Referral G 2/21 (ʺPlausibilityʺ) is pending before the Enlarged Board of Appeal at the EPO. We reported the provisionally referred questions here. The aim of the referral is to clarify whether an effect can be relied on when proof for the effect rests solely in post-published evidence and what role, if any, plausibility should play in this assessment. This note provides an update on the events that have occurred since the questions were referred.
The referred questions
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)?
Stay of proceedings due to G 2/21
The EPO issued an Official Notice (OJ, 2021, A87; available here), announcing that all examination and opposition proceedings before the EPO “in which the decision depends entirely on the outcome of the referral” will be stayed ex officio until the Enlarged Board has issued its decision.
In light of this notice we are seeing an increase in the number of requests for a stay of proceedings. For parties interested in requesting a stay of proceedings it should be borne in mind that a stay might not be granted unless the outcome of two individual inventive step assessments – one in which the relevant post‑published evidence is taken into consideration and one in which it is not taken into consideration – is different. Therefore, it might not be possible to stay proceedings prior to any oral proceedings because a definitive outcome of the two individual inventive step assessments would not be known, i.e. it would not be possible to determine if the decision depends “entirely on the outcome of the referral”. For parties interested in avoiding a stay of proceedings, it might be worth considering whether or not the post‑published evidence is the only evidence relevant for the effect under inventive step. If it is not then it could be argued that the decision does not depend “entirely on the outcome of the referral”, because referred question 1 relates to an effect for which the proof rests exclusively in post-published evidence.
Amicus curiae briefs
Amicus curiae briefs are written statements filed by interested parties concerning points of law raised in a referring Board’s decision. The deadline for filing amicus curiae briefs in G 2/21 was 29th April 2022. By this date 21 interested parties filed amicus curiae briefs, including the Chartered Institute of Patent Attorneys (CIPA), which is the UK’s largest intellectual property organisation, the Institute of Professional Representatives before the European Patent Office (epi), which represents all ~13,000 professional representatives from all the EPC member states, and the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the biopharmaceutical industry operating in Europe and includes members such as AstraZeneca, Bristol Myers Squibb, GSK, Amgen, Johnson & Johnson, Novartis, Pfizer and Takeda. The President of the EPO also provided a written statement.
The interested parties’ proposed answers to the questions
The majority view of the interested parties is that question 1 should be answered “no”, i.e. applicants/patentees should be able to rely on post‑published evidence to support an effect and there should be no requirement for plausibility, and consequently the Enlarged Board of Appeal does not need to answer questions 2 and 3. The majority of the interested parties argued that this view is consistent with the EPO’s long-standing practice of allowing reformulation of the technical problem when, for example, a new closest prior art document comes to light after the filing date. In addition, most agreed that some requirement is needed to prevent “speculative patenting” or “armchair inventions”, but that there are already safeguards in place for this and therefore a further plausibility requirement is not needed. Examples of such safeguards include EPO Board of Appeal decision T 939/92 (“AgrEvo”), Article 123(2) EPC (added matter), which imposes restrictions on what can be claimed based on the information in an application as filed, and Article 83 EPC (sufficiency), which requires that there is sufficient information in an application as filed to enable the skilled person to put the invention into effect without undue burden.
Further, most of the parties agreed that should the Enlarged Board of Appeal answer question 1 with a “yes”, then question 3 should be answered with a “yes”, i.e. applicants/patentees should be able to rely on post-published evidence to support an effect if the effect was “not implausible” at the filing date.
“Plausible” vs “not implausible”
According to the referring Board, there is an inconsistency in the EPO case law because two different plausibility hurdles have been applied by the Boards when assessing whether post-published evidence may be used to support an effect. The first of these is the more demanding hurdle that the effect must be considered “plausible” based on positive indications in the application as filed and the common general knowledge (see referred question 2: “ab initio plausibility”). The second is the lower hurdle that the effect must merely be considered “not implausible”, i.e. there must be an absence of negative indications, based on the application as filed and the common general knowledge (see referred question 3: “ab initio implausibility”).
However, in the President of the EPO’s written statement it is questioned whether the different outcomes in these decisions were a result of the application of different plausibility standards or in fact just a consequence of different specific circumstances in the respective cases. Indeed, the President of the EPO noted that in all of the decisions the respective Boards stated that they were following the established practice according to which the effect must be “plausible”, and the fact that some Boards found no serious doubts that the effect could be achieved seems to have been used only as a supplementary indicator to acknowledge plausibility. Further, the President of the EPO pointed out that in all of the decisions it was concluded that the effect was “plausible”, i.e., there was no mention of the effect being “not implausible”.
Plausibility vs reformulating the technical problem
The referring Board considered that there is a tension between the requirement of disclosing a plausible effect at the filing date and the EPO’s well-established practice to allow applicants to reformulate the technical problem if, for example, a new closest prior art document comes to light after the filing date.
However, the President of the EPO appears to disagree. In his written statement the President states that according to well-established practice at the EPO, reformulation of the technical problem is possible if a new effect to be used as a basis for reformulating the technical problem is “derivable” from the application as filed or at least “implied by or related to” the technical problem initially suggested in the application as filed, and that “it is not immediately apparent” why the need for the new effect to be at least plausible at the filing date would have to be disregarded. Thus, the President’s view seems to be that an effect is, by definition, plausible if it is “derivable” from the application as filed or at least “implied by or related to” the technical problem initially suggested in the application as filed.
Inventive step vs sufficiency
As mentioned above, most interested parties are of the view that plausibility should not be a factor in determining whether post-published evidence can be used to support an effect under inventive step. However, if plausibility does play a role then some parties (e.g. CIPA) indicate that it should be uniform for inventive step and sufficiency (specifically, “ab initio implausibility” for both), whereas other parties such as EFPIA believe that it should be different (specifically, no plausibility for inventive step and “ab initio implausibility” for sufficiency).
EFPIA’s position may be summarised as follows.
First, if the effect is a feature of the claim then plausibility must be assessed under sufficiency of disclosure, whereas if the effect is not a feature of the claim then plausibility must be assessed under inventive step. Sufficiency of disclosure is satisfied if the effect in the claim is enabled from the application as filed and, similarly under novelty, the effect in the claim must be enabled in the prior art for it to be novelty-destroying. It is established in the EPO case law that the standard for enablement under sufficiency of disclosure and novelty is the same. Thus, it follows that for a second medical use claim where the effect is a therapeutic treatment, an unsupported disclosure of the treatment in the prior art would be novelty‑destroying if there were no safeguard under sufficiency of disclosure owing to the uniform application of enablement under sufficiency of disclosure and novelty. But this would be inconsistent with standard EPO practice, in which a prior art document is deemed to be novelty‑destroying only if it enables the treatment, and specifically only if it is at least credible that the treatment is achieved.1
Second, an effect that is recited in a claim defines the scope of protection by virtue of being a limiting feature, and thus embodiments that do not possess the claimed effect are excluded. This means that unlike for inventive step the claim is no longer open to challenge under the T 939/92 (AgrEvo) line of case law because the effect is a requirement of that claim. EFPIA considers that the EPO’s current case law under sufficiency such as T 609/02 “already strikes the right balance when it comes to concepts of “plausibility” in the context of sufficiency, and provides an important safeguard against speculative patenting” and should be used in this context under sufficiency on a case-by-case basis and there is no need to set further requirements. EFPIA also argued that T 609/02 does not fit neatly into the referring Boards concepts of “ab initio plausibility” and “ab initio implausibility” but in the event that one of these specific plausibility standards is to be applied under sufficiency, it should be ab initio implausibility.
The Enlarged Board of Appeal has just announced that the oral proceedings will take place on 24th November 2022.2 Thus, we expect a decision to be issued in Q2-Q3 2023. In the meantime, we will continue to help clients find the best worldwide filing strategy given the uncertain position in relation to plausibility and the use of post-published evidence at the EPO.
1Case law of the Boards of Appeal of the EPO, ninth edition, July 2019, I.C.4.11.
2Order from the Enlarged Board of Appeal dated 28th July 2022.