Merz Pharmaceuticals v Viatris Santé (CoA, 27 April 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 27 April 2026 (UPC_CoA_917/2025), the Court of Appeal sets aside the Paris Local Division order of 21 November 2025, which had refused Merz’s application for provisional measures as out of time, and prohibits Viatris Santé, in France and until 25 July 2026 inclusive, from marketing its generic FAMPRIDINE VIATRIS LP 10 mg, which falls within French supplementary protection certificate No. 13C0033 (fampridine, FAMPYRA®). The main contribution concerns the starting point of the Rule 211.4 period in generics cases: a marketing authorisation does not amount to an imminent infringement, whereas completion of the national pricing and reimbursement procedures may (paragraph 53). The order also clarifies the consequences of dropping an invalidity defence during the proceedings.

Facts and procedure

Merz Pharmaceuticals LLC, owner of patent EP 2 377 536 and of the certificate, Merz Therapeutics GmbH, exclusive licensee, and Merz Pharma France, exclusive sub-licensee in France, applied to the Paris Local Division on 31 July 2025 after Viatris launched its generic in June 2025. The division held that Merz knew or should have known of the imminent infringement from 2 January 2025, when it recovered direct exploitation rights in France, and refused the application (paragraphs 8 and 9). On appeal, Viatris withdrew its invalidity arguments against the patent and the certificate on 13 April 2026 (paragraph 15). Hearings took place on 5 February 2026 on urgency and on 16 April 2026 on the remaining issues.

The applicable law

Rule 211.4 allows provisional measures to be refused where the applicant has delayed unreasonably. Article 62(2) UPCA requires the interests of the parties to be weighed, and Rule 211.3 calls for an assessment of necessity and proportionality. The certificate confers the same rights as the patent (Articles 25(a) and 30 UPCA). Under Article 76(2) UPCA, the parties submit the grounds, facts and evidence.

Question

When does the period within which a right holder must act against a generic start to run, and are provisional measures still proportionate three months before the certificate expires?

Decision

Time runs from when the applicant has, or should have had with due diligence, the necessary facts and evidence (paragraph 49). The evidence shows a strong likelihood that the CEPS notification of 9 October 2024 went no further than Acorda’s counsel, so Merz could not have learned of it (paragraphs 62 and 63). The price listing of 22 November 2024 did not lead one to expect a launch within six months, since Article 3 of the LEEM-CEPS framework agreement does not require one (paragraphs 68 to 73). Merz, aware from 2 July 2025, acted without unreasonable delay (paragraph 75). With the invalidity defence withdrawn and infringement undisputed, only urgency and proportionality remained in issue (paragraph 18). Irreparable harm is not a necessary condition and patients’ interests may be taken into account (paragraphs 86 and 88), the supply shortages relied on do not justify a refusal (paragraphs 91 to 96), and the short remaining term of the certificate does not stand in the way of an injunction (paragraph 101). The Court also orders delivery up to a bailiff, with penalties of up to EUR 100,000 and EUR 50,000 per day, refuses a guarantee that would allow continued marketing and requires no security from Merz (paragraphs 107 to 110). Viatris bears the costs of both instances, with an interim award of EUR 56,000.

Key points for practice

• The grant of a marketing authorisation to the generic company does not by itself start the Rule 211.4 period, completion of the pricing and reimbursement procedures may (paragraph 53).
• Dropping an invalidity defence is neither a change of claim (Rule 263) nor a withdrawal (Rule 265), the Court decides what remains in issue and may order the party to bear the costs caused (paragraph 17).
• Irreparable harm is not required: direct competition from a generic may justify measures preserving the prior status quo (paragraphs 86 and 87).
• Practical point: the right holder must be able to prove when it learned of the launch, and a defendant relying on earlier knowledge, for instance through the CEPS, must prove that the information was actually passed on (paragraphs 62 and 63).

Provisions applied

Agreement on a Unified Patent Court

Arts. 25(a), 30, 62(2) and (3), 69(1) and 76(2)

Rules of Procedure

Rules 206.2(d), 211.3, 211.4, 213.1, 222.2, 263 and 265

Case law cited

Boehringer Ingelheim v Zentiva, Court of Appeal, 13 August 2025 (UPC_CoA_446/2025 and 520/2025), on when time starts to run, Mammut v Ortovox, Court of Appeal, 25 September 2024 (UPC_CoA_182/2024), Biolitec v Light Guide, Court of Appeal, 24 February 2025 (UPC_CoA_540/2024), Sumi v Syngenta, Court of Appeal, 3 March 2025 (UPC_CoA_523/2024), Insulet v EOFlow, Court of Appeal, 30 April 2025 (UPC_CoA_768/2024), Meril v Edwards, Court of Appeal, 25 November 2025 (UPC_CoA_464/2024), on costs.

Related decisions

• Merz Therapeutics v Viatris Santé, 21 November 2025, Paris Local Division order set aside.

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.