II. SUFFICIENCY OF DISCLOSURE
DE – Germany
Federal Court of Justice of 11 September 2013 (X ZB 8/12) – Dipeptidyl peptidase inhibitors
Keyword: sufficiency of disclosure – functional feature – second medical use
The patent application concerned the use of dipeptidyl peptidase effectors to lower blood sugar levels to treat hyperglycaemia. Administration of insulin was known in the prior art. Newer methods, such as installing subcutaneous depot implants or transplanting intact Langerhans cells, were technically complex and risky. The claimed invention therefore sought to solve the technical problem of providing a simple, cost-effective and minimally invasive method of lowering blood sugar levels. The solution proposed in the single remaining claim as defended in the main request was: "Use of inhibitors of dipeptidyl peptidase IV (DP IV) enzymatic activity for lowering the blood sugar level below the glucose concentration characteristic of hyperglycaemia in the serum of a mammalian organism with diabetes mellitus."
The court had to decide whether the use according to the main request was disclosed sufficiently clearly and completely for it to be carried out by a person skilled in the art. It observed that the requirement of enabling disclosure of the invention did not act as a general bar to a certain degree of generalisation in the claim wording. The court held that the description did not have to include instructions as to how to obtain all possible component variants within a functional definition in order to meet the requirement of clear and full disclosure.
The patent applicant is in principle at liberty not to limit the claimed protection to embodiments that are explicitly described in the documents originally filed, but to make certain generalisations, provided that this takes account of the legitimate desire to cover the invention in its entirety.
Whether the wording of a patent claim that contains a generalisation satisfies the requirements of an enabling disclosure depends on whether a scope of protection is sought which does not extend beyond what would appear to a person skilled in the art, in view of the specification and the embodiments contained therein, to be the most generalised technical teaching by which the problem underlying the invention is solved (with reference to T 435/91 and T 694/92).
Describing a group of compounds according to their function in a use claim is not precluded by the fact that claim wording of this kind encompasses not only compounds that are already known or are disclosed in the patent specification, but also the use of compounds that will only be provided at some time in the future; nor is it precluded by the fact that the provision of such compounds may require inventive activity.
Editor's note : In the decision T 544/12 the board made reference to the above decision by the Federal Court of Justice but disagreed with its conclusion regarding sufficiency of disclosure.
FR – France
Paris Court of Appeal of 21 March 2012 (09/23852) – Arcelormittal v Voestalpine
Keyword: sufficiency of disclosure – one-in-three success rate – extensive research
The appellant (Voestalpine) asked the court to reverse the judgment refusing to revoke French patent 0 004 427 for insufficiency in the description.
In essence, the patent related to the manufacture, from a strip of rolled sheet steel, of parts with very high mechanical properties and protected by a metallic surface coating applied before, not after, the sheet was formed.
Voestalpine contended that the description was confusing and contained several imprecise and contradictory expressions. In support of its claim that these shortcomings prevented the skilled person from carrying out the invention, it produced a Max Planck Institute report which contained a table of results showing that, of a total of 24 experiments, eight had been unsuccessful because the sheets had burned. Contrary to the contested judgment, the court held that all these experiments had been conducted under conditions in line with those set out in the patent and, rejecting the position taken by the patent proprietor (Arcelormittal), ruled that such laboratory conditions were much more precise and controllable than those of industrial production and so did not diminish the reliability of the results.
The court held that the sufficiency requirement was not met where the preferred embodiment in the description had only a one-in-three success rate. It also took into account the fact that an EPO board of appeal had revoked European patent 1 143 029, based on the priority of the French patent at issue (decision of 18 August 2011 in T 345/09). The board had likewise found the description insufficient because the skilled person wishing to carry out the invention would be faced with the undue burden of extensive research.
FR – France
Paris Court of Appeal of 23 March 2012 (10/22368) – VSL International v Freyssinet International
Keyword: sufficiency of disclosure – confidential standard – novelty
European patent 1 211 350 related to individually protected strands used in civil engineering, especially to harness or suspend construction parts.
The appellant asked the court to revoke claims 1 to 8 of the French part of the patent on the grounds of lack of novelty and/or inventive step and, in any event, on the ground of insufficiency in the description.
The court dismissed that last ground. That the proprietor's internal specifications were confidential or that the relevant standard had not yet been adopted at the time of filing did not alter how the skilled person, using his common general knowledge, would necessarily understand the description, which had to be clear and complete and enable him to carry out the invention without undue burden. The proprietor had conceded that the features disclosed in the description were among those not yet regulated by a standard, this standard not having been adopted until after the priority date. However, in this case, the standard's later adoption did not prevent the skilled person from understanding the invention as described.
The court observed that a lack of novelty could be established only if it were shown that the subject-matter could be derived clearly, precisely, unambiguously and directly from the prior art and that all the disclosed features were already known. A clear indication that this was not the case was that an expert opinion (the results of which were anyway disputed by all parties) had been required to establish whether the claimed subject-matter was novel. The fact that the tests designed to prove novelty were conducted on the basis of specifications not known at the date of filing was not, in itself, a reason not to admit the results since they had been debated in adversarial proceedings and it was not disputed that the tests had been conducted with the requisite objectivity.
The court held that, for the skilled person to assess inventive step, he had to combine his knowledge of the prior art with his common general knowledge in the field. Faced with all the mathematical calculations put forward by the appellant, which were by no means simple and involved a series of elaborate equations, the skilled person would not have expected to arrive at the solution in claim 1, and the same went for the tests carried out by an external laboratory at the appellant's request. In any event, since those tests were conducted in the knowledge of the result to be achieved, they amounted to a retrospective assessment of inventive step and resulted from an ex post facto analysis, which was an impermissible approach to examining the inventive step in a claim. Thus, the appellant had failed to show that the claim in question lacked inventive step.
GB – United Kingdom
Patents Court of 15 December 2011 – Sandvik Intellectual Property AB v (1) Kennametal UK Ltd (2) Kennametal European GmbH [2011] EWHC 3311 (Pat)
Keyword: sufficiency of disclosure
Arnold J held inter alia that Sandvik's patent (EP (UK) 0 603 144) was invalid for insufficiency, summarising the law on insufficiency as follows. A patent is invalid "if the specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art" (s. 72(1)(c) Patents Act 1977). The patent will be insufficient if the skilled person is unable to carry out the claimed invention given the description of it in the specification and common general knowledge (sometimes called "classical insufficiency"). There have also been repeated attempts by parties seeking to revoke patents to argue that a patent may be invalid on the ground of insufficiency as a result of either ambiguity or excessive breadth of the claims.
Considering classical insufficiency, Arnold J cited Aldous J in Mentor Corp v Hollister Inc [1991] FSR 557, who stated that the law requires the skilled man to be able to perform the invention, but does not lay down the limits as to the time and energy that the skilled man must spend seeking to perform the invention before it is insufficient. Clearly there must be a limit. Aldous J also cited T 226/85 with approval. In Evans Medical Ltd's Patent [1998] RPC 517, Laddie J said, "It is not enough if the instructions are such that a number of equally qualified notional addressees can arrive at completely different end points, some within the scope of the claimed invention and some not. If reasonable addressees can come to different conclusions there is a conundrum as to which is right. That is not enablement. This view appears to be consistent with the approach of ... T 226/85 ...". Arnold J considered T 226/85 to represent the settled approach of the boards of appeal of the EPO, although it had been elaborated on subsequently. Thus, in Novartis AG v Johnson & Johnson Medical Ltd [2010] EWCA Civ 1039, Jacob LJ cited three later decisions, T 435/91, T 694/92 and T 1743/06 and summarised the position as follows, "The heart of the test is: 'Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?'"
On the matter of ambiguity, in the decision under appeal in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, the Court of Appeal had held that it was sufficient that some uEPO could be tested against eEPO by SDS-PAGE. The fact that it did not specify which uEPO and that choosing one uEPO would bring the product within the claim and another would not was 'lack of clarity dressed up to look like insufficiency'. The House of Lords disagreed: "The lack of clarity did not merely create a fuzzy boundary between that which will work and that which will not. It made it impossible to work the invention at all until one had found out what ingredient was needed."
In MedImmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat), Arnold J had reviewed the authorities on excessive claim breadth, particularly the House of Lords' decisions Biogen Inc v Medeva plc [1997] RPC 49, Kirin-Amgen (supra), Generics (UK) Ltd v H. Lundbeck A/S [2009] UKHL 12. The main points were:
- From Biogen
a) A claim will be invalid for insufficiency if the breadth of the claim exceeds the technical contribution to the art made by the invention. Thus the disclosure of one way of performing the invention in the specification may not be enough.
b) The breadth of the claim will exceed the technical contribution if the claim covers ways of achieving the desired result which owe nothing to the patent or any principle it discloses.
- From Kirin-Amgen the explanation of what was meant by "a principle of general application" in Biogen: "It simply means an element of the claim which is stated in general terms. Such a claim is sufficiently enabled if one can reasonably expect the invention to work with anything which falls within the general term."
- From Generics:
a) It was important for UK patent law to be aligned, so far as possible, with the jurisprudence of the EPO (see Biogen). Furthermore, the statement of principle quoted from T 409/91 correctly stated the law.
b) The instant case was to be distinguished from Biogen because the claim was to a single chemical compound whereas Biogen concerned a product-by-process claim of broad scope.
c) It was a mistake to equate the technical contribution of the claim with its inventive concept.
GB – United Kingdom
Court of Appeal of 5 September 2012 – Eli Lily & Co v Human Genome Sciences (HGS) Inc [2012] EWCA Civ 1185
Keyword: sufficiency of disclosure
The Court of Appeal here decided on validity issues concerning HGS's European patent (UK) 0 939 804 left over for determination by Supreme Court decision Human Genome Sciences Inc v Eli Lilly & Co [2011] UKSC 51 (see chapter I. E. "Industrial applicability"). HGS had appealed the first instance finding that claims 18 and 19 were insufficient and Eli Lilly inter alia the finding that claim 13 was sufficient (the claim numbering resulted from decision T 18/09 on the same patent). Claims 18 and 19 concerned pharmaceutical and diagnostic compositions. Commercially, the important claim was claim 13, which, in its amended form, effectively concerned the isolation of any antibody that binds specifically to neutrokine-α. HGS's appeal was allowed (as in T 18/09, where these claims were also held sufficiently disclosed and revocation of the patent was set aside), while Eli Lilly's appeal was dismissed.
Eli Lilly's main argument on insufficiency was that, even though individual antibodies of claim 13 could be made and isolated, the patent gave no idea which, if any, actually had any practical use and that it would take undue effort to find out which of the millions had any use. The patent was aimed at products with a valuable use, particularly as a pharmaceutical or diagnostic, and so claim 13 should be read as confined to such products. The court rejected Eli Lilly's submissions. According to Jacob LJ, at the level of generality of the patent, all the antibodies had a "use". The Supreme Court had decided that each member was susceptible of industrial applicability and that was enough. All the claim called for was an antibody which specifically binds to neutrokine-α; that in itself was its potential utility. The second answer was one of construction. The claim did not contain any limitation to "useful". One did not read words into patent claims unless the context compellingly so required. The context here did not. The skilled reader would know that the patentee had not limited himself to any particular utility. Moreover, "useful" did not have any precise meaning. The reasonable skilled man reading the claim would not import a meaning of imprecise scope.
Jacob LJ also rejected Eli Lilly's subsidiary argument based on the insufficiency of claims 18 and 19. Eli Lilly argued that claims 18 and 19 were for pharmaceutical and diagnostic compositions respectively and limited to compositions with identifiable (from the patent) pharmaceutical or diagnostic uses. Since such uses could not be identified from the patent and could only be discerned after research amounting to undue effort, the claims were insufficient. Jacob LJ, however, agreed with HGS's contention that, read in the context of the specification as a whole, there was no reason for the skilled person to suppose that in these claims the patentee intended any specific application for the claimed compositions. This was in accordance with the principles of claim construction laid down in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46. The contrary view was not, involving as it did the skilled reader in ignoring the very general high level nature of this invention.
Jacob LJ also found that, even if claims 18 and 19 were insufficient, the argument would still fail because the antibodies of claim 13 could all be made. Even if the antibodies to be used for the products of claims 18 and 19 did form a narrower class which could not be ascertained without undue effort, which is what Eli Lilly had argued, this did not mean that the whole class of claim 13 was not enabled. The same was true in Chiron v Murex [1996] RPC 535.
As to the argument based on Pharmacia v Merck [2001] EWCA Civ 1610, claim 1 was to a Markush claim consisting of a large number of compounds, without limitation as to purpose or number. However, the specification made clear that the patentees had found a class of compounds that could be made which at least had anti-inflammatory action. The wide class claim was ruled to be insufficient because it included compounds which did not have the promised activity – it was not enabled across its scope even though all the compounds could be made. Eli Lilly's submission that the same applied here because only those of the antibodies which were useful were the real invention and that the claim was insufficient in the same way it was in Pharmacia was rejected by the Court. The patent at its level of generality was not limited to a specific activity as in Pharmacia. The skilled reader was not led to expect any specific activity, only a host of possibilities which may or may not in fact be. The fact of binding to neutrokine-α was all that the invention of claim 13 was. The objection in Pharmacia was of an AgrEvo type (see T 939/02) – that the claim included many compounds as to which there was no technical contribution. In the case at issue there was a technical contribution – claim 13 was for products susceptible of industrial application. The technical contribution was the limited one of a product which binds to neutrokine-α.