Case background

Boehringer Ingelheim’s patent (EP1830843B) covers nintedanib for use in treating idiopathic pulmonary fibrosis, and is in force until 21 December 2025.

With this patent, Boehringer Ingelheim holds IP rights for nintedanib (marketed as Ofev®) in Portugal.

In August 2024, Zentiva was granted two marketing authorisations for generic nintedanib products, by the Portuguese health agency, Infarmed.

In Portugal, a prior evaluation procedure (PEP) is required for drugs to be sold to public hospitals, to set a maximum price, and other conditions of sale. In December 2024 – more than a year before the patent’s expiry – Infarmed announced the grant of Zentiva’s PEP application, allowing the commercialisation of its generic products.

On that basis, Boehringer Ingelheim applied for a preliminary injunction against Zentiva in all UPC states in which the patent is in force.

Part of their justification for provisional measures was that the price of Zentiva’s generic products will be at least 30% lower than for Ofev®. Such price competition would typically cease (or otherwise significantly reduce) the acquisition of innovator products, and impact prices in other countries that conduct international reference pricing.

At first instance, the Lisbon Local Division of the UPC decided that, although Boehringer Ingelheim’s patent covers Zentiva’s nintedanib products, a risk of imminent infringement had not been demonstrated. In reaching that decision, the Local Division noted that requesting a PEP before the expiry of innovator patents is standard practice for generic pharmaceutical companies in Portugal. Overall, the Local Division held that applying for marketing authorisation or a PEP “are mere administrative actions that… do not, in themselves, establish [a risk of imminent infringement]”.

On that basis, the Local Division denied the request for provisional measures, and costs were awarded to Zentiva.

Appeal

Boehringer Ingelheim appealed against this decision.

The UPC’s Court of Appeal upheld that a generic pharmaceutical company merely applying for marketing authorisation (or the grant of such) does not constitute imminent infringement.

However, the Court of Appeal found that completing the national procedures to market a drug can amount to imminent infringement.

In this case, the Court of Appeal found that Zentiva had applied for a PEP prematurely; that nothing now prevents Zentiva from offering the generic products in Portugal – except self-restraint; and Infarmed’s database already indicated that Zentiva’s products were available for sale.

In their defence, Zentiva referred to the proposed amendment of the EU Bolar Exemption. The current exemption excludes certain acts for obtaining regulatory approval of a generic pharmaceutical or biosimilar, from patent or SPC infringement. The proposed amendment seeks to harmonise European practice, by further including exemption of (for example) pricing and reimbursement activities. However, given that the proposed amendment is not enforceable, the Court of Appeal applied the existing legislation when making their decision.

Overall, the Court of Appeal concluded that there was a risk of imminent infringement: “On balance, it is more likely than not 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.”

In addition, the Court of Appeal considered that Boehringer Ingelheim’s application for provisional measures was filed sufficiently urgently (about six weeks after Infarmed notified the public that Zentiva’s PEP had been approved); and that provisional measures were necessary, given the significant potential impact on Ofev®’s pricing and sales.

Accordingly, the Court of Appeal overturned the first instance decision, and granted provisional measures in all UPC states in which the patent is in force. The costs order was also reversed.

Comment

It may be important for generic pharmaceutical and biosimilar companies to complete national procedures (such as applying for marketing authorisations, and a PEP in Portugal) in time to launch their products on innovator patent/SPC expiry. Therefore, the Court of Appeal’s confirmation that grant of marketing authorisation does not constitute imminent infringement may be reassuring to such companies. However, based on the overall decision, generic pharmaceutical and biosimilar companies should be cautious not to complete all marketing preparations too early, as this may suggest imminent patent/SPC infringement through offering for sale.

If the proposed amendment of the EU Bolar Exemption enters into force, and if it amounts to exempting completion of national marketing preparations, it could have a detrimental effect on patent/SPC-protected innovator drug pricing and sales. We doubt this is the intention of the European Commission, and will await development in this area with interest.

Case details at a glance

Decision level: Court of First Instance, Lisbon
Case: UPC_CFI_41/2025
Order: ORD_18599/2025
Parties: Boehringer Ingelheim International GmbH v Zentiva Portugal, LDA
Date: 08 May 2025
Decision (PDF): https://dycip.com/upc-ord-18599-2025

Decision level: Court of Appeal, Luxembourg
Case: UPC_CoA_446/2025 and UPC_CoA_520/2025
Order: ORD_33516/2025
Parties: Boehringer Ingelheim International GmbH v Zentiva Portugal, LDA
Date: 13 August 2025
Decision (PDF): https://dycip.com/ord-33516-2025