[The IPKat] UPC Court of Appeal confirms "lowered" test for imminent infringement in Boehringer Ingelheim v Zentiva PI appeal

[Annsley Merelle Ward]

Earlier this year, 

the UPCKat reported on what appeared to be a high bar to stop generic market entry set by the Lisbon Local Division in its 8 May 2025 ruling in Boehringer Ingelheim v Zentiva UPC_CFI_41/2025. The UPC Court of Appeal has now – three months later - reversed the LD Lisbon’s decision and granted the preliminary injunction (PI) sought by Boehringer Ingelheim (UPC_CoA_446/2025; UPC_CoA_520/2025, 13 August 2025).

The UPCKat (this time in the form of Christina Guazzi, Hiske Roos and Andrew Hutchinson, all of Carpmaels) return during this hot summer to break down the Court of Appeal’s refreshing reasoning in this landmark decision for the pharma sector:  

"Background to the case - Recap

Boehringer Ingelheim markets its nintedanib-containing blockbuster Ofev® for the treatment of lung diseases. Zentiva holds marketing authorisations in Portugal for generic medicines comprising nintedanib (the “Zentiva generics”).

Boehringer Ingelheim brought PI proceedings in the Lisbon Local Division (LD) against Zentiva. While it wasn’t in dispute that the Zentiva generics fall within the scope of Boehringer Ingelheim patent EP 1 830 843 B1 (EP 843), its requests were nevertheless rejected as the LD Lisbon wasn’t convinced that there was imminent infringement. The specific details of the case are set out in the UPCKat’s report on the LD Lisbon’s decision. In summary, Zentiva had gone through administrative steps, i.e., obtaining a marketing authorisation as well as a Prior Evaluation Procedure (“PEP”) followed by a notification by a Portuguese administrative body called INFARMED indicating that it was possible to commercialise the Zentiva generics.  Those steps were required in Portugal to offer or sell their Zentiva generics to the national health service, alongside other steps. The LD Lisbon noted that other steps include concluding framework agreements relating to public procurement procedures – the framework agreement in place had listed Boehringer Ingelheim as sole contractor. -  

Test for imminent infringement: “setting the stage”

Pursuant to Art. 62(1) and (4) UPCA. The UPC may grant injunctions against an alleged infringer, intended to prevent any imminent infringement.

In this case, the Court of Appeal set out the legal standard for imminent infringement as follows (emphasis added), confirming that imminent infringement may be present when the potential infringer has set the stage for infringement to occur. It confirmed that MA application and grant cannot be sufficient for setting that stage, but noted that certain national administrative proceedings can: 

46. The Court of Appeal agrees with Boehringer Ingelheim’s contention that a situation of imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. The infringement is only a matter of starting the action. The preparations for it have been fully completed. These circumstances must be assessed on a case-by-case basis.

 47. In the context of marketing of generics, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one.

48. Completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement [UPCKat: in Portugal, this is the PEP]. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case.

As the patentee, the burden of proof was on Boehringer Ingelheim to show with a sufficient degree of certainty that it is more likely than not that a patent infringement is imminent.

Imminent infringement test satisfied

In determining that infringement was imminent, the Court of Appeal held that the relevant question to answer was whether there are any further administrative procedures required that prevent Zentiva from offering the generics to public hospitals in Portugal after it has obtained a market authorisation and PEP. It considered the following circumstances:

1.  Zentiva argued that a drug will only be listed as “available” in INFARMED’s database following pre-notification to INFARMED of marketing commencement. However, the Court of Appeal concluded that this pre-notification is a formality which can be fulfilled by the supplier with relative ease and at short notice, and there was no way for Boehringer Ingelheim to ascertain from time to time if the generics are on the Portuguese market, or are soon to be launched, in order to prevent infringement (para. 59-62 of the decision).
2. Zentiva had put forward that a Framework Agreement relating to public procurement procedures– which was only in place with Boehringer Ingelheim - was required for purchasing nintedanib medicine. Boehringer Ingelheim had however shown that public hospitals could place orders for medicines outside of the existing Framework Agreement e.g. where the use of the Framework Agreement would lead to the payment of a price at least 10% higher. It was therefore more likely than not that Zentiva’s PEP would enable it to offer the generics to Portuguese public hospitals (para. 66-69 of the decision).
3. Zentiva argued that it would be prevented from participating in public procurement procedures, because under Portuguese law contractors and contracting entities alike are bound by the respect for intellectual property rights. The Court of Appeal rejected this defence, finding that Zentiva had not adequately explained the relevant national legal framework, and so ultimately it came down to an argument that participation it in public procurement procedures prior to patent expiry would constitute patent infringement, which could incur liability. This would mean that self-restraint by Zentiva was the real mechanism for preventing infringement (para. 70-76 of the decision).

The Court of Appeal also clarified that taking part in public procurement procedures while the patent is still in force will “generally constitute infringement through offering, regardless of whether a public procurement procedure is classified as pre-contractual under national” (para. 63-65 of the decision, emphasis added).

Interestingly, in determining this third point above, the Court of Appeal made an important statement about its approach to assessing points of national law, which is reflected in the headnotes of this decision:

“Although national law is a source of law pursuant to Art. 24 UPCA, it is for the parties to bring forward facts and evidence about the content of national law and its application.”

Bolar exemption not applicable to pricing and reimbursement procedures

Zentiva argued that Bolar exemption set out in Art. 27(d) UPCA should be interpreted in line with the current draft Bolar provisions intended to be introduced as part of the proposed EU pharma legislative package, and that pricing and reimbursement procedures should therefore be exempt from infringement. However, the Court of Appeal rejected this interpretation of the existing legislation.

Necessity and urgency requirements met

The Court of Appeal accepted that the necessity requirement for a PI was made out because the price of the Zentiva generics would be at least 30% lower than Ofev®, leading to permanent price erosion (following the reasoning in a previous Court of Appeal decision in Sumi Agro v Syngenta UPC_CoA_523/2024).

The panel agreed with the decision of LD Lisbon that a separate PI covering Portugal only that Boehringer Ingelheim had obtained from the Portuguese IP Court based on an SPC for a different patent than EP 843 did not form a basis for dismissing the proceedings on grounds of lack of necessity.

The urgency requirement was made out as Boehringer Ingelheim had brought the UPC proceedings just over a month after INFARMED made public that the PEP for the Zentiva generics had been approved.

UPC-wide scope confirmed, but request for information denied

Although Zentiva does not hold any marketing authorisations outside Portugal, the PI – per Boehringer’s request - extends to all UPC member states for which EP 843 has effect, in line with Art. 34 UPCA and the UPC’s usual practice.

Boehringer Ingelheim’s requests for information about the arrangements in place for the import and sale of the Zentiva generics were refused on the basis that the infringement in this case was imminent, rather than completed, and there was no indication that the requested information actually exists.

A relief for originators?

The Court of Appeal has now weighed in on the question of imminent infringement by a generic and appears to have taken a more patentee-friendly stance than the first instance decisions to date (in both this case and Novartis/Genentech v Celltrion UPC_CFI_166/2024 PIs were denied at first instance, following a finding of no imminent infringement).

This UPCKat team expects that pharma originators will be relieved that the evidential burden for establishing imminent infringement by a generic seems to have been lowered: while obtaining marketing authorisation is unlikely to amount to an imminent infringement, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic may well do so.  At the same time, this decision gives clearer guidance to generics as to what steps they can take without opening the door to PIs. The UPC Court of Appeal has stressed that this will depend on all the circumstances of the case, and must be assessed within the national regulatory and legislative context, which is to be explained by the parties in their evidence and submissions. The burden of determining such circumstances will now fall on the generic in this case, as having taken steps only in Portugal, they are now faced with a immediately enforceable PI across all 18 contracting member states, demonstrating the power of the territorial scope of the UPC."