Nintedanib (Ofev): when 'preparing to launch' becomes an infringement across 17 countries

What was decided

Boehringer Ingelheim’s European Patent 1 830 843 covered nintedanib for idiopathic pulmonary fibrosis and ran until 21 December 2025. Zentiva obtained two Portuguese marketing authorisations for generic nintedanib in August 2024 and then applied to INFARMED’s Prior Evaluation Procedure, the step that fixes a medicine’s price, reimbursement and hospital purchasing terms in Portugal. Boehringer asked the Unified Patent Court for a preliminary injunction.

The Lisbon Local Division refused on 8 May 2025: there was no evidence that infringement was imminent. The Court of Appeal reversed on 13 August 2025. Its reasoning draws the line that matters. Merely applying for, or holding, a marketing authorisation is not a threat to infringe, because an authorisation can sit unused. But entering the national procedure that sets price and reimbursement, when nothing else stands between the generic and the market, shows an intention to sell while the patent is in force. The remaining formality (a pre-notification) was something a supplier could complete at short notice, so it did not break the chain. The injunction applies in every UPC country where the patent was in force, with financial penalties per infringing pack.

Timeline

Date	Event
August 2024	INFARMED grants Zentiva two marketing authorisations for generic nintedanib
2024–25	Zentiva applies to the Prior Evaluation Procedure (pricing and reimbursement)
8 May 2025	UPC Lisbon Local Division refuses a preliminary injunction
13 August 2025	UPC Court of Appeal reverses and grants the injunction across the UPC states
21 December 2025	The patent reaches the end of its term

What it means if you are…

A generics or launch planner. At the UPC, the pricing and reimbursement application is the trigger, not the marketing authorisation. If you want authorisations in place for day one without inviting a Europe-wide injunction, keep the pricing step until the patent is about to expire, or be ready to argue that your particular procedure leaves real steps between you and the market. The Court of Appeal left open how it would treat a procedure completed just before expiry.

A wholesaler or buyer. Stock bought ahead of an announced generic launch can be stranded by a single order covering most of the EU. Where a launch depends on a UPC-litigated patent, the safe assumption is that nothing moves until the patent expires or the court says otherwise.

A parallel trader. The UPC decides once for 17 countries, so a generic enjoined in Portugal is enjoined in Germany and France on the same day. The exceptions are the countries outside the UPC, including the UK, Spain, Poland and Switzerland, where the national position governs; a UPC injunction tells you nothing about those markets.

Status and what to watch

The patent has now expired, so the commercial effect is spent; the legal test survives. Watch for the first case in which a generic completes pricing and reimbursement in the final weeks of a patent, which is the situation the Court of Appeal did not decide.