Thursday, September 28 2023   \  Published by Venner Shipley .

The impact of G2/21 on biotech patent drafting – extraordinary claims require extraordinary evidence

The impact of G2/21 on biotech patent drafting – extraordinary claims require extraordinary evidence

G2/21 is a recent Decision issued by the European Patent Office’s highest law-making court, the Enlarged Board of Appeal (EBoA). The details of the specific case are reported elsewhere and will not be discussed in depth in this article. The Decision of the EBoA, however, has important implications for patent Applicants, in the biotech field in particular, in relation to the amount of data that should be included in a patent application in support of the technical effect of a patent claim. In summary, while patent Applicants should always seek to include as much supporting data as possible in a patent application, for sufficiency of disclosure the amount of data required is related to the credibility of the claimed invention, whereas in relation to inventive step, post-filed evidence of a technical effect may be admissible under the circumstances outlined in G2/21.

Background and the concept of plausibility

In G2/21, the EBoA considered the issue of “plausibility”. The concept of plausibility of a technical effect is relevant to the requirements of both inventive step and sufficiency of disclosure. Both of these aspects are discussed in the G2/21 Decision, and must be considered by Applicants when deciding how much supporting data should be included in a biotech patent application. Read more

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