FRANCE Trends and Developments Contributed by: Denis Schertenleib, Marc Lauzeral and Célia Benmesbah, Schertenleib Avocats
Hence, even though only sitagliptin was inven- tive since metformin was in the public domain and the combination sitagliptin/metformin had no synergic effect, the Court held that the com- bination SPC sitagliptin/metformin was a prod- uct protected by the patent within the meaning of Article 3(a). In this case, the Court ruled that there was no requirement for the patent to demonstrate that the said product formed by the combination sit- agliptin/metformin, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fell under the invention covered by that patent. A simple mention of that combina- tion in the claims was sufficient for the product to be considered protected by the basic patent within the meaning of Article 3(a). The second question was with regard to Article 3(c) of the SPC Regulation. The Court of Appeal held that the first SPC should not be the first SPC filed but the first SPC granted. The Court then indicated that the combination SPC sitagliptin/metformin was valid, since although it was filed after the single sitagliptin SPC, it had been granted earlier. These two questions have been the subject of referrals to the ECJ under case numbers C-119/22 (sitagliptin) and C-149/22 (ezetimibe), which led to the ECJ judgment of 19 December 2024. Firstly, the ECJ confirmed that the two-stage test outlined in the Teva v Gilead judgment has gen- eral applicability. This test applies indistinctly, whether or not the product in question is explic- itly mentioned in the basic patent claims.
This means that a simple mention in the claims is no longer sufficient for a product to be con- sidered protected by the basic patent within the meaning of Article 3(a). More specifically, the ECJ stated that if one of the two ingredients comprising the product is known and is in the public domain at the filing date or priority date of the patent, it can only be considered as falling under the invention covered by that patent if the basic patent itself discloses that the combination of the two active ingre- dients has a synergic effect which contributes to the solution of the technical problem. This means that the patent itself shall demonstrate a combined effect going beyond the mere addition of the effects of those two active ingredients. This new outcome may impact the action on the merit to come in this case. Focus on Some of the First Decisions on the Merit of the UPC Paris Local Division Procedural Order of the Court of First Instance of the Unified Patent Court delivered on 1 March 2024, UPC_CFI_397/2023, C-KORE V NOVAWELL The Paris Local Division issued the first deci- sion on an application to withdraw an order to preserve evidence of the UPC. The Paris Local Division dismissed Novawell’s application in its entirety, considering that Novawell failed to prove a new element of fact or law that would have changed the decision to issue the order to preserve evidence. This deci- sion confirms that an ex parte order to preserve evidence can be issued to prove the infringe- ment in a scenario other than extreme urgency, such as a trade fair.
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