Life Sciences

Sanofi v Accord, Stadapharm, Reddy & Zentiva (UPC_CFI_145, 463, 146, 496, 147, 374, 148 & 503/2024)

Decision date:

08 May 2025

Court
Munich LD
Patent
EP 2 493 466

Full decision available here:

Osborne Clarke summary

  • The decision concerns the infringement actions relating to EP 466 brought by various Sanofi entities against multiple defendants, including Accord Healthcare, STADA, Reddy Pharma, and Zentiva, concerning various CABAZITAXEL products.
  • The judge-rapporteur decided to exercise their case management powers in Rule 332(d) RoP, referring all requests to the panel for decision after the main oral hearing. With respect to the preliminary objections raised, the judge-rapporteur reminded the parties that the Court of Appeal has already ruled that there can be a carve-out of certain UPC contracting member states and that the UPC has jurisdiction over acts committed before 1 June 2023. The Court of Appeal has also held that Article 34 UPCA has the effect that it is sufficient to prove an act of infringement in one UPC contracting member state in order to claim infringement in all.
  • As for the validity of the patent at issue, the judge-rapporteur noted that the French designation of the patent had been invalidated at first instance and that an appeal was pending, but also that the EPO Opposition Division had upheld the patent and a further appeal was pending. The non-final invalidation in France raised doubts about the validity of the patent and therefore it would be more economical to wait for the EPO Board of Appeal's decision. Likewise, infringement of the patent could not be decided and, again, it would be better to wait for the EPO Board of Appeal's decision.
  • The judge-rapporteur found that Sanofi's representative had not succeeded in submitting a clear and unambiguous set of claims and requests. However, the court decided not to dismiss the action on formal grounds at this stage. Instead, any ambiguities would be interpreted by the panel to ensure that they were decided on their merits, although there might be costs implications for Sanofi because of the ambiguities.
  • The preliminary objections were ordered to be dealt with in the main proceedings, and the remaining pending requests were referred to the panel for decision after the main oral hearing. The written procedure closed on 8 August 2025, with oral hearings scheduled for 14-17 October 2025.

Issue

Procedural
Preliminary objection

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