UPC CoA 917/2025

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

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

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

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

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

Merz should have been aware of imminent infringement from Biogen being informed by CEPS in October 2024

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

Product shortages in May 2025 and March 2026 show Merz cannot reliably supply the French market and thus provisional injunction would harm patients

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

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

The short time remaining before SPC expiry on 25 July 2026 means provisional measures are not necessary and the court should await merits proceedings