The Paris Local Division of the Unified Patent Court (UPC) issued its decision in Merz Therapeutics GmbH and Others v Viatris Santé (Case No. UPC_CFI_697/2025) on November 21 2025 – marking the UPC’s first ruling on the enforcement of a supplementary protection certificate (SPC) in a pharmaceutical originator-generics dispute. This decision warrants close attention – not only for what it decides but for what it signals.
The dispute in brief
Merz Group entities, holding European patent 2 377 536 (EP 536) and the associated French SPC No. 13C0033, brought proceedings against Viatris Santé, the French marketing authorisation holder for a generic version of Fampyra (fampridine), indicated for improving walking speed in adult multiple sclerosis patients.
The patent’s history was complex: the EPO opposition division had initially revoked it for lack of novelty before the board of appeal reinstated it in amended form in 2019, and the German Federal Patent Court subsequently invalidated the German national part for lack of inventive step in March 2024, with an appeal pending. The SPC extends French protection for fampridine until July 25 2026.
Merz had acquired the rights through a $185 million transaction as part of a court-approved sale arising from Acorda Therapeutics’ bankruptcy proceedings. This acquisition context would prove relevant for the court’s reasoning on urgency.
Procedural framework: page limits and case management
Before reaching the merits, the case produced a striking procedural episode.
Merz filed a 30-page application on July 31 2025, which is the same day that the opt-out of EP 536 and the SPC was withdrawn, and the judge-rapporteur set a timetable capping replies at ten pages each. Viatris then filed its objection – a document with 473 pages.
The judge-rapporteur was unambiguous: a 470-page objection was “not appropriate in the context of provisional measures”. Viatris was ordered to file a 70-page summary within two days; Merz was permitted a 40-page focused reply; and, notably, the court scheduled a case management meeting ahead of the oral hearing.
That last step is worth pausing on: the UPC Rules of Procedure provide for interim conferences in main proceedings but not expressly in preliminary injunction (PI) proceedings. The judge-rapporteur's decision to convene one anyway demonstrates the court’s readiness to adapt its procedures where the complexity of proceedings demands it. From a German litigation perspective, this judicial case management goes further than is typical before German courts, specifically in PI proceedings. Furthermore, page limits are not routinely imposed in German PI proceedings, even though judges sometimes request summary submissions before a hearing.
What about urgency?
The substantive heart of the first-instance decision concerns urgency.
The court found that the French administrative procedure for authorising Viatris’s generic was finalised on November 22 2024, the date on which the product was assigned a price and reimbursement rate, making generic market entry foreseeable from that point.
Critically, the court rejected Merz’s argument that “imminent infringement” and “actual infringement” constitute two successive – and therefore separate – starting points for urgency. Instead, they are alternative triggers: once either situation is known or knowable, the clock starts running. In pharmaceutical cases, a generic product automatically falls within the scope of an SPC once classified as a generic of the protected product, meaning patentees need not wait for market launch to take action.
The court also held that Merz, as an acquirer of significant intellectual property rights, was under a due diligence obligation to audit those rights and therefore should have been aware of imminent infringement at least from January 2 2025, when it assumed direct exploitation responsibilities. Merz did not send a warning letter until June 18 2025 and did not file the PI application until July 31 2025. That, the court found, was too long.
The court also rejected the argument that actual market entry on June 10 2025 created a fresh urgency trigger point, holding that this event “was already [to be] expected and does not revive urgency”.
Merz has appealed the decision to the UPC Court of Appeal. An appeal hearing concerning urgency took place on February 5 2026 via videoconference; it can be derived from an order of February 25 2026 that the Court of Appeal concluded that there is reason to hold a continued oral hearing, which is summoned for April 16 2026. It is expected that a decision will be issued a couple of weeks thereafter.
Since the February 25 2026 order also provides Viatris with a further deadline to lodge a response to the grounds of appeal in relation to matters other than urgency, this suggests that the case may not be resolved on urgency alone. This is already an interesting development in view of the first-instance decision.
The appeal will be closely monitored.
