Boehringer v Zentiva (UPC_CoA_446/2025)
Decision date:
13 August 2025
Osborne Clarke summary
- Boehringer applied to the Lisbon LD for provisional measures (preliminary injunction) against Zentiva in relation to its nintedanib generics. Boehringer alleged that the generic fell within scope of the patent and that there was a serious threat of infringement. The Lisbon LD denied the preliminary injunction, holding that Boehringer had not demonstrated that there was a risk of imminent infringement.
- The Court of Appeal overturned the Lisbon LD, granting Boehringer a pan-UPC preliminary injunction on the basis that infringement was "imminent" in Portugal following completion of pricing and reimbursement processes.
- The Court of Appeal held that the test for "imminent infringement" was whether the potential infringer has "already set the stage" for infringement to occur, such that it was "only a matter of starting the action" as the "preparations for it have been fully completed". This needs to be assessed on a case-by-case basis. The "set the stage" test has previously been used by the Düsseldorf LD in Novartis and Genentech v Celltrion (although in that case the stage was deemed not to have been set so no preliminary injunction was granted).
- In the generics context, the mere application for an MA does not amount to an imminent infringement, nor does the grant of one create imminence.. However, completion of national health technology assessment, pricing and reimbursement procedures can amount to an imminent infringement. This needs to be assessed in light of the national regulatory and legislative context and the circumstances of the case.
- In Zentiva's case, the Court of Appeal found it more likely than not that, having obtained PEP approval in Portugal, Zentiva could offer its generics to public hospitals without any further administrative steps or procedures. There was nothing but "self-restraint on Zentiva’s side" to stop it from offering its products for sale in public procurement exercises. The court also stated that Zentiva had "not offered any credible explanation" why, other than patent infringement, it had obtained its PEP over a year before Boehringer's patent expired.
- The court concluded that Zentiva had set the stage for offering its generics in Portugal, so that the infringement was only a matter of starting the action because the preparations had been fully completed. It went on to consider that the requirements for a PI of both "necessity" (given the lower price of Zentiva's products, which would undercut Ofev® by at least 30%) and "urgency" were met, and ordered a PI.
- For more information, see our Insight here.
Issue
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