In the pharmaceutical field, exclusivity is measured in months and every month is measured in millions. The decisive question is therefore no longer only whether a generic infringes, but whether it is about to do so. That is the whole point of imminent infringement, a notion the Unified Patent Court (UPC) has profoundly reshaped.<\/p>\n
The conceptual tension is this: a body of law designed to sanction completed acts now governs probabilities. With the Boehringer v. Zentiva<\/em> decision of the UPC Court of Appeal (UPC_CoA_446\/2025, 13 August 2025), the dispute no longer concerns what has been done, but what could be done tomorrow. Patent law becomes predictive, a system of precaution as much as of sanction.<\/p>\n For originators and generic manufacturers alike, this development redraws the geography of risk: a single set of proceedings before a single court<\/a> can now lock down, or open up, the entire territory of the Contracting Member States.<\/p>\n Before the UPC, each Member State applied its own framework. French law, under Article L. 615-3 of the Intellectual Property Code, looked for outward indicia of intent: filings with the pricing committee (CEPS), promotional campaigns, communications to health authorities. A mere application for amarketing authorisation<\/a> was not enough to establish imminence (Paris Court of First Instance, 19 August 2010, Sanofi v. Teva<\/em>). German law favoured a probabilistic analysis of the sequence of commercial acts and made the cease-and-desist declaration with a contractual penalty (Unterlassungserkl\u00e4rung) the central instrument for neutralising risk.<\/p>\n The UPC applies a more objective test: are the preparations so complete that launch depends solely on the defendant's own decision? Article 62(1) UPCA authorises orders to prevent any imminent infringement; Rule 211(2) of the Rules of Procedure requires reasonable evidence providing a sufficient degree of certainty. The standard applied is \"more likely than not\". Intent, the French category, is absorbed into a calculation of probability.<\/p>\n The Lisbon Local Division had dismissed Boehringer's application for provisional measures (UPC_CFI_41\/2025, 8 May 2025), treating Zentiva's steps as merely preparatory despite the completion of the Portuguese prior evaluation procedure. The Court of Appeal reversed that decision on 13 August 2025 (the text is available in the UPC register of decisions<\/a>).<\/p>\n Its reasoning deserves attention. The absence of pre-notification to the Portuguese authority did not exclude imminence. Participation in public tenders could constitute an offer within the meaning of Article 25 UPCA. Zentiva established no legal obstacle to its effective participation in those tenders. Above all, the prior evaluation had been obtained unusually early, more than a year before patent expiry, without any credible explanation. The Court concluded that Zentiva had assembled every element enabling the infringement and that marketing depended only on its own decision.<\/p>\n The decisive lesson for at-risk launch practice: a mere unilateral statement of non-launch does not neutralise a risk shown to be more likely than not. Silence, once the generic manufacturer's elementary caution, becomes incriminating evidence.<\/p>\n Zentiva relied on the draft reform of EU pharmaceutical law, whose Article 85 would extend theBolar exemption<\/a> to pricing and reimbursement procedures. The Court rejected the argument: a text under negotiation is not positive law.<\/p>\n An update is nonetheless required. In December 2025, the European Parliament and the Council reached a provisional agreement on the pharmaceutical package<\/a> which expressly extends the exemption to studies and steps carried out to obtain a marketing authorisation, a health technology assessment or a pricing and reimbursement approval, or to submit to a public tender. That agreement still has to be formally adopted. And even once in force, it will cover the regulatory steps themselves, not the assembly of a complete launch infrastructure: the line drawn by Boehringer<\/em> between exempt preparation and established imminence will retain its relevance.<\/p>\n On the procedural front, the Court also accepted that the generic's entry, with a price cut of at least 30%, would probably cause irreversible price erosion, in line with Sumi v. Syngenta<\/em> (UPC_CoA_523\/2024, 3 March 2025). As for urgency under Rule 206(2)(d), it runs from the day the applicant possesses the facts and evidence enabling it to act: a filing made six weeks after that starting point satisfied the required diligence.<\/p>\n By default, under Article 34 UPCA, UPC orders cover all Contracting Member States where the patent is in force, eighteen States today, subject to proportionality. The provisional order in Boehringer<\/em> applied to the entire UPC territory even though Zentiva held a marketing authorisation only in Portugal.<\/p>\n The Court of Appeal expressly stated that it does not apply national law but treats the national regulatory context as a factual circumstance. Proportionality, already enshrined in Article 3(2) of Directive 2004\/48\/EC<\/a>, bridges national traditions and the UPC: both systems converge towards a global balancing of interests grounded in concrete market realities.<\/p>\n Behind the formal divergences, a substantive convergence is emerging. The French courts and the UPC both proceed by a holistic assessment of a body of facts, not by the characterisation of isolated acts. In France, a marketing authorisation is neither an act of infringement nor, on its own, an imminent threat (Paris Court of First Instance, 5 April 2011, Novartis v. EG Labo<\/em> ; Paris Court of Appeal, 21 March 2012, Novartis v. Mylan<\/em> ; Paris Court of Appeal, 23 May 2013, Sanofi v. Arrow<\/em>), but it may contribute to one when combined with early filings before the CEPS. The UPC's procedural rigour feeds national reflexes in return.<\/p>\n Later case law has refined the picture. In Merz v. Viatris<\/em> (UPC_CoA_917\/2025, 27 April 2026), the Court of Appeal specified that the urgency clock runs on the patentee's provable knowledge, not on mere inferences drawn from national regulatory signals. Imminent infringement is established objectively; urgency, for its part, must be proved subjectively. Together, the two decisions map out the new regime of pharmaceutical litigation over provisional measures<\/a>.<\/p>\n For innovators, this objective test restores confidence in exclusivity: a single application for a provisional injunction<\/a> can protect the entire unified European market, with, should an actual launch occur, damages before the UPC<\/a>to follow. For generic manufacturers, the window between regulatory preparation and patent expiry is shrinking, and the choice of forum, analysed in our study of forum shopping before the UPC<\/a>, becomes a parameter of the risk calculation, as does the coordination of parallel proceedings<\/a> at national and European level.<\/p>\n It is the situation in which all preparations for an infringing exploitation are complete, so that launch depends only on the defendant's decision; Article 62(1) UPCA then allows provisional measures to be obtained before any act of marketing.<\/p>\n No, neither in France nor before the UPC: the marketing authorisation is one element of a body of evidence which becomes probative only when combined with other steps, such as early pricing filings or participation in tenders without credible justification.<\/p>\n An at-risk launch consists of marketing a generic before the expiry of the patent or SPC while betting on their invalidity; the Boehringer<\/em> case law compresses that strategy by allowing the patentee to act as early as the preparation stage, across the entire UPC territory.<\/p>\n By calibrating the timetable of its regulatory steps, documenting the justification for each stage, where appropriate signing a firm undertaking not to launch, and filing a protective letter<\/a> with the UPC so as to be heard before any ex parte measure.<\/p>\n Dhenne Avocats advises originators and generic manufacturers on launch strategies, provisional measures before the UPC and pharmaceutical patent litigation, together with pharmaceutical regulatory matters<\/a>. Talk to us<\/a>.<\/p>\nFrom intent to probability: two legal logics<\/h2>\n
Boehringer v. Zentiva: when preparation amounts to performance<\/h2>\n
The limits of the Bolar exemption<\/h2>\n
Territorial scope and proportionality<\/h2>\n
Converging systems, a geopolitics of risk<\/h2>\n
Key takeaways<\/h2>\n
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Frequently asked questions<\/h2>\n
What is imminent infringement before the UPC?<\/h3>\n
Is a marketing authorisation enough to establish imminence?<\/h3>\n
What is an at-risk launch and how does the UPC treat it?<\/h3>\n
How can a generic manufacturer reduce its exposure?<\/h3>\n