Boehringer Ingelheim International v Zentiva Portugal (CoA, 13 August 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 13 August 2025 on the appeal (UPC_CoA_446/2025) and cross-appeal (UPC_CoA_520/2025) against the order of the Lisbon Local Division of 8 May 2025 (UPC_CFI_41/2025), the Court of Appeal (Presiding Judge Kalden, Judge Simonsson as judge rapporteur, Judge Rombach and Technical Judges Gustafsson and Wagner) reversed the refusal of provisional measures and enjoined Zentiva Portugal, in the seventeen states where EP 1 830 843 has effect, from any exploitation of nintedanib products for idiopathic pulmonary fibrosis. The Court held that applying for or obtaining a marketing authorisation does not in itself amount to imminent infringement, whereas completion of national pricing and reimbursement procedures may. The ruling is of direct concern to generic companies preparing entry before patent expiry.

Facts and procedure

Boehringer Ingelheim markets Ofev in Portugal. The patent, directed to a second medical use, was due to expire on 21 December 2025. Zentiva obtained Portuguese marketing authorisations for generics on 30 August 2024, followed by approval under the prior evaluation procedure (PEP) for pricing and reimbursement, made public by INFARMED on 12 December 2024. Boehringer applied to the Lisbon division on 23 January 2025, the division dismissed the application for lack of imminent infringement and ordered it to pay EUR 92,944.15 in interim costs. A Boehringer group company had also obtained a Portuguese injunction on 25 March 2025 based on a supplementary protection certificate.

The applicable law

The Court applied Arts. 25, 27(d), 34, 62 and 67 UPCA, the Bolar exemption in Art. 10(6) of Directive 2001/83, and Rules 191, 206, 211.4, 213, 222 and 354.3 RoP. Portuguese medicines and public procurement law was taken into account as a source under Art. 24 UPCA, its content to be proven by the parties (paragraph 72).

Question

Does approval of pricing and reimbursement for a generic, without actual marketing, amount to imminent infringement justifying provisional measures?

Decision

Yes, on the facts. Both parties’ late evidence was excluded (Rule 222 RoP) and the Portuguese injunction, based on another right and limited to Portugal, did not remove the need for measures (paragraphs 39 to 43). Infringement is imminent where preparations are complete and only the act remains, which the applicant must show to be more likely than not (paragraphs 44 to 46). A marketing authorisation is not enough (paragraph 47), completion of health technology assessment, pricing and reimbursement procedures may be, depending on the national context (paragraph 48). The PEP allows Zentiva to respond without further formality to public hospital tenders, direct awards and consultations, acts that would be an infringing offer. Only its self-restraint holds it back, which is not enough (paragraphs 64 to 81). Lasting price erosion justifies the measure (paragraphs 82 to 85), time runs from 12 December 2024 and the application was not late (paragraphs 86 to 89). The injunction, backed by a penalty of up to EUR 10,000 per package, covers all states where the patent has effect, even without marketing authorisations outside Portugal (paragraphs 90 and 91). The request for information was refused as no infringement had yet occurred (paragraph 94). Zentiva bears the costs of both instances, including the cross-appeal, and must pay EUR 199,000 as an interim award (paragraphs 95 to 97).

Key points for practice

• The Court draws a clear line between a marketing authorisation, which is insufficient, and pricing and reimbursement procedures, which may establish the threat (paragraphs 47 and 48).
• Taking part in a public procurement procedure, even at the pre-contractual stage, is an offer within Art. 25 UPCA (paragraphs 64 to 69).
• The injunction extends to every state where the patent has effect, regardless of where the generic company holds authorisations (paragraph 91).
• Practical point: for the patentee, publication of the pricing and reimbursement approval starts the urgency clock, for the generic company, relying on its own restraint offers no protection against an injunction.

Provisions applied

Agreement on a Unified Patent Court

Arts. 24, 25, 27(d), 34, 62, 67, 73 and 76

Rules of Procedure

Rules 9.2, 118.2, 191, 206.2, 209.2, 211.2, 211.4, 213, 220.2, 221.1, 222 and 354.3

Other provisions

Directive 2001/83/EC, Art. 10(6), Directive 2001/82/EC, Art. 13(6), Portuguese Decree-Law 97/2015, Portuguese Public Contracts Code

Case law cited

Sumi Agro v Syngenta, Court of Appeal, 3 March 2025 (UPC_CoA_523/2024), Mammut v Ortovox, Court of Appeal, 25 September 2024 (UPC_CoA_182/2024)

Related decisions

• Zentiva Portugal v Boehringer Ingelheim International, 8 May 2025, Lisbon Local Division order reversed.

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.