Overview

The Court of Appeal of the Unified Patent Court (UPC) has reversed a decision from the Lisbon Local Division of the UPC (LLD UPC) in the case of Boehringer Ingelheim International GmbH (Boehringer Ingelheim) v. Zentiva Portugal, LDA (Zentiva). Contrary to the LLD UPC, the UPC Court of Appeal considered that the application 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 for a medicine with nintedanib as an active pharmaceutical ingredient constituted a risk of imminent infringement. In reaching its conclusion, the UPC Court of Appeal applied a four-step test.

Background

This case involved Boehringer Ingelheim seeking a preliminary injunction to stop Zentiva Portugal from launching generic versions of its drug Ofev, alleging imminent infringement of its European patent No. EP 1 830 843 for nintedanib in treating idiopathic pulmonary fibrosis. Zentiva obtained two marketing authorisations in August 2024 and completed the Prior Evaluation Procedure (PEP) in December 2024, allowing potential sales to public hospitals, over a year before the patent’s expiry. 

The LLD UPC provided detailed guidance on the assessment of imminent infringement under Articles 25 and 62 UPCA. It held that merely obtaining marketing authorisations and completing administrative steps (such as a PEP) does not, in itself, establish a concrete risk of imminent infringement. The applicant must show that the defendant’s conduct makes it more likely than not that market entry will occur before patent expiry. In this case, as Zentiva had not taken any further steps towards commercialisation, the LLD UPC found no imminent infringement and dismissed the application for provisional measures. 

The decision highlighted the UPC’s high threshold for proving imminent infringement in pharmaceutical cases, requiring compelling evidence demonstrating a real and immediate risk before granting injunctive relief.

Court of Appeal decision

The UPC Court of Appeal confirmed the findings of the LLD UPC that the mere application or even grant of a marketing authorisation for generics does not constitute patent infringement. However, the completion of national procedures concerning a health technology assessment, pricing and the reimbursement of generics may constitute a patent infringement.

To assess whether the completion of the PEP in Portugal equated to an imminent infringement, the UPC Court of Appeal considered four criteria:

• 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.

After considering the facts in Portugal, the UPC Court of Appeal stated that there was a risk of imminent infringement, as:

• There was no need for Zentiva to take any further administrative steps to commercialise the generics – once they were labelled as blue in the INFARMED database, as they could be delivered immediately;
• The pre-contractual characterisation of the acquisition procedure is not relevant – public tenders constitute an act of infringement, no matter whether direct awards or prior consultations for public tenders are precontractual;
• Portuguese public hospitals have various other ways to acquire generics besides public procurement procedures; and
• Zentiva was not hindered from participating in acquisition procedures for nintedanib products in Portugal.

In addition, the UPC Court of Appeal considered that obtaining the PEP more than a year before patent expiry could only be objectively justified as a means to offer the generics and hence infringe the patent.

Accordingly, after the assessment of urgency, necessity and balance of interest, the UPC Court of Appeal granted a provisional injunction against Zentiva, assorted with a daily penalty of up to EUR10,000 for each infringing package. The injunction was granted for all UPC contracting states where the patent is in force, not just Portugal. Zentiva is ordered to pay an interim award of EUR199,000 to Boehringer Ingelheim plus its legal costs. 

This ruling represents the first preliminary injunction granted in the pharmaceutical sector since the UPC’s establishment, leaving no prior UPC case law from which to benchmark the level of monetary relief awarded.

Implications and key takeaways

Pharmaceutical companies cannot rely on an application for or grant of a marketing authorisation for generics to demonstrate an imminent risk of infringement justifying a preliminary injunction in UPC contracting states where the patent is in force.

However, they may rely on the completion of national procedures concerning a health technology assessment, pricing and the reimbursement of generics to claim imminent infringement, provided that they can demonstrate that the procedures:

(i) enable the commercialisation of the generics without further administrative steps; and 
(ii) have no legitimate justification other than the offering of the generics. 

This means that any claim of imminent risk of infringement should demonstrate the risk of imminent commercialisation of the generics in the state where a health technology assessment, pricing and reimbursement procedures have been completed. However, it remains unclear whether the UPC will consider that completion of such procedures just before the expiry of the patent also constitutes an imminent threat of infringement.