked novelty if the only difference between it and the prior art was the a new dosage regime for a known medical condition. The Court was not therefore "bound" by a ratio in this decision. However, it would be free but not bound to depart from the ratio decidendi of its own earlier decision if it was satisfied that the EPO boards of appeal had formed a settled view of European patent law which was inconsistent with that earlier decision. Generally, the Court of Appeal would follow such a settled view.
FR France
Paris District Court of 28 September 2010 (07/16296) - Actavis v Merck
Keyword: second therapeutic use – dosage regime – Swiss-type claim
Company M's European patent related to a medicament to treat androgenic alopecia. The patent stated that the problem to be solved was how "to administer the lowest dosage possible of a pharmaceutical compound to a patient and still maintain therapeutic efficacy".
Company A brought a case against Company M, seeking the revocation of the patent (French part) primarily on the grounds that a dosage was a treatment method and as such was not patentable.
The Court held that the use of finasteride to treat androgenic alopecia was already known, so just the dosage of around 0.05 to 1.0 mg was being claimed as new and protectable. The question was whether company M could patent the invention in respect of a particular dosage. Company M cited G 2/08.
The Court said that French courts were not bound by the decisions of the EPO, which was not a court of law: its decisions – even those issued by the Enlarged Board of Appeal – merely set out the analysis made by the EPO for the purposes of granting European patents. The same applied to the courts of EU member states.
The Court held that the Enlarged Board had drawn the logical conclusion from the new Art. 54(4) EPC, which allowed the same substance to be patented for a second medical indication, pointing out that Swiss-type claims were no longer applicable.
In addition, Art. 54(4) EPC, under which the same medicament could be patented for a second medical use, was totally silent on the possibility of patenting a certain dosage. This meant that the reply of the Enlarged Board was not based on the EPC but rather on an interpretation of what a dosage was, i.e. a second medical indication, something it was clearly not.
The Court held that a specific dosage for the treatment of an illness was neither a first nor a second medical use, but rather a mere indication of the range within which that substance was effective for treating a particular illness.
A medical use could therefore only apply to the use itself of a substance for treating a specific illness and not to the choice of a particular dosage from a range of effective dosages. It was up to the medical practitioner to determine the right dosage of the substance for treating the illness.
The ideal dosage as the sole indication belonged to the virtual world, and only the doctor was entitled to determine the appropriate dosage for a patient.
It was irrelevant whether the medicament thus protected was marketed by the company holding the patent together with a leaflet recommending a certain dosage, because that information was just a guideline and only the doctor was entitled to prescribe the appropriate dosage for treating a particular patient. Moreover, the leaflet that had to accompany every marketed medicament released for sale in France pointed out that the stated dosages merely provided a general indication and that a doctor should be consulted. In any event, the marketing of a medicament was not a relevant criterion for assessing its patentability.
It was therefore possible to patent a medicament for treating one illness and then a second, but not a dosage for treating those illnesses. Seeking a patent for a dosage would be an attempt to patent a therapeutic method, which was excluded as belonging to the realm of treatment and a matter for the doctor's discretion and responsibility.
The only novel aspect of claim 1 of patent EP 0 724 444 vis-à-vis the state of the art was the dosage specified, so it was excluded from patentability and therefore had to be revoked pursuant to Art. 53(c) EPC 2000.
As obiter dictum, the Court noted that even the patentability conditions set by the EPO had not been met, because there was no way of applying the problem-solution approach: no particular problem had been claimed since no side effects were described for the new dosage to cure. The fact of administering the weakest dosage possible of a pharmaceutical compound to a patient and still maintaining therapeutic efficacy could not be considered to be a specific problem needing a solution in its own right, particularly when the use of the medicament was already known and protected.
FR France
Paris District Court of 9 November 2010 (09/12713) - Teva v Merck
Keyword: dosage regime - Sufficient disclosure of the invention - Revocation of European patent
Teva is a pharmaceutical group active in the markets for generic and brand name drugs. A company established under US law, Merck, is the market leader in pharmaceuticals and proprietor of a European patent (EP 0 724 444) entitled "treatment of androgenic alopecia with 5α-reductase inhibitors".
Teva brought an action against Merck, seeking revocation of all the claims in the French part of the European patent on the grounds of extension beyond the content of the application as filed, lack of novelty, insufficiency in the description of claim 1 and lack of inventive step in claims 2 and 3.
Teva submitted that the technical problem underlying the patent was to administer in "the lowest dosage possible" a medicament for the treatment of androgenic alopecia with the active ingredient finasteride, which was known in this composition and for such use. It argued that claim 1 was null and void on the ground that its subject-matter had been extended beyond the description because the application related only to daily administration of finasteride, whereas claim 1 protected any frequency of administration. It was also null and void on the ground that the description was insufficient because it did not present any results of experimental tests in support of the patent application or describe the pharmacological properties. Teva also maintained that claim 1 was invalid for lack of novelty because the second therapeutic application was not novel and so non-patentable, or, in the alternative, for lack of inventive step in the light of the "Diani" citation, which anticipated claim 1 in terms of the oral administration of finasteride in a dose of 0.001 to 10 mg/kg body weight, European patent EP 0 285 382, which disclosed the common general knowledge in the art, and the anticipatory article by Dr S.
Merck observed that, in parallel procedures which had taken place in other European countries, the English Court, in a decision of 21 May 2008, had held that the patent was not directed to a non-patentable method of treatment, was novel and so valid, whereas the German Federal Patents Court, citing the Federal Court of Justice's Carvedilol II judgment, had ruled that the German part of European patent EP 0 724 444 lacked novelty. Merck also cited the findings in G 2/08 of 19 February 2010 in support of its contention that the subject matter of the patent was not excluded from patentability under Art. 53(c) EPC.
At the parties' request, the Paris District Court agreed to hear their arguments on 27 September 2010. Merck then asked the District Court to stay its ruling pending the outcome of an appeal lodged with the Court of Appeal against the judgment of 28 September 2010 in Actavis v Merck. The District Court refused this request, inter alia, on the ground that Teva's grounds of appeal differed from those put forward by Actavis.
On the merits, the Court observed that, first of all, the patent's scope, and so its subject-matter, had to be defined in the light of the prior art.
It held that, since use of finasteride to treat androgenic alopecia was already known, only the dosage of approximately 0.05 to 1.0 mg was claimed to be novel and patentable.
It dismissed the ground of appeal alleging an extension of the claim beyond the application as unfounded.
As to insufficiency of the description, it found that, for the description of an invented medicament to be deemed sufficient in the field of pharmacology, it had to specify the medicament's pharmacological properties and one or more therapeutic applications. Thus, although inventors were not required to present test results, they had to state that they had sought and obtained such results and conducted tests and experiments to prove the alleged therapeutic effect. Although the patent contained several examples, nowhere did it state that those procedures had been applied to x number of people for x amount of time or that the results had been compared with a sample of people who had been given a "substrate" for the same time. Nor could this be concluded from the mere description of a photographic procedure for counting hairs on a particular part of the head if it were not stated that studies had actually been conducted using that procedure. Example 4 could not be regarded as a test report because it gave no information as to the conditions of any such test. Nor did the test mentioned in example 5 appear have any probative value and had been cited solely in order to meet the requirements as to sufficiency of the description to which both grant of the patent and any assessment of its validity were subject, given that it did not relate to any serious research into the efficacy of the product for which protection was sought.
Accordingly, the District Court held that the description in the European patent was insufficient and that claim 1 had to be revoked on that ground, while claim 2, which concerned a use dependent on claim 1 in which the dosage was 1.0 mg, and claim 3, which concerned treatment of male pattern baldness and was dependent on claims 1 and 2, both had to be revoked on the same ground, since only the taught dosage was novel over the prior art.
5. Taxol stents (EP 0 706 376)
GB United Kingdom
House of Lords of 9 July 2008 - Conor Medsystems Inc v Angiotech Pharmaceuticals Inc et al. [2008] UKHL 49
Keyword: inventive step - obviousness - obvious to try - sufficiency of disclosure - parallel proceedings
The claim in issue was to a stent, a tubular metal scaffold inserted into an artery to keep it open, coated with the anti-proliferative drug taxol for "treating or preventing recurrent stenosis". Whereas in parallel proceedings before the District Court of The Hague Conor's request for revocation of the patent on the ground of obviousness had been refused, in both the Patents Court and the Court of Appeal it succeeded. However, this outcome was reversed upon appeal to the House of Lords. Lord Hoffmann, giving the leading judgment, recognised that for various reasons it was inevitable that national courts will occasionally give inconsistent decisions on the same patent, but stressed that on a question of principle, it was desirable that so far as possible there should be uniformity on the way the national courts and the EPO interpret the EPC. Here, the question was how to identify the concept embodied in the invention which may constitute the "inventive step" for the purposes of Art. 56 EPC and s. 1(1)(b) Patents Act 1977.
The line of argument advanced by Conor and accepted in the lower courts had been to deny that the inventive step disclosed by the specification was to coat the stent with taxol. Rather, the inventive concept of the invention was the more general idea of trying some, one or more, taxol/polymer combinations to determine whether restenosis could thereby be treated. Thus, on the basis that the patent taught no more than that taxol was worth trying, it added nothing to existing knowledge. It was common ground that taxol was, like many other anti-proliferative drugs, worth a try. This was obvious. In Conor's submission, it did not have to show that it was obvious actually to use taxol to treat restenosis because the patent did not teach that it would work.
Lord Hoffmann considered this approach to be an illegitimate amalgam of the requirements of inventiveness (Art. 56 EPC) and either sufficiency (Art. 83 EPC) or support (Art. 84 EPC) or both. It was the claimed invention which had to involve an inventive step, which meant prima facie that specified in the claim (s. 125(1) Patents Act 1977). In the instant case, the alleged inventiveness lay in the claim that the product would have a particular property, namely, to prevent or treat restenosis (cf. Pharmacia Corp v Merck & Co Inc [2002] RPC 775). So the question of obviousness was whether it was obvious to use a taxol-coated stent for this purpose, and the patentee was entitled to have this question determined by reference to his claim, not to some vague paraphrase based upon the extent of his disclosure in the description. Agreeing with the opinion of the District Court of The Hague (at paragraph 4.17) Lord Hoffmann stated that neither the EPC nor the statute required that the specification must demonstrate by experiment that the invention would work or explain why it would work. It was absolutely clear that the teaching of the specification, as far as it supported the contested claim, was that a taxol-coated stent would prevent or treat restenosis. Lord Hoffmann further agreed with the Dutch Court (at paragraph 4.17)) that the "patentee sufficiently clearly indicates in the patent that it is advantageous to use taxol (inter alia but also specifically for restenosis) and states as reason for this that taxol ... scores well in the CAM assay to demonstrate its anti-angiogenic effect, bearing in mind that the patentee saw the solution for restenosis in the use of an anti-angiogenic factor". Accordingly, the question was whether that was obvious, and not whether it was obvious that taxol (among many other products) might have this effect. It was hard to see how the notion that something was worth trying or might have some effect could be described as an invention in respect of which anyone would be entitled to a monopoly.
It was true that a patent would not be granted for an idea which was mere speculation, unsupported by the specification (cf. Art. 84 EPC, s. 14(5)(c) Patents Act 1977). In the case in hand the specification did claim that a taxol-coated stent would prevent restenosis and Conor had not suggested that this claim was implausible. With regard to the finding of the lower courts that the patent contained no "disclosure" saying that taxol was specially suitable for preventing restenosis, Lord Hoffmann agreed that the description, although offering a theory (its anti-angiogenic properties) as to why taxol would prevent restenosis, did not offer any evidence that this would turn out to be true. If it had not turned out to be true, the patent would have been insufficient. However, there was no reason as a matter of principle why, if a specification passed the threshold test of disclosing enough to make the invention plausible, the question of obviousness should be subject to a different test according to the amount of evidence which the patentee presented to justify a conclusion that his patent would work.
The question of when an invention could be considered obvious on the ground that it was obvious to try had been dealt with comprehensively in the Court of Appeal by Jacob LJ, who had correctly summarised the authorities, starting with Johns-Manville Corporation's Patent [1967] RPC 479, by saying that the notion of something being obvious to try was useful only in a case in which there was a fair expectation of success. How much of an expectation would be needed depended on the facts of the case.
The increasing use of the concept of "obvious to try" was also commented on, with further references, by Lord Walker. Since the time of Johns-Manville, which concerned a fairly low-tech process, the volume of high-tech research had increased enormously, especially in the fields of pharmaceuticals and biotechnology. The resources committed to research were enormous, because the potential rewards in world-wide markets were so great. Competition was fierce. In this climate "obvious to try" had tended to take on a life of its own as an important weapon for challenging the validity of a patent.
Editor's note: Lord Walker's analysis of the concept of obviousness, in terms of obvious to try, was adopted by the High Court of Ireland in its judgment of 26 June 2009 in Glaxo Group Ltd v Patents Act [2009] IEHC 277 (see para. 31 of the judgment).
NL Netherlands
The Hague Court of Appeal (Gerechtshof te's Gravenhage) of 27 January 2009 - Sahajanand v Angiotech
Keyword: inventive step
The European patent in suit (EP 0 706 376) related to a stent coated with taxol for the prevention of restenosis. The application was derived from a parent application covering taxol and many other anti-angiogenic means of treating cancer, restenosis and other diseases.
At the previous instance, Angiotech had sued Sahajanand for infringement. In response, the defendant contested the validity of the patent. The District Court had considered the use of taxol to be inventive and the patent to be infringed. In its view, the prior art did not provide sufficient pointers for the skilled person to choose taxol out of a number of claimed substances in the expectation that it would or might prevent restenosis. Sahajanand lodged an appeal against this decision.
The Court of Appeal found that the basis of the patent at issue was that an anti-angiogenic factor, in particular taxol, prevented blood-vessel formation and thus undesired tissue growth. The patent specification did not teach that taxol was the substance to be selected, but made it clear that taxol was the one to be preferred. With regard to inventive step, the Court of Appeal held that there were no clear indications in the prior art which would have induced the skilled person to choose taxol. The choice of taxol as an alternative to other substances was not obvious to the average skilled person - there were pointers in the prior art which argued both for and against the choice of taxol. Moreover, there was no safety profile of taxol at the time, so that, despite the fact that it had been known for some while, the average skilled person would be very reluctant to choose taxol for a vascular polymer-coated stent to be inserted in the coronary artery near the heart. In conclusion, none of the cited prior art was regarded as prejudicial to inventive step and the appellant's arguments were dismissed.
6. Soya-bean meal (EP 0 546 090)
Editor's note: This case related to the import of soya-bean meal from Argentina to various European countries. The meal originated from Argentina, but had been produced from genetically modified soya beans originally provided by Monsanto. The soya beans carried a DNA sequence which conferred resistance to Monsanto's Roundup herbicide. Monsanto had no patents protecting the soya beans in Argentina, but a patent was in force in Europe. Monsanto initiated various infringement proceedings against the importers of the Argentinean soya beans. In the Dutch parallel proceedings, The Hague District Court referred the case to the ECJ after finding that the legal issues required an interpretation of Biotechnology Directive 98/44/EC. In its decision of 6 July 2010, Monsanto v Cefetra C 428/08, the ECJ held that Art. 9 of the Directive did not confer protection on a patented DNA sequence contained in soya meal, where it did not perform the function for which it was patented. This was the case regardless of the fact that it had performed that function previously in the soya plant, of which the meal was a processed product, and that the DNA could again perform its function after extraction from the soya meal and insertion into the cell of a living organism. The following decisions summarise the outcome of the Monsanto proceedings in Spain, the UK and the Netherlands, which preceded the ECJ decision.
ES Spain
Madrid Commercial Court (Juzgado de lo Mercantil) of 27 July 2007 (infringement action no. 48/2006) - Monsanto Technology LLC v Sesostris S.A.E
Keyword: patentability - function of a DNA sequence
Monsanto Technology filed a lawsuit against Sesostris for infringement of its European patent EP 0 546 090, validated in Spain (ES 2 089 232). According to the plaintiff, the defendant had imported soybean meal from Argentina which contained the DNA sequence patented by the plaintiff, without its authorisation. Claim 1 of the patent, which was considered to be infringed, related to an isolated DNA sequence which included the codification of a certain Class II EPSPS enzyme.
The Commercial Court of Madrid stated that the defendant did not import the DNA sequence, but soy flour, which was not included in the patent claim. Accordingly, the defendant did not infringe Art. 50.1a) Spanish Patents Act. However, to establish whether biotechnological material contained in a product infringed the patent in suit, it was also necessary to verify whether the imported soy meal complied with the conditions set out in Art. 50.4 Spanish Patents Act (also Art. 9 of the Biotechnology Directive). In that regard, the Court stressed that patents in the field of biotechnology were governed by the same principles as patents in other technical fields and that the purpose of the Directive was not to broaden the scope of protection of biotechnological patents. Further, because patent laws granted exclusive rights, that is, as an exception to the principle of free enterprise referred to in Art. 38 of the Spanish Constitution, they, like any exception to general principles, had to be interpreted restrictively.
The Commercial Court concluded that, in the light of recitals 23 and 24 of Directive 98/44/EC, biotechnological inventions did not consist of the DNA sequence, but of the function it fulfilled. The Court went on to note that Art. 50.4 Spanish Patents Act required that the product contained the genetic information, that the genetic information was incorporated and contained in the new material, and fulfilled its function. It was especially relevant to prove that the genetic information incorporated into the new material continued to fulfil its function in order to comply with the industrial application criterion (recital 24 of the Directive). The plaintiff could not prove, however, that the genetic information sequence had fulfilled its function in the soybean meal imported by Sesostris.
GB United Kingdom
Patents Court of 10 October 2007 - Monsanto v Cargill [2007] EWHC Civ 2257 (Pat)
Keyword: term "isolated DNA sequence" - "product directly obtained by means of the process"
The claimants brought an action for alleged infringement of EP (UK) 0 546 090 against Cargill. The invention concerned enzymes, referred to in the specification as EPSPSs, which, if expressed in a plant, conferred resistance to the Roundup herbicide. The defendants had bought soya beans grown from seed carrying the gene for one of the EPSPSs (CP4R, known as Roundup Ready) disclosed in the patent in Argentina, and from it meal had been manufactured which they imported into the UK. All the Roundup Ready soya bean plants in Argentina were lineal descendants of the original plant transformed in accordance with the patented process.
Cargill submitted that the patent related essentially to DNA sequences and that no single or double-stranded DNA would survive the treatment undergone by the soya beans when they were processed into meal. The DNA would be degraded, with the result that the imported material would not constitute an infringement. Cargill also challenged the validity of the patent on the grounds of anticipation, obviousness and insufficiency, although it accepted that the discovery of the CP4 enzyme was an invention. Monsanto alleged that their existing claims were valid and had been infringed, but applied unconditionally to amend the claims of the patent in suit. The patent was held valid but not infringed. The application for permission to amend succeeded.
Issues of construction arose in relation to the allegation of infringement. In particular, was the RuR gene in the meal "isolated" (certain claims referred to "an isolated DNA sequence"), what was a "Class II EPSPS enzyme" and did the RuR sequence in the meal encode for it?
In this context, the question also arose whether the meal was a product "directly obtained by means of the process", as required by s. 60(1)(c) Patents Act 1977. According to the judge, this meant, prima facie, "the immediate product of the process", or, where the patented process was an intermediate stage in the manufacture of some ultimate product, that product, but only if the product of the intermediate process still retained its identity. In most cases, the assessment would be a matter of fact and degree, but not always. All Roundup Ready soya bean plants in Argentina were lineal descendants of the original transformed plant and so the soya meal could be described as the ultimate product of the original transformation of the parent plant. However, the judge could not see that it could be properly described as the direct product of that transformation, a phrase he would reserve for the original transformed plant. Monsanto's argument confused the informational content of what passed between the generations (the Roundup Ready genomic sequence) with the product, which was just soya-bean meal with no special intrinsic characteristics from one of the generations of plants. This aspect of the claim therefore failed.
A further question was whether the processed meal actually still contained any of the claimed DNA sequences. The judge ruled that, although the Monsanto experiments were open to criticism, Cargill had not provided any hard results which threw sufficient doubt upon the results that appeared to have been achieved. He therefore found as a fact that there was present in the meal some genomic DNA which included the RuR EPSPS gene, and that some or all of that DNA was double-stranded. However, the judge further ruled that the DNA found did not match that in the claims which related to an isolated DNA sequence. The word "isolated" had precisely the meaning that the expert witness for Cargill gave to it, that is, "separated from other molecular species in the form of a purified DNA fragment" for the purposes that he identified. In its context in this specification, the judge concluded that this was what the claim was about. It was not about genomic DNA, of which it was the antithesis, and it was not about the DNA of the progeny of a plant or plants transformed using a plasmid incorporating DNA having that sequence. As a consequence, the allegation of infringement of all claims requiring an isolated gene sequence failed accordingly.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 19 March 2008 - Monsanto v Cefetra
Keyword: term "isolated DNA sequence"
With reference to the reasoning of the English Patents Court, the Dutch District Court held that the soybean meal did not infringe the patent claims directed to "isolated" DNA (claims 1 and 4 and dependent claims 2, 3 and 5) because the DNA was not present as an isolated substance but merely incorporated into the soybean meal. The District Court could not accept Monsanto's argument that the DNA sequence had been introduced into the DNA of the soy plant from its natural environment – the bacterial chromosome – and that the meal from the bean ought therefore to be regarded as an isolated DNA sequence. A person skilled in the art would understand the term "isolated DNA" to mean DNA that had been derived from the cell or cell nucleus of an organism for further processing in a manner customary in the relevant field. Monsanto had not provided any reason for assuming in the case at issue that a person skilled in the art would construe this term other than according to its common meaning.
Moreover, the Court rejected the view that the soy meal should be regarded as a product directly obtained from the patented method, as described in the claims 14 and 17 to 19 directed to a "method of producing genetically transformed plants which are tolerant toward glyphosate herbicide". It held that the soy plant and the soy beans themselves might indeed have been obtained directly from the patented method. However, the beans were subsequently separated into various components with a new identity by means of a crushing process and using a series of additional steps that resulted in the production of soybean meal. According to the Court, that process was too far-reaching for the skilled person to consider that a direct link existed between the method and the soya-bean meal product.
7. Escitalopram (S-enantiomer) (EP 0 347 066)
GB United Kingdom
House of Lords of 25 February 2009 - Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12
Keyword: sufficiency of disclosure - product claims - technical contribution
Lundbeck had succeeded in separating the racemate of its earlier patents for the anti-depressant drug citalopram into its two enantiomers and found that the anti-depressant effect was caused entirely by the (+)-enantiomer. Based on the method of isolating this enantiomer, the company obtained a patent for a new variation of the previous drug called escitalopram, which was an isomer of citalopram.
The patent included a product claim to the (+)-enantiomer, and a product claim to a pharmaceutical composition comprising that single escitalopram active ingredient. Generics had challenged the patent in the lower courts on the grounds of lack of novelty, obviousness and insufficiency. It had argued that Lundbeck had made only a limited technical contribution to the resolution of citalopram, because it had fully disclosed only one method of producing the (+)-enantiomer. Therefore, the principle laid down in T 409/01 invalidated the claims because, although expressed as ordinary product claims, they were really product-by-process claims and should have been limited to escitalopram as produced by the diol intermediate method.
The Court of Appeal had found the patent valid. The only point in issue on appeal before the House of Lords was that on which the Court of Appeal had disagreed with the judgment in the High Court, namely whether the claim to the (+)-enantiomer was insufficient. Accordingly, the Lords proceeded on the basis that the enantiomer was a new product and that the obtaining of the enantiomer was not obvious.
The distinction between product claims and process claims, especially in relation to the appropriate test for sufficiency, was at the heart of the appeal. According to Lord Mance, the fundamental issue was whether a patent claim which related to a product, rather than a method, rendered the patent liable to revocation on the ground of insufficiency under s. 72(1)(c) Patents Act 1977 if the only inventive step involved in the product consisted in the method by which it was made available and if its description and specification disclosed only that inventive method and superior methods were found by others which owed nothing to that method. The Lords decided unanimously that such a patent was not so liable to revocation.
At first instance, the judge had held the claims to be invalid for insufficiency based on the principle, laid down by Lord Hoffmann in the House of Lords judgment Biogen v Medeva, that the first person to find a way of achieving an obviously desirable goal was not permitted to monopolise every other way of doing so. This was overturned by the Court of Appeal - the judge at first instance had taken too broad a principle from his analysis of Biogen, in which the product claim in question was to a class of DNA molecules which expressed in a host cell the antigens of the hepatitis B virus. In Biogen, the House of Lords had held that the product claim to a class of molecules would only be enabled if the skilled person could work the invention in respect of all members of that class.
The House of Lords upheld the Court of Appeal decision unanimously, delivering opinions in agreement with the analysis in the Court of Appeal and dismissing the appeal. Biogen did not deal with a single product claim but with a claim which was as much a process claim as a product claim ("almost a process-by-product-by-process claim"). One had to distinguish between identification of the inventive step and the technical contribution made. When considering the validity of a simple product claim, it could be that concentrating on the identification of the inventive step rather than the technical contribution could lead to error. "Inventive step" suggested how something had been done, and, in the case of a product claim at any rate, one was primarily concerned with what had been allegedly invented, not how it had been done. On the other hand, where the claim was for a process or, as in Biogen, included a process, the issue of how the alleged invention had been achieved seemed to be more relevant.
The House of Lords rejected the contention that, if the patent extended to escitalopram as a product, the respondents would be accorded a monopoly which exceeded their technical contribution to the art. Although it was an extra-statutory concept, Lord Neuberger of Abbotsbury accepted that, at least as a general rule, the monopoly to be granted to the patentee was to be assessed by reference to the "technical contribution" made by the teaching of the patent. That was an approach regularly adopted by the boards of appeal of the EPO (see for example T 409/91, OJ EPO 1994, 653, point 3.3 of the Reasons). However, to put it at its lowest, it could be said that the respondent's technical contribution in this case was to make available, for the first time, a product which had previously been unavailable, namely the isolated (+)-enantiomer of citalopram. On that basis, it would appear to follow that the respondent was entitled to claim the enantiomer. The approach of the boards of appeal had been consistently along the same lines as that of the Court of Appeal in this case (see also e.g. T 595/90, OJ EPO 1994, 695).
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 8 April 2009 - Tiefenbacher v Lundbeck
Keyword: novelty - disclosure of a racemate
With regard to the assessment of the novelty of an enantiomer as opposed to a racemate, the District Court followed the line of the established case law of the EPO, according to which the disclosure of a racemate was not automatically detrimental to the novelty of an enantiomer thereof. That would be the case only in the event of a direct and unambiguous disclosure of this very compound in the form of a technical teaching (see T 1046/97). The theoretical possibility that a known racemate could be split into separate enantiomers was immaterial to the assessment of novelty (see also T 296/87, point 6.5 of the Reasons). While the prior art in the case at issue ("Smith") did present the structural formula of the (R) enantiomer of citalopram, it could not be deduced from the publication whether, and if so how, that enantiomer, let alone the (S) enantiomer, had been actually obtained in individualised form. Since it was not established that escitalopram was actually to hand before the priority date, the Court regarded the substance as novel.
As to the assessment of inventive step, the Court held all the claims of Lundbeck's patent (and the Dutch Supplementary Protection Certificate which was based upon it) invalid for lack of inventive step. Since the closest prior art described a method for obtaining racemic escitalopram through the use of the diol, it would have been obvious to the skilled person that conducting an SN2-reaction with the enantiomeric diol represented the only possible way to obtain escitalopram. Moreover, the Court agreed with Tiefenbacher that the FDA regulations provided a strong incentive to investigate the activity of the separate enantiomers and, therefore, to separate the enantiomers. Lundbeck's assertion that the inventive step involved in the escitalopram enantiomer lay in the art of obtaining it because citalopram was unusually difficult to separate into the individual enantiomers was thereby rejected. In the Court's view, the person skilled in the art would have obtained escitalopram without undue burden based on the general technical knowledge.
The Dutch Court explicitly distinguished its decision from the earlier English Court decision on the matter, due to evidence put forward by Tiefenbacher that had not been admitted into the English proceedings.
DE Germany
Federal Court of Justice of 10 September 2009 (Xa ZR 130/07) - Escitalopram
Keyword: substance protection
The European patent at issue concerned an enantiomer and its preparation. The protected chemical compound was known by the international non-proprietary name citalopram and had proven effective as an anti-depressant. According to the patent specification, its entire development had been carried out with the racemate, a mixture of two equal amounts of enantiomers. However, it did not set out expressly the underlying technical problem. After the presentation of the prior art, it was stated that it had surprisingly been shown that it was possible to resolve the racemic mixture specified in the patent claims into its enantiomers and convert them stereoselectively into the enantiomers of citalopram.
The Federal Patents Court had revoked the patent. It had considered that the technical problem was to obtain the two enantiomers of citalopram in separated form and held that the skilled person would not have faced an undue burden in separating the enantiomers with the materials commercially available at the date of priority.
The Federal Court of Justice took a different view. In the case at hand, the skilled person was faced with the problem of preparing a substance which could be considered for use as an alternative anti-depressant to citalopram. Whilst it could be argued that it would have made sense to the skilled person to attempt to obtain the citalopram enantiomers in order to solve the problem, the arguments were not so compelling that other solutions could be ruled out from the outset. The decision to opt for the citalopram enantiomers was thus already a part of the solution. Where the skilled person was faced with the problem of preparing a substance which could be used as a medicine in specific fields of application as an alternative to those already in use, and several substances or groups of substances came into question, the decision to opt for a particular substance was already part of the solution.
As a rule, the enantiomers themselves could not be directly and unambiguously derived from a publication from which it could be inferred that they have to exist, unless the publication enabled the skilled person to obtain the enantiomers without further difficulty. Obtaining a single enantiomer of a compound so far existing only as a mixture of enantiomers (racemate) might entail an inventive step even if the existence of the enantiomers was rendered obvious by the prior art. The decisive factor was whether, at the priority date, there was an obvious way for the skilled person to obtain the enantiomer.
FR France
Paris District Court of 30 September 2010 (10/08089) - ratiopharm GmbH v Lundbeck
Keyword: inventive step - ex-post-facto analysis
The Court dismissed the objection of lack of novelty. On lack of inventive step the Court stated expressly that the person skilled in the art had to be defined in this case as a team. The Court stressed the necessity for avoiding an ex-post-facto analysis, starting at the time of the invention in question. The Court finally rejected the objection of lack of inventive step as unsubstantiated. In conclusion, it rejected the nullity action against the SPC.
8. Oxycodone (EP 1 810 697; EP 0 722 730; EP 1 258 246)
GB United Kingdom
Court of Appeal of 1 April 2009 - Napp Pharmaceutical Holdings Ltd v ratiopharm GmbH; and Napp Pharmaceutical Holdings Ltd v Sandoz Ltd [2009] EWCA Civ 252
Keyword: amendments to claims - added subject-matter
The case concerned the validity and alleged infringement of two patents (EP 0 722 730, EP 1 258 246) which related to controlled-release formulations of a painkiller called oxycodone. Both patents were derived from "divisionals". The judge in the Patents Court had held the patents valid, but not infringed. One of the issues with which the Court of Appeal was concerned when considering validity was whether the patents were invalid because of "added matter" introduced when amendments were made as the consequence of the patentee making divisional applications.
The Court of Appeal referred to G 1/93 as the leading authority in the EPO on Art. 123(2) EPC and noted that the UK courts applied the principles laid down there which coincided with those already laid down by Aldous J in Bonzel v Intervention (No 3) [1991] RPC 553. According to this, the test for examining whether an amendment involved the adding of subject-matter was as follows:
(1) To ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly, in the application.
(2) To do the same in respect of the patent as granted.
(3) To compare the two disclosures and decide whether any subject-matter relevant to the invention has been added whether by deletion of addition. The comparison is strict in the sense that subject-matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly.
This formulation had recently been elaborated upon by Kitchen J in European Central Bank v Document Security Systems [2007] EWHC 600 (Pat), 26 March 2007 (and confirmed by the Court of Appeal in that case):
(1) First, the court has to construe both the original application and specification to determine what they disclose. For this purpose, the claims form part of the disclosure, though clearly not everything which falls within the scope of the claims is necessarily disclosed.
(2) Second, the court must carry out this exercise and do so through the eyes of the skilled addressee. Such a person will approach the documents with the benefit of the common general knowledge.
(3) Third, the two disclosures must be compared to see whether any subject-matter relevant to the invention has been added. This comparison is a strict one. Subject-matter will be added unless it is clearly and unambiguously disclosed in the application as filed.
(4) Fourth, it is appropriate to consider what has been disclosed both expressly and implicitly. Thus the addition of a reference to that which the skilled person would take for granted does not matter. On the other hand, a patentee is not permitted to add matter by amendment which would have been obvious to the skilled person from the application.
(5) Fifth, the issue is whether subject-matter relevant to the invention has been added. As stated in G 1/93, whether an added feature which limits the scope of protection is contrary to Art. 123(2) EPC must be determined from all the circumstances. If it provides a technical contribution to the subject-matter of the claimed invention then it would give an unwarranted advantage to the patentee. However, if the feature merely excludes protection for part of the subject-matter of the claimed invention as covered by the application as filed, the adding of such a feature cannot reasonably be considered to give an unwarranted advantage to the applicant. Nor does it adversely affect the interests of third parties.
(6) Sixth, it is important to avoid hindsight.
In Vector Corporation v Glatt Air Techniques Inc [2007] EWCA Civ 805, the Court of Appeal had endorsed this approach and added the following observations:
(7) When amendment of a granted patent is being considered, the comparison to be made is between the application for the patent, as opposed to the granted patent, and the proposed amendment.
(8) A particular form of extended subject-matter is what goes by the jargon term "intermediate generalisation".
After having summarised this general approach to added subject-matter, the Court of Appeal considered a more specific point relating to amendments consisting of "undisclosed disclaimers". The Court of Appeal agreed with the judge in the Patents Court that the reason that disclaimers of accidental and deemed anticipations do not offend is that they do not add subject-matter relevant to the invention. If a disclaimer introduced by a divisional application does not add subject-matter relevant to the invention, but merely excludes subject-matter from protection, then it too will not offend against the provision.
On the facts of the case it was decided that there was no added subject-matter.
DE Germany
Düsseldorf Court of First Instance of 30 March 2010 (4a O 13/10) - Mundipharma v Sandoz
Keyword: novelty - inventive step
The European patent EP 1 810 679 in this case related to a controlled-release oxycodone hydrochloride dosage formulation. The problem underlying the patent was to provide a method for substantially improving the efficiency and quality of pain management. The application was filed on 5 January 2007 by Napp Pharmaceutical Holdings Ltd (Cambridge, UK) as a divisional application from the European patent application EP 1 438 959, which itself stemmed from parent application EP 0 576 643. In an infringement action before the Landgericht Düsseldorf, Mundipharma, a sister company of Napp, requested an interim injunction for infringement of its patent by Sandoz's generic versions of controlled-release oxycodone compositions (retard tablets).
The Court ruled that the contested embodiments made literal use of the teaching of the patent. Contrary to the view of the respondents, the patent understood the term "controlled release" not in the general sense that the location and timing of the active agent's release were controlled, but rather that the release was "prolonged" (as opposed to "immediate"). In other words, compared with immediate-release formulations, the effect of oxycodone hydrochloride was designed to act more slowly and last longer. This was explained in the description, which under Art. 69 EPC was to be used to interpret the claims. Even though the examples did not all relate to embodiments of the invention, the fact remained that the term "controlled release" in the patent specification was generally accepted as meaning "prolonged release" as defined above.
The respondents unsuccessfully counter-argued that, according to the patent specification, in order to obtain a controlled-release dosage form having at least a 12-hour therapeutic effect it was usual in the pharmaceutical art to produce a formulation that gave a peak plasma level of the drug 4 to 8 hours after administration, and it had surprisingly been found that in the case of oxycodone a peak plasma level at 2 to 4.5 hours after administration gave a 12-hour therapeutic effect. In the Court's view, the object of the patent was not to reduce the otherwise normal delay period of 4 to 8 hours but to provide any dosage formulation at all with oxycodone hydrochloride as the active agent and a controlled, e.g. prolonged, rather than immediate release. This interpretation was largely consistent with the skilled person's common understanding of the term "controlled release".
With respect to the invalidity objections, the Court upheld the validity of the European patent. It considered that the technical problem specified in the patent had indeed been expressed in appropriate terms, whereas the respondents' view that the technical problem involved creating the simplest possible retard formulation having an equivalent, controlled oxycodone release seemed to be misguided because it recast part of the solution, namely the selection of the right active agent, as a part of the technical problem. On the basis of the above-mentioned technical problem, the Court found that the teaching of the claim in suit was not obvious because the person skilled in the art would have no reason to use oxycodone hydrochloride as an alternative to known agents such as morphine and hydromorphone in a controlled-release dosage formulation for the treatment of severe and very severe pain.
In the course of the proceedings, the German court also cited the case law of the English Court of Appeal and the Netherlands' Rechtbank te 's-Gravenhage, which had upheld the validity of parallel oxycodone patents.
NL Netherlands
The Hague District Court (Rb. te 's-Gravenhage) of 7 April 2010 - Mundipharma v Sandoz
Keyword: sufficiency of disclosure - disclaimer
Mundipharma is the holder of the Dutch part of European patent EP 0 722 730 relating to formulations for the controlled release of oxycodone or a salt thereof with the purpose of providing pain relief to cancer patients. On the basis of a divisional application, the patent had been granted for "a controlled release dosage matrix, other than an acrylic resin matrix". Both the divisional and its parent application mentioned acrylic resin as the preferred embodiment, whilst this embodiment was claimed in the parent application. The disclaimer "other than an acrylic resin matrix" had been added to the divisional application to distinguish it from the patent granted on the basis of the parent application. In the infringement proceedings that followed, the District Court held that the patent was valid and infringed by Sandoz's specific dosages. The Court dealt extensively with the defendant's nullity arguments, in particular with regard to sufficiency of disclosure and the allegedly undisclosed disclaimer.
To the extent that Sandoz argued that neither the disclaimer nor the remaining claimed subject-matter had a direct and unambiguous basis in the original application, the Court stated that the parent application disclosed sufficiently clearly to the average skilled person that in order to obtain the desired formulation with prolonged release, a controlled release matrix could be used in which – exclusively or among other things – acrylic resin was used. It was clear to the average skilled person what subject-matter had been excluded from the scope of protection by means of the disclaimer and therefore what subject-matter was still protected by the patented claim. Whether or not the addition of the disclaimer in the ultimately granted version was in violation of the requirement of clarity (Art. 84 EPC) was at the discretion of the EPO and could no longer be taken into account in the assessment of the validity of the patent by the national court. Contrary to what Sandoz argued, the Court could not deduce from G 1/03 (OJ EPO 2004, 413) that the Enlarged Board of Appeal meant to add Art. 84 EPC as a ground for invalidation of a patent in proceedings before the national court. Since the current proceedings concerned the validity of claim 1 as granted and not a request for amendment, Art. 84 EPC could not be invoked.
As to Sandoz's position that the disclaimer could not meet the requirements for undisclosed disclaimers as set out in G 1/03 (OJ EPO 2004, 413), the Court considered that the disclaimer contained material that was not literally found in the parent application but deducible from it by the average skilled person. The Court found support for this in G 1/03, where it was taken as a starting point that the inclusion of a disclaimer could not be refused based on a breach of Art. 123(2) EPC merely because of the fact that neither the disclaimer nor the subject-matter excluded by the disclaimer had been disclosed in the original application. The latter meant that the subsequently excluded subject-matter had been positively disclosed in the parent, because it would otherwise not make sense to make a distinction with a disclaimer, i.e. a formulation in negative terms, in the divisional. In the case at issue, the disclaimer was deemed disclosed and could therefore not be assessed on the basis of the requirements of G 1/03.
Moreover, Sandoz stated that the disclaimer had a technical meaning. On this point, the Court ruled that the average skilled person acknowledged the disclaimer as having been included exclusively for a legal reason, namely to prevent double patenting with respect to the parent patent. The disclaimer merely excluded a part of the invention so that a more limited group of substances for a controlled-release matrix remained from which a choice could be made for the composition of the controlled-release matrix. A technical meaning could not be attributed to this; the technical teaching of the patent had not been altered.
The Court awarded Mundipharma a preliminary injunction and suspended the decision in the principal action while awaiting the outcome of the appeal in the pending opposition proceedings (T 1676/08).
NO Norway
Borgarting Court of Appeal (Lagmannsrett) of 20 December 2010 - Mundipharma AS v ratiopharm and Acino Pharma
Keyword: novelty - inventive step - problem-solution approach
Mundipharma was the holder of two Norwegian patents relating to controlled-release oxycodone salt formulations (NO 307 028 and NO 318 890). The claims defined the formulations largely by the plasma levels to be achieved over a period of 12 hours after administration. ratiopharm and Acino had filed an invalidity action, joined by an infringement action, against the patents, and invoked several grounds of invalidity. In its judgment of 15 October 2009, the Oslo District Court had held both patents invalid for lack of inventive step. Mundipharma appealed to the Borgarting Court of Appeal, which overturned the decision of the lower Court.
With regard to novelty, the Court held that a prior-art controlled-release oxycodone salt formulation did not anticipate the invention. Neither did the claims disclose any plasma levels for this particular formulation nor was there any necessary correlation between in vitro and in vivo data which could have made it possible for the skilled person to predict whether the formulation would produce the same plasma levels over 12 hours as those defined in the patents.
With regard to inventive step, the Court applied the problem-solution approach. A document dealing with problems with morphine related to titration and dose variation was regarded as the closest prior art. The Court held that the patents in suit credibly solved these problems by oxycodone, the choice of which was not obvious to the skilled person (here a team consisting of a clinician, a pharmacologist and a formulation pharmacist). There were no clear pointers to the solution in the prior art, as there were several opioids that could have been tried, and it was not predictable that oxycodone would lead to lower dose variation and easier titration. Thus, the patents were held to involve an inventive step.
Furthermore, the Court further regarded the priority date as valid and the invention as sufficiently disclosed. The necessity of conducting in vivo tests in order to determine whether an embodiment fell outside the claim was not considered an undue burden.
A disclaimer in one of the patents regarding certain formulation excipients did not provide a ground for invalidity as the disclaimer did not qualify as an inadmissible amendment. According to the Court, the disclaimer only delimited the scope of the protection against excipients already claimed in the parent application.
Editor's note: The judgment was appealed to the Supreme Court, but the appeals were dismissed without any hearing on the merits.
9. Occlusion device (EP 0 808 138)
GB United Kingdom
Court of Appeal of 22 June 2010 - Occlutech GmbH v AGA Medical Corporation & Ors [2010] EWCA Civ 702
Keyword: interpretation of claims - scope of protection - relevance of Art. 69 EPC
The defendant, AGA Medical Corporation, appealed against a judgment of the Patents Court granting Occlutech a declaration of non-infringement of the patent in suit, which concerned intravascular devices for treating certain medical conditions.
The issues of alleged infringement turned almost exclusively on what was meant by "clamps" and clamping "the strands at the opposed ends of the device" in the product claim. Occlutech said this meant that protection was being claimed only in respect of a device which used clamps at both ends in order to secure the strands of braided metal so as to prevent them from unravelling. Its own products were made in a different way using a mesh sock made out of metal wire in which there were cut strands only at one end. These were secured by welding rather than by an external clamp. The questions to be answered were thus:
1. Were the Occlutech devices clamped in the sense described in the patent at issue, given that the ends of the metal strands were secured together by welding?
2. What did the words "clamps (15) are adapted to clamp the strands at the opposed ends of the device" mean? Were the Occlutech devices clamped in this way, given that the metal fibres all terminated at one end of the device rather than at both ends?
In considering these issues of construction the Court of Appeal adopted the summary of the relevant principles recently set out in Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062:
The task for the court is to determine what the person skilled in the art would have understood the patentee to have used the language of the claim to mean. The principles are summarised as follows:
- The first overarching principle is that contained in Art. 69 EPC.
- Art. 69 EPC says that the extent of protection is determined by the claims and that the description and drawings must be used to interpret the claims. In short the claims are to be construed in context.
- It follows that the claims are to be construed purposively - the inventor's purpose being ascertained from the description and drawings.
- It further follows that the claims must not be construed as if they stood alone - the drawings and description only being used to resolve any ambiguity. Purpose is vital to the construction of claims.
- When ascertaining the inventor's purpose, it must be remembered that he may have several purposes depending on the level of generality of his invention. Also, purpose and meaning are different.
- Thus purpose is not the be-all and end-all. One is still at the end of the day concerned with the meaning of the language used.
- It follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements.
- It also follows that where a patentee has used a word or phrase which, acontextually, might have a particular meaning (narrow or wide) it does not necessarily have that meaning in context.
- It further follows that there is no general "doctrine of equivalents".
- On the other hand, purposive construction can lead to the conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively. This is not because there is a doctrine of equivalents: it is because that is the fair way to read the claim in context.
- Finally, purposive construction leads one to eschew the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge.
The Court of Appeal found that this guidance provided a useful compromise between the earlier over-literal approach in the UK and the reliance in some countries on the essence of the invention in order to displace the consequences of that kind of interpretation. Catnic Components was an early example of this purposive construction and provided the genesis for much of the reasoning in Kirin-Amgen. However, the latter decision was important for its recognition that the purpose of the patent, whilst operating as an obvious contextual aid to construction, was not necessarily determinative of the scope of the claims.
The Court of Appeal noted that in the Netherlands and the UK the courts of first instance had ruled in favour of Occlutech by holding that the reference to clamping the "strands at the opposed ends of the device" did not cover the occlusion devices in which the strands were clamped at only one end. In Germany, however, the decision of the lower court that the claims were not limited to devices in which the ends of the wire strands of the material used were clamped together at each end of the device was upheld by the appellate court - the language used had to be read as referring to the clamping of the opposed ends of the strands (rather than of the device) and the use of two separate clamps in each device was not an essential feature or limitation on the scope of the claims. The German approach was right if one assumed that all aspects of the teaching were intended to be encompassed in the claims; then the language fell to be construed accordingly. The reasoning of the German court proceeded on this assumption. However, the third Improver question was not asked: "Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim." The possibility that the patentee had deliberately limited the scope of the claims over the teaching was not therefore considered.
The Court of Appeal found that a clamp excluded an external device placed over and physically attached to the welded ends after the completion of the moulding process. Nor did clamping include soldering or welding. There was nothing to cause the skilled addressee to take a different view from that which the natural meaning of the words would give him. The reference to clamps (plural) would be seen as a distinctive and necessary feature of the invention. The appeal was therefore dismissed.
NL Netherlands
The Hague Court of Appeal (Gerechtshof te 's-Gravenhage) of 19 October 2010 - AGA v Occlutech
Keyword: interpretation of claims - prosecution file
AGA was the holder of the European patent pertaining to an occlusion device used to treat structural heart disease, including structural heart defects. AGA's medical device comprised a metal fabric formed of braided metal strands characterised by clamps adapted to clamp the strands at the opposed ends of the device. The patentee sought an injunction against Occlutech, the producer of dumbbell-shaped medical devices for occluding cardiac septum defects. Although Occlutech's device contained only one clamp at one end of the device, AGA argued that the relevant feature fell within the scope of protection, infringing its patent by equivalent means. At first instance, the District Court had ruled that this was not the case.
In the proceedings before the Court of Appeal, the patentee invoked three paragraphs in the description, which allegedly demonstrated that a device with one clamp had also been claimed. Occlutech relied on the prosecution file in support of its interpretation of the patent, arguing that a device with one clamp was not covered by the claims.
The Court regarded clamping at the opposed ends of the device to be an essential feature of the claim. Such essential features could not be interpreted too broadly unless the description and the drawings provided clear indications for a different approach. For the purpose of construing what the claims were intended to convey to the skilled person, the Court admitted the contents of the prosecution file as a basis for interpretation irrespective of the fact that it was the defendant and not the patentee that had introduced it to the proceedings. The prosecution file revealed that a non-unity objection had been raised against the original application which led to AGA dropping some of the claims. The passages of the description invoked by the patentee referred to a dropped claim and should have been deleted. They could therefore not serve in the case at issue as a basis for a broad interpretation of other claims. Confirming the decision of the lower court, the Court of Appeal concluded that Occlutech's devices did not infringe and dismissed the appeal.
DE Germany
Federal Court of Justice of 10 May 2011 (X ZR 16/09) - Occlusion device
Keyword: interpretation of claims - scope of protection - Art. 69 EPC
The claimant was the proprietor of a European patent which had been granted with effect for Germany, among other countries, and concerned an intravascular occlusion device and a method of forming such a device. The collapsible medical device comprised a metal fabric of "braided metal strands" and "clamps ... to clamp the strands at opposed ends". The claimant brought an action against the defendant, alleging literal, or at least equivalent, infringement of the patent in suit.
On appeal, the Düsseldorf Court of Appeal had found that the contested embodiment corresponded to the technical teaching of the claim on the basis of its literal wording. It had rejected the defendant's argument that the contested device only gathered the wire strands at one end of the device. In the Court's view, when considered from a philological point of view, the patent in suit taught more than one clamp and, in addition, prescribed that those clamps be used to clamp the strands at opposite ends of the device. However, the skilled person would not content himself with such a purely linguistic interpretation. He would understand that the clamps served to gather the strands together, irrespective of whether they were left lying flat or if their ends were placed on top of each other by folding, because the two strand ends did not then cease to exist. The skilled person would therefore assume that, according to its essential technical meaning, the claim also included other embodiments in which one strand end was placed over the other and both were secured at just one end of the device.
The Federal Court of Justice took a different view. The claim required clamps attached at opposite ends of the device, but that requirement was not met by a single clamp attached at one end. It was true that, considered in isolation, neither "clamps" nor "ends" gave any clue as to how many were needed, and could, in principle, be interpreted as generic terms, as the Court of Appeal had at first rightly observed. However, it had then failed to take due account of the fact that the wording "at opposed ends of the device" was a specification that clamps be attached at opposite ends and that therefore, as both the English and the Dutch courts had found, there inevitably had to be two clamps. Therefore, opposite ends of the device could only be understood literally.
Whilst the protected subject-matter could not be established on a literal construction of the patent claims, that did not mean, on the other hand, that it was permissible to extend that subject-matter by generalising the means of solving the problem which were specifically indicated in the claim. In particular, a narrow claim could not be interpreted in accordance with a broader description. Rather, the claim took precedence over the description, so that any elements not reflected in the claims could not fall within the scope of patent protection. Although Art. 69(1), 2nd sentence, EPC provided that the description and drawings were to be used to interpret the claims, such use could not result in an extension of the content or material limitation of the subject-matter as defined by the claim's literal meaning. In the event of a contradiction between the claims and the description, those elements of the description not included in the claims were, as a rule, excluded from the scope of the patent. Accordingly, account could be taken of the description only in so far as it could be read as an explanation of the subject-matter of the claim. If the description disclosed more than one way of achieving a given technical effect, but only one of those ways was included in the claim, use of one of the other ways did not generally constitute an infringement of the patent by equivalent means.
Accordingly, the judgment of the Court of Appeal was set aside.
VI. INSTITUTIONAL MATTERS
1. Judicial status of the EPO boards of appeal
DE Germany
Munich Administrative Court of 20 November 2006 (5 BV 05.1586) - Dismissal of belated submissions / TV set
Keyword: institutional issues - legal nature of the boards of appeal
The claimant brought before the Munich Administrative Court an action challenging the decision by an EPO board of appeal to revoke a previously granted European patent and based on the argument that the board's dismissal of auxiliary requests as belated was incompatible with the mandatory standards applicable to judicial proceedings under the German Basic Law, including the right to be heard.
The Court observed that there was no right of appeal to the administrative courts against judicial acts of supranational courts. In particular, decisions of the boards of appeal were judicial decisions which did not fall within the jurisdiction of the administrative courts.
In support of its view that the boards' decisions were judicial acts, the Court observed that appeal proceedings under Art. 106 et seq. EPC against opposition division decisions were wholly separate and independent from the proceedings at first instance and that their function was to provide a judicial decision on the correctness of a strictly separate earlier decision of the first-instance department. Appeal proceedings had to comply with the principles of the rule of law and so were subject to the rules generally applicable to judicial proceedings. The Court referred to the objective and personal independence of the board members, who could not, in principle, be removed from office (Articles 21 and 23 EPC). Nor could they be members of the EPO department which had issued the contested decision at first instance. Finally, any party to the proceedings could object to board members under Art. 24(3) EPC, in particular on the grounds of suspected partiality.
It was true that the boards of appeal were part of the EPO and used its letterhead (see Art. 15(f) and (g) EPC). However, they were sufficiently separate from other departments conducting procedures at first instance (Art. 15(a) to (e) EPC) not only under the procedural rules described, but also in organisational terms under R. 10 EPC 1973 (R. 12 EPC) - which provided for the boards' own Presidium. As an autonomous authority within the organisational unit comprising the boards of appeal, the Presidium adopted the boards' rules of procedure and - in its extended composition including all board chairmen - allocated duties among the members according to subject matter before the beginning of each working year. This guaranteed a separation of executive and judicial powers also in organisational terms.
DE Germany
Federal Constitutional Court of 27 April 2010 (2 BvR 1848/07) - Automatic wood-cutting machine
Keyword: Constitutional complaint against decisions of the EPO boards of appeal
The EPO had granted the complainant, a legal person under Italian private law, a patent valid in Germany, having rejected an opposition to grant filed by an Italian competitor. That competitor had then lodged an appeal against that decision. Revoking the patent, the board of appeal had observed that neither party had requested oral proceedings and that it had likewise considered such proceedings unnecessary, especially since the parties had had an opportunity to comment. The complainant objected to the procedural action of the board of appeal before the Federal Constitutional Court on the ground that its fundamental right to be heard had been infringed because the board ought to have given it an opportunity to explain its legal position at an oral hearing. The complainant also asserted a breach of its fundamental right under Art. 19(4) German Basic Law in so far as there was no right of appeal from the board's decision.
First of all, the Court clarified that decisions of the boards of appeal were legal acts which could, as a rule, be challenged by way of a constitutional complaint. The Court had first established the rule that acts of supranational authorities could be challenged by such a complaint in relation to secondary legislation adopted by the institutions of the European Community (Maastricht judgment), and later expressly extended it to cover legal acts of the European Patent Organisation on a functional interpretation of the term "public authority" because the Organisation was an intergovernmental organisation within the meaning of Art. 24(1) German Basic Law. It was an autonomous international legal person, with authority to exercise public powers having been transferred to the EPO.
As a further prerequisite, the contested legal act had to be of a supranational nature, i.e. it had to directly affect the addressee's legal position de jure. Only then could it constitute a legal act "affecting" persons with fundamental rights in Germany within the meaning of the Maastricht judgment. In the Court's view, the contested board of appeal decision was indeed such a legal act with supranational effect:
On being granted a European patent, the complainant had obtained an industrial property right together with all the associated legal powers and economic advantages (see Articles 2(2) and 64(1) EPC). As a result of the board's decision, it no longer had a right equivalent to a German patent in Germany. Accordingly, the contested appeal decision had direct implications within the German legal system. Nevertheless, the present constitutional complaint did not meet the standards of substantiation applicable to such complaints against supranational sovereign acts: according to the Court's case law, constitutional complaints were inadmissible from the outset if it was not shown in the grounds that the organisation concerned did not generally and manifestly provide for the indispensable fundamental protection postulated by the Constitution.
In the case at hand, the complainant had merely asserted generally that the European Patent Organisation did not provide for an adequate standard of protection for fundamental procedural rights, because there was no right of appeal to the European Court of Justice and the Organisation's organs had not expressed a commitment to protect fundamental rights. According to the Court, this did not suffice to constitute a substantiated assertion of a deficient standard of protection of fundamental rights within an organisation. The complainant ought to have thoroughly addressed the double right of legal redress within the organisation and the related procedural provisions as well as the case law of the boards of appeal. A substantiated plea of a deficit in protection of fundamental rights could not be made in the absence of such an analysis, especially since the Federal Constitutional Court had already held on several occasions that, in view of the opportunities for appeal, the independence of the board members and the development of procedural standards through their case law, the system of legal protection under the EPC essentially met the standards set out in the German Basic Law.
2. Examination of decisions by the EPO and national courts
DE Germany
Federal Court of Justice of 15 April 2010 (Xa ZB 10/09) - Roll-forming machine
Keyword: taking EPO case law into account - violation of the right to be heard
In the appeal on a point of law to the Federal Court of Justice, the respondent asserted that the German Patents Court had ignored its argument that the EPO opposition division had, on the basis of the same argument, upheld the European patent with claims which were identical to claims in the contested utility model. The respondent's right to be heard had thus been violated.
The Federal Court of Justice held that German courts were required to consider decisions rendered by organs of the EPO and courts in other EPC contracting states and pertaining to a largely similar issue and, where appropriate, address the reasons leading to a diverging result in the earlier decision. Insofar as points of law are concerned, this also applied, for instance, to the question of whether the subject-matter of a property right was obvious in the light of the prior art. However, not every violation of this obligation breached the relevant party's right to be heard.
In the case at issue, the Patents Court did not have to explicitly address the assessment of the EPO opposition division in the grounds of the contested decision in order to protect the respondent's right to be heard, since the respondent had failed to produce the opposition division's decision or elucidate the grounds on which this decision was based.
Editor's note: See full text of the decision in the EPO official languages, OJ EPO 2010, 622. On the question of the legal nature of decisions of the boards of appeal, see for example the following decisions in the present report: Barcelona Court of Appeal (Audiencia Provincial) of 18 October 2007 (ES); Paris District Court of 9 January 2008 (FR); Paris District Court of 28 September 2010 (FR); Court of Appeal of 8 October 2008 (GB); Board of Appeal of the Norwegian Patent Office of 7 January 2010 (NO); Patents Court of 12 October 2007 (GB).
3. Stay of national proceedings
DE Germany
Federal Patents Court of 20 October 2006 (3 Ni 7/06 (EU)) - Torasemide
Keyword: parallel proceedings - EPO opposition proceedings - nullity action - admissibility - principle of subsidiarity
The European patent concerned a "new crystal modification III of torasemide", which had been limited with effect in Germany, at the patent proprietor's request, by the German Patent Office. The claimant seeking revocation, amongst others, had filed a notice of opposition against the patent with the EPO. The proceedings before the EPO opposition division were still pending. In support of its action, the claimant submitted that the European patent's scope of protection had been inadmissibly extended in the (national) limitation proceedings. It contended that, irrespective of § 81(2) German Patents Act, the action was admissible because it was based on a ground for revocation which did not constitute at the same time a ground for opposition under Art. 100 EPC. § 81(2) German Patents Act precluded the initiation of revocation proceedings during the period for filing opposition or - as in this case - where the patent was the subject of pending opposition proceedings (principle of subsidiarity).
The German Federal Patents Court had declared the action inadmissible on the ground that § 81(2) German Patents Act was also applicable to actions for revocation of European patents based on the ground of inadmissible extension of protection, even if that ground had not been cited in opposition under Art. 100 EPC. This followed from the wording of the provision, which did not distinguish between the German Patent Office and the EPO opposition proceedings, and was also supported by the prevailing doctrine. Moreover, § 81(2) German Patents Act precluded actions for revocation generally, where opposition proceedings were still pending, and did not grant any scope for assessment or discretion or for other exceptions to the principle of subsidiarity it enshrined.
Contrary to the claimant's view, the subsidiary character of the action for revocation was designed to preclude generally the issuing of decisions on the full or partial invalidity of a patent where it was not yet clear whether or not it would ultimately be upheld in the opposition proceedings, and if so, in what form. § 81(2) German Patents Act served to prevent parallel decisions on the validity of a patent, irrespective of the legal ground for the challenge, and also to relieve the Federal Patents Court of complex revocation proceedings. The exclusion of revocation proceedings during pending opposition proceedings formed a general rule, whereby the relevant provision should not be interpreted as according discretionary powers or foreseeing exceptions from the principle of subsidiarity postulated therein.
GB United Kingdom
Court of Appeal of 31 January 2008 - Glaxo v Genentech and Biogen [2008] EWCA Civ 23
Keyword: parallel proceedings - EPO opposition proceedings - stay of proceedings
The defendants Genentech and Biogen appealed against a decision of the Patents Court dismissing their application for a stay of the revocation proceedings brought by the claimant, Glaxo, in respect of the UK designation of the defendants' second medical use patent. The claimant had first filed an opposition at the EPO and then commenced revocation proceedings in the UK.
On appeal, the defendants argued that it was prima facie vexatious and an abuse of process for a claimant to bring two claims against the same defendant in respect of the same cause of action to obtain the same relief. There should be a strong presumption in favour of a stay pending conclusion of the EPO proceedings.
The Court of Appeal dismissed the appeal.
Discussion about the inherent power of the English courts to stay legal proceedings should start with terms of its statutory recognition and saving in s. 49(3) of the Supreme Court Act 1981. This retained the inherent power of the court to stay any proceedings before it "where it thinks fit to do so" either of its own motion or on the application of any person. This was the widest possible judicial discretion.
The Court of Appeal should not interfere with the exercise of this very wide discretion unless there was an error of legal principle or for some other reason the decision was plainly wrong.
The approach of the courts to the exercise of judicial discretion was plain. All the circumstances relevant to the balance of justice in the case had to be weighed.
The structure and terms of the EPC were relevant to the context of the court's power to stay national proceedings. This was different from the starting point in the commercial conflict-of-laws cases in which there was only supposed to be one court for determining the issue in question. This feature of the forum conveniens cases supported a general presumption or inclination in favour of a stay of one of the sets of proceedings.
Business needed to know where it stood. The claimant had a genuine commercial interest in the revocation of the patent. The judge had found that the claimant would suffer actual prejudice if there were any delay in resolving the validity of the patent.
The judge in the Patents Court had made a correct assessment of factors for and against a stay and was entitled to conclude that the balance of justice was in favour of rejecting the defendants' application to stay the claimant's revocation action.
General guidance on the Patents Court's discretion to stay legal proceedings on the ground that there were parallel proceedings before the EPO was also offered:
- The discretion, which is very wide indeed, should be exercised to achieve the balance of justice between the parties having regard to all the relevant circumstances of the particular case.
- It is the discretion of the Patents Court, not of the Court of Appeal.
- Although neither the EPC nor the Patents Act 1977 contains express provision relating to automatic or discretionary stay of proceedings, they provide the context and condition for the exercise of the discretion.
- The possibility of duplication of proceedings contesting the validity of a European patent is inherent in the EPC. National courts exercise exclusive jurisdiction on infringement issues and have concurrent jurisdiction with the EPO on validity issues.
- This setting indicates that one factor affecting the discretion will usually carry more weight than any other. That is the length of time it will take for the respective proceedings to achieve certainty on the issue of validity so that business knows where it stands.
- There are no grounds justifying the application by the Patents Court of a presumption that the duplication of legal proceedings is, without more, a ground for stay of proceedings before the Patents Court.
- The Patents Court judge is entitled to refuse a stay where, as here, some commercial certainty could be achieved considerably earlier before the UK court than the EPO.
- Much weight should be given to an assertion by a commercial party that it has a good reason for resisting a stay. Competitors' contentions that there is no need should be viewed with suspicion.
- Other considerations may affect the balance of justice, but they are in general of lesser importance than achieving commercial certainty sooner. The actual exercise of the discretion does not require the judge to deliver a judgment dealing in detail with all points taken by the parties.
GB United Kingdom
Court of Appeal of 25 April 2007 - Unilin Beheer BV v Berry Floor NV, Information Management Consultancy Ltd [2007] EWCA Civ 364
Keyword: parallel proceedings - res judicata - estoppel - damages for infringement
Unilin's European patent concerning floor covering was granted on the basis of a divisional application under Art. 76 EPC. Unilin sued Berry Floor for infringement in the UK. In parallel, in March 2003, Berry Floor's parent company started opposition proceedings against Unilin's patent before the EPO. In the national infringement proceedings Fysh J, sitting in the Patents Court, held the UK part of the patent valid and infringed by Berry. He awarded Unilin financial relief for the infringements, but held that there was no res judicata in respect of damages and account of profits, and Berry was not estopped from challenging Unilin's claims in this regard. However, Fysh J declined to exercise his discretion to stay the inquiry in view of the pending EPO proceedings. Both parties appealed his judgment.
The Court of Appeal disagreed with the lower court on the issue of estoppel. Jacob LJ held that the judgment on damages was res judicata, and there was indeed an estoppel whatever the ultimate result in the EPO. If the EPO subsequently revoked the patent, any injunction would fall with it, but this would not affect the patentee's right to damages won earlier. If the patent were revoked, the way would be cleared; if it were upheld and held infringed, then compensation would be payable for past acts.
The Court of Appeal also addressed questions relating to cross-over issues between national courts and the EPO. Jacob LJ said it was not helpful to ask whether the national court or the EPO should be "top" during parallel infringement proceedings. In his opinion, it all depended on the circumstances, as illustrated by the following two scenarios:
(i) The patent is still under opposition when a national court holds it valid and the EPO then revokes – so the EPO is "top";
(ii) The EPO holds the patent valid and a national court subsequently revokes it (there is no estoppel created by an EPO decision as to validity, see Buehler v Chronos [1998] RPC 703) – so the national court is "top".
As to the effect the revocation of a European patent could have on national infringement proceedings (including attacks in validity), Jacob LJ referred to the previous case law on res judicata and extended this principle to the UK part of European patents. He held that it was impossible to find in the UK Patent Act 1977 any intention that a final and binding decision of the UK courts was to be regarded as only provisional. He did not think the untidy compromise reached by the EPC was that any final decision of a national court rejecting an invalidity attack was to be regarded as merely provisional. On the contrary, the compromise was to allow a patentee to sue for infringement and for third parties to attack a national patent in a national court from the moment of grant. If the contracting parties had wanted to say that the result, if favourable to the patentee, was merely provisional, the EPC would surely have expressly said so. Moreover, if the result went the other way, i.e. the patent was revoked by a national court, the result was certainly not provisional; a subsequent EPO opposition decision upholding the patent would not reinstate it in the contracting state concerned.