The Enlarged Board of Appeal (EBA) has issued its preliminary opinion in G2/21 on plausibility. The final decision in this referral has the potential to either lower or increase the plausibility requirement in EPO inventive step analysis. The non-binding preliminary opinion offers a glimpse into what the EBA is thinking prior to oral proceedings. In its preliminary opinion, the EBA hedges its bets but hints at accepting a standard of lack of ab initio implausibility for a technical effect supporting inventive step.
Case Background: Post-filed data for plausible inventive contribution
The referral relates to the validity of patent EP2484209 for an insecticide containing two type of compound. The patentee relied on the synergistic effect of the compounds for inventive step. The patent description provides data for the synergistic effect of some example compounds covered by the claims against two species of moth. At Opposition, the Opponent submitted data showing that certain compounds falling under the scope of the granted claims did not have a synergistic effect against another species of moth for which data had not been provided in the patent.
It's not just cats that are cute |
In response, the Patentee submitted post-filed data showing a synergistic effect of some example compounds against yet another species of moth. The question became whether the Opponent's and/or the Patentee's additional data were admissible to debunk or support the inventive contribution of the claimed compounds.
Referral to the EBA
The full wording of the referred questions is provided below*. A simplified summary of the referring Board of Appeal's questions to the EBA is as follows:
(1) Should post-filed data be disregarded if these data are the sole evidence for a technical effect for inventive step.
(2) If yes to (1), can post-filed data be taken into account if the technical effect was plausible when the application was filed (ab initio plausibility)The practical difference between (2) and (3) rests in where the burden of proof lies. If additional data can only be taken into account when a technical effect is already plausible at the filing date, this puts the burden of proof on the applicant/patentee to show that the effect was plausible at the filing date. If additional data can only be taken into account when a technical effect was not implausible, this lightens the burden for the patentee. It is then up to the patent office or opposing party to provide reasons why an effect would have been implausible to a skilled person at the filing date.
The difference between plausibility and lack of implausibility was also explored in Warner-Lambert v Actavis [2018] UKSC 56 (IPKat).
Question 1
Question 1 of the referral in G 2/21 asks whether post-filed data be disregarded if these data are the sole evidence for a technical effect. The preliminary view of the EBA is that the EPO is governed according to the principle of free evaluation of evidence. For the EBA, this principle "does not appear to allow disregarding evidence per se insofar as it is submitted and relied upon by a party [...] and is decisive for the final decision. Disregarding such evidence as a matter of principle would deprive the party submitting and relying on such evidence of a basic legal procedural right generally recognised [...] and enshrined in Articles 113(1) and 117(1) EPC".
For the EBA, post-filed evidence should therefore not be disregarded. The EBA therefore answers "no" to Question 1.
Questions 2 and 3
The remaining questions relate to how much weight should be given to post-filed evidence of a technical effect in an inventive step analysis. The EBA is of the preliminary opinion that it is on the basis of the application as filed that the plausiblity of a technical effect should be assessed. Critically, however, the EBA concludes that the test for plausibility is whether a skilled person "would have had any significant reason to doubt" the technical effect at the filing date. In other words, the technical effect must not have been implausible at the filing date. In the lack of any substantiated doubts, the EBA see no reason why post-filed evidence should not be considered relevant to the question:
In the absence of any such doubts, the reliance on post-published evidence, such as experimental data, for the purported technical effect would seems to serve as a potential source for a deciding body to conclude whether or not it is convinced of said technical effect when deciding on the inventiveness of the claimed subject-matter.
According to the EBA's preliminary view, the plausibility of a technical effect should therefore be assessed according to the same test as the broader principle of sufficiency. The sufficiency of a claim can only be challenged with serious doubts, substantiated by verifiable facts, that the skilled person would have been unable to work the invention. Does this suggest a lowering of the current plausibility bar for inventive step?
The need to accommodate inventive step arguments against prior art that was unknown at the filing date is one of the reasons for the arguably divergent case law on plausibility. The EBA does not mention in the preliminary opinion whether new evidence can support a technical effect for a post hoc inventive step argument. The EBA merely points out that the technical effect relied upon needs to be encompassed by the technical teaching and "embody the same invention".
On whether post-filed evidence can be relied on to overcome the fact of an implausible technical effect at the filing date, the EBA does not yet seem to have made up its mind. The EBA merely notes that it "appears questionable" that post-filed evidence could be used to cure ab initio implausibility.
Final thoughts
In its preliminary opinion, the EBA has accepted that there are questions to be answered but has not yet formed a clear view on those answers. Both parties still have all to play for in the upcoming oral proceedings in Haar on 24 November 2022. Cases in which the outcome of the referral is influential have been stayed until the EBA reaches a decision.
Further reading
- Enlarged Board of Appeal to tackle the "Humpty Dumpty-ish" plausibility question (G2/21) (25 Oct 2021)
- Reasons for an EBA referral on plausibility, post-published evidence and problem-solution (21 Sep 2021)
- New referral expected to the EBA on the use of post-published data to support inventive step (10 Aug 2021)
*The referred questions
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)?
I'll be interested to see whether the EBA elaborates at all on what the test might be for determining whether a technical effect is "encompassed by the technical teaching" and "embod[ies] the same invention". This feels potentially quite similar to the "core inventive advance test" from SPC case law; if so, it may be a rather vague and subjective standard to meet.
ReplyDeleteIt's also unclear to me at this stage how those criteria might be met in the case of a technical effect which isn't mentioned anywhere in the application as filed, but which becomes relevant under the EPO problem-solution approach once previously-unknown closest prior art comes to light. Is such a technical effect going to face a higher hurdle to prove compliance with those criteria? If so, adoption of these criteria could lead to more inventions being deemed "mere alternatives". If so, that could act as a counterweight to the otherwise patentee-friendly consequences of a "lack of implausibility" standard.
I'm not surprised that the Board seems not yet to have reached a "clear view" because, I guess, so much hangs on getting right its answers to the questions put to it.
ReplyDeleteWhen the USA was switching from First to Invent to First to File, numerous Chicken Little commentators warned that the result would be a total clogging up of the patent system by the A publications of prematurely filed, woefully speculative claims. There was an easy rebuttal, that under First to File, premature filing has gruesome consequences: your invention is published for all the world, but none of your claims will survive inspection of their patentability and your rival, who filed a little later than you, but less speculatively, is the party that ends up with an enforceable patent on the invention.
Does one of the two possible answers to the plausibility questions map better to the public policy objective of encouraging inventors to file early, but not too early? Which of the two answers would be better at delivering the desired result, a patent system that optimally "promotes the progress" in all fields of technology?
I suspect that the answer is "neither of them" and that what is important is an answer that gives the Patent Office enough flexibility to adjudicate with fairness and justice individual priority disputes between rival inventors, one case at a time, based on the unique matrix of fact in each such case. If the mammoth dispute over CRISPR patent rights in Europe does not settle, it will, I suppose, provide an early and extremely high profile run-out for the EBA's answers to the present questions
The sentence “the plausibility of a technical effect should therefore be assessed according to the same test as the broader principle of sufficiency” seems misleading.
ReplyDeleteIn Point 14, the EBA noted that the referring board acknowledged sufficiency and the EBA therefore does not consider it appropriate to extent the clear scope of the referral beyond the question of inventive step.
I fail thus to see that the EBA said directly or indirectly said that “the plausibility of a technical effect should therefore be assessed according to the same test as the broader principle of sufficiency”.
When looking at G 1/03 (Reasons, point 2.5.2, last §) the following can be read.
“a lack of reproducibility of the claimed invention … may become relevant under the requirements of inventive step or sufficiency of disclosure. If an effect is expressed in a claim, there is lack of sufficient disclosure. Otherwise, i.e. if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step”.
As in the referred case the effect is not expressed in the claim it is right that the objection is lack of inventive step.
By not wanting to deal at the same time with sufficiency the EBA appears prima facie to ignore G 1/03.
Not only the opponent, but also the president of the EPO and some amicus curiae have mentioned the link between inventive step and sufficiency depending on what is claimed. The interplay with Art 83, 84 and 56 has been perfectly illustrated in T 2001/12.
By not wanting to discuss at the same time sufficiency, the problem of plausibility will still continue to exist for sufficiency.
A decision of the EBA just dealing with plausibility and inventive step will thus only potentially solve half the problems linked with plausibility.
My reading was that the EBA are more than hinting and are clearly planning to tell the examining division to either provide reasons for not accepting plausibility of a technical effect, or to get on and grant a patent.
ReplyDeleteAn important point of the preliminary opinion appears to be that the Enlarged Board stipulates the requirement that "The Enlarged Board understands from the case law of the boards of appeal and of courts of the EPC Contracting States [...] that the core issue rests with the question of what the skilled person, with the common general knowledge in mind, understands at the filing date from the application as originally filed as the technical teaching of the claimed invention. The technical effect relied upon, even at a later stage, needs to be encompassed by that technical teaching and to embody the same invention."
ReplyDeleteA mere statement in the application as filed that some effect is obtained, may not always meet the threshold of a "technical teaching". If that requirement is not met from the outset, there may be no need for the opponent demonstrate "significant reasons for doubt".
In other words, the EBA will endorse, at least for IS the existing practice.
DeleteWhat about sufficiency?
Curious asks: what about sufficiency. My guess is that the EBA is fixated on the notion of "judicial economy" (deciding only what is unavoidably necessary to decide and eschewing to answer any other questions that arise). Generally, it's a good idea. Here though, when the EBA does what anonymous expects, and sets the referring Board straight, the answer on sufficiency will not need to be given explicitly because it will be implicit and 100% clear.
ReplyDeleteReaders wanting a clear exposition of the issue before the EBA could do worse than to read the EPO President's amicus brief. In my opinion, whoever wrote that has a superb grasp of the issue and a beautifully clear way of explaining it. Funny, eh, that the administrative branch of the EPO has a clearer understanding of the law than an EPO Board of Appeal.