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Those active before the EPO in the pharmaceutical and biotech fields will be aware that a “hot topic” at the EPO is the requirement for a “plausible” disclosure of efficacy in the application as originally filed. This is a complex topic, and it is perhaps fair to say that the case law of the boards of appeal is not always consistent or clear in this area.
We may now have some welcome clarity on this topic: in a recently published set of minutes from EPO Board of Appeal hearing on 22 July 2021 (appeal number T0116/18) regarding European patent EP2484209, the Board of Appeal indicated that it would be referring a number of questions to the Enlarged Board of Appeal. The Enlarged Board will be asked whether and under what circumstances data which is not present in the application as filed can be relied on when assessing inventive step. In particular, it will be asked to clarify whether the requirement for a plausible disclosure requires some technical information (such as experimental results) which support an assertion of biological activity, or whether all that is required is a mere assertion of biological activity which is prima facie credible.