FRANCE Trends and Developments Contributed by: Denis Schertenleib, Marc Lauzeral and Célia Benmesbah, Schertenleib Avocats
Bayer was also the owner of a European pat- ent protecting the compound of Rivaroxaban, which expired in 2020. The supplementary pro- tection certificate (SPC) based on this patent also expired in 2024. On 8 February 2018, Sandoz obtained three marketing authorisations for the drug “Rivar- oxaban Sandoz”. By summons dated 14 June 2022, Sandoz initi- ated proceedings against Bayer before the Paris Judicial Court to invalidate Bayer’s patent EP 961 for lack of inventive step. In this case, the technical problem the invention sought to solve was to provide an initial dosage of Rivaroxaban for the treatment of prophylaxis and thromboembolic disorders. The prior art submitted during the proceedings by Sandoz essentially consisted of Phase I clini- cal studies, which involved a limited number of healthy volunteers and not patients. The study presented in the patent was a Phase II study involving patients undergoing total hip replace- ment surgery. With regards to this prior art (Phase I clinical studies), the Court held that the solution of a single daily administration claimed in the patent amounted to a routine trial. It could not, there- fore, be regarded as having the surprising or unexpected effect argued by the parties. From these elements, it followed that the claimed invention of a dosage consisting of one daily administration of Rivaroxaban in the form of a fast-release tablet was obvious to a per- son skilled in the art as of the priority date. The uncertainty surrounding the half-life of Rivaroxa- ban, and the mention in the patent of a half-life
of ten hours or less, was not, in itself, sufficient to demonstrate the inventive step asserted by Bayer. Phase II or III Clinical Trials Create a Reasonable Expectation of Success Judicial Court of Paris, 6 September 2024, Case No 21/06416, Accord Healthcare France and Accord Healthcare v Sanofi Winthrop Industrie, Sanofi-Aventis France and Sanofi Mature IP Sanofi Mature IP was the holder of a European patent covering the use of Cabazitaxel for pallia- tive purposes in metastatic prostate cancer after failure of hormone deprivation therapy and sub- sequent failure of a first-line docetaxel-based therapy. Accord Healthcare France and the Spanish entity Accord Healthcare had been marketing a hybrid drug of Jevtana in France since 14 June 2021. They initiated an action against Sanofi in order to obtain the nullity of the opposed patent. Sanofi then filed an infringement action against the Accord companies on 8 September 2021. The two proceedings were joined. The Paris Judicial Court invalidated Sanofi’s pat- ent, citing, among other reasons, a lack of inven- tive step based on prior Phase I and II clinical data on Cabazitaxel and an ongoing Phase III trial for the claimed indication. The technical problem here was to provide an alternative treatment for metastatic castration- resistant prostate cancer in patients previously treated with a docetaxel-based regimen, whose cancer had progressed during or after such treatment.
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