In preparation of the OP to be held on 24.11.2022 in case G 2/21, the EBA has published a communication pursuant Art 13 and 14(2) RPEBA.
The question of plausibility is very important in chemistry/pharmacy and it is thus comprehensible that those industries want to keep the free evaluation of evidence as much as possible.
Especially in second medical use claims the effect is part of the claimed invention and is thus of paramount importance when assessing inventive step but also when assessing sufficiency. As the effect a functional part of the claim, then sufficiency is at stake and not inventive step.
The amicus curiae filed
When looking at the 20 amicus curiae some tendencies are discernible.
Whatever the replies say otherwise, the free evaluation of evidence should be kept intact and by no means be curtailed by the decision of the EBA in matters of plausibility.
One writer is however of the opinion that legal certainty should exclude post-published evidence.
On the one hand speculative patenting should be avoided, especially in view of the first to file system applicable at the EPO.
On the other hand it is the essence of the problem-solution-approach (PSA) which can be based on prior art not known to the applicant/proprietor at filing which leads to the necessity of filing post-published evidence in order to assess IS. The formulation of the objective technical problem could lead to express different effect(s) to that(those) mentioned in the original application.
All technical domains should be on a par and no specific rulings should be established for specific technical areas, especially for the pharmaceutical industry.
One amicus curiae summarised the situation quite nicely: the approach to plausibility should lie between the two extremes of excluding post filed data completely and not taking plausibility into account at all.
In general, the answer to question 1 should be No which renders any answer to the questions 2 and 3 superfluous.
Some also proposed to rewrite the questions.
I have some sympathy with this position as the question referred only to plausibility with respect of inventive step and did not broach the topic sufficiency.
Next to the 20 amicus curiae there was one observation of a third party. Like in a plurality of the former, the third party mentioned the effect resulting from the application of the PSA to be taken into account. The third party considers that mere allegations in the description cannot be taken into account to identify an effect; corroborating evidence is required.
Position of the President of the EPO
The president of the EPO considers the referral admissible but is of the opinion that answers are not only required under Art 56 but also under Art 83.
Ab initio plausibility is a question to be addressed by the applicant/proprietor and ab initio implausibility is a question to be addressed by the opponent.
New effects might be relied upon provided that the effects are implied or related to the problem initially suggested.
The EPO must be put in a position to establish whether there is any technical effect at all, i.e. whether the technical effect is achieved and whether the subject-matter was non-obvious compared to the state of the art.
No exception to the principle of free evidence is actually needed.
Depending on the prior art, the re-formulation of the technical problem could lead to the objective technical problem being less ambitious than originally envisaged by the applicant.
The EBA’s communication
For the EBA, the referral appears admissible.
For the EBA, the principle of free evidence is a fundamental principle which cannot be ignored and is recognised in the contracting states and is enshrined in Art 113(1) and 117(1).
The EBA intends to provide guidance on the issues referred to in questions 2 and 3.
The EBA does however not intend to go further than the referral and only intends to reply in the framework of the assessment of inventive step.
Neither does the EBA see the need for the referred questions to be re-drafted or re-ordered.
The Enlarged Board recalls that in the light of the case law of the EPO and the Contracting States, what matters is what technical knowledge the person skilled in the art, with his general knowledge, would understand at the filing date from reading the application as filed. The technical effect relied upon, even at a later stage, must be encompassed by that instruction and embody the same invention.
For the Enlarged Board, the question is therefore whether, in view of this technical teaching of the application and the general knowledge, the person skilled in the art would have significant reason to doubt the alleged and invoked technical effect.
In the absence of such doubts, the decision-making body should be able to rely on post-published evidence to decide whether or not it is convinced of the presence of the technical effect.
If, on the other hand, the person skilled in the art has significant doubts, the possibility of using post-published evidence successfully seems questionable.
It appears the the EBA will, like for instance in the disclaimer decision G 1/03, endorse the existing practice of the EPO and its boards of appeal.
Comments – Inventive step and sufficiency
The EBA made clear that it only intends to reply to the questions raised in the framework of the assessment of inventive step.
On the other hand, even if the referral only raises the question of plausibility when assessing inventive step, the same criterion also applies when assessing sufficiency. This is also the position of the opponent in the referring decision T 116/18.
It is thus difficult to follow the EBA on this point.
In G 1/03 the Enlarged Board of Appeal stated the following (See Reasons, point 2.5.2, last §):
“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”
T 2001/12 is not an isolated decision and has exemplified the interplay between Art 83, 84 and 56.
What is at stake in T 2001/12 is the effect claimed by the applicant in its original disclosure. If said effect is not credibly (=not plausible) achieved with the information originally disclosed but not claimed then the objection should be lack of IS. If the effect is not credibly (=not plausible) achieved but claimed, the objection should be lack of sufficiency.
In the referring decision T 116/18, the effect is not claimed as such and hence according to G 1/03 the question at stake is thus a question of IS and not of sufficiency. The effect is not the effect resulting of the problem-solution approach, but the effect as originally disclosed in the application as filed, cf. §  in EP 2 484 209 A1.
I am thus of the opinion that, in spite of the referral only aiming at the assessment of IS, answers should also be given for the assessment of sufficiency.
It might be true that in application of the problem-solution-approach (PSA) the applicant/proprietor might be faced with new prior art which was unknown to him.
It remains nevertheless that any invention is a technical solution to a technical problem. The question at stake can be formulated as follows: which is the technical problem to be taken into account when deciding on IS or sufficiency. Is it the original problem disclosed in the original application (or which can be interred from the latter), or the objective technical problem resulting from the PSA.
Reliance should be given to the problem which was initially disclosed in the application (or which can be interred from the latter), and not the objective technical problem resulting from the application of the PSA.
Although it was for assessing added subject-matter when criticising the “essentiality test” (now the three point test) in T 2311/10, the board made clear the “problem” to be taken into account in step 2) of the then “essentiality test” is the problem as defined originally in the application and not the “objective problem” when it comes to asses inventive step.
The situation is similar when it comes to IS or sufficiency. What matters is the originally defined problem and not the objective problem resulting from the PSA.
The technical effect relied upon, even at a later stage, must be encompassed by this problem and effects originally stated and embody the same invention. This is a difficulty which it will be interesting to see whether the EBA will discuss or will ignore.
It is clear that depending on the prior art, the re-formulation of the objective problem could lead to the objective technical problem being less ambitious than originally envisaged by the applicant.
Even less ambitious, it should not allow to later claim effects or advantages which were not originally disclosed.
This is also the reason why the acknowledgement of prior art to be introduced in the description after examination should remain purely factual and not relate to effects or advantages not originally disclosed. Anything else would end up with an objection of added matter. Here we would be back to T 2311/10.
It is to be seen whether the EBA will maintain its strict stance and limit its replies to the assessment of IS, including the effects resulting from the objective technical problem, or if he will also deal with sufficiency.
The OP before the EBA on 24.11.2022 promise to be highly interesting.
It is foreseen that the OP will be in-person on the premises of the BA in Haar (Room CONF201-auditorium).