Merz v. Viatris on appeal: urgency remains decisive, but not every signal is urgent

In provisional measures litigation before the Unified Patent Court (UPC), urgency is everything. But not every signal is urgent: that is the ridge line drawn by the Court of Appeal on 27 April 2026 in Merz v. Viatris (UPC_CoA_917/2025), the first case brought before the Court on the basis of a supplementary protection certificate.

The conceptual tension is a fertile one: the holder of a pharmaceutical patent owes a duty of active diligence, but that diligence is measured against what it provably knew, not against what it might have inferred from regulatory noise. The urgency clock runs on evidence, not on assumptions.

For originators and generic manufacturers alike, the judgment sets out the operating manual for thepreliminary injunction at the end of a patent's life, when every week on the market carries weight.

A familiar pharma scenario, an unfamiliar procedural path

The dispute concerned European patent EP 2 377 536 and French supplementary protection certificate No. 13C0033 covering fampridine (FAMPYRA®), indicated for multiple sclerosis. Viatris launched its generic on 10 June 2025, although the SPC was not due to expire until 25 July 2026. Seised on 31 July 2025, the Paris Local Division had refused provisional measures for lack of diligence.

The Court of Appeal reversed that refusal and ordered a marketing ban until SPC expiry, together with delivery up of the products, a penalty of EUR 100,000 per day and EUR 56,000 in interim costs. The decision can be consulted in the UPC register of decisions.

The invalidity defence disappears

A remarkable procedural feature: Viatris withdrew its invalidity arguments before the appeal hearing. The Court treated this not as an amendment of the case, but as a party's decision to abandon submissions, permissible under Article 76(2) UPCA. In principle, this flexibility benefits generic manufacturers: it allows a defence concentrated on urgency and proportionality, while preserving invalidity arguments for other proceedings.

The downside is immediate: by abandoning invalidity, Viatris simplified the structure of the dispute. With validity and infringement uncontested, the injunction had only one hurdle left to clear. The tactical waiver of a ground of defence is paid for at the final balancing of interests.

Urgency: the rejection of regulatory intuition

The Court confirms the established standard: the diligence period runs from the moment the applicant knew, or should have known, that an imminent infringement existed with reasonable prospects of action. The whole question was what Merz "should have known" of the generic's pricing and reimbursement process, completed by publication in the Official Journal in November 2024.

Unlike the Local Division, the Court of Appeal rejects presumptions of knowledge. The CEPS communications had not actually reached Merz, and completion of the pricing and reimbursement process in France does not guarantee, within the LEEM-CEPS framework, a launch within six months. The decisive knowledge came from the actual launch notices of 30 June and 2 July 2025: the filing of 31 July 2025 was therefore diligent.

The lesson joins, while refining, the Boehringer case law analysed in our article on imminent infringement before the UPC : imminence is assessed objectively on the defendant's side, but urgency must be proved subjectively on the applicant's side. Regulatory signals must translate into demonstrable knowledge, not mere inference.

Proportionality: patients matter, but evidence matters more

Viatris argued that the injunction was disproportionate: alleged shortages of FAMPYRA®, an inconvenient new packaging, healthcare costs, and the minimal residual term of the SPC. The Court dismissed these arguments one by one: the shortages were limited and linked to packaging transitions, and the generic had its own supply delays, while Merz demonstrated its capacity to supply the market until expiry.

Patient interests matter, as the Insulet v. EOFlowcase law had already accepted, but the preservation of exclusivity against direct competition justifies provisional measures, consistently with the proportionality requirement enshrined in Article 3(2) of Directive 2004/48/EC. Public interest defences require tangible evidence, pharmacy data, supply chain material and medical evidence in support, not rhetoric.

Guarantee and security: the most fragile part of the reasoning

The Court refused to allow continued marketing against a financial guarantee, a solution deemed inappropriate in the presence of a valid and infringed SPC. As for an obligation on Merz to provide security for Viatris's benefit, it set it aside in view of the patentee's financial solidity and its presence in the Union.

That reasoning appears too narrow. Security does not cover insolvency risk alone: it performs a proportionality function, particularly where the injunction excludes the generic from a commercially decisive market window close to SPC expiry. Reducing security to a question of solvency deprives the balancing of interests of one of its finest instruments.

Strategic readings

For originators, the judgment reassures without dispensing with caution. Merz prevailed partly thanks to singular circumstances: the bankruptcy of the previous marketing authorisation holder, an operator transition, failures in the CEPS communications. In a cleaner configuration, the pricing and reimbursement process alone could suffice to establish knowledge: the safe strategy remains active monitoring of regulatory publications, prompt warnings and upstream evidence preparation, in line with the UPC's strategic lessons for life sciences.

For generic manufacturers, the defeat is procedural, not one of principle. The Court endorses their central argument: urgency requires demonstrable knowledge, not regulatory presumptions. The prudent generic manufacturer will therefore build a limpid record: direct notification to the patentee, dated launch intentions, proof of receipt, and, defensively, a protective letter filed with the UPC; the choice of forum, examined in our study of forum shopping before the UPC, completing the arsenal.

Key takeaways

• First SPC litigation before the UPC Court of Appeal: the judgment of 27 April 2026 (UPC_CoA_917/2025) reverses the Paris refusal and bans marketing of the generic until certificate expiry.
• Withdrawing invalidity arguments on appeal is permissible (Art. 76(2) UPCA), but it simplifies the dispute to the patentee's advantage.
• Urgency runs from provable knowledge of the imminent infringement: regulatory signals that were never received create no presumption of knowledge.
• Completion of the French pricing and reimbursement process does not, by itself, guarantee a launch within six months under the LEEM-CEPS framework.
• Public interest and patient access defences require concrete evidence; rhetoric weighs nothing in the proportionality balance.
• The refusal of any security for the generic's benefit, based solely on the patentee's solvency, is the most questionable point of the judgment.

Frequently asked questions

When does the urgency period start running for provisional measures before the UPC?

From the moment the applicant knew, or should have known, that an imminent infringement existed with reasonable prospects of action; since Merz v. Viatris, that knowledge must be provable and cannot be presumed from regulatory publications alone.

Can a defendant abandon its invalidity arguments on appeal?

Yes: the Court of Appeal treats this as a permissible abandonment of submissions under Article 76(2) UPCA, but the withdrawal leaves validity and infringement uncontested and makes the injunction correspondingly easier to grant.

Can patient interests defeat a preliminary injunction?

They are taken into account in the proportionality balance, but only if supported by tangible evidence: supply data, medical material, and a demonstrated impact on patients.

Can marketing continue against a financial guarantee?

The Court refused this in Merz v. Viatris : where the SPC is held valid and infringed, continued launch against security is deemed inappropriate, as the guarantee does not compensate the harm to exclusivity.

Dhenne Avocats acts in provisional measures and interim proceedings before the Unified Patent Court and the French courts, for patentees and defendants alike. Talk to us.

This article is an original and substantially updated adaptation of an analysis by Matthieu Dhenne first published on Kluwer Patent Blog on May 19, 2026: Merz v. Viatris on Appeal: Urgency Is Still Everything, But Not Every Signal Is Urgent.