Key points
- As abundantly reported elsewhere, Technical Board 3.3.02 referred questions to the Enlarged Board about ‘plausibility’.
- The TBA has carefully formulated questions, but let's approach the referral from a different angle in this blog post. The topic of ‘plausibility’ lends itself to a broad enquiry, but there is a point to resolve on a quite narrow issue where there is a divergence in the case law.
- Perhaps at the outset, it must be noted that ‘plausibility’ is not a term used in the EPC and the mechanical Boards typically don't ‘do’ plausibility. Nevertheless, the issue of plausibility is by no means a priori restricted to the chemistry/pharma/biotech field.
- The narrow issue is, as summarized by Arnie Clarke (link): “As much as Dasatinib [ (T 488/16 of Board 3.3.01] raised the plausibility threshold, Almirall [T 2015/20 ; Board 3.3.07] appears not just to return the bar to its previous position but significantly lowers it, if not quite removing it completely. As much as the pharmaceutical industry should be pleased to see a relaxation of the Dasatinib [T 488/16] standard, the volte face by this EPO board of appeal could be a significant impediment to industry, with “not implausible” armchair inventions blocking legitimate innovation and development. Will other boards follow [T2015/20/ Almirall]?”
- The present Board 3.3.02 identifies a third option, namely: "no plausibility requirement at all" based on T 0031/18 (Novartis; Board 3.3.07) and T 2371/13 (Board 3.3.10) (the latter decision taken before the written decision in T 488/16 was available).
- Plausibility, in this context, means the (supposed) rule that post-published documents can only be considered as evidence for a technical effect in the assessment of inventive step, if that technical effect is at least made plausible by the application as filed.
- The three referred questions basically present three options: 1 - Novartis (no plausibility requirement); 2 - Dasatinib (plausibility requirement) and 3 - Almirall (soft plausibility requirement of "not implausible"), in this order.
- The actually important difference between options 2 and 3 is that “under the ab initio plausibility line [i.e. question 2], it is the patent proprietor that has to prove plausibility while in the ab initio implausibility line [i.e. question 3] it is the opponent that has to show implausibility.”
- The referring Board also discusses the UK Supreme Court decision of 14.11.2018 Mylan v Warner-Lambert [2018] UKSC 56, and three articles in the literature:
- C. Floyd, "Plausibility: where from and where to", GRUR, 2021, page 185 (Festschrift for Peter Meier-Beck - GRUR 2/2021),
- R. Jacob, "Plausibility and Policy", Bio-Science Law Review 17(6), page 223, and
- A.Slade, "Plausibility: a conditio sine qua non of patent law?", (2020) Intellectual Property Law Quarterly 180-203; open access copy as SSRN, also available via hdl.handle.net/2381/12410771.v1,
- As a comment, I'm not sure why only English authors are cited by the referring Board. E.g. Kutik and Renken in epi Information 2019/3 also discuss the topic (link). Other national courts have also discussed plausibility in the past (e.g. French Supreme Court, 6 December 2017, No. 15-19726 ; ECLI:FR:CCASS:2017:CO01514 ; link; (MSD/Teva)).
- A lot more can be said about the topic but of course the amicus curiae briefs will be available on the EPO website in due course.
- I recommend reading the entire decision (relevant part for the referral) either on the EPO website or below and as of yet refrain from making a bullet point summary of the Board's reasons.
If for acknowledgement of inventive step the patent proprietor relies on a technical effect and has submitted evidence, such as experimental data, to prove such an effect, this evidence not having been public before the filing date of the patent in suit and having been filed after that date (post-published evidence):
1. Should an exception to the principle of free evaluation of evidence (see e.g. G 3/97, Reasons 5, and G 1/12, Reasons 31) be accepted in that post-published evidence must be disregarded on the ground that the proof of the effect rests exclusively on the post-published evidence?
2. If the answer is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have considered the effect plausible (ab initio plausibility)?
3. If the answer to the first question is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have seen no reason to consider the effect implausible (ab initio implausibility)?
T 0116/18 -
https://www.epo.org/law-practice/case-law-appeals/recent/t180116ex1.html
11. Referral - Introduction
11.1 After acknowledgement of sufficiency of disclosure and novelty, the next point to be assessed was inventive step. During this assessment, it turned out that questions needed to be referred to the Enlarged Board of Appeal on whether evidence not public before the filing date of the patent in suit and filed after that date ("post-published evidence") can be taken into consideration in view of the plausibility case law of the boards.
11.2 For a referral to be admissible, it is generally considered necessary that the decision on the referral questions be decisive for the outcome of the referral case.
As is clear from the above, the appellant's objections as regards sufficiency and novelty were not successful. Whether an inventive step can be acknowledged will therefore be decisive for the outcome of this case.
source http://justpatentlaw.blogspot.com/2021/11/t-011618-ii-referral-g221-plausibility.html
