Merz and A&O overturn PI decision in Fampyra case in second instance at the UPC

Things are looking up for Merz in its battle over Fampyra in Europe. Only recently the Munich Regional Court issued preliminary injunctions against several generics manufacturers, blocking them from marketing their fampridine generics in Germany. Now the UPC Court of Appeal in Luxembourg has granted Merz a PI against Viatris Santé regarding the French SPC of patent-in-suit EP 2 377 536, thus overturning a first-instance decision from the Paris local division (case ID: UPC_CoA_917/2025).

Consequently, Viatris is no longer permitted to market its generic version Fampridine Viatris in France until the French SPC 13C0033 expires on 25 July. The order is immediately enforceable.

Shaping case law on SPCs

On 31 July 2025, Merz Therapeutics, the US subsidiary of German pharmaceutical company Merz, revoked the opt-out from the UPC system for its EP 536. The patent covers multiple sclerosis drug fampridine, which Merz markets under the brand name Fampyra. The drug aims to improve walking ability in multiple sclerosis patients. Currently, the drug is covered by French SPC 13C0033, which is based on EP 536.

Merz filed a PI request at the Paris local division against Viatris, which had launched a generic version in France, but failed in the first attempt for lack of urgency. The patent holder appealed the decision.

Three days before the hearing in Luxembourg, Viatris Santé unconditionally waived its invalidity defence regarding the patent and SPC. Thus the discussion focused on the questions of urgency and what constitutes an unreasonable delay, as well as proportionality.

In this first-ever UPC case concerning an SPC, the Court of Appeal has now overturned the first-instance judgment. The judges’ bench consisted of presiding judge Rian Kalden, legally qualified judges Ingeborg Simonsson, and Patricia Rombach, as well as technically qualified judges Anna Hedberg and Jeroen Meewisse.

A matter of urgency

The Court of Appeal came to different conclusions regarding urgency and proportionality.

The first instance had found that Merz could have known about the foreseeable market entry of Viatris in France from 22 November 2024 at the latest and could have taken action against it based on imminent infringement. The Paris local division stated that the marketing authorisation by the French regulators was completed and publicly known on this date. At this time, the Viatris product was assigned a price and a reimbursement rate.

The appeal court has now found that the conditions for imminent infringement were not satisfied before the actual launch of Viatris’ generic product. Based on new evidence, the judges found that the information did not reach either previous patent owner Acorda, Merz or its French distribution partner Biogen. According to the appeal court, the mere publication of price and reimbursement rate gave no sufficient certainty of imminent launch. Thus Merz had no duty to assume it would be marketed within six months.

The second instance court saw the French national regulatory authority’s publication of the actual launch of the generic on 30 June as the date Merz could have become aware of the launch. Since the patent holder filed the PI application on 31 July 2025, this was well within the RoP requirements for urgency.

Price pressure

Furthermore, the Court of Appeal rejected Viatris’ proportionality objections. The judges found a provisional injunction necessary because the parties are direct competitors, and the launch of the generic creates price pressure and permanent price erosion.

Following Boehringer vs Zentiva this is the second time that the UPC Court of Appeal has ruled on the question of urgency in PI proceedings in a pharma case. Citing the former, the court clarified that “in the context of marketing of generic medicines, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one. Completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine may amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case” (Boehringer Ingelheim vs Zentiva, paragraphs 47-48).

A&O vs Schertenleib

Merz relied on a team from A&O Shearman from the beginning of the proceedings. The law firm is also active in the German part of the case. Paris-based partner Laëtitia Bénard and Charles Tuffreau led the proceedings at the UPC, pleading on imminence, urgency and proportionality.

From the in-house department of Merz Therapeutics, a team consisting of Vice President and General Counsel Cornelia Keller, Head of Legal Corporate Maike Bermüller, and Head of Global IP Nikolai Graf v. Keyserlingk handled the case and worked closely with the lawyers of A&O Shearman.

A team from Carpmaels & Ransford was also present at the hearing. Patent attorneys and partners Edward Oates and David Holland previously handled the EPO proceedings and litigator Agathe Michel-de Cazotte was involved at first instance at the UPC.

Paris IP firm Schertenleib acted for Viatris from the start of the UPC case. Partner Marc Lauzeral led the case alongside name partner Denis Schertenleib. The boutique firm often works for the generics company in high-profile pharmaceutical cases. Examples include a national case against Bayer concerning cancer drug Nexavar, against Biogen over market access for a Tecfidera generic, and against MSD over Inegy.