Boehringer Ingelheim International v Zentiva Portugal (CFI, 8 May 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

The Lisbon Local Division refused Boehringer Ingelheim International’s application for provisional measures against Zentiva Portugal under EP 1 830 843 (nintedanib, treatment of fibrotic diseases) and ordered the applicant to pay EUR 92,944.15 in interim costs. It upheld its jurisdiction despite the involvement of an administrative authority and rejected the argument based on parallel national measures, but held that imminent infringement had not been shown: the marketing authorisations and the completed prior evaluation procedure before Infarmed were mere administrative steps (paragraphs 62 and 63).

For pharmaceutical patentees, the order confirms that an application based solely on the generic company’s regulatory position is unlikely to succeed: the applicant must show conduct of the defendant itself making market entry before patent expiry more likely than not.

Facts and procedure

EP 1 830 843, in force in 17 UPC states, expires on 21 December 2025. A Portuguese supplementary protection certificate (SPC 679) runs until 9 April 2026 (paragraphs 11 to 14 and 20 to 22). Zentiva has held two marketing authorisations for nintedanib generics since 30 August 2024, with Ofev® as reference product (paragraph 31). On 12 December 2024 Infarmed informed public health bodies that the prior evaluation procedure requested by Zentiva was complete and that the product could be purchased, the holder having one year to start marketing (paragraphs 39 and 40).

The application, filed on 23 January 2025, sought an injunction in the states where the patent is in force, information orders and a penalty of EUR 250,000 (paragraph 8). Zentiva challenged jurisdiction. Meanwhile, the Portuguese Intellectual Property Court granted provisional measures in parallel proceedings based on the SPC. The oral hearing took place on 9 April 2025. The order is dated 8 May 2025 in its heading, the signature block bears the date of 7 May 2025.

The applicable law

Article 25 UPCA lists offering and placing on the market among infringing acts, and Article 62 allows measures against imminent infringement. Jurisdiction rests on Articles 31, 32(1)(a) and (c) and 33(1) UPCA, read with Articles 71a and 71b of Regulation (EU) No 1215/2012. Costs follow Article 69 UPCA and Article 14 of Directive 2004/48.

Question

Does completion of the regulatory steps preceding the sale of a generic (marketing authorisation, prior evaluation procedure) suffice, by itself, to establish imminent infringement justifying provisional measures?

Decision

No. The division first rejected the jurisdictional objection: it is irrelevant that the notice came from an administrative body, since the allegation that the defendant may at any time offer or place the product on the market suffices to found jurisdiction (paragraphs 46 and 47). The Portuguese measure did not deprive the application of its purpose: the rights, parties and territory differ, and that provisional measure can be reversed (paragraphs 49 to 52).

On the substance, the division assessed the threat autonomously under the UPCA rather than national law, relying on the Düsseldorf order in Celltrion: the applicant must show, case by case, that market entry before patent expiry is more likely than not (paragraphs 55 to 58). Applications for authorisation and prior evaluation are mere administrative steps. Without some further act showing an intention to market, they are not enough (paragraphs 62 and 63). The alleged early timing of the request was not substantiated (paragraph 64), the one-year period in the notice says nothing about the date of entry (paragraph 65), and there was no sign of sales to private hospitals, about 2% of the market (paragraph 67). The application was refused (paragraph 68). The value in dispute was set at EUR 1,000,000 and the substantiated representation costs of EUR 92,944.15 were awarded on an interim basis (paragraphs 69 to 74).

Key points for practice

• The UPC’s jurisdiction over provisional measures is not excluded because the act relied on was issued by a national administrative authority.
• A national provisional measure based on an SPC does not render moot an application before the UPC based on the European patent, which covers a different territory and different parties.
• The imminent threat must stem from the generic company’s own conduct. Regulatory steps, even the last one before sales to public hospitals, are not enough on their own.
• Practical point: applicants should gather evidence of market entry drawn from the defendant’s own conduct, failing which they will bear its representation costs.

Provisions applied

Agreement on a Unified Patent Court

Arts 25, 31, 32(1)(a) and (c), 33(1), 62, 69 and 83(2)

Rules of Procedure

Rules 206.1 and 211.1

Regulation (EU) No 1215/2012

Arts 4(1), 35, 71, 71a and 71b

Directive 2004/48/EC

Art. 14

Case law cited

Celltrion v Novartis AG, Düsseldorf Local Division, 6 September 2024, SharkNinja Europe, Court of Appeal, 20 January 2025, Sumi Agro v Syngenta, Court of Appeal, 3 March 2025 (UPC_CoA_523/2024)

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.