The UPC Court of Appeal has overturned a decision of the Lisbon Local Division and granted Boehringer Ingelheim (“Boehringer”) a provisional injunction for imminent patent infringement. In doing so, it has confirmed that completion of national pricing and reimbursement procedures for generic drugs may be sufficient to trigger injunctive relief.
Case: Boehringer Ingelheim International GmbH (Boehringer Ingelheim) v. Zentiva Portugal, LDA (Zentiva); UPC_CoA_446/2025 and UPC_CoA_520/2025
Background
Boehringer sought injunctive relief against Zentiva Portugal in respect of the launch of a generic version of its drug marketed as Ofev® (containing nintedanib used for treating chronic lung diseases). Pursuant to Article 62 of the UPC Agreement, Boehringer alleged imminent infringement of its patent, EP 1 830 843 (for nintedanib in treating idiopathic pulmonary fibrosis), which lapses on 21 December 2025. Although Zentiva only holds marketing authorisations in Portugal, Boehringer sought preliminary relief across all UPC contracting member states designated by the patent (which is in line with Article 34 of the UPC Agreement). In this case, it was not disputed that the generic product fell within the scope of the patent.
In order to assess whether there was a risk of imminent infringement, the proximity of generic launch was considered. Of significance is the fact that Zentiva had applied for a Prior Evaluation Procedure (“PEP”) - on INFARMED, the Portuguese human medicines and health products regulator - to obtain pricing, reimbursement and acquisition conditions from public hospitals in respect of the generic. It was accepted that the PEP procedure had been concluded by Zentiva earlier than usual (more than a year ahead of patent expiry). However, Zentiva had not taken some further steps required in order to sell its product to the Portuguese national health service, including concluding framework agreements.
At first instance decision, the Lisbon Local Division of the UPC ruled that the procedural steps taken did not constitute imminent infringement. It held that Boehringer must show that Zentiva’s activities evidenced that it is more likely than not to enter the market prior to patent expiry, being the applicable test. In this case, the Lisbon Local Division dismissed the application for provisional measures on the basis that Zentiva had not taken sufficient steps to establish this threshold had been met.
This decision was appealed to the UPC Court of Appeal (“CoA”).
CoA decision
The CoA firstly clarified that the application for – or grant of - a marketing authorisation by a generics company did not constitute imminent infringement (in line with the Local Division). However, completion of national procedures like the PEP ahead of generic launch can amount to an imminent infringement, having regard to the facts of the case and the national regulatory and legislative context.
It then applied a four-stage criteria to assess whether imminent infringement has arisen in this case:
- whether Zentiva needed to take further administrative steps to commercialise the generics;
- whether the characterisation of the pharmaceutical acquisition procedures under Portuguese law as precontractual actually matters;
- whether the acquisition of generics by public hospitals could only be acquired by public procurement procedures; and
- whether Zentiva was effectively hindered from taking part in any proceedings for the acquisition of generics.
Having considered the procedural steps taken by Zentiva, the CoA ruled that there was a risk of imminent infringement in this case. Amongst other factors, it relied on the fact that the generics were labelled as blue in the INFARMED database, which indicated that the drugs could be delivered immediately to public hospitals. It also made clear 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 procedure.”
It concluded that (emphasis added):
“Zentiva has not offered any credible explanation why, absent patent infringement, it would be useful for it to obtain the PEP more than one year before the patent expires. The Court of Appeal concludes that the only way a completed PEP can be of any use for Zentiva from an objective point of view is for the offering of the generics.
On balance, it is more likely than not that Zentiva has set the stage for offering the generics in Portugal, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed.”
The CoA also assessed the other requirements for ordering provisional measures – namely necessity, urgency and a balance of interests - ruling in favour of Boehringer in respect of each of these.
Impact
This decision marks a shift towards lowering the bar for establishing imminent infringement, with the CoA adopting a more patentee-friendly approach than seen in first instance decisions previously (such as Novartis/Genentech v Celltrion UPC_CFI_166/2024). This adds to Boehringer’s successful enforcement campaign, following the decision of the Portuguese IP Court in which Boehringer had obtained a preliminary injunction against Zentiva in Portugal (only) on an SPC for a separate patent.
The clear guidance provided by the CoA ought to now form part of the FTO assessment undertaken by generics companies operating in Europe, bearing in mind the risk of being blocked from generic launch across all participating member states. The main takeaway from the decision is that – whilst securing marketing authorisations may not amount to imminent infringement - generic pharmaceutical and biosimilar companies should err on the side of caution when undertaking marketing preparations, as early completion of these steps may be enough to establish imminent infringement and trigger wide-reaching injunctive relief.
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