Boehringer Ingelheim fails in bid for PI at local division Lisbon

The German pharmaceutical company Boehringer Ingelheim sought to pre-emptively prohibit Zentiva from selling generic versions of its respiratory drug Ofev. However, UPC judges saw no grounds for granting the injunction.

The UPC local division in Lisbon is not among the busiest in terms of case numbers. But as a relatively unknown entity compared to the established German local divisions, Lisbon has gained a reputation as an interesting venue for preliminary injunctions.

According to the UPC’s latest statistics, Lisbon has heard one infringement claim and two preliminary injunction cases. It has already ruled on both PI applications, rejecting them in each instance. In October 2024, the court denied Ericsson’s request for a PI against AsusTek in the division’s first such case.

No imminent infringement

Now the Lisbon local division has again rejected a PI application, this time from Boehringer Ingelheim against Zentiva (case ID: UPC_CFI_41/2025). The panel comprised presiding judge and rapporteur Rute Lopes, who heads the Lisbon local division, alongside legally qualified judges Camille Lignières from France and Petri Rinkinen, who leads the Helsinki local division.

Boehringer argued there was a risk of imminent infringement of its patent EP 1 830 843 B1, which protects the use of nintedanib or nintedanib esylate, from 12 December 2024. The pharma company also owns the related SPC 679, granted by the Portuguese Industrial Property Office in 2015 and due to expire on 9 April 2026.

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.

The plaintiff decided to file the PI application following a notice from Portugal’s National Authority of Medicines and Health Products that a Zentiva generic could be available from that date. Boehringer asked the court 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.

EP 843 is valid in the UPC countries Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Portugal, Romania, Slovenia, and Sweden.

However, the panel saw no danger of infringement by Zentiva, stating “no imminent infringement has been demonstrated”. Consequently, they rejected the PI application. Boehringer can now appeal the ruling, but it has so far not indicated it will do so.

Major battle looms

EP 843 is valid until 21 December 2025. Boehringer is likely aware that other generic companies are also preparing to launch their own nintedanib products. After all, Ofev was Boehringer’s second best-selling product in 2023.

The PI dispute in Lisbon is therefore highly likely to be a precursor to an intense battle in which Boehringer will try to keep generic products off the market later this year, thus securing important revenues. JUVE Patent is already aware of other generics companies preparing for this fight.

Boehringer and Zentiva also clashed at Portuguese courts earlier this year. 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.

Nevertheless, the company also applied for a PI at the Portuguese Intellectual Property Court, which the court granted.