D. Sufficiency of disclosure
FR France
Paris Court of Appeal, 12 January 2016 (13/13050) – Clinipro v General Hospital Corporation (US)
Keywords: sufficiency of disclosure – imprecise and contradictory information
Having been sued by General Hospital for infringement of claim 1 of its European patent 1 490 005 for "devices for selective disruption of fatty tissue by controlled cooling", Clinipro had counterclaimed for revocation of that claim. However, the court ruling at first instance had been that it had infringed the patent.
Observing that an excess of fatty cells gave skin an unappealing look, frequently compared to orange peel, General Hospital had submitted that its invention was designed to reduce the risk that removing subcutaneous fatty tissue by cryodamage would cause collateral damage to the dermis and/or epidermis.
On appeal, the Court, having dismissed Clinipro's request for revocation of claim 1 for lack of novelty, went on to consider its auxiliary request for revocation for insufficiency of disclosure.
Summarising the principles governing examination of this ground, the Court observed that the skilled person had to be able to derive from the description the means of readily carrying out the invention, using his common general knowledge of theory and practice, together with the information set out in the patent. The skilled person here was a team composed of a specialist in skin biology and a specialist in cryogenics (in particular, cryolipolysis, a cooling treatment used to destroy fat).
It found that, in order to carry out the invention, the skilled person first had to establish what cooling temperature to apply, how long to apply it and what area of the skin should be cooled, and then examined each of these parameters in detail. Having considered, in connection with the results of experiments on pigs which were mentioned in the description, an expert report adduced by General Hospital, it found that its author, a doctor specialising in dermatology, did not fall within its definition of the relevant skilled person and had also based his conclusions on studies conducted after the patent's priority date. Sufficiency of disclosure, however, had to be assessed as at the priority date, which in this case had been in 2002. At that time, the skilled person could not have extrapolated the results of experiments on pigs to humans.
The Court concluded that, being faced with a very large amount of imprecise and even mutually contradictory information as to the temperature, the duration of its application and the area to be treated, but unable to single out any piece of it as especially relevant, the skilled person defined in this case would have been unable to derive from the description the means of readily carrying out the invention using his common general knowledge of theory and practice. The description therefore did not meet the Art. 83 EPC requirements for sufficient disclosure. The Court thus overturned the ruling at first instance.
Editor's note: See also Court of Cassation, 4 October 2016 (PIBD (2016) 1060-III-873).
FR France
Paris Court of Appeal, 17 May 2016 (14/10335) – Rabaud v SEE
Keywords: sufficiency of disclosure – drawings
Société d'Équipement pour l'Environnement (SEE) had brought an infringement action against Rabaud in respect of its French patent 2 795 661 and European patent 1 066 883, both entitled "Shredding apparatus for vegetal or other material" (the European patent had claimed the priority of the French application under the Paris Convention). In a counteraction, Rabaud had requested that the two patents be revoked.
A problem encountered in shredding branches is the need to sort the vegetal or other material to be shredded because, whereas shredders with knives are needed for branches with medium to large diameters, shredders with flails are better for small branches. The solution proposed in the patent was a shredder comprising in particular a chamber equipped with a rotor on which tools specific to shredding different types of vegetal or other material were arranged alternately to form a multi-purpose active drum.
In support of its request for the French patent's revocation for insufficiency of disclosure, Rabaud argued that the patent failed to specify how the rotor might be structured to create an airflow that pushed material towards the ejection zone – as described in claim 1.
The Court observed that a patent's description had to enable the skilled person to reproduce the invention readily, using his common general knowledge of the theory and practice, plus the teaching in the patent; otherwise, the patent was open to revocation. In this case, the skilled person could not derive from the drawings the means of creating the airflow according to claim 1, because the S-shaped lines in them were unannotated and did not enable claim 1 to be understood such that those means were fan blades. By contrast, claim 1 of the similar European patent described this very ventilation method in detail, which implied that the skilled person would indeed be unable, using only his general knowledge, to reproduce the invention without such a description. The Court revoked claim 1 for insufficiency of disclosure. It added that a claim dependent on another revoked on that ground was necessarily invalid for the same reason: the skilled person could not reproduce its subject-matter if he was unable to reproduce that of the claim on which it depended.
GB United Kingdom
Patents Court, 22 October 2015 – Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd & Anor [2015] EWHC 2973 (Pat)
Keywords: sufficiency of disclosure – plausibility – disclosure of priority document
Ono's European patent (UK) 1 537 878 related to the use of anti-PD-1 antibodies for the treatment of cancer. Claim 1 was in Swiss form and claim 3 was a purpose-limited product claim (EPC 2000). Birss J rejected all lines of attack by Merck and held the patent valid.
An important objection concerned the plausibility of the disclosure of the priority document and of the patent. Birss J pointed out that this question had come up in the cases in the context of industrial application, sufficiency, priority, and obviousness. The term was not to be found in the legislation and, as an aspect of patent law, it was fairly new. It had been considered by the Supreme Court in Human Genome Sciences v Eli Lilly [2011] UKSC 51 primarily in the context of industrial application and sufficiency. According to Lord Hope there, the sense that the word "plausible" conveyed was that there must be some real reason for supposing that the statement was true; the standard was not any higher than that. And in Regeneron v Genentech [2013] EWCA Civ 93, Kitchin LJ had emphasised that it had to be possible to make a reasonable prediction that the invention would work with substantially everything falling within the scope of the claim. However, this decision had also stated that if it was possible to make such a prediction then it could not be said that the claim was insufficient simply because it was not demonstrated that the invention worked in every case.
Concerning the invention in question, Birss J held that to a skilled person reading the patent application (or the priority document) when it had been filed, the document made a soundly based and reasonable prediction that the therapy would work to treat cancer. It was plausible that it was likely to work for cancer in general. Success in this context did not mean success in every patient in all circumstances. The skilled person would not predict 100% success across the board.
The evidence of what had happened in practice showed that the treatment was indeed effective to treat a range of cancers and could well treat many more. Anti-PD-1 monotherapy probably did not work to treat most colorectal cancers but there were colorectal cancers which it did treat. It probably did not work to treat prostate cancer. Birss J recognised that both prostate and colorectal cancers were significant diseases which afflicted a large number of people. Nevertheless, in his judgment neither point undermined the teaching of the patent. The generalisation was fair at the time and supported by the disclosure. It was a major advance. Moreover, with all the information now available, it was still a fair generalisation. If anti-PD-1 monotherapy did not work for a large variety of different kinds of cancer then that might have been a different matter. When anti-PD-1 antibodies had been shown to work or to be very much worth testing in such a wide variety of cancers, the generality of the principle disclosed was not undermined by the lack of success in these two instances. The relevant claims were sufficiently disclosed and were commensurate with the technical contribution of the patent. The same was true for the priority document and so the claims were entitled to priority.
GB United Kingdom
Patents Court, 16 November 2015 – Actavis Group PTC EHF & Anor v Eli Lilly and Company [2015] EWHC 3294 (Pat)
Keywords: sufficiency of disclosure – inventive step – plausibility
Actavis sought revocation of Eli Lilly's European patent (UK) 0 721 777 with Swiss form claims directed to atomoxetine for treating ADHD, and alleged inter alia that the disclosure of the patent lacked plausibility and was therefore insufficient or obvious on the basis of lack of technical contribution.
The question arose whether the standard of "plausibility" was the same for sufficiency as for obviousness. Henry Carr J held that the policy considerations underlying plausibility for sufficiency were different from those underlying fair expectation of success for obviousness, which indicated that the standard for assessment of plausibility was not the same as assessment of obviousness. For obviousness, a fair expectation of success was required because, in an empirical art, many routes could be obvious to try, without any real idea of whether they would work. The denial of patent protection based upon the "obvious to try" criterion alone would provide insufficient incentive for research and development in, for example, pharmaceuticals and biotechnology, and would lead to the conclusion that a research program of uncertain outcome would deprive a patent of inventive step. The reason for the requirement of plausibility in relation to sufficiency was different. It was to exclude speculative patents, based on mere assertion, where there was no real reason to suppose that the assertion was true.
Henry Carr J rejected Eli Lilly's submission that, in circumstances where an invention could be put into practice, and did in fact work, the imposition of a test of plausibility would be contrary to TRIPS, the EPC, or the 1977 Patents Act. Plausibility was a factor to be taken into account while interpreting the requirements of susceptibility of industrial application, sufficiency and inventive step. The requirement of plausibility applied not only to claims of wide scope, although generally it was likely to be easier, as a matter of fact, to show plausibility for a claim of narrow scope.
As was established by the relevant cases, plausibility was a threshold test which was satisfied by a disclosure which was "credible", as opposed to speculative. That disclosure could subsequently be confirmed or refuted by further evidence obtained subsequent to the priority date. If it was subsequently shown that the invention did not work with substantially all of the products or methods falling within the scope of the claim then the scope of the monopoly would exceed the technical contribution and the patent would be invalid. This indicated why plausibility was only a threshold test. A plausible invention could nonetheless be shown to be insufficient.
On the facts of the case, Henry Carr J concluded that the disclosure of the patent that atomoxetine was effective in the treatment of ADHD was plausible. He also found that the cited prior art did not make it obvious to try atomoxetine for the treatment of ADHD.
GB United Kingdom
Court of Appeal, 13 October 2016 – Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Ors [2016] EWCA Civ 1006
Keywords: sufficiency of disclosure – plausibility
Generics and Actavis challenged the validity of Warner-Lambert's European patent (UK) 0 934 061 with Swiss-type claims directed to pregabalin. Claim 1 was very broad and concerned the treatment of pain, while claim 3 concerned the treatment of neuropathic pain. At first instance Arnold J (Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat)) had held all claims inventive, but had found several, including claims 1 and 3, invalid for insufficiency due to lack of plausibility. The Court of Appeal confirmed this aspect of the decision of the Patents Court.
In the Court of Appeal, Floyd LJ examined the meaning of the requirement of plausibility, i.e. that the specification should make the invention plausible or credible. He pointed out that the requirement of plausibility originated in the jurisprudence of the boards of appeal of the EPO, where similar requirements arose in several contexts, in particular in relation to industrial applicability (Art. 57 EPC) and inventive step (Art. 56 EPC). He summarised the boards' case law (with reference to T 609/02; also T 1329/04) in the following propositions:
(i) a mere assertion that compound X is suitable for treating disease Y is not sufficient without any more to render the invention plausible;
(ii) the disclosure of the patent specification does not have to be definitely predictive of the efficacy of the invention: in vitro tests which may well not be reproducible in humans or animals may suffice;
(iii) an example of adequate support to amount to a plausible disclosure would be experimental tests, showing that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease;
(iv) later published data are not admissible if they alone render the invention plausible;
(v) ultimately the purpose of the requirement of sufficiency is to place the reader in possession of the invention without imposing undue burden on him by way of further investigation or research.
According to Floyd LJ, the EPO and domestic cases indicated that "the requirement of plausibility is a low, threshold test. It is designed to prohibit speculative claiming, which would otherwise allow the armchair inventor a monopoly over a field of endeavour to which he has made no contribution. It is not designed to prohibit patents for good faith predictions which have some, albeit manifestly incomplete, basis".
Arnold J's conclusions on the sufficiency of the claims were held to be correct. With respect to claim 3 in particular, while it was considered plausible concerning peripheral neuropathic pain, it was too speculative regarding central neuropathic pain.
Editor's note: This case is now pending before the UK Supreme Court under Case ID UKSC 2016/0197 (permission to appeal granted on 6 March 2017).
For parallel proceedings in other national jurisdictions concerning this European patent, see chapter H.2 Pregabalin.