1. Key takeaways
Mere marketing authorisation for generics does not constitute imminent infringement (Art. 62(1) UPCA; R. 206.2(c) RoP)
The grant or application for a marketing authorisation alone is insufficient to establish imminent infringement. Additional steps are required for the threshold to be met, and the Court of Appeal clarified that this threshold can be crossed when a generic company completes national procedures for health technology assessment, pricing, and reimbursement.
The court's legal test is whether the potential infringer has "already set the stage for it [the infringement] to occur," meaning all preparations have been fully completed and the infringement is "only a matter of starting the action".
Completion of national pricing and reimbursement procedures may amount to imminent infringement (Art. 62(1) UPCA; R. 211.2 RoP)
The completion of pre-launch steps, such as health technology assessment, pricing, and reimbursement, can constitute an imminent infringement if the potential infringer has "already set the stage for it to occur". The assessment depends on the specific national regulatory framework. In this case, Zentiva's completion of Portugal's Prior Evaluation Procedure (PEP) was the decisive factor, as it enabled offers to public hospitals without further significant administrative steps. The court found that Zentiva's potential self-restraint was not a sufficient legal safeguard, concluding all preparations were complete and an infringing offer was merely "a matter of starting the action".
Provisional measures require necessity, urgency, and a balance of interests (Art. 62(1)-(2) UPCA; R. 211.4 RoP)
Provisional measures require the applicant to demonstrate necessity, urgency, and that the balance of interests favors them. The Court of Appeal found the necessity requirement was met due to the significant risk of irreparable harm to the patentee. Specifically, the introduction of Zentiva's generic, priced at least 30% lower, would likely lead to a "permanent price erosion" and a near-complete market switch, which the court deemed a critical factor.
Regarding urgency, the court confirmed that an application must be filed without "unreasonable delay" (R. 211.4 RoP) from the moment the applicant becomes aware of the facts justifying the measure. It found Boehringer Ingelheim acted in a timely manner by filing its application approximately one month after the decisive event—the public notification of the generic's pricing and reimbursement approval.
The balance of interests thus favored the applicant, as the potential for irreversible market damage and price collapse outweighed the harm to the defendant from being enjoined from a premature market entry.
Orders to communicate information require actual infringement and necessity (Art. 67 UPCA; R. 191 RoP)
An order to communicate information requires actual infringement and necessity, and the Court of Appeal denied the applicant's request on these grounds. Such orders, governed by Article 67 UPCA and Rule 191 RoP, are typically directed at an "infringer" to disclose details like supply chains and quantities sold.
The court reasoned that since this case only involved an imminent infringement, there was "no allegation of any completed infringement".
Consequently, there was no indication that the requested information actually existed yet. Furthermore, the applicant failed to provide a sufficient explanation as to why the information was "reasonably necessary for the purpose of advancing that party's case", as required by the rules. The court therefore concluded that it saw no reason to issue such an order based merely on the finding of an imminent threat.
2. Division
Court of Appeal
3. UPC number
UPC_CoA_446/2025, APL_24205/2025 (appeal); UPC_CoA_520/2025, APL_27935/2025 (cross-appeal)
4. Type of proceedings
Proceedings for provisional measures (appeal and cross-appeal)
5. Parties
Applicant/Appellant: Boehringer Ingelheim International
GmbH
Defendant/Respondent/Cross-Appellant: Zentiva Portugal, LDA.
6. Patent(s)
EP 1 830 843
7. Jurisdictions
UPC
8. Body of legislation / Rules
Art. 62(1)-(2) UPCA (Provisional measures, balance of interests), Art. 27(d) UPCA (Bolar exemption), Art. 67 UPCA (Order to communicate information), Art. 24 UPCA (National law as a source of law), Art. 34 UPCA (Territorial scope), R. 206.2(c), 209.2(b), 211.2, 211.4, 213, 354.3 RoP (Provisional measures, urgency, penalty payments), R. 9.2, 191, 220.2, 221.1, 222 RoP (Procedural rules, evidence, information orders), Art. 10(6) Directive 2001/83/EC (Bolar exemption)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
