Time to act - Urgency and Imminent Threat of Infringement before the Unified Patent Court (UPC)

When seeking interim relief before the UPC, timing is everything. 

Patent proprietors must act quickly to protect their market share, but not so early that they cannot prove infringement. Filing too late, however, risks losing the chance for provisional measures due to a lack of (temporal) urgency: concrete market access activities of a potential infringer will trigger the urgency period to start running even if infringing acts have not yet occurred. Thorough market observation and swift internal reporting, as well as the timely preparation of the action, are key to a successful enforcement strategy.

For potential defendants, any activity that could be seen as imminent marketing in any UPC country should be avoided, as preparatory steps in one country can trigger an imminent threat of infringement across the entire UPC territory. Therefore, regulatory measures, where applicable, also require thorough coordination across Europe and close cooperation between the business and the legal team. 

Strategic fine-tuning is of the essence to both prepare for potential loss of exclusivity on the one hand and to secure a successful market entry on the other hand. 

Legal Framework: What Constitutes “Urgency”?

The UPC’s legal requirements for provisional measures are set out in Article 62 UPCA and Rules 206 et seq. of the Rules of Procedure (RoP): 

• Rule 206.2(c) and (d) RoP: Sets out measures that are necessary to prevent (threatened) infringement.
• Rule 211.4 RoP: Stipulates that the court will consider any undue delay in seeking provisional measures. This applies equally to infringement and imminent infringement (Rule 211.2 RoP).
• Rule 209.2 and 209.3 RoP: Emphasizes the need for temporal urgency, including cases of “extreme urgency”.

The urgency requirement balances the patent proprietor’s need for effective enforcement against the risk of unfairly restricting alleged infringers in summary proceedings.

The core question is: what standard must be met to establish “urgency” for a preliminary injunction and when does the urgency period start to run?

UPC Case Law: Defining and Applying Urgency

While the Local Divisions initially adopted different timelines for the length of the urgency period (typically one or two months after obtaining knowledge of the infringement), the UPC Court of Appeal (CoA) clarified the following in Mammut vs. Ortovox (UPC_CoA_182/2024, 25 Sept 2024):

• First, the relevant time for calculating the delay within the meaning of R. 211.4 RoP is the day on which the applicant has, or should have had, such knowledge of the infringement as would enable it to file a promising application for provisional measures.
• Second, the question of when an unreasonably long delay exists depends on the circumstances of the individual case. With that, the CoA rejected the application of a rigid deadline to determine the actual length of the urgency period.

Case law from the Local Divisions (LDs) suggests that the temporal urgency is (only) lacking if the infringed party behaved in such a negligent and hesitant manner, that the infringed party objectively does not seem interested in promptly enforcing its rights (cf. Occlutech vs. Lepu Medical (UPC_CFI_553/2025, 21 Oct, 2025) LD Hamburg – with reference to: Ballinno vs. UEFA (UPC_CFI_151/2024, 3 June 2024) LD Hamburg ; 10x Genomics vs. Curio Bioscience (UPC_CFI_463/2023, 30 April 2024) LD Düsseldorf; 10x Genomics vs. NanoString Technologies (UPC_CFI 2/2023, 19 Sept 2023) LD Munich; Ortovox vs. Mammut (UPC_CFI_452/2024, 9 April 2024) LD Düsseldorf.

In practice, this means that patent proprietors must act swiftly after obtaining reliable knowledge of the infringement. Still, they have a certain scope for performing the necessary technical analyses where needed and for a serious preparation of the application. 

Usually, the patent proprietor will have a viable interest to get a request for provisional measures on file rapidly anyhow to stop infringement. However, when is the earliest point in time to act without risking a dismissal of the application for preliminary relief? 

Imminent Threat of Infringement and Urgency 

In Boehringer Ingelheim vs. Zentiva (UPC_CoA_446/2025, 13 Aug 2025) the CoA defined an imminent threat of infringement as a situation in which certain circumstances suggest that infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. Infringement is only a matter of starting the action, whereas preparations for it have been fully completed. 

In a regulated market like e.g. the pharma market, particular attention will have to be paid to regulatory requirements: the CoA clearly considers the application for and the grant of a pharmaceutical marketing authorisation not to amount to an imminent infringement. This is in line with respective national case-law in view of such acts being excluded from infringement by the so-called “Bolar-exemptions” (cf. Art. 10(6) of Directive 2001/83/EC; Art. 27 (d) UPCA). 

This may, following the court’s reasoning, be judged differently for other regulatory requirements such as procedures of national health technology assessment, pricing and reimbursement. This will also depend on local particularities and the circumstances of the case. Generally, it can be concluded that infringement is imminent once no further hurdles are to be overcome to actually start marketing. 

In the case at hand, certain regulatory acts following market approval were completed in Portugal (only). Marketing authorisations had not been granted in any other UPC country. Even though the defendant was thus legally barred from launching the product elsewhere, the injunction covered all UPC countries for which the patent at issue had effect.

Accordingly, preparatory acts that qualify as imminent infringement based on the local regulatory environment in one UPC Contracting State, may lead to a provisional injunction being issued for the whole UPC territory. This applies even if there are no attempts to launch the product in any other UPC country. 

In an earlier decision in Novartis vs. Celltrion (UPC_CFI_165/2024, 6 Sept 2024), the LD Düsseldorf rejected the request for provisional measures as lacking imminent infringement: the defendant had displayed, at a conference, advertising of its biosimilar being approved. However, since the applicant couldn’t prove that the defendant had already started price negotiations or applied for reimbursement, potential customers would regard statements about a future market entry as vague announcements. This was not deemed to be sufficient to create imminent infringement. 

In Occlutech vs. Lepu Medical (UPC_CFI_553/2025, 21 Oct 2025), the LD Hamburg by contrast found that a CE-mark approval provides an indication of an expected market entry in any of the EU Member States in the foreseeable future. Publicly announcing the CE-mark approval on social media, on the website and at trade fairs, while providing “ordering information” and showcasing the approved products at another trade fair in Germany, created an imminent threat of infringement. 

With respect to urgency, the defendants claimed that the applicant had knowledge about the products way before the CE-mark approval, without acting. The LD Hamburg rejected this argumentation: the CE-mark approval was a prerequisite for legally entering the market with a medical device in the European Union. Accordingly, any knowledge of the Applicant regarding the attacked embodiments prior to the CE-mark approval was not deemed relevant. 

The duty of the patent proprietor to act swiftly as soon as infringement is imminent, is further supported by the LD Paris in Merz v. Viatris (UPC_CFI_697/2025, 21 Nov 2025): the court dismissed an application for interim measures for lack of urgency because the applicant did not take action until six (6) months after the pricing and reimbursement procedures for the infringing drug had been completed in France. The LD Paris emphasised that the relevant point in time was not the actual market launch, but the moment when the applicant should have been aware of the necessary facts to act. This decision particularly illustrates that the “urgency clock” starts ticking once infringement is imminent. Urgency does not revive when actual infringement is taking place (cf. also Cilag vs. Rivolution (UPC_CFI_374/2025, 29 Aug 2025) LD The Hague with respect to “intensified acts” of infringement).  

What's this all mean? 

As a consequence, a patent proprietor does not have to take action as long as an actual market launch is legally impossible. Prior knowledge then does not count for the urgency period. Conversely, this suggests that a preliminary injunction request must fail when a market launch is impossible from a legal point of view. Once it is possible, the applicant must take the necessary measures for filing an action, because from that moment on infringement might be imminent. 

Practical Guidance

The right timing to file an application for provisional measures is key: the urgency period starts running as soon as infringement is imminent, i.e. when the stage is set for a market entry of the infringing product. 

For patent proprietors: 

• Document the Timeline: Record when you first became aware of the potential (imminence of) infringement, what steps you took to investigate and analyse, and when you obtained sufficient evidence to file a promising application. All of these acts should be performed without undue delay.
• Distinguish Suspicion from Reliable Knowledge: Only act when legal requirements for market entry are met where applicable.
• Act decisively: Once you have the facts, move quickly – delays can forfeit your right to interim relief.  

For Potential Defendants: 

• Take caution with respect to any activities that may qualify as imminent infringement anywhere in the UPC territory.
• Understand the national regulatory landscape, where applicable and coordinate closely with the national legal teams.
• Document the Timelime: If a patent proprietor delays action, even though infringement was imminent in a UPC country, this can be a valuable defense - consider including it in a protective letter to secure safe market access across the entire UPC territory

Evolving Legal Landscape

Whichever side you are on, stay alert when you are planning your offensive or defensive strategy way ahead. 

Double-check and update your strategy according to the development of the European patent and regulatory landscape. The amended “Bolar exemptions” as provided for in the upcoming EU Pharma Package for example, may affect the start of the urgency period for generics and biosimilars.  For more on the EU Pharma Package, read our article here. 

If you want to know more, please get in touch via your usual Bird & Bird contact or via upc@twobirds.com.