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UPC CoA 917/2025
Dec 8, 2025·EP2377536 +1 more: Methods of Using Sustained Release Aminopyridine Compositions
- Case details
- StatusOral PhaseActionAppealCategoryMain Appeal
- Parties
- ClaimantsReps: Laëtitia Bénard (Allen & Overy Shearman Sterling LLP, Paris, France)
- Division
- Court of Appeal
- Technology
- Pharmaceutical & Medical
- Language
- English
- First decided
- Jan 26, 2026
- Last decision
- Apr 27, 2026
Decisions
- 2026-04-27PI grantedAppeal decisionAppeal RoP220.1
The Court of Appeal set aside the Paris Local Division's order denying provisional measures, finding that Merz did not act with unreasonable delay. A provisional injunction was granted ordering Viatris Santé to cease making, offering, placing on the market, using, importing or storing the generic product FAMPRIDINE VIATRIS LP 10 mg in France until SPC 033 expires on 25 July 2026, and ordering delivery up of infringing stock to a bailiff. Viatris Santé was also ordered to pay Merz an interim award of costs of 56,000 EUR.
Legal issues:Urgency / unreasonable delay in filing provisional measures (R. 211.4 RoP)Whether CEPS notification to Biogen/Acorda created awareness of imminent infringementWhether publication of price and reimbursement listing created knowledge of imminent launchWaiver of invalidity defence in provisional measures proceedings (Art. 76 UPCA, R. 263, R. 265 RoP)Proportionality of provisional injunction (Art. 62(2) UPCA, R. 211.3 RoP)Product shortage and patients' interests in balance of interests assessmentAdmissibility of new evidence on appeal (R. 222.2 RoP)Delivery up of infringing stocks (Art. 62(3) UPCA, R. 211.1(b) RoP)French regulatory framework (LEEM-CEPS framework agreement, Art. 3) - 2026-01-26Application RoP262-2
The Court of Appeal issued an order on Merz Pharmaceuticals' request under R. 262.2 RoP to keep certain information (including Exhibit 823) confidential in the Merz v. Viatris Santé proceedings. The Court reiterated that R. 262.2 RoP requests are addressed to future public access requests, not to the other party. Protection against the other party's use of confidential information requires a R. 262A RoP confidentiality order. The Court declined to issue a decision on the R. 262.2 request at this stage pending any public access application.
Legal issues:Confidentiality request (R. 262.2 RoP)Distinction between R. 262.2 and R. 262A RoPTiming of confidentiality decisions
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| action.communication.general | 2026-04-28 | Not public |
| action.phaseChange.caseClose | 2026-04-27 | Not public |
| Final Order | 2026-04-27 | Public |
| action.issueDecision.decision | 2026-04-27 | Not public |
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| action.communication.general | 2026-04-24 | Not public |
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| action.phaseChange.oralPhaseClose | 2026-04-16 | Not public |
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| action.issueOrder.order | 2025-12-10 | Not public |
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| Order | 2025-12-10 | Public |
| action.publishOrderDecision.case | 2025-12-10 | Not public |
| Application document Appellant | 2025-12-08 | Not public |
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| Statement of the Grounds of Appeal | 2025-12-08 | Not public |
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| Receipt | 2025-12-08 | Not public |
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| Statement of Appeal | 2025-12-08 | Not public |
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Accepted arguments
What the court agreed with — by party.
Merz did not have knowledge of imminent infringement from the CEPS notification of 9 October 2024, as the information did not reach Acorda or Biogen beyond the French counsel who was unable to relay it
ClaimantLegal basis: R. 211.4 RoP; Art. 76(2) UPCAPublication of price and reimbursement rate on 22 November 2024 did not provide sufficient certainty that generics would be launched within six months, as Article 3 LEEM-CEPS does not impose an absolute obligation to launch within six months and evidence showed actual launches many months after price publication
ClaimantLegal basis: R. 211.4 RoP; Art. 3 LEEM-CEPS framework agreementMerz became definitively aware of the infringement on 2 July 2025 when Viatris confirmed it had already launched in France, and filing the Application on 31 July 2025 satisfies the urgency requirement
ClaimantLegal basis: R. 211.4 RoPProvisional injunction is necessary to prevent direct competition from an infringing product, with price erosion and permanent loss of market share as consequences that cannot be fully remedied by damages
ClaimantLegal basis: Art. 62(2) UPCA; R. 211.3 RoPSupply of FAMPYRA by Merz is sufficient to cover the French market including demand after withdrawal of the generic, so patients' interests will not be jeopardized
ClaimantLegal basis: Art. 62(2) UPCA; R. 211.3 RoP
Rejected arguments
What the court did not agree with — and why.
Merz should have been aware of imminent infringement from Biogen being informed by CEPS in October 2024
RespondentLegal basis: R. 211.4 RoPFrench regulatory framework (LEEM-CEPS Art. 3) imposes an obligation on generic companies to launch within six months of price publication, such that patent holders must assume launch will occur within six months
RespondentLegal basis: Art. 3 LEEM-CEPS framework agreement; R. 211.4 RoPProduct shortages in May 2025 and March 2026 show Merz cannot reliably supply the French market and thus provisional injunction would harm patients
RespondentLegal basis: Art. 62(2) UPCA; R. 211.3 RoPAllowing continuation of marketing subject to a guarantee of up to 260,000 EUR is appropriate in lieu of injunction
RespondentLegal basis: Art. 62(2) UPCAGranting the provisional injunction would lead to higher costs for the French health system and patients since only the more expensive originator would be available
RespondentLegal basis: Art. 62(2) UPCA; R. 211.3 RoPThe short time remaining before SPC expiry on 25 July 2026 means provisional measures are not necessary and the court should await merits proceedings
RespondentLegal basis: Art. 62(2) UPCA; R. 211.3 RoP