Merz v. Viatris on Appeal: Urgency Is Still Everything — But Not Every Signal Is Urgent

This week, I have the pleasure of speaking in Amsterdam at C5’s 19th Annual Forum on Pharma & Biotech Patent Litigation in Europe, in a panel devoted to running and defending preliminary injunctions at the UPC and beyond. The programme expressly puts urgency, proportionality, timing, knowledge and delay at the centre of the discussion. Merz v. Viatris will inevitably be part of that conversation.

I had already commented on the Paris Local Division’s first-instance order, where I described urgency as something that must be preserved, not merely asserted.1 The Court of Appeal’s order of 27 April 2026  does not make that reading obsolete. It makes it more precise.2 The result is, on its face, an originator victory: the UPC Court of Appeal set aside the Paris Local Division’s refusal and granted provisional measures against Viatris Santé. But the reasoning is more nuanced and, in some respects, less hostile to generics than the operative part suggests.

The case in brief: a familiar pharma scenario, an unfamiliar procedural path

The dispute concerned EP 2 377 536 and French SPC No. 13C0033, covering fampridine, marketed by Merz as FAMPYRA® for improving walking speed in adult patients with multiple sclerosis. Viatris Santé had launched FAMPRIDINE VIATRIS® in France on 10 June 2025. The SPC expires on 25 July 2026, so the litigation was always taking place in that familiar last stretch of exclusivity where every week has economic significance.

The case was also symbolically important. At first instance, it was widely described as the first UPC decision in proceedings concerning the assertion of an SPC in an originator/generic dispute. The rights had been acquired by Merz from Acorda in the context of a USD 185 million transaction  involving (F)AMPYRA® and related assets, which added an additional layer to the urgency debate: what must an acquirer of pharmaceutical IP know, and when must it know it?3

The Paris Local Division refused the PI because it considered that Merz had not acted without unreasonable delay. Its reasoning rested on a simple sequence: Viatris had obtained its French marketing authorisation years earlier, was listed as a generic in September 2024, obtained price and reimbursement on 22 November 2024, and had told CEPS in October 2024 that the product would be made available within six months. On that basis, the Local Division found that Merz should have known of an imminent infringement well before the actual launch and well before filing its PI application on 31 July 2025.

The Court of Appeal reversed. It ordered Viatris Santé to stop making, offering, placing on the market, using, importing or storing the generic in France until 25 July 2026, imposed a 48-hour grace period for compliance with the injunction, ordered delivery up of stocks to a bailiff within one week after notification, and attached daily penalty payments of up to EUR 100,000 for breach of the injunction and EUR 50,000 for breach of the delivery-up order. Viatris was also ordered to pay EUR 56,000 as an interim award of costs.

That sounds straightforward. It is not.

A procedural twist: the invalidity defence disappears

One of the most interesting aspects of the order is procedural. Shortly before the second appeal hearing, Viatris withdrew its arguments, facts and evidence relating to the likelihood of invalidity of the patent and SPC. The Court of Appeal held that, in provisional-measures proceedings, an invalidity defence is not a separate action. Its waiver is therefore neither an amendment of a party’s case under Rule 263 RoP nor a withdrawal under Rule 265 RoP. It is simply a party deciding, under Article 76(2) UPCA, no longer to rely on certain grounds, facts and evidence.

This is important. For generics, it confirms that invalidity arguments in PI proceedings remain procedurally flexible. A defendant may decide to fight the PI on urgency and proportionality without forcing the Court to conduct a provisional validity assessment. That can be strategically rational, especially where the defendant wishes to preserve its invalidity case for another forum or later proceedings.

But it is also dangerous. Once validity and infringement are no longer disputed, the balance of interests changes radically. The Court could state, almost mechanically, that SPC 033 was valid and infringed, and that the only remaining issues were urgency and proportionality. Procedural autonomy therefore came at a price: Viatris avoided an adverse provisional validity ruling, but it also made the injunction easier to grant.

This is perhaps the first practical lesson of the case. In UPC PI proceedings, withdrawing invalidity is not a technical housekeeping exercise. It changes the architecture of the case.

Urgency: the Court of Appeal rejects regulatory intuition

The core of the appeal was urgency. The Court confirmed the general test developed in Mammut v. Ortovox and Boehringer v. Zentiva: delay under Rule 211.4 RoP runs from the moment the applicant knew, or should have known, of the infringement or imminent infringement in a way that would allow it to file a PI application with a reasonable prospect of success. There is no abstract deadline. The test is factual, evidential, and case-specific.

In pharmaceutical cases, Boehringer v. Zentiva remains the anchor. A marketing authorisation alone does not amount to imminent infringement  . Additional steps are needed.4 Completion of pricing and reimbursement procedures may amount to imminent infringement if, in the relevant national context, the alleged infringer has effectively “set the stage” for launch.

Merz v. Viatris does not overrule that. It disciplines it.

The Paris Local Division had treated the French regulatory sequence as sufficiently predictable. The Court of Appeal did not. It found that the first-instance reasoning rested on “double assumptions”: first, that CEPS had informed Biogen; second, that Biogen had informed the right holder. On appeal, new evidence suggested that the CEPS information had not actually reached Acorda, Biogen or Merz in a way that could trigger the urgency clock.

That point matters for both sides. Originators cannot rely on ignorance if the evidence shows that they knew, or should have known. But generics cannot rely on an administrative fiction if they cannot prove that the relevant information actually reached the party against whom urgency is invoked. The clock does not start because information exists somewhere in the regulatory system. It starts when knowledge, or legally relevant constructive knowledge, can be established.

The Court of Appeal was equally careful on French pricing and reimbursement. Viatris argued that, under the LEEM–CEPS framework, a generic company had to launch within six months once price and reimbursement had been published. The Court disagreed. Article 3 of the framework agreement did not, on its literal reading, impose such a launch obligation. The evidence also showed that practice was flexible: generics could obtain price and reimbursement and still launch much later, sometimes years later.

Thus, the publication of price and reimbursement on 22 November 2024 did not provide sufficient certainty that Viatris would launch within six months. Merz therefore had no reason, in the absence of further evidence, to assume that marketing would take place within that period. The decisive knowledge came later: actual launch was published by ANSM on 30 June 2025 and confirmed by Viatris on 2 July 2025. Filing on 31 July 2025 was therefore timely.

The lesson is not that regulatory milestones do not matter. They do. The lesson is that they do not speak the same language in every Member State. In Portugal, in Boehringer, completion of the relevant procedure could mean launch readiness. In France, in Merz, price and reimbursement did not automatically mean launch certainty.

That is a useful point for generics. It prevents the UPC from transforming every pricing decision into an automatic trigger of urgency. But it is also a warning. If a generic wants to rely on the patentee’s delay, it must build an evidential record that is direct, traceable and litigation-ready. A launch signal must be capable of being proved, not merely inferred.

The most important practical point may be this: The clock starts with provable knowledge.

Proportionality: patients matter, but evidence matters more

The second major issue was proportionality. Viatris argued that the injunction would be disproportionate because FAMPYRA® had allegedly suffered shortages, because the new packaging was inconvenient for patients, because the French health system and patients would bear higher costs, because price erosion was not automatic, and because only a few months remained before SPC expiry.

The Court rejected those arguments. It accepted that patient interests may be relevant in the balance, consistently with Insulet v. EOFlow. It also repeated that irreparable harm is not a necessary condition for provisional measures. Direct competition between the patented product and the allegedly infringing product may be enough to justify preserving the pre-infringement status quo.

On the facts, Viatris’ public-health argument did not carry the day. The May 2025 shortages of FAMPYRA® appeared limited and linked to a packaging transition. The March 2026 tensions were treated as transient and, importantly, the Court accepted Merz’s explanation that they may have been caused by the generic’s own supply problems. Viatris had admitted shipment delays, while Merz produced evidence that it could supply the French market until SPC expiry.

The Court was also unimpressed by the packaging argument. The French health authorities had approved the packaging, and the Court considered that national authorities were best placed to act if any packaging irregularity required intervention. As to healthcare costs, the Court stated that Viatris was pursuing its own interest by asking the Court to maintain a two-product market situation before SPC expiry.

This is the part of the order that deserves the most critical attention.

Of course, Viatris was pursuing its own interest. Every defendant resisting an injunction does. But in pharmaceutical cases, the defendant’s commercial interest may overlap with public interests: continuity of supply, affordability, patient convenience, and the functioning of reimbursement systems. The overlap does not make the argument right. But it should prevent the Court from treating it too quickly as merely self-serving.

Here, the outcome is understandable because the evidence was weak. The alleged shortages were contested, the generic itself had supply difficulties, and Merz produced evidence of supply capacity. But the broader point remains. Patient access and healthcare-system costs should not become decorative factors in UPC proportionality analysis. They must be capable, in an exceptional case, of changing the result.

For generics, the message is therefore severe but useful: public-interest arguments will not work as rhetoric. They need hard evidence. They need data, not impressions. They need pharmacy-level proof, supply-chain evidence, medical evidence where relevant, and a credible explanation of why damages or a short delay until trial would not protect the relevant interests.

Guarantee and security: the most fragile part of the reasoning

Viatris had also asked, in the alternative, to continue marketing the generic subject to a guarantee. The Court rejected that request, considering that allowing continued supply against a guarantee would be inappropriate where a valid and infringed SPC was at stake. That conclusion is unsurprising. Once validity and infringement are not disputed, a guarantee looks very much like a compulsory licence ordered in provisional proceedings.

The security point is more delicate. Viatris asked that Merz be ordered to provide security in case the provisional measures were later found unjustified. The Court rejected this too, essentially because Viatris had not shown serious difficulties in recovering damages from Merz, given Merz’s financial stability and EU presence.

That reasoning is efficient, but narrow. Security is not only about collection risk. In pharmaceutical PI cases, especially close to SPC expiry, security is also a way of allocating the risk of error. A wrongly granted injunction may exclude a generic from a short and commercially decisive market window. Even if damages are theoretically recoverable, litigation over those damages will be complex, delayed, and uncertain.

This does not mean security should be automatic. It should not. But a more developed UPC approach would be welcome. The Court should distinguish between security as protection against insolvency and security as a proportionality tool. The second function may be particularly important in life sciences litigation, where the injunction often decides the market before the merits are ever heard.

What does the decision mean strategically?

For originators, Merz seems, at first sight, reassuring. The Court of Appeal did not accept that every regulatory step automatically accelerates the urgency clock. It did not impose an unrealistic duty to reconstruct knowledge from administrative signals that never reached the relevant corporate decision-makers. It also confirmed that, where validity and infringement are not in dispute, direct competition and market preservation remain powerful reasons to grant a PI.

But originators should not read the decision as permission to wait. Merz won because the evidence on knowledge was unusual. The Acorda bankruptcy, the Biogen transition, the CEPS communication problem, and the ambiguity of the French regulatory framework all mattered. In a cleaner case, a pricing or reimbursement decision may well be enough to establish imminent infringement. The safest strategy remains active monitoring, rapid warning letters, and immediate preparation of evidence on supply, pricing, market share and patient impact.

For generics, the decision is a defeat in result, but not in principle. It confirms that urgency can start before actual launch. It also confirms that pricing and reimbursement may matter. But it requires proof. If a generic wants to convert regulatory progress into a delay defence, it should not rely only on public databases or communications through administrative channels. It should create a clear record: direct notice, precise launch intention, evidence of completed preparations, and proof that the originator received or should have received the information.

The most important practical point may be this: the clock needs a witness.

Conclusion: time remains decisive, but it must be proved

My earlier comment on the Paris Local Division order was that urgency at the UPC was becoming a duty, not a reaction. After the Court of Appeal’s decision, I would refine the formula.

Urgency is still a duty. But it is not a fiction.

The UPC will not protect a patentee who sleeps on objectively available facts. Nor will it punish a patentee for failing to infer an imminent launch from regulatory signals that, in the relevant national context, did not make launch sufficiently certain.

This makes Merz v. Viatris a more balanced decision than its operative part suggests. The injunction favours the originator. The reasoning, however, is not blind to the generic perspective. One may even wonder whether, on the specific record, the Court’s approach was not somewhat demanding for the generic: several elements did point towards Merz having, at least, substantial indications that commercialisation was approaching. Yet the legal point remains understandable. In PI proceedings, especially where urgency is decisive, indications are not enough unless they can be translated into provable knowledge of an imminent launch. That is the useful, but severe, lesson of the case.

The reasoning therefore gives generics a roadmap: make launch signals explicit, make knowledge provable, substantiate patient and public-interest arguments, and treat security as a serious procedural issue rather than an afterthought.

In UPC pharma litigation, time remains a decisive legal resource. But after Merz, the urgency clock runs on proof, not assumptions. It is not merely what appears in a regulatory file. It is what a party can prove the other side knew, or should have known, when action was still possible.

• 1Matthieu Dhenne, “Merz v. Viatris: Why Urgency Matters in UPC Pharma Injunctions”, Kluwer Patent Blog, 26 November 2025.
• 2UPC Court of Appeal, Merz Pharmaceuticals LLC, Merz Therapeutics GmbH and Merz Pharma France v Viatris Santé, Order of 27 April 2026, UPC_CoA_917/2025, concerning a request for provisional measures (R. 211 RoP). Unless otherwise indicated, the references in this post are to that order. See especially paras 1-10 (background and first-instance sequence), 15-18 (waiver of invalidity defence), 49-75 (urgency), 76-100 (necessity/proportionality), 101-108 (delivery up, guarantee and security), 109-113 (grace period, penalties and costs), and operative order I-IX. Official access via the UPC Case Management System; search for “UPC_CoA_917/2025”.
• 3Merz Therapeutics, “Merz Therapeutics Closes $185M Asset Purchase Agreement with Acorda Therapeutics”, 10 July 2024, Merz Therapeutics press release.
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  Matthieu Dhenne, “Imminent Infringement: The UPC’s New Geography of Pharmaceutical Risk”, Kluwer Patent Blog, 30 octobre 2025.