FRANCE Trends and Developments Contributed by: Denis Schertenleib, Marc Lauzeral and Célia Benmesbah, Schertenleib Avocats
Paris Court of Appeal, 27 September 2024, Case Nos 23/08706 and 23/08707, Ono Pharmaceutical co. Ltdv and Dr Honjo v Director General of the INPI) In this case, the first-instance judge held that the patent description contained no indications, such as a concrete embodiment or any other teaching, enabling the specific individualisation of pembrolizumab. Therefore, it was not spe- cifically identifiable by a person skilled in the art based on their knowledge and the state of the art at the filing date. The Court of Appeal noted that the patent only referenced “well-known” methods, which per- tained not to the production of monoclonal antibodies, the class to which pembrolizumab belonged, but to polyclonal antibodies. A routine method was also mentioned, as well as other already known techniques, but no explanation of their implementation was disclosed in the patent. Only bibliographic references to these techniques were provided. The Court thus found that the patent relied solely on assertions. It therefore failed to demonstrate that the methods for producing monoclonal anti- bodies were well known to a person skilled in the art at the filing date of the EP 878 patent application or its earliest priority date. The Court of Appeal consequently held that pembrolizumab was not a “product protected by a basic patent in force” within the meaning of Article 3(a) of the SPC Regulation. This decision aligns with the 2024 Dana-Farber decision mentioned above.
Validity of a Combination SPC Where One of the Active Ingredients is in the Public Domain Based on Articles 3(a) and 3(c) of SPC Regulation Summary proceedings, Paris Court of Appeal, 12 January 2024, Case No 22-16673, Mylan Ireland Limited v MSD France, VIATRIS Santé S.A.S., Sitagliptin The first question was whether the explicit men- tion in the claims of the basic patent of the active ingredient combination sitagliptin/metformin was sufficient to consider that this combination is protected by the basic patent in accordance with Article 3(a) of the SPC Regulation. This question arose from the two-stage test established in the judgment Teva v Gilead of 25 July 2018, C-121/17. The Court held, in the light of the judgments Teva v Gilead and Royalty Pharma (30 April 2020, C-650/17), that the two-stage test recom- mended in Teva v Gilead to determine whether a product is protected by an existing basic patent, within the meaning of Article 3(a) of SPC Regula- tion, was only necessary when the product is not explicitly mentioned in the claims of the basic patent. The Court added that it was not required by the ECJ for the claimed combination to be included in a single claim explicitly listing all the com- pounds of the combination. The Court then held that each compound was individually and expressly mentioned in at least one claim of the basic patent of MSD, and that the combination of these active ingredients was also covered, even though the claim for the com- bination was made from a selection from one list.
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