2026-04-27 - CoA - Merz v. Viatris Sant - UPC-COA-0000917/2025

ENGLISH: Unlike proceedings on the merits, where the Statement of defence shall include a Counterclaim for revocation (R. 25.1 RoP) if there is an assertion that the patent alleged to be infringed is invalid, an invalidity defence raised in proceedings for provisional measures is not a separate action. Similarly, a waiver of an invalidity defence in proceedings for provisional measures is not an application to change the claim or amend the case in the meaning of R. 263 RoP, nor is it a withdrawal in the sense of R. 265 RoP. It follows from Art. 76(2) UPCA that it is for the parties to submit grounds, facts and evidence. If a party declares that it no longer relies on arguments, facts and evidence that it has submitted, the Court can proceed based on the remaining issues in the proceedings. The Court may order the withdrawing party to compensate the costs that the other party has made in connection with the withdrawn arguments, facts and evidence.

The Court of Appeal allowed Merz's appeal and granted a provisional injunction against Viatris's generic FAMPRIDINE on the French market until expiry of SPC 033 on 25 July 2026, reversing Paris LD's denial for unreasonable delay. The headnote articulates a structural rule for invalidity defences in PM proceedings: unlike merits proceedings where invalidity must be raised by counterclaim under R. 25.1 RoP, an invalidity defence in PM proceedings is not a separate action; waiving that defence is therefore neither an R. 263 amendment nor an R. 265 withdrawal — it is governed by Art. 76(2) UPCA, with the court free to proceed on the remaining issues (and to award costs for the abandoned arguments). On urgency, the CoA held that Merz could not have obtained the CEPS notification (the only known recipient was Acorda's mandated lawyer, who could not relay it post-liquidation; Biogen was not informed); that Article 3 of the LEEM–CEPS framework agreement does not impose a legal duty to launch within six months (it conditions only when listing may be published); and that the 22 November 2024 price publication therefore did not start the urgency clock. Merz's awareness arose at the earliest on 30 June 2025 (ANSM publication) and the PM lodged 31 July 2025 satisfied R. 211.4 RoP. On necessity, the CoA reaffirmed that direct competition with the originator product justifies a PI to maintain status quo; that interim cost reimbursement is capped at 50% of the AC ceiling (Meril v. Edwards); and that delivery up is distinct from recall under French distribution rules.