Sanofi v Accord Healthcare (CFI, ORD_69482/2024, 15 September 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 15 September 2025 under Rule 105.5 RoP, following the second interim conference of 12 September 2025, the judge-rapporteur of the Munich Local Division organises the hearing of the four infringement actions brought by Sanofi group companies on European patent EP 2 493 466 against Accord Healthcare, STADAPHARM, Reddy Pharma and Zentiva (UPC_CFI_145/2024 to UPC_CFI_148/2024), together with the related counterclaims. The order, common to the four proceedings, sets the oral hearing for 14 to 17 October 2025, provides for two party experts to be heard and rules on late filings by Zentiva.

Question

How should the oral phase of four parallel proceedings be organised, and may evidence filed late by Zentiva be admitted?

Decision

The four counterclaims are heard together and the four infringement actions separately. Two party experts, one for Sanofi and one for all the defendants, are to be heard on 14 October 2025 on the TROPIC phase III study and the reasonable expectation of success. To the defendants’ objection that legal questions may not be put to experts, the judge-rapporteur answers that hearing them will help the panel decide the legal question of obviousness, with the parties free to question them within the limits of Rule 178.5 RoP. Zentiva’s declaration D116 is admitted, the second affidavit D117 of 8 August 2025 is excluded, since an application to file further evidence could have been made earlier. The parties may comment by 8 October 2025 on the written reasons of the EPO Board of Appeal, which upheld the patent after the hearing of 2 to 4 June 2025.

Key points for practice

• Evidence filed late, where an application to file further evidence could have been made earlier, is excluded.
• Hearing party experts on factual questions may assist the panel in deciding the legal question of obviousness.

Provisions applied

Rules of Procedure

Rules 102.2, 103, 105.5, 115, 178.5, 333 and 355

Related decisions

• Sanofi v Accord Healthcare, 15 September 2025, order summoning the party experts.

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.