G2/21 Plausibility – The Enlarged Board of Appeal has heard the final arguments on whether post-filed data can be used to support inventive step

About the authors:  

Edward Rainsford: Edward is a senior associate and patent attorney. He has experience assisting a wide variety of biotechnology and medical device companies to protect their innovations. Edward’s time working in academia helps him understand the needs of universities and spin-outs when commercialising their research.

Edward’s experience includes patent drafting, patent prosecution, European Patent Office (EPO) oppositions and appeals, proceedings at the Intellectual Property Enterprise Court (IPEC), freedom to operate reports, and registered design filing.

Sarah Gibbs: Sarah is a senior associate and patent attorney. Sarah helps clients protect their inventions in both the chemical and biochemical fields. As a result of working with a wide variety of clients in these sectors, she has experience and understanding of the challenges faced by different companies.

Sarah’s work includes providing patentability advice, drafting patent applications, prosecuting patent applications in the UK, Europe and worldwide and handling large international portfolios. Sarah also has experience conducting and providing freedom to operate advice as well as advising on patent infringement and validity matters.

During oral proceedings held on 24 November 2022, the Enlarged Board of Appeal heard the final arguments in this case and a written decision is expected in spring 2023.

 

Background

As we previously reported (here), post-published evidence can be crucial to establishing patentability, especially in the Pharmaceutical and Biotechnology fields. As such, applicants will often provide additional data during prosecution in order to support the patentability of an invention. It has been established by the case law of the Boards of Appeal that such evidence must relate to a technical effect that was at least “plausible” at the filing date of the application, taking into account the common general knowledge at that date and the disclosure in the application.

The referral in G2/21 asked the question of whether post-published evidence can be used to support inventive step and, if so, under what circumstances.

The referral arose from opposition and related appeal proceedings on EP2484209 (T0116/18). EP2484209 relates to an insecticide comprising two compounds which provided a synergistic effect. In order to establish inventive step, the patentee relied upon post-published evidence of the alleged synergistic effect. Therefore, the post-published evidence was key to the determination of inventive step. When considering whether this evidence could be taken into account, divergent strands of case law were highlighted by the Board of Appeal:

 

a) ab initio plausibility, wherein post-published evidence can be taken into account only if the skilled person would have had reason to assume the purported technical effect to be achieved (given the contents of the application as filed and the common general knowledge at the filing date);

b) no plausibility, wherein the concept of plausibility is rejected entirely. This reflects the idea that ground-breaking inventions merit broad claim scope in line with their contribution to the art, whilst acknowledging that proving that such scope is plausible ab initio may represent an undue burden on the applicant; and

c) ab initio implausibility, wherein post-published data can be used in support of inventive step, provided that the alleged technical effect is not implausible.

 

Therefore, the following questions were referred to the Enlarged Board of Appeal:

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 be an exception to the principle of free evaluation of evidence (see e.g. G 3/97, Reasons 5, and G 1/12, Reasons 31) and 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)?

 

 

Preliminary opinion

Given the implications for the assessment of inventive step and plausibility, there has unsurprisingly been significant interest in the case. Indeed, at least 20 amicus curiae briefs were filed ahead of the hearing. 

The Enlarged Board of Appeal issued its preliminary, non-binding opinion ahead of the hearing in October, taking into account the amicus curiae briefs as well as comments submitted by the President of the EPO. It was the Board’s preliminary view that the principle of the free evaluation of evidence does not allow for the disregarding of evidence per se. Although this suggested that the Board considered the answer to the first questions to be “no”, and as such that questions 2 and 3 need not be addressed, it nevertheless acknowledged a need to provide guidance regarding ab initio plausibility and ab initio implausibility.

On the point of plausibility, the Board appeared to preliminarily favour the ab initio implausibility approach (i.e., the “not implausible” test). However, the Board also noted that the technical effect being relied upon should be encompassed by the technical teaching of the patent application, as filed, and should also embody the same invention. This suggested that reformulation of the technical effect to something unrelated to the original disclosure would not be allowed. However, if it is established that the technical effect was encompassed by the disclosure of the application as filed, the Board suggested that the question is whether there would be any significant reason to doubt the existence of the alleged technical effect at the time of filing.

The Board’s preliminary view was in line with the generally accepted view that post-published evidence can be used to confirm a technical effect if the technical effect is deemed plausible. It also appeared unlikely, although not impossible, that the bar would be lowered such that post-published data can be taken into account in all circumstances for the assessment of inventive step. Indeed, based on the preliminary opinion, as well as the established case law, it was expected that the decision would centre on where the burden of proof of implausibility lies.

 

The hearing

The hearing was held on 24 November 2022 and having heard the arguments from each party, the Enlarged Board of Appeal closed the proceedings without giving a final decision. The Board stated that they recognized the importance of this case, and that publication of the written decision will be given priority.

During the hearing, the patentee, opponent, and representatives of the EPO were all given opportunities to present their arguments.

The patentee’s representative argued that there should be no new barriers for allowing patents which are not set out in the European Patent Convention and no “doctrine of plausibility” should be established at the EPO.

Regarding the general allowability of post-filed evidence and how much weight it should be afforded, the patentee’s representative also mentioned that there is an inconsistency in the wording of Article 117(1)(c) EPC between the official languages. The German version uses the term “Vorlegung von Urkunden”, (which translates in English as “presentation of documents”) whereas the English version uses the term “production of documents” and the French version uses “la production de documents”. The patentee’s representative asserted that the English and French versions allow for the creation of evidence, i.e. new data, to support a technical effect rather than the German version, which may be more narrowly interpreted as merely having a right to present further supporting documents. Despite this inconsistency, the patentee’s representative argued that Article 117(1)(c) EPC indicated that the drafters of the EPC meant for an ab initio implausibility approach to be applied at the EPO.

The opponent’s representative argued that synergy, such as the synergy shown between the insecticides in the patent in suit, cannot be predicted. Even if the compounds are described in an application as filed and there is a broad statement that any combination can be used, evidence is required in order to support a claim over the entire scope of protection. In light of this, the opponent favoured the ab initio plausibility approach in which post-published evidence should only be taken into account if the skilled person believed that the technical effect was plausible from the application as filed.

In the opinion of the opponent’s representative, only the ab initio plausibility approach helps to determine if there is an invention based on the application as filed and the ab initio implausibility test leads to speculation and potentially speculative patents being granted which could lower the quality of patents from the EPO.

The opponent’s representative also argued that the ab initio implausibility approach could lead to a situation in which a patentee is able to take data from an application as filed and combine it with post-published evidence to create a new invention with a new technical effect.

One interesting question raised by a member of the Board referred to the standard for plausibility, and if it changes based on the field of invention. The question was directed to the opponent and touched on the fact that it would appear easier in the fields of mechanical engineering and electronics to achieve grant of a patent relating to a technical effect not mentioned in the application as filed, compared to the fields of chemistry and life sciences. The point was not entirely resolved during the hearing other than an assertion from the opponent that post-published evidence in all cases should only support a technical effect if the claim is plausible from the application as filed.

Given the questions asked by the Board, our opinion is that the Board continues to favour the ab initio implausibility approach, but this remains to be seen following the Boards final deliberations.

We now eagerly await the written decision from the Enlarged Board of Appeal. This is expected in spring 2023.  

Related posts