The EPO’s Enlarged Board of Appeal has issued a communication hinting at a potential relaxing of the law concerning the doctrine of ‘plausibility’ and the use of post-filed data to support inventive step.
In our previous articles (here and here), we reported that due to diverging strands of jurisprudence, the EPO’s Boards of Appeal had requested clarification from the Enlarged Board of Appeal on the important issue of the circumstances in which post-filed data may be used as evidence of a technical effect for the purposes of assessing inventive step.
THE FACTS AND ARGUMENTS
The referring Board of Appeal acknowledged the divergence in established case law concerning post-filed data, and so referred the following questions (paraphrased) to the Enlarged Board of Appeal:
- Must post-filed data be disregarded if the proof of a technical effect rests exclusively on those data?
- If yes to Q1, can post-filed data be taken into account if the effect is plausible from the application as filed (ab initio plausibility)?
- If yes to Q1, can post-filed data be taken into account if the effect is not implausible from the application as filed (ab initio lack of implausibility)?
In spite of challenges to the admissibility of the referral and the wording of these questions, the Enlarged Board of Appeal has indicated that the referral is admissible, and it looks set to consider the questions as originally posed.
The Enlarged Board of Appeal’s latest communication provides important insights into its current views and the likely outcome of the referral.
Concerning Question 1, the Enlarged Board of Appeal comments that disregarding post-filed data as a matter of principle would deprive a party submitting and relying on such evidence of a basic legal procedural right. Accordingly, as expected, the Enlarged Board of Appeal does not seem inclined to introduce a blanket prohibition on post-filed evidence.
Concerning Questions 2 and 3, the Enlarged Board of Appeal comments that post-filed data may be relied on as evidence of a technical effect which the skilled person would not have had “any significant reason to doubt” based on the application as filed in view of the common general knowledge.
The Enlarged Board of Appeal’s communication seems to indicate that post-filed data may be taken into account provided the skilled person at the filing date would have seen no significant reason to consider the technical effect implausible.
Such an approach will come as a surprise to many who had been expecting maintenance of the status quo or even a tightening up on the admissibility of post-filed data. This is all the more the case given the EPO’s fundamental 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. T1329/04 was a landmark decision which indicated that the disclosure in an application should at least make it plausible that its teaching solves the problem it purports to solve.
We expect that, if the Enlarged Board of Appeal ultimately endorses an ab initio lack of implausibility approach, this will need to be carefully qualified to prevent abuse. In practice, we wonder whether the adoption of an ab initio lack of implausibility approach may be less about lowering the bar for the consideration of post-filed data, but instead a shifting of the burden away from the applicant or patentee for demonstrating plausibility and onto the EPO or opponent for demonstrating implausibility. This would be in line with the EPO’s approach for assessing sufficiency of disclosure, in which an objection requires “serious doubts substantiated by verifiable facts”.
Innovators, particularly those in the life sciences sector, will be encouraged by the potential lowering of the bar with respect to post-filed evidence, due to the often-significant challenges of obtaining conclusive evidence at what is normally an early stage in the product development cycle.
Furthermore, the EPO’s problem-and-solution approach for assessing inventive step relies on a consideration of whether a technical effect for the invention relative to the closest prior art has been demonstrated. It is common that an applicant will not be aware of the closest prior art at the time of filing an application, and so the lowering of the bar to require only an ab initio lack of implausibility may increase the opportunities for applicants to utilise post-filed data as evidence of a technical effect. The Enlarged Board of Appeal has not directly addressed this point in their communication and so further clarification is needed.