The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Tuesday, 25 April 2017

Fordham 25 (Report 8): The sun rises on plausibility, but where (and when) will it set?

Everyone knows the AmeriKat is not a morning person.  Although in recent months she has been up and out at the crack of dawn, she is not a fan preferring prowling into the quiet night undisturbed.  So although there were two Sunrise Sessions at Fordham that struck her fancy (especially the data mining session), she left the reporting to her German pal Christopher Weber (Kather Augenstein). The AmeriKat enjoyed reading the report, which touched on points raised in her presentation the day before in the trade secrets session as to whether and what role sufficiency (and indeed plausibility) should really have in patent validity given the reality of technical disclosure in the product development cycle and the disclosure doctrine, while safeguarding against speculative patents (subject of another post).  Christopher reports:

Brian Cordery
"After getting an early start to my New York day, being fortunate enough to still be operating internally on CET, this Kat friend arrived early to the second day of the excellent Fordham Conference and just in time to eat bagels, drink coffee and attend the slightly misleadingly named “Sunrise Seminar I: Second Medical Use & UK Plausibility”. As it turned out, it was 99% about plausibility and only 1% about Second Medical Use.

After an introduction by Brian Cordery (Bristows), who highlighted the importance that the plausibility check has gained in patent validity matters in the UK, Floyd LJ explained the complete history of plausibility in less than 5 minutes and with 5 decision. An astonishing act made somewhat necessary/easier by the strict rules of the conference itself. He reported that currently most cases would contain the allegation of lacking plausibility, which certainly raises the question why someone would use an implausible solution or even fight about it in the first place. The issue here is of course, that one has to look at the priority date.

The trouble began – so to say – with the EPO decision in AgrEvo/Triazole Herbicides (T 0939/92) of September 1995 – which does not even contain the word “plausible”. Headnote 1 of that decision describes the problem:
"1. If a claim concerns a group of chemical compounds per se, an objection of lack of support by the description pursuant to Article 84 EPC cannot properly be raised for the sole reason that the description does not contain sufficient information in order to make it credible that an alleged technical effect (which is not, however, a part of the definition of the claimed compounds) is obtained by all the compounds claimed (see reasons 2.2.2)."
The Lilly mega judgment on "educated guess"
The notion that there needs to be support e.g. in the form of (rudimentary?) test data or experiments first found its way into English law with the Prendergast’s Applications decision, which concerned four speculative applications in the swiss-type claim format for new medical uses of known compounds. The decision to decline the application was upheld to prevent applications being granted “in relation to all sorts of speculative uses for established drugs and other chemicals without a shred of evidence as to whether they would work, let alone as to whether they do work.” The other cases that were discussed where HGS v Lilly (follow this link to a classic Jeremy’s discussion of the “mega-judgment”) which set the bar at “an educated guess can suffice” and “some real reason for supposing that the statement is true” and Regeneron v Bayer in which an implausibility attack against the use of VEGF antagonists for certain diseases failed because the patent claim was deemed to be based on a “fair prediction”. Finally, in Warner-Lambert v. Generics UK the UK Court of Appeal found that the claims alleged to be infringed lacked sufficiency, because the patent did not render it plausible that it would work. The case law was summarized by the guideline that the patent’s monopoly should not exceed the patent’s contribution to the art and that it should not be possible to write a patent from an armchair. Although still “if you are lucky enough to draw up a working experiment, you would get it past the examiner”.

The first question of this still quite early day was asked by Trevor Cook and it turned out to be as concise as it was pertinent: “It is an old problem, why do we need a new solution?”

The "Plausiblity Attack Kat" is coming for your patent
Nicola Dagg (A&O) gave her perspective on the problem and pointed out that plausibility as a separate revocation ground is neither found in the UK Patents Act 1977, nor in the EPC and may even be prohibited by TRIPS because it is a limitation of intellectual property rights. She posited that it should be deemed sufficient if the active ingredient could be made and successfully used to treat the claimed indication at the priority date. Most cases would only cover a fraction of possible use cases and the EPO’s Factor-9/JOHN HOPKINS (T1329/04) considered that supplementary post-published evidence may in the proper circumstances also be taken into consideration, however, that it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve. She stressed that there is a need for a strong incentive for expensive medical research and that it is economically vital that the patent is able to file before clinical testing (which becomes public) even if the only available data to support the claim may be from animal testing.

Judge Rian Kalden of the Court of Appeal of The Hague, Dr. Ute Kilger (Böhmert & Böhmert), Munich, and Miquel Montana (Clifford Chance) then reported on their respective countries’ perspectives on plausibility as a separate requirement. I think it is fair to save everybody’s reading time by saying that there is hardly any such separate requirement in these countries and that the respective questions are handled under the headlines of sufficient disclosure and inventive step. It is not necessary e.g. that each and every claimed compound is explicitly disclosed to solve the patent’s problem.
Jurgen  Dressel 
Jürgen Dressel, Head of Global Patent Litigation Strategy at Novartis gave the innovators industry’s global perspective. The industry would increasingly be faced with prior art created by its own medical trial data. Thus, there is a need to safeguard inventions on the basis of surrogate parameters such as animal data or genetic data from which it should be fair to extrapolate from. His main wish, however, was for a realistic and pragmatic threshold for plausibility on a global basis. The industry would need patents across jurisdictions which diverge on this question around the world. He characterized the US as one extreme which would allow filing early for the patent and supplement tests only later and Asian countries as the other extreme where a lot of data would be needed early to get a patent. After all, the industry would need harmonization to have a fair chance to get a patent.

Nicola Dagg
This started the more general discussion. Here different attendees voiced concern for the Canadian patent system (i.e. the promise doctrine) in this regard before coming back to second medical use claims. It was posited that they are per se a functional limitation of a claim and that in the end the question should always be for the technical contribution of the patent. This was indeed the consensus: Patents need to add to the prior art to fulfil their part of the contract between patentee and society, i.e. disclosure for protection. However, no consensus emerged on the question whether there should be a plausibility test in the first place against the background of TRIPS and the limited number of revocations grounds enumerated in law.

Nevertheless, in the end everybody agreed with Brian Cordery, that the Sunrise Seminar was plausible in the original meaning: worthy of applause."

3 comments:

Anonymous said...

In the Agrevo decision, it may have been wise to quote Headnote 2 also, or even instead of Headnote 1.

Trevor has the right idea. Let's not believe we are now just inventing the wheel, when in practice it is simply being re-named, albeit the facts of each case are becoming more testing.

Nicola appears to be pulling the old 'apply politics to the position on behalf of the well-heeled client, instead of applying the law' routine: "It's just not fair, M'Lud". Allen & Overy, Bristows, and Powell Gilbert have all played this card in recent memory. Double-patenting problems or problems of one's own negligence, anyone?

Nicola asserts 'plausibility' is not a separate ground for revocation in UK/EPC, but if Nicola reads Agrevo (Headnote 2), she will find that lack of inventive step is a ground for revocation, and can deal with the issues quite well. Speculative compound scope = invention in making alternative compounds, therefore all compounds equally suitable, hence obvious. Try and claim the invention is in making active compounds - well, that just isn't plausible, because it isn't plausible without data in the spec that the compounds will not work.

Anonymous said...

p.s. If clinical data is needed to support inventive step (did I not say 'plausibility'?) then we must live with that, as we always have done. If in vitro data/animal models does not support the alleged claimed effect, because the scientists say so, then it cannot support an invention. If the clinical trial in such circumstances is being run speculatively (as is common) then the disclosure of the trial taking place will not be prejudicial to patentabilty.

Anonymous said...

Anonymous is making a lot of assumptions about how the disclosure of a clinical trial will be treated by the Patent Office's around the world.

We have seen clinical trials become prior art for novelty in Germany, whilst in the US once a particular use has been suggested (by a clinical trail for instance) then that use would have been 'obvious to try' which is the end of the story.

In my view there is nothing wrong with a speculative claim or even a guess, so long as its plausible and it turns out to be right. If the claim is for broad applicability of all compounds of a particular class being suitable for the suggested use, then it needs to right across its entire scope and if its not the scope of the claim should be pegged back accordingly (assuming there is basis).

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