A referral has now been made to the EPO’s Enlarged Board of Appeal asking it to clarify the law concerning the doctrine of ‘plausibility’ and the use of post-filed data to support inventive step.
In our previous article, we reported that the EPO’s Boards of Appeal were expected to request clarification from the Enlarged Board of Appeal on the important issue of whether post-filed data may continue to be used as evidence of an inventive step which is already ‘plausible’ from the application as originally filed.
The case in question is an appeal against the decision of the EPO’s Opposition Division to maintain Sumitomo Chemical Company’s European patent no. 2484209 as granted following an opposition by Syngenta.
During oral proceedings before the Board of Appeal, it was noted that there is growing divergence in the EPO jurisprudence concerning plausibility and the admissibility of post-filed data.
The Board of Appeal has now issued its decision as T0116/18 in which it has referred the following questions 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):
- Should an exception to the principle of free evaluation of evidence…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?
- 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)?
- 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)?”
These questions are identical to those proposed by the Board of Appeal during the oral proceedings, despite a request from the appellant for the questions to be altered to assess plausibility (or implausibility) based on the information in the priority application.
The outcome of a referral concerning plausibility and post-filed data could have wide-reaching implications for applicants, particularly in the field of life sciences where data generation can be slow and costly.
In our previous article, we explained that we consider it unlikely that the EPO will lower the bar for admissibility of post-filed data, due to its belief, as explained in T1329/04 and subsequent decisions, in the principles that an applicant should have the invention in hand at the time of filing an application, and is entitled to a scope of protection commensurate with its contribution to the art.
Innovators will, no doubt, hope that the EPO does not significantly raise the bar for admissibility of post-filed data, due to the often significant challenges of obtaining conclusive evidence, particularly clinical trial data, at what is normally an early stage in the development cycle.
A tightening up on the admissibility of post-filed data would mean that applicants in the chemistry and life sciences fields may need to consider more carefully whether to delay filing an application until they have obtained further data, or whether to file an application which targets protection more narrowly around their existing data. This consideration is critical, since by definition a lack of plausibility cannot be remedied after filing. Another option includes filing as normal for the rest of the world and making use of the 18 month publication cycle to gather key data for inclusion in a separate patent application intended specifically for the EPO.
It is likely to be one or two years before a decision is issued. For pending applications and opposed patents where these questions are likely to be determinative, we expect that the EPO will allow a stay of proceedings pending the outcome of the referral.