The Unified Patent Court (UPC) Court of Appeal (CoA) issued a pivotal ruling recently in Boehringer Ingelheim International v Zentiva Portugal (UPC CoA 446/2025).

On August 13, 2025, the CoA granted a preliminary injunction (PI) across 17 UPC territories against a generic for Boehringer’s respiratory drug Ofev, after the Lisbon Local Division had previously denied relief.

This decision sets a new benchmark for what constitutes imminent infringement in pharmaceutical patent litigation, particularly regarding generics’ pre-launch preparations.

Case Background: Lisbon Local Division rejects PI application

Boehringer holds European patent EP 1 830 843 (“Indolidone derivatives for the treatment or prevention of fibrotic diseases”), expiring in December 2025, covering the use of nintedanib, marketed as Ofev.

Although second medical use claims have been asserted, the specific requirements for infringement of this claim type have not been contested here (unlike in the case before the Düsseldorf Local Division Sanofi Biotechnology v Amgen, UPC CFI 505/2024; appeal pending).

Zentiva sought to launch a generic equivalent in Portugal, securing marketing authorisations in August 2024 and completing the Prior Evaluation Procedure (PEP)—covering pricing and reimbursement—on December 6, 2024, more than a year before patent expiry.

At first instance, the Lisbon Local Division held that these administrative steps, while unusual in timing, did not indicate an intention to infringe imminently (decision of May 8, 2025, UPC CFI 41/2025). It found no evidence indicating forthcoming market entry or intent beyond carrying out standard regulatory procedures. Consequently, Boehringer’s request for a PI was refused.

Turning point before the CoA

The UPC CoA reversed that decision, introducing a pragmatic interpretation of imminent infringement: the infringement may not yet exist, but if the alleged infringer has already ‘set the stage’ with all necessary preparatory steps complete, only self-restraint remains to prevent infringement—satisfying the threshold for a PI.

Importantly, the CoA reaffirmed that:

• Obtaining marketing authorisation (MA) alone does not constitute imminent infringement.
• However, completing all national procedures—including for pricing and reimbursement—can, depending on context, rise to that level.

In the Portuguese context, notably:

• The PEP approval granted on its own is regarded as the final administrative barrier before launching the product.
• The pre-notification to INFARMED (the Portuguese National Authority of Medicines and Health Products) of marketing commencement is merely a formality, easily satisfied at short notice, reflecting an absence of other regulatory barriers.
• Participation in public procurement is considered an ‘offer’, even if still ‘pre-contractual’.

Zentiva applied for the PEP more than a year before patent expiry. The only barrier to Zentiva launching was voluntary self-restraint—a scenario the CoA found sufficient to constitute imminent infringement.

The CoA’s test for imminent infringement mirrors what the Düsseldorf Local Division considered in an earlier decision (decision of September 6, 2024, UPC CFI 165/2024). In that case, the court refused a PI noting that no price negotiations or reimbursement applications had been started.

Requirements for a PI: Imminence, necessity and urgency

Apart from imminent infringement, a PI under Article 62 UPCA requires necessity and urgency. The CoA found:

• Necessity: Zentiva’s generic would likely enter the market at a significantly lower price (around 30% lower), leading to irreversible price erosion, not just temporary deterrence.
• Urgency: Boehringer filed the PI application promptly—becoming aware of the PEP on December 19, 2024 and requesting a PI on January 23, 2025—meeting the timeliness requirement.

Broad territorial scope: Pan-UPC impact

Although the case concerned Portugal, the injunction was ordered across all 17 UPC contracting member states where the patent is in force. The CoA endorsed the principle that a threat in part of its jurisdiction may justify a pan-UPC PI under Article 34 UPCA, unless specific reasons warrant limitations. The fact that Zentiva only holds an MA for Portugal did not change this.

Zentiva has argued that a PI should be refused because Boehringer had already obtained a national PI against the same product in Portugal based on an SPC that expires in April 2026, after the patent in suit.

The Lisbon Local Division rejected this because the national PI was based on a different right (an SPC based on a different patent), obtained by a different Boehringer entity, and limited to only one country. The CoA agreed with this.

Strategic and legal implications

This decision marks a shift towards a more proactive posture for pharmaceutical patentees at the UPC:

• Generics must tread carefully: securing regulatory approvals too early can be considered evidence of imminent infringement and may result in a PI across all UPC member states.
• Patentees now have firmer guidance on leveraging administrative milestones—particularly pricing and reimbursement steps—as grounds for an injunction.

Yet, the decision remains fact-specific—courts continue to assess on a case-by-case basis, weighing national procedures and regulatory contexts. Not all UPC countries have pricing and reimbursement procedures so other circumstances may also be relevant for assessing when the stage has been set.

Changes to the Bolar exemption that are currently being discussed (see EU Parliament’s proposal COM(2023)0192 final, Article 85 (draft)) could allow generics to carry out more pre-launch activities before patent expiry. If enacted, completing such steps may have different implications for assessing imminent infringement.

Conclusion

The UPC CoA’s ruling in Boehringer Ingelheim v Zentiva establishes a threshold for preliminary relief in generics litigation for obtaining an UPC-wide injunction. The concept of ‘setting the stage’ offers a pragmatic standard for what counts as imminent infringement and is in line with the standard adopted by some national courts.

Combined with the emphasis on price erosion and prompt action, this case equips patentees with a clearer strategy—and generics with a cautionary signal—within the evolving UPC landscape.

As a result, businesses now face a more nuanced calculus when pre-launching generics under patent scrutiny.

Originally published on Life Sciences Intellectual Property Review