The UPC’s “Set the Stage” Test for Imminent Infringement
Under the UPCA, a patentee can seek a preliminary injunction “to prevent any imminent infringement”. The Rules of Procedure require showing that provisional measures are needed to prevent a threatened infringement (Rule 206.2(c) RoP).
In Boehringer v. Zentiva, the Court of Appeal defined imminent infringement as a situation where the potential infringer “has already set the stage for [the infringement] to occur, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed”. Imminent infringement exists where the only real mechanism for preventing infringement is the infringer’s self-restraint.
The CoA emphasized that this is a fact-specific assessment. Importantly, it stressed that a mere application for a marketing authorization (“MA”), or even its grant, does not amount to imminent infringement. Regulatory approval alone is not enough; further concrete steps toward commercialization are needed to satisfy the test. Regarding the standard of proof, it is the usual civil standard: the applicant must show with a sufficient degree of certainty that, on the balance of probabilities, it is more likely than not that patent infringement is imminent.
Case Law: Market Authorizations vs. Launch Preparations
The emerging UPC case law distinguishes between simply having regulatory approval, and having taken affirmative steps to enter the market.
In Boehringer Ingelheim v. Zentiva, the patentee (Boehringer) owned a patent for nintedanib (“Ofev”), valid until late December 2025. Zentiva had obtained MAs for generic nintedanib by August 2024, and had also completed all health technology assessments, pricing and reimbursement procedures in Portugal by December 2024. Every regulatory and administrative step necessary for sales was complete, and the only factor preventing launch was Zentiva’s choice to wait for the patent’s expiry.
Although the preliminary injunction was denied at first instance, the Court of Appeal found a risk of imminent infringement. Applying the “setting the stage” doctrine, the Court held that Zentiva had no further formal steps to take to commence sales: infringement was only a matter of starting the action. The Court therefore granted an injunction, observing that imminent infringement must be assessed case-by-case, in light of national regulatory and legislative context.
By contrast, in Novartis & Genentech v. Celltrion (UPC_CFI_165/2024 & 166/2024), the Düsseldorf Local Division found no imminent infringement. Celltrion had obtained a European MA for a biosimilar alleged to infringe, but had not yet pursued pricing or reimbursement approvals in any UPC country. There had been some promotional statements about future market entry, but no concrete launch preparations. The Court held that, since the necessary steps to actually enter the market were incomplete, any infringement was not imminent. This decision underscores that just having regulatory approval is insufficient – there must be tangible steps indicating that sales “without further ado” are highly likely during the patent term.
An interesting extension of the doctrine came in a medical device case, Occlutech v. Lepu (UPC_CFI_553/2025, Hamburg Local Division). The defendant (Lepu) had obtained a CE-mark for medical devices allegedly infringing Occlutech’s patent. Unlike medicines, medical devices do not require MAs, but obtaining a CE-mark is a prerequisite to market them in Europe. The Court held that the “setting the stage” logic applies equally to devices: although a CE-mark can be a strong indicator of intended market entry, it does not automatically establish imminence. However, Lepu had gone further: it publicly announced its CE approval, provided ordering information on its website, and announced to show-case the products at trade fairs, activities that went beyond mere preparation.
The Court noted that gaining knowledge of the CE-mark approval marks the starting point for the patentee to investigate the situation, because from that moment on an infringement might be imminent.
Overall, the UPC case law draws a line between early preparations and actionable readiness. An MA or CE-mark alone is not enough, but further actions – in particular completing pricing and reimbursement – likely cross into imminent infringement. The central question is whether the stage is set for the alleged infringer to enter the market without any remaining administrative obstacles.
The Bolar Exemption and Pending Reforms
The above standard naturally raises the question: what about the Bolar exemption – doesn’t it allow generics to do preparatory acts while the patent is in force? The EU Bolar exemption, found in Directive 2001/83/EC Article 10(6), provides that acts done “necessary for obtaining a marketing authorization” (such as conducting studies and clinical trials) are exempt from patent infringement. This allows generic and biosimilar developers to get their regulatory approvals before a patent or SPC expires, without incurring liability. However, the current Bolar exemption is limited to those regulatory test and trial activities: pricing and reimbursement applications are not covered by the existing safe harbor.
In Boehringer v. Zentiva, the generic argued that its post-MA steps (pricing and reimbursement in Portugal) should not count as acts of infringement at all, because those steps would eventually be exempt under an anticipated change in the law: Zentiva was pointing to the draft EU Pharmaceutical Directive, which includes a broadened Bolar-style provision. Indeed, Article 85 of the proposed directive would explicitly extend the patent exemption to cover “uses of a reference medicinal product for the purpose of … pricing or reimbursement” procedures, among other things. In essence, EU lawmakers have prioritized day-one launches of generics by shielding from patent claims not only scientific testing but also health system approval steps (like getting a drug listed for reimbursement). If this proposal is enacted in its current form, a generic could complete all regulatory and market-access formalities during the patent term without being considered to infringe.
However, the UPC Court of Appeal in Boehringer made it clear that draft legislation has no bearing on current cases: Zentiva urged the court to interpret “imminent infringement” in line with the policy of the pending directive, which was flatly rejected. It emphasized that the proposed new Bolar exemption will only come into play once it is enacted, and until then the current law applies.
Practical Implications for Life Sciences Litigants
For patentees, the UPC’s developments are encouraging, as the “setting the stage” test arms them with a clearer path to proactive injunctions. Innovators don’t need to wait for a first sale that causes irreversible damage: if a competitor has completed all steps necessary for launch, provisional measures may be sought before market entry.
In practice, this means life sciences companies should closely monitor competitors’ regulatory status and market-access activities. Key signs of the “stage being set” include: obtaining required approvals (MA or CE-mark), completing pricing/reimbursement conditions, public procurement listings, marketing efforts signaling availability, etc. Once a patentee learns that these boxes have been ticked, taking action is justified.
By Violeta Loygorri, Valentin Wagner, Akiva Friedmann and Chiara Prinz