Fordham 27 (Report 8): Second Medical Use/Plausibility

The Plausibility/Second Medical Use session at Fordham IP

The final patent track session on the first day of the Fordham IP Conference was on the Second Medical Use/Plausibility session, moderated by John Richards (Ladas & Parry LLP, New York), focused on two key issues: (1) what do you need in order to get a patent for a second medical use and (2) when can you enforce that patent? 

Kat friend and Fordham guest Kat, Amy Crouch (Simmons & Simmons) reports on the session.

Over to Amy: 

"Klaus Grabinski (Federal Court of Justice, Karlsruhe) started the discussion by outlining infringement of second medical use patents in German case law.  An important difference from the approach taken by the UK Supreme Court in Warner Lambert v Generics is that in Germany second medical use claims (whether Swiss form or EPC 2000 form) are always purpose-bound product claims, rather than method claims. 

Recent case law of the Düsseldorf Court of Appeal has extended the protection to forms of use beyond “manifest arrangements” when the use can be related to the protected purpose of the substance. This requires (i) that the substance is suitable for the protected second medical use, (ii) the use is of some significance and (iii) the implementer knows about it or “blinds himself” and in this way takes advantage of circumstances that allows the substance to be used for the protected purpose.  In the recent Fulvestrant case it was found that there was no expectation of a future infringing use and therefore no injunctive relief was granted.

Unrestricted injunctive relief is not available when such an order would not only cover the second medical use but also use not protected by the patent.  So how can the injunction be tailored to the second medical use alone?  It is a controversial legal issue whether inclusion of a statement that the product must not be used for the second medical use in the patient information leaflet is compatible with EU law on the authorisation of medical products.  Alternative injunctive relief that has been requested is only allowing marketing of a product after alleged the infringer has contacted professional associations of doctors or pharmacists, although at the moment there is no legal basis for requiring associations to comply and it entirely depends on their willingness to cooperate.

The take home message is that the law on second medical use patents is very much a work in progress.  The courts are struggling with this and a reference to the CJEU may well be required in Germany.

Lord Hoffman then presented on the new problems created by (1) DNA patents and (2) second medical use.  What these have in common is that they both involve attempts to patent products (new or old) on the basis that they may have some beneficial use but clinical trials are required to prove as much and, of course, that cannot be done until after the patent has already been applied for.   For a DNA patent the question is one of industrial applicability, whereas for second medical use the question is one of sufficiency.  But really these are one and the same question:  how far “upstream” into research on the potential use of a product can a patent be obtained?

In the Supreme Court case of HGS v Eli Lilly [2011], the BioIndustry Association made submissions on the extent of R&D funding necessary after discovery of a naturally occurring molecule and the importance of funders being reasonably confident that a patent will be granted.   But it was also stated that “the purpose of the patent system is not to reserve an unexplored field for research for the applicant”.  In Lord Hoffman’s view this was a misnomer, as, practically, that was what the patentee was doing in preserving neutrokine-α for themselves.  The real question is whether this is justified?  What is the purpose of the patent system?  HGS contains no discussion of this question.  If the purpose is to provide an incentive to innovate by rewarding successful innovation, why not wait until the inventor has delivered the goods?

In 1977 Edmund Kitch said that the grant of a patent could also have the purpose of encouraging further research on the patented subject matter, giving an analogy to a mining claim of staking out an area for further research.   This has the advantages of avoiding wasteful duplication of further research by competitors and enables funding to be obtained, although this of course raises concerns about competition issues.   On the other hand, an upstream patent does not exclude further research in competitors but may result in both parties needing each other’s licence to market the competitor’s product.  Further, if a patent is granted early, it will expire early and the public will gain benefits earlier.

The Warner Lambert v Generics case again raised the question of whether a patentee can mark out a field in which he will have protection while undertaking further research.  The Supreme Court notably made no mention of any of these policy issues - neither did they refer to the HGS case - instead choosing to focus on analysing the EPO case law in the obscure area of plausibility.

Rob Burrows (Bristows LLP, London) then dealt with Plausibility in the UK following the Supreme Court’s decision in Warner Lambert v Generics [2018] UKSC 55.  In short, the result is that we still have plausibility.  It is said to be a low hurdle, but still one that patentees sometimes do not get over, as was the case for Warner Lambert.   Whilst there was a split decision on plausibility / sufficiency of the claims covering neuropathic pain, the majority view was that neither the treatment of peripheral nor central neuropathic pain with pregabalin was plausible:

The “patent bargain” was emphasised:  patent monopoly must be in return for disclosing the invention.   The leading case in the UK post pregabalin is Eli Lilly v Genentech [2019] EWHC 387, where Arnold J also found that the plausibility threshold was not met.

The key take home message is that plausibility is alive and well in the UK. Plausibility applies to all claim types but is particularly relevant to medical use claims, especially claims involving broad classes of compounds and/or lists of therapeutic uses.

Takeshi Maeda (Kobe University, Graduate School of Law, Kobe) then addressed infringement of medical use claims in Japan, where such uses must be protected by product claims.   The scope of medical use claims is determined by the “Label” doctrine:  transferring the product constitutes infringement of a medical use claim only when it is transferred with a “label” which shows that it is for the claimed use.  Pharmaceutical products are always transferred with a package insert, which is required by law to designate the indication, dosage and administration of the product.

In the case of Sandoz AG v Kyowa (Tokyo D, Ct., April 2002), concerning a claim for a prophylactic agent, infringement was found based on the description in the package inserts after examining the dosage and administration information in detail.  In contrast in Takeda v Kowa KK (I.P. H. Ct. July 2016), where the claim was to a specific dosing regimen, no infringement was found.   The “label” doctrine is supported by the practice of pharmaceutical regulations in Japan as drugs must be used for the use designated in the package insert to be covered by national insurance.

Lastly John Pegram (Fish & Richardson, P.C., New York) addressed the American view on Plausibility, first explaining that there are no second medical use claims in the US, because method of treatment claims are allowed.  England and America are said to be two countries separated by the same language.  But is it the language that is different or is it the law?

The "patent bargain" is conceptually similar                                                  

Credibility arises in the US in connection with the utility requirement. There must be a credible basis, but only one credible assertion of specific utility, not across entire breadth of the patent.  The Written Description requirement was explained by the Federal Circuit in Amgen v Sanofi as the patentee needing to convey through the disclosure that it “had possession” of the claimed subject matter as of the filing date.  Demonstrating possession requires “precise definition” of the invention. How does one show this precise definition?

The concept of enablement again is similar to the European requirement.   In Janssen v Teva (2009) the Federal Circuit stated that mere plausibility does not suffice to meet this requirement, if it did then patents could be obtained for little more than “respectable guesses”.   This suggests that “plausibility” per se does not have the same meaning at the Federal Circuit as it now has in the UK.  “Plausibility” of the disclosure supporting a claim is also not a requirement for unobviousness in the US.

Panelist Laura Whiting (Freshfields Bruckhaus Deringer LLP, London) commented that the real difficulty in Europe for patent applicants now is determining how much data there should be in your application. There are EPO cases which say you don’t need any experimental evidence.  Other decisions state that at least some mechanistic theory must be included.  How is the applicant meant to square the circle and work out how much is enough?  Particularly at the application date when the issue will be addressed at a later date if subject to opposition or national litigation?   Patents are judged by different standard ten years later. That is a genuine problem and it is not clear how we solve that.

A lively question and answer session followed.  Robin Jacob (Former Lord Justice of Appeal of the Court of Appeal) opened with: “I am going to advance a proposition that the law has gone mad. An inventor tells you here is my invention, and he is right.  He gives no details why it is going to work. Plausibility has got out of hand. Plausibility should only play a role when something is not plausible. We ought to be thinking very carefully about requiring clinical trials and evidence.”  Rian Kalden (Court of Appeal of The Hague), speaking in her personal capacity, noted that in some EPO cases the test is that there must be “no reason to doubt the invention”.  In comparison, the session questioned whether the UK has been unnecessarily strict in terms of the test advanced.   Klaus Grabinski commented that it must always be kept in mind that plausibility has two sides:  sufficiency and obviousness.  By and large the standard has to be the same and, in his personal view, the threshold should not be too high."

Given the intense debate it will be interesting to see what resolution will agreed between National/Regional Groups and ultimately passed on the question of plausibility at this year's AIPPI Congress in London (to see AIPPI's plausibility study question, click here).