Paris court revokes Sanofi cabazitaxel patent

The Judicial Court of Paris has revoked Sanofi’s EP 2 493 466 on the grounds of inter alia obviousness, in view of prior Phase I and II clinical data on cabazitaxel and an ongoing Phase III trial on the claimed indication. This is a further setback for Sanofi in the dispute with generic drug companies over its chemotherapy drug Jevtana.

Moreover, French judges’ rulings in pharmaceutical disputes over fingolimod and dimethyl, and now cabazitaxel, show their expectations regarding inventive step. French judges continue to position themselves in favour of generics.

Use patent challenged

Sanofi’s EP 466 is a second medical use patent and protects a novel antitumour use of cabazitaxel. In combination with prednisone or prednisolone, the drug forms the basis of chemotherapy drug Jevtana. Healthcare professionals use it to treat hormone-refractory metastatic prostate cancer, which they previously treated with docetaxel-based chemotherapy.

Originators in Europe seldom submit second medical use patents due to difficulties in the practical enforcement of these patents. When the EPO granted the use patent in February 2021, twelve opponents immediately challenged the decision. These included French defendants Teva, Accord Healthcare and Ever Pharma.

Initially, Sanofi had applied for a preliminary injunction at the Judicial Court of Paris to prevent the parties marketing their generic products in France. However, the judges rejected the application in all three cases due to lack of inventive step.

In the case against Teva, Accord, and Ever Pharma, Sanofi had appealed against the judgment but later withdrew the appeal alongside the infringement action in the main proceedings. Thus, in France, the dispute with Teva and Ever Pharma are over.

Accord has been marketing its rival drug in France since 2021. Numerous generics companies are now active in various European countries with their own generic versions after having received favourable decisions from the UK courts in 2018 and from German courts in 2019.

EPO and UPC still to come

There is more to come, however, as in April 2025 the EPO Technical Boards of Appeal will hear the appeal against the granting of the patent.

In addition, an infringement action (case ID: ACT_16112/2024) and a counterclaim for revocation (case ID: ACT_44999/2024) are also pending at the UPC’s Munich local division. Sanofi filed a lawsuit against the generics companies Accord, Zentiva, Dr Reddy’s and Stada in May 2024. Accord filed its counterclaim for revocation this summer. The court has not yet handed down any rulings.

Accord is working with Jules Fabre and Marina Jonon of Pinsent Masons in the French proceedings. Fabre is also leading the team for Accord in the parallel UPC proceedings. The team also incudes associate Louise Millot from Paris, legal director Arjan Reijns from Amsterdam, and London partner Catherine Drew. Henrik Skodt form Aera IP acts for Accord in the EPO proceedings.

Frédéric Chevallier of Herbert Smith represented Sanofi in the French hearing. He is also lead counsel in the UPC proceedings against Accord, Dr Reddy’s, Stada, and Zentiva.

Dr Reddy’s relies on Christian Meyer from Maiwald (case ID: ACT_16119/2024) in the UPC case.

Meanwhile, Stada is working with its regular representatives from Preu Bohlig, Daniel Hoppe from Hamburg and Konstantin Schallmoser in Paris (ACT_16116/2024) at the UPC.

Zentiva regularly works with a team led by Anja Lunze from Taylor Wessing, as in this UPC case (case ID: ACT_16120/2024). For the latter, the Taylor Wessing team works closely with Elisabeth Greiner from df-mp, who is also representing Zentva in the EPO proceedings.