FRANCE Trends and Developments Contributed by: Denis Schertenleib, Marc Lauzeral and Célia Benmesbah, Schertenleib Avocats
In its analysis of the inventive step, the Court stated that the disclosure of Phase II or Phase III clinical trials specifically related to the patented application creates, in itself, a reasonable expec- tation of success for a person skilled in the art. Indeed, even though a Phase II or Phase III clini- cal trial does not in itself negate the inventive step, it is capable of influencing and strength- ening the teaching derived from the rest of the prior art. The person skilled in the art is therefore neces- sarily encouraged to search the prior art for any- thing that might support the hypothesis of the therapeutic approach disclosed as sufficiently promising to warrant a Phase III clinical trial. SPC – Clarification of the Interpretation of Article 3 of Regulation (EC) No 469/2009 (the “SPC Regulation”) The year 2024 was also significant for SPCs, bringing an end to numerous uncertainties sur- rounding the interpretation of Articles 3(a) and 3(c) of the SPC Regulation. A Product, Where it Meets a Functional Definition Contained in the Claims of a Basic Patent, May Be Considered To Be Protected by that Basic Patent, Within the Meaning of Article 3(a) of the SPC Regulation Court of Cassation, 31 January 2024, No 22-18.374, Dana Farber Cancer Institute Inc v INPI (the French Patent and Trade Mark Office) The Court of Cassation clarified that a product defined by a functional definition is protected under Article 3(a) of the SPC Regulation, pro- vided it is specifically identifiable in the patent by a person skilled in the art at the date of filing or priority, based on their general knowledge and the information disclosed in the patent.
However, the Court emphasised that this is not the case when the said product is developed after the filing date through an independent inventive activity. In this case, the product avelumab (a human monoclonal antibody) was not claimed in the patent, and a large number of antibodies fell under the functional definition of the patent claims. Nevertheless, the patent disclosed rou- tine, well-established assays that allowed for the generation and identification of an antibody tar- geting a given antigen. The Court of Appeal held that these elements were sufficient to enable a person skilled in the art to specifically identify avelumab in the patent and did not result from an independent inventive activity. The Court of Appeal further specified that nei- ther the filing of a patent covering, among other things, avelumab, nor the three years of research leading to its discovery, were sufficient to dem- onstrate that avelumab was developed through an independent inventive activity. The Court of Cassation upheld the reasoning of the Court of Appeal and concluded that the INPI had not provided evidence that avelumab was developed through an independent inven- tive activity. It is noteworthy that this decision reached a different outcome than the Dana-Farber case of last year even though the same patent was at stake and that the Atezolizumab was also a monoclonal antibody (Paris Court of Appeal, 5th Division, 2nd Chamber, 26 May 2023, Case No 21/17890, Dana-Farber Cancer Institute Inc. v Director General of the INPI).
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