In the ongoing case between Sanofi and the generic drug manufacturer Accord, the Paris Judicial Court has fully revoked Sanofi’s patent for the chemotherapy drug Jevtana. The patent EP 2 493 466, which protects a new use of cabazitaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer, was invalidated on the grounds of lack of inventive step, considering earlier Phase I and II clinical data and an ongoing Phase III trial. This ruling is another setback for Sanofi in its dispute with generic manufacturers.
Sanofi had previously sought a preliminary injunction to prevent the generics from entering the market but was unsuccessful. In France, the dispute with Teva and Ever Pharma has already concluded after Sanofi withdrew its appeal and the main action. Accord has been marketing its generic version of Jevtana in France since 2021, and similar generics are available in other European countries after favorable rulings in the UK and Germany.
The legal battles are not entirely over. In April 2025, the appeal against the patent grant will be heard by the Technical Boards of Appeal of the European Patent Office (EPO). Additionally, infringement proceedings and a counterclaim for revocation are pending before the Munich division of the Unified Patent Court (UPC), with Accord, Zentiva, Dr. Reddy’s, and STADA involved.
Dr. Reddy’s is represented in the UPC case by Marco Stief, Christian Meyer and Andreas Ledl from Maiwald (Case ID: ACT_16119/2024).
This text is a summary of an article published by JUVE Patent. The full text of the article is available here.
