The Launch Letter: How Generics and Biosimilars Should Write to Avoid UPC Urgency

Before the Unified Patent Court, a launch communication leads a double life. It can show that infringement is imminent. It can also fix the moment when the right holder knew enough to ask for provisional measures. Safe drafting therefore starts well before the drafting: with a precise, consistent and auditable account of what the business can actually do, when, and under which genuine constraints.

A launch letter is written to reassure. The wholesaler wants a date, the payor wants availability, the investor wants momentum. The Unified Patent Court opens the same document with a colder question: what does it prove?

Rather a lot, as it turns out, and often for both sides. A sentence drafted to calm the market can end up showing that only the last commercial step remains to be taken. The same sentence, routed through a regulatory channel, can end up showing that the patent proprietor knew, or should have known, enough to move for a preliminary injunction. One document, two procedural lives, at different stages of the analysis.

There is no autonomous "launch letter doctrine" in the Agreement on a Unified Patent Court or in the Rules of Procedure. Recent case law has nevertheless given launch communications a procedural weight of their own. Boehringer v Zentiva shows how objective launch readiness can establish imminent infringement. Merz v Viatris shows that the meaning of a launch statement, the route it travelled and the person who received it may decide whether the proprietor acted in time. Guardant v Sophia Genetics adds the organisational layer: whose knowledge inside a company counts, and when a specific piece of information creates a duty to investigate.

The lesson is uncomfortable for both camps. No carefully chosen sentence will neutralise an operational record showing that everything is ready; but loose commercial language will happily let the written record run ahead of the facts. Drafting and launch governance have to be designed together.

Three questions hiding inside one word

The vocabulary of urgency tends to blur three separate issues.

The first is imminence. Article 62(1) UPCA allows the Court to prevent an imminent infringement or to prohibit provisionally the continuation of an alleged infringement, and Article 62(4) sets the evidential threshold: the applicant may be required to satisfy the Court, with a sufficient degree of certainty, that its right is being infringed or that infringement is imminent.1

The second is necessity. The applicant must explain why provisional measures are needed pending the decision on the merits. Rule 206.2(c) requires the reasons for that necessity, while Article 62(2) UPCA and Rule 211.3 direct the Court to weigh the potential harm on each side.

The third is delay. Rule 211.4 requires the Court to consider any unreasonable delay in seeking provisional measures, the relevant date being the point at which the applicant had, or should have had after due diligence, the facts and evidence needed to file with a reasonable prospect of success.2

A launch communication touches each of the three differently. It may reveal future conduct, help explain why immediate market intervention is needed, or date the moment when the applicant possessed a viable case. Treat urgency as one undifferentiated requirement and these distinct evidential functions disappear from view.

The Court reads the whole launch architecture

The Court of Appeal’s order in Boehringer Ingelheim v Zentiva begins with a careful limit. In the generic medicines context, applying for a marketing authozisation, and even obtaining one, does not by itself amount to imminent infringement. Completion of national health technology assessment, pricing and reimbursement procedures may carry a different evidential weight, depending on the national framework and the circumstances of the case.3

Then comes the operational question: has the potential infringer already "set the stage" for infringement, so that the preparations are fully complete and only the start of the infringing action remains? The Court looked at what the completed Portuguese Prior Evaluation Procedure actually allowed Zentiva to do, whether further administrative steps were required, how public and private hospitals could purchase the product, and why the procedure had been completed more than one year before patent expiry.4

It found no credible obstacle beyond Zentiva’s own restraint. No "hard mechanism" prevented an offer, and the completed regulatory process had created expectations among hospitals that the generic would be offered before expiry. On that factual record, imminent infringement and necessity were established.5

This does not turn every pricing or reimbursement step into an automatic proxy for infringement: the order insists on national regulatory context and case-by-case assessment. Its deeper lesson is evidential. An act may be lawful and non-infringing when performed and still reveal what is likely to happen next; the legal character of today’s preparation does not erase its relevance to tomorrow’s conduct.6

That is where drafting alone reaches its limit. A statement that no pre-expiry launch is intended may well be relevant, but the Court will read it against ordering systems, tender access, distribution arrangements, stock release, customer communications and whatever controls are genuinely enforceable. Boilerplate weighs little once every operational switch has been turned on.

Commercial teams tend to concentrate on the announced date. The judicial question is broader: once the communication has gone out, what remains genuinely impossible?

Merz: evidential rigour, legal uncertainty

The litigation between Merz and Viatris illustrates the opposite side of the problem. During the French pricing and reimbursement process, Viatris wrote to the Economic Committee for Health Products on 3 October 2024 that its generic did not infringe the notified patents and would be available for sale within six months of publication in the French Official Journal. The product’s price and reimbursement rate were published on 22 November 2024.7

At first instance, the Paris Local Division treated that regulatory chronology and those communications as sufficient to conclude that Merz knew, or should have known, of the imminent launch well before filing its application on 31 July 2025. It rejected the application for unreasonable delay.8

The Court of Appeal reversed on 27 April 2026 by reconstructing the entire evidential chain. It asked what Viatris had said, what the statement meant in the French regulatory framework, how it had travelled, who had received it and whether that recipient’s knowledge could be attributed to the right holder. The materials showed that the Committee had sent Viatris’s response to a law firm. They did not establish that the relevant information reached Biogen or another person whose knowledge mattered for Rule 211.4.9

The Court applied the same contextual method to the six-month statement. On a literal reading, the relevant clause of the LEEM–CEPS framework agreement did not require actual marketing within six months after price publication. Evidence of later launches and administrative practice also showed flexibility. Publication of the price and reimbursement rate therefore did not make a launch within six months sufficiently certain.10

Merz was definitely informed on 2 July 2025, when Viatris replied that the generic had already been launched in France. The application filed on 31 July therefore satisfied Rule 211.4.11

The logic of the reasoning is easy to understand. The Court refuses shortcuts and examines each signal in its full setting. A regulatory milestone does not speak in the abstract. Its evidential force depends on national practice, wording, transmission, receipt, corporate attribution and whether the resulting information would have supported a provisional-measures application with a reasonable prospect of success. The method is rigorous and, on the particular record, defensible.12

The cost of that precision appears before the dispute, when the parties must decide how to act. The patentee cannot know with confidence when caution becomes delay: filing on an equivocal signal may be premature, while waiting for provable knowledge may later be characterized as unreasonable. The generic faces the mirror uncertainty. A statement may be specific enough to support imminent infringement, yet insufficient to start the proprietor’s urgency clock. A clearer and more traceable notice may do the opposite and accelerate an application for provisional measures.

Merz therefore strengthens factual accuracy but does little for ex ante predictability. That may be the unavoidable cost of a fact-sensitive test, however, it remains a real cost in terms of legal certainty. The case-by-case method is careful, yet it offers neither side a stable rule. Right holders cannot know exactly when they must file. Generics cannot know exactly what they must say, to whom, and through which channel, for their communication to have the intended procedural effect. The urgency clock depends on proof. Which proof is enough may become clear only once the litigation has begun.

Corporate knowledge is part of the communication

The Court of Appeal’s July 2026 order in Guardant Health v Sophia Genetics sharpens the knowledge inquiry. As a general rule, a patentee has no duty to monitor the entire market; but once specific circumstances suggest infringement, it is expected to investigate with due diligence so that it can act promptly against the relevant infringers.13

For a corporate applicant, the decisive knowledge is that of its authorized representative body, or of an individual who, by virtue of his or her position, can pursue the infringement or report it internally: an employee of the legal department, a senior sales employee, a mystery shopper specifically engaged to investigate intellectual property infringements. Mere attendance by employees at online seminars did not, on those facts, establish the necessary corporate knowledge.14

The same order held that a document analyzed for one patent cannot simply be ignored where it also indicates infringement of another. It further accepted that a proprietor may usually wait a reasonable time for an answer to a warning letter, while limiting that principle to the patents the letter actually addressed.15

The distribution list of a launch communication therefore carries legal significance of its own. A broad message to ordinary commercial contacts is not traceable receipt by a person able to initiate or report enforcement; writing directly to an IP or legal function may have sharper timing implications. Either way, the information must still be specific enough to support the relevant legal analysis.

The first-instance Guardant order shows the limits of publicity from the other end. Commercial documents without technical information were too general to establish the relevant knowledge, and a press release did not show with sufficient certainty how the accused software operated. The technology there was unusually complex, so the conclusion cannot be transplanted mechanically into a pharmaceutical launch. The wider evidential point travels well enough: information does not become legally sufficient merely because it is public.16

Vagueness is not a shelter

All of this exposes the weakness of a common instinct: reduce every statement to the vaguest formulation available.

A communication stripped of substance can still create expectations among purchasers while telling the proprietor nothing it could act upon. In a given case, it may give enough market signal to feed an argument about readiness, and too little legal or technical information to identify the point from which the Rule 211.4 clock should run. The inference is necessarily fact-dependent, but the combination should concern both sides.

Maximum vagueness is therefore poor governance rather than prudence. The document should draw an accurate boundary between preparation and commercial launch: which steps are complete, which acts remain unauthorised, and which objective event will change that position.

Overconfidence produces the mirror-image problem. Words such as "available", "launch-ready", "immediate" and "unconditional" acquire procedural meaning once they appear across regulatory correspondence, wholesaler notices, tender documents, investor updates and websites. A closing sentence stating that launch remains subject to intellectual property rights will do little work if the operational record points the other way.

An accurate record serves both sides. It lets the proprietor assess whether judicial action is genuinely required, it reduces satellite disputes about notice and delay, and it protects the market entrant against having its commercial rhetoric treated as an admission that launch was already executable.

A six-point launch communication protocol

1. Know what the document is for. A regulatory response, a customer notification, a tender submission and an investor announcement do different jobs, and recycling one sentence across all four is how contradictions are born. Each document should identify the product, territory, indication, audience and commercial act to which it relates.

2. Separate regulatory status from commercial authority. State accurately which authorisations, prices, reimbursement decisions or listings have been obtained. State separately whether an offer, tender participation, shipment or sale has been internally authorized. Regulatory eligibility should not be translated into commercial certainty unless the business is truly ready to act.

3. State only conditions that are real. A stated launch condition should correspond to an objective constraint capable of verification: expiry of an identified right, a court order, completion of a legally required administrative step, or a formal release decision coupled with operational controls. Invented conditions, freely revocable reservations and generic promises of self-restraint are unlikely to survive the factual inquiry applied in Boehringer.17

4. Give dates their correct legal meaning. A date may be fixed, earliest, expected or conditional, and the document should say which. The Merz appeal shows the cost of attributing a mandatory launch consequence to a six-month period that the governing framework did not, on the evidence, impose in that form.18

5. Align the whole record. Regulatory correspondence, official listings, customer letters, tender activity, supply-chain instructions, websites, sales scripts and investor materials should be reviewed together. One contradictory document becomes the exhibit through which the rest of the launch is read.

6. Preserve provenance. Keep the approved version, the decision owner, the recipient list, proof of transmission, the attachments and the operational information on which each statement was based. Merz and Guardant both show that the inquiry runs past the wording, into receipt, internal attribution and the timing of the underlying analysis.19

Freedom-to-operate statements deserve particular care. An unqualified assertion that a product "does not infringe" is both a legal position and, depending on its context, evidence that the company sees no patent obstacle to launch. Confine it to the identified rights, territory, product and factual assumptions actually reviewed.

What a disciplined paragraph looks like

A launch communication is better built on dated facts than on promotional conclusions. Something along these lines:

That is an illustration, not a template. It has to be true, territory-specific and updated when the facts change. Where launch can in reality be authorized by an informal instruction, calling it conditional creates no hard stop. Where a genuine control architecture exists, describe it accurately and without exaggeration.

The real letter is the governance behind it

A reliable review begins well before the final draft. What the company needs first is a launch-readiness matrix covering regulatory status, pricing, reimbursement, stock, distribution, tenders, patent position, territory, internal approval and the earliest executable date, each with an owner, a status, supporting evidence and a rule for change.

The legal team can then test every external statement against that matrix. This matters most for multi-state launches, because a UPC provisional injunction may, depending on the patent and the relief sought, extend across the Contracting Member States in which the European patent has effect. A phrase drafted for one national pathway should not quietly become a Europe-wide statement.20

The discipline does not ask a generic or biosimilar company to abandon lawful preparations, and it does not ask a proprietor to accept artificial warning. It asks the documentary record to reflect commercial reality, so that a court considering provisional relief decides on facts rather than on accidental rhetoric.

When litigation begins, the Court will often see the launch communication before it hears a witness, and will read it against the objective acts and the chronology. The letter cannot erase those facts. It can stop them being misstated.

Conclusion

The launch letter is a short document with a double procedural life. It can help establish that infringement is about to occur, and it can help establish that the proprietor already had enough information to act. Precision decides which.

Boehringer teaches that objective readiness defeats empty reservations. Merz teaches that a statement acquires force through meaning, transmission, receipt and national context. Guardant teaches that corporate knowledge belongs to identifiable people and processes.

For generics and biosimilars, the working rule is simple enough. Make the language move at the same speed as the launch. Do not announce what the company cannot yet do, and do not conceal what it has actually authorised. Keep every condition real, every date qualified and every recipient traceable.

A preliminary-injunction dispute may end up being argued over hundreds of pages. The exhibit that decides it may still be one paragraph written months earlier.

• 1Agreement on a Unified Patent Court (2013/C 175/01), OJ C 175, 20 June 2013, p. 1, Art. 62(1) and 62(4).
• 2Rules of Procedure of the Unified Patent Court, as amended with effect from 1 January 2026 and corrected on 26 February 2026, Rules 206.2(c)-(d), 209.2(b), 211.2-211.4; UPC Court of Appeal, Order of 25 September 2024, Mammut Sports Group AG v Ortovox Sportartikel GmbH, UPC_CoA_182/2024, APL_21143/2024, headnotes 5-6.
• 3UPC Court of Appeal, Order of 13 August 2025, Boehringer Ingelheim International GmbH v Zentiva Portugal, Lda, UPC_CoA_446/2025 and UPC_CoA_520/2025, paras 44-48.
• 4Ibid., paras 46 and 52-54.
• 5Ibid., paras 72-85, especially paras 74, 77, 80-81 and 84-85.
• 6Ibid., paras 47-48 and 52-58.
• 7UPC Court of Appeal, Final Order of 27 April 2026, Merz Pharmaceuticals LLC and others v Viatris Santé, UPC_CoA_917/2025, paras 55-58. The email stated that the product did not infringe the patents claimed and would be available for sale within six months of publication in the French Official Journal.
• 8UPC Paris Local Division, Final Order of 21 November 2025, Merz Therapeutics GmbH and others v Viatris Santé, UPC_CFI_697/2025, paras 45 and 53-70.
• 9UPC Court of Appeal, Merz v Viatris, cited above, paras 55-63.
• 10Ibid., paras 64-73.
• 11Ibid., paras 74-75 and operative order. The Court of Appeal allowed the appeal and granted provisional measures.
• 12

  UPC Court of Appeal, Merz v Viatris, cited above, paras 49-75. See also Matthieu Dhenne, “Merz v. Viatris on Appeal: Urgency Is Still Everything But Not Every Signal Is Urgent”, Kluwer Patent Blog, 19 May 2026.

• 13UPC Court of Appeal, Final Order of 2 July 2026, Guardant Health, Inc. v Sophia Genetics SA and others, UPC-CoA-19/2026, headnotes 1-4 and paras 114-130.
• 14Ibid., headnote 5 and paras 128-132.
• 15Ibid., headnotes 1-2 and 6, paras 114-120 and 140-148.
• 16UPC Paris Local Division, Final Order of 23 January 2026, Guardant Health, Inc. v Sophia Genetics SA and others, UPC_CFI_808/2025, paras 27-36 and 144-149. See also UPC Court of Appeal, Guardant v Sophia Genetics, cited above, paras 128-132.
• 17UPC Court of Appeal, Boehringer v Zentiva, cited above, paras 74-85.
• 18UPC Court of Appeal, Merz v Viatris, cited above, paras 64-73.
• 19Ibid., paras 55-75; UPC Court of Appeal, Guardant v Sophia Genetics, cited above, paras 114-147.
• 20Agreement on a Unified Patent Court, Art. 34; UPC Court of Appeal, Boehringer v Zentiva, cited above, para. 91. Territorial scope remains dependent on the title, the territories in which it has effect, the parties, jurisdiction and the relief sought.