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UPC CoA 917/2025

Dec 8, 2025·EP2377536 · Methods of Using Sustained Release Aminopyridine Compositions

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Case details
Status
Case Closed
Action
Appeal
Category
Main appeal
Parties
Claimants
Representatives
Respondents
Representatives
Division
Court of Appeal
Judges
Technology
  • Chemistry
    Pharmaceuticals
Language
English
First decided
Jan 26, 2026
Last decision
Apr 27, 2026
EPO Opposition
  • Actavis Group PTC ehfAdmissible2013-12-05
  • Synthon B.V.Admissible2013-12-06
  • neuraxpharm Arzneimittel GmbHAdmissible2013-12-06
How this compares
How long the court takes to reach a first decision.
Median days to first decision
All UPC124
Judge Rian KaldenLocked
Judge Ingeborg SimonssonLocked
Judge Patricia RombachLocked
Judge Anna HedbergLocked
Judge Jeroen MeewisseLocked

At the UPC: Merz Pharmaceuticals LLC (7 cases)·Viatris Santé (6 cases)

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Related cases
All proceedings on this patent

This dispute contains 5 other proceedings

UPC CFI 3259/2026·UPC CFI 1901/2026·UPC CoA 906/2025·UPC CFI 697/2025·UPC APP 36985/2025

1 other defendants litigating the same or a related patent

UPC CFI 3290/2026

Start a free trial to see how each one ended.

More cases: Court of Appeal·2025

Decisions
  • 2026-04-27
    Appeal RoP220.1Public

    Summary: 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.

    Show the legal issues (9)
    • Urgency / unreasonable delay in filing provisional measures (R. 211.4 RoP)
    • Whether CEPS notification to Biogen/Acorda created awareness of imminent infringement
    • Whether publication of price and reimbursement listing created knowledge of imminent launch
    • Waiver 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 assessment
    • Admissibility 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)
  • 2026-01-26
    Application RoP262-2Public

    Summary: 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.

    Show the legal issues (3)
    • Confidentiality request (R. 262.2 RoP)
    • Distinction between R. 262.2 and R. 262A RoP
    • Timing of confidentiality decisions
Documents
Show all 505 documents
Document titleDatePublic
Communication2026-04-28Not public
Case closed2026-04-27Not public
Final Order2026-04-27Public
Decision2026-04-27Not public
Final Order2026-04-27Not public
Communication2026-04-24Not public
Receipt2026-04-22Not public
Cover sheet2026-04-22Not public
Document2026-04-22Not public
Document2026-04-22Not public
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) UPCA

  • Publication 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 agreement

  • Merz 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 RoP

  • Provisional 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 RoP

  • Supply 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 RoP

  • French 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 RoP

  • Product 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 RoP

  • Allowing continuation of marketing subject to a guarantee of up to 260,000 EUR is appropriate in lieu of injunction

    RespondentLegal basis: Art. 62(2) UPCA

  • Granting 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 RoP

  • The 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