Court of Appeal grants final victory to Boehringer in PI case against Zentiva

The Court of Appeal has overturned a first-instance decision from the local division Lisbon and granted Boehringer Ingelheim a PI against Zentiva. The dispute concerns Boehringer’s EP 1 830 843 B1, which protects the use of nintedanib or nintedanib esylate. The patent is valid until 21 December 2025 in the UPC countries Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Romania, Slovenia, and Sweden.

Boehringer markets nintedanib under the brand name Ofev to treat idiopathic pulmonary fibrosis. Ofev is also indicated for other chronic fibrosing interstitial lung diseases in adults and systemic sclerosis-associated interstitial lung disease.

Setback for Boehinger at first instance

In May, the Lisbon local division rejected a PI application filed by Boehringer against Zentiva (case ID: UPC_CFI_41/2025). Boehringer had argued there was there was a risk of imminent infringement of its patent from 12 December 2024 following a notice from Portugal’s National Authority of Medicines and Health Products that a Zentiva generic could be available from that date.

In Portugal, medicines containing nintedanib as an active substance are restricted to hospital use. Almost all purchases of Ofev are made by public hospitals under the national health system. Special authorisation and a contract are required to supply the hospitals. Boehringer is currently the only manufacturer supplying nintedanib.

Boehringer asked the local division to prohibit Zentiva from manufacturing, offering, placing on the market, using, importing or storing products containing nintedanib, particularly Zentiva’s generics, within the UPC territory. However, the judges saw no danger of infringement by Zentiva, stating “no imminent infringement has been demonstrated”.

Boehringer Ingelheim appealed the ruling.

Court of Appeal says stage is set

On 13 August 2025, the second panel under presiding judge Rian Kalden upheld the appeal (case ID: UPC_CoA_446/2025 APL_24205/2025), finding that Zentiva has “set the stage for offering the generics in Portugal, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed”.

The panel also comprised legally qualified judges Ingeborg Simonsson and Patricia Rombach, as well as two technically qualified judges Andreas Gustafsson and Carola Wagner.

The judges stated that, although it is customary for generics companies in Portugal to apply for a Prior Evaluation Procedure (PEP) before the expiration of a patent, Zentiva had concluded this procedure prematurely and there appeared nothing “in place nationally but self-restraint on Zentiva’s side to prevent it from taking part in public procurement procedures, direct awards or prior consultations, acts that would likely constitute infringement by offering the products”.

The judges therefore set aside the decision of the local division Lisbon and granted the PI against Zentiva in 17 contracting UPC states in which the patent is in force. In addition, they ordered Zentiva to pay Boehringer € 199,000. The judgment is enforceable immediately.

Parties retain same counsel

Portuguese IP firm NLP represtented Boehringer in both instances. Joana Piriquito Santos led the case. In 2024, Piriquito Santos founded founded the IP boutique NLP together with two former colleagues of Portuguese firm Vieira de Almeida — Sara Nazaré and Beatriz Lima.

Patrícia Paias, partner at Portuguese firm Antas da Cunha ECIJA represented Zentiva. She worked as in-house counsel for Sandoz and Gilead before joining DLA Piper in 2022 and moving to Antas da Cunha ECIJA a year later.

The decision is likely to further strengthen the confidence of pharmaceutical originators in the UPC system. Several new pharmaceutical lawsuits have recently been filed. For example, GSK filed lawsuits against Moderna, BioNTech and Pfizer over mRNA patents at the UPC local division The Hague. Merz Therapeutics has also filed the UPC’s first SPC claim against Viatris at the Paris local division.