WORKING SESSION
Exclusions from patentability with special focus on the medical field
Brigitte GÜNZEL - Chairman of the Legal Board of Appeal - Exclusions from patentability of relevance in the medical field - recent cases before the Enlarged Board of Appeal
In the period since the 14th European Patent Judges' Symposium in Bordeaux three decisions have been handed down by the Enlarged Board of Appeal on subject-matters concerning exclusions from patentability which are of relevance in the medical field. The main focus of the present contribution will be the Enlarged Board's decision G 1/07 of 15 February 2010, which concerns the exclusion from patentability of methods for treatment of the human or animal body by surgery.
1. G 2/06
The first of the three decisions given was G 2/06 of 25 November 2008 (OJ EPO 2009, 306), in which the Enlarged Board was concerned with issues relating to the patenting of human embryonic stem cells. The referred questions were whether Rule 28(c) EPC forbids the patenting of claims directed to products (here: human embryonic stem cell cultures) which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived. The referring board had also asked whether, if the answer to that question is no, Article 53(a) EPC forbids patenting such claims. Furthermore, the referring board had asked whether it is of relevance that after the filing date the same products could be obtained without recourse to a method necessarily involving the destruction of human embryos.
According to Article 53(a) EPC European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to "ordre public" or morality. Rule 28(c) EPC, corresponding to Article 6(2)(c) of Directive 98/44/EC of 6 July 1998 ("the Biotech Directive"), specifically addresses the issue of human embryos by providing that under Article 53(a) EPC European patents shall not be granted in respect of biotechnological inventions which concern uses of human embryos for industrial or commercial purposes.
As regards the substance of the referred questions, the Enlarged Board held that Rule 28(c) EPC forbids the patenting of claims directed to products which - as described in the application - at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims. In that context it is not of relevance that after the filing date the same products could be obtained without recourse to a method necessarily involving the destruction of human embryos (supra, Answers to Questions 2 and 4). Since Rule 28(c) EPC forbids the patenting of such claims, no answer was required to the question whether the patenting of such claims would also offend against Article 53(a) EPC (supra, Answer to Question 3). Hence, the Enlarged Board did not deal with that issue other than by generally stating - albeit in a different context - that Rule 28(c) EPC is within the scope of Article 53(a) EPC (supra, point 31 of the Reasons).
2. G 1/07
In decision G 1/07 of 15 February 2010 the Enlarged Board was concerned with the scope of the exception to patentability under Article 53(c) EPC of methods for the treatment of the human or animal body by surgery. The questions put to the Enlarged Board more specifically referred to imaging methods for a diagnostic purpose (being limited to the examination phase within the meaning of decision G 1/04) comprising an invasive step (injection into the heart) for the purpose of administering a contrast agent to the patient.
2.1 The main issue underlying the first referred question was whether the exception to patentability is to be construed as limited to surgical methods that are performed for a therapeutic purpose. That this is so had been held in several recent decisions of the boards of appeal (starting with decision T 383/03, OJ EPO 2005, 159), which had thereby overturned a previous line of jurisprudence of the boards of appeal holding the contrary (see in particular decisions T 182/90, OJ EPO 1994, 641 and T 35/99, OJ EPO 2000, 447).
2.2 The Enlarged Board first of all rejected the proposition advanced by the appellant in the case underlying the referring decision that a principle of narrow interpretation of exclusions from patentability should be applied to the exclusion clause contained in Article 53(c) EPC. The Enlarged Board held that no such general principle which would be applicable a priori to the interpretation of exclusions can be derived from Articles 31 and 32 of the Vienna Convention on the Law of Treaties. At least equally if not more important is, besides the ordinary meaning to be given to the wording of the provision, that the provision is interpreted in such a manner that it takes its effect fully and achieves the purpose for which it was designed (point 3.1 of the Reasons).
2.3 Making reference to its earlier opinion G 1/04 (OJ EPO 2006, 334, point 6.2.1 of the Reasons), the Enlarged Board then confirmed the principle underlying the practice and jurisprudence hitherto that a method claim falls under the prohibition of patenting methods for treatment by therapy or surgery (now) under Article 53(c) EPC if it comprises or encompasses at least one feature defining a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy (points 3.2 et seq. of the Reasons).
This also applies to methods for a diagnostic purpose when these methods comprise or encompass a surgical step. The appellant's argument that this would undermine the narrow construction of the exclusion of diagnostic methods from patentability adopted in opinion G 1/04 was rejected by the Enlarged Board. In order to be patentable a claimed invention must fulfil all requirements for patentability and must not be excluded from patentability by any of the exclusions foreseen in the EPC. The three alternative exclusions in Article 53(c) EPC are thus cumulative requirements (point 3.3 of the Reasons).
2.4 Furthermore, that the exclusion of methods of treatment by surgery from patentability is one of three alternatives prima facie indicates that the situations covered by each of the alternatives were not meant to be identical since the inclusion of the term "by surgery" in Article 53(c) EPC would be pointless if the meaning of that alternative was already entirely contained in the exclusion from patentability of the other alternative, i.e. the "treatments by therapy" (point 3.3.1 of the Reasons). In today's medical and legal linguistic usage the term "treatment" is not restricted to a treatment serving a curative purpose but may also include treatments for other, non-curative purposes such as cosmetic treatment, the termination of pregnancy, castration, sterilisation, artificial insemination, embryo transplants, treatments for experimental and research purposes and the removal of organs, skin or bone marrow from a living donor. When carried out by surgery, these treatments are regarded as surgical treatments(point 3.3.3 of the Reasons, making reference to decision T 182/90). After having explored in detail the legislative history of Article 52(4) EPC 1973, which provision had not been amended in the EPC 2000 revision but only shifted to Article 53(c) EPC, the Enlarged Board concluded that the travaux préparatoires do not confirm that only such surgical methods as are of a therapeutic nature were intended to be excluded from patentability (point 3.3.2.3 of the Reasons).
2.5 The commonly accepted ratio legis of Article 53(c) EPC that medical and veterinary practitioners should be free to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients uninhibited by any worry that some treatment might be covered by a patent calls for exclusion from patentability of any serious and risky surgical interventions which require considerable professional medical expertise to be carried out and involve serious health risks even when carried out with the required professional care and expertise, e.g. in cosmetic surgery, organ transplantation, embryo transfer, sex change operations, sterilisation and castration (point 3.3.7 of the Reasons).
On the other hand, considered from this angle, the broad construction of the kind of interventions being of a surgical nature developed in decision T 182/90 (supra, points 2.2 and 2.3 of the Reasons) that it covers any non-insignificant intervention performed on the structure of an organism by conservative ("closed, non-invasive") procedures such as repositioning or by operative (invasive) procedures using instruments including endoscopy, puncture, injection, excision, opening of the bodily cavities and catheterisation, or, as in the practice of the EPO, any methods involving irreversible damage to or destruction of living cells or tissues of the living body, irrespective of the underlying mechanism of the intervention (e.g. mechanical, electrical, thermal, chemical), is overly broad when considering today's technical reality.
The advances in safety and the now routine character of certain, albeit invasive, techniques, at least when performed on uncritical parts of the body, have led to many such techniques nowadays being generally carried out in non-medical, commercial environments such as cosmetic salons and beauty parlours and it appears, hence, hardly still justified to exclude such methods from patentability. This applies as a rule to treatments such as tattooing, piercing, hair removal by optical radiation, and micro abrasion of the skin.
If so, that can also not be ignored when it comes to the application of routine interventions in the medical field.
Today, numerous and advanced technologies do exist in the medical field concerning the use of devices which in order to operate must in some way be connected to the patient. Methods for retrieving patient data useful for diagnosis may require administering an agent to the patient, potentially by an invasive step like injection, in order to yield results or at least they yield better results when using such a step.
Considering this technical reality, excluding from patentability also such methods as make use of what are in principle safe routine techniques, even when of an invasive nature, appears to go beyond the purpose of the exclusion of treatments by surgery from patentability in the interest of public health.
2.6 As regards the scope of the definition given in decision G 1/07, the Enlarged Board emphasises that on the basis of the particular set of circumstances underlying the referral it is not possible for the Enlarged Board, when trying to redefine the meaning of the term "treatment by surgery", to give a definition which would, once and for all, also delimit the exact boundaries of such a new concept with respect to the whole comprehensive body of technical situations which might be concerned by it. The first-instance bodies and the boards of appeal are much better suited to that task. Defining the boundaries includes considering that the required medical expertise and the health risk involved may not be the only criteria which may be used to determine that a claimed method actually is a "treatment by surgery" within the meaning of Article 53(c) EPC. Other criteria such as the degree of invasiveness or the complexity of the operation performed could also determine that a physical intervention on the human or animal body is a "treatment by surgery" within the meaning of Article 53(c) EPC (point 3.4.2.4 of the Reasons).
2.7 In a second question the referring board had asked whether, if the answer to question 1 is in the affirmative, the exclusion from patent protection could be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it.
2.7.1 In its answer to this question the Enlarged Board first of all confirmed the established jurisprudence of the boards of appeal that a claim encompassing an embodiment which is excluded from patentability under now Article 53(c) EPC, then Article 52(4) EPC 1973, cannot be left unamended (point 4.1 of the Reasons).
2.7.2 The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming an embodiment or embodiments which are methods of treatment by surgery within the meaning of Article 53(c) EPC, but the overall patentability of any such claim depends on the remaining requirements of the EPC and, where applicable, the conditions defined in decisions G 1/03 and 2/03 also being fulfilled. Whether or not this is the case is to be decided in each case, individually. This applies also to the question of which form the disclaimer can or must take, i.e. whether - only - a particular embodiment can or must be disclaimed or whether a disclaimer can and/or must take a more general form, as e.g. by use of the word "non-surgical" (point 4.2 of the Reasons).
2.7.3 A more complex issue is whether the surgical step can be omitted. In this respect the Enlarged Board first makes some general remarks and then turns to the specific issue of methods only concerning the operation of a device.
Article 84 EPC in conjunction with Rule 43 EPC requires that the claims define the matter for which protection is sought. Hence, the claim should explicitly specify all of the essential features needed to define the invention. Furthermore, the claim must be clear (G 1/04, supra, point 6.2 of the Reasons). Under Article 84 EPC, whether or not a step being or encompassing a surgical step excluded from patentability can be omitted either by using positive wording for such omission like "predelivered" or by simply leaving it out from the claim depends on whether the claimed invention is fully and completely defined by the features of the claim without that step (point 4.3.1 of the Reasons).
However, a typical class of cases in which the invention would be fully defined without requiring the presence of the potentially surgical step as a positive feature of the claim would be cases in which the invention only concerns the operating of a device, for which cases the boards of appeal have constantly held that a method which is only concerned with the operating of a device without any functional link between the claimed method and the effects produced by the device on the body does not qualify at all as a method for treatment within the meaning of Article 52(4) EPC, even if the application of the device as such needs a surgical step to be practised on the body. Expressions like "predelivered" or "preimplanted" have been allowed to make clear that the feature pertaining to that step was not part of the claimed invention.
The Enlarged Board points out that it sees no reasons for calling that approach into question. Methods which are merely directed to the operating of a device without themselves providing any functional interaction with the effects produced by the device on the body are teachings in which the performance of a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy is not required in order for the teaching of the claimed invention to be complete. Hence, even if in such a case the use of the device itself requires the application of a surgical step to the body or is for therapeutic treatment the same does not apply to the claimed method for operating the device. It appears therefore to be correct to say that such inventions are not methods for treatment of the human or animal body within the meaning of Article 53(c) EPC and that the distinction made in the jurisprudence of the technical boards properly delimits patentable methods of a merely technical nature from such inventions as fall within the exclusion under Article 53(c) EPC (point 4.3.2 of the Reasons).
However, when omission of a step from a claim is being considered, the remaining requirements of the EPC for the allowability of such omission and the patentability of a claim not containing the omitted feature must furthermore also be fulfilled. These are in particular Article 123(2) EPC and, in opposition proceedings, Article 123(3) EPC, but Articles 83 or 56 EPC may also come into play, e.g. if, as a result of the omission the claimed invention can no longer be carried out over the whole breadth of the claim or the problem is not thereby solved (point 4.3.3 of the Reasons).
2.8 As a last question the referring board had asked whether a claimed imaging method for a diagnostic purpose (not being excluded under Article 52(4) EPC 1973 as such) is to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC 1973 if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.
The Enlarged Board's answer is that since in that case the imaging method is a complete teaching per se the fact that it can be used in a potentially particularly advantageous way in the course of a surgical intervention does not preclude the imaging method from being claimed per se. Even if used in the course of a surgical intervention that does not alter the character of the imaging method of not being a surgical step in itself.
Article 53(c) EPC prohibits the patenting of surgical methods and not the patenting of any methods which can be used in the context of carrying out a surgical method. Otherwise, many methods which are used during surgical interventions, even if not requiring themselves a surgical step to be carried out on the body, e.g. all methods for operating devices used in context with surgical activities, would be unpatentable.
Hence, the fact that one of the possible and described uses of the imaging method is the use by a surgeon during a surgical intervention, allowing the surgeon to decide on the course of action to be taken in the intervention by taking note of the immediately produced image data, does not render that imaging method excluded from patentability (point 5 of the Reasons).
3. G 2/08
In decision G 2/08 of 19 February 2010 (OJ EPO 2010, 456) the Enlarged Board dealt with the patentability of claims based on further medical uses under Article 54(5) EPC. In the referring decision the referring board had asked whether, where it is already known to use a particular medicament to treat a particular illness, this known medicament can be patented under Article 54(5) EPC for use in a different, new and inventive treatment by therapy of the same illness, and furthermore, if the answer to that question was yes, whether such patenting is also possible where the only novel feature of the treatment is a new and inventive dosage regime.
The Enlarged Board first of all confirmed the prior jurisprudence of the boards of appeal that, where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament can be patented for use in a different treatment by therapy of the same illness (points 5.10 et seq. of the Reasons). Furthermore, such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art (points 6 et seq. of the Reasons). In future, however, the aforementioned principles apply with the proviso that where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a Swiss-type claim. The main reasons is that that claim format was allowed by the Enlarged Board in decision G 5/83 only in order to fill a perceived lacuna in the law. The legislator now having closed the loophole existing in the provisions of the EPC 1973 by permitting purpose-related product protection for any further specific use of a known medicament, it is no longer justified to allow Swiss-type claims. Swiss-type claims could be and have been objected to as regards fulfilment of the patentability requirements, due to the absence of any functional relationship of the features (belonging to therapy) concerning novelty and inventiveness, if any, and the claimed manufacturing process. However, for reasons of legal certainty and to protect the legitimate interests of applicants, the Enlarged Board allowed a time limit of three months after publication of the decision in the Official Journal of the EPO in order that future applicants can comply with this new situation (points 7 et seq. of the Reasons).