The Unified Patent Court's Court of Appeal has issued its first preliminary injunction in the pharmaceutical sector, blocking generic drug manufacturer Zentiva Portugal from launching generic versions of Boehringer Ingelheim's pulmonary fibrosis treatment Ofev across 17 European territories. The landmark decision reverses a lower court ruling and establishes new precedent for determining "imminent infringement" in pharmaceutical patent disputes.
Historic Reversal Sets New Legal Standard
The Court of Appeal overturned the Lisbon Local Division's earlier decision that dismissed Boehringer Ingelheim's application for provisional measures against Zentiva. The case centered on European patent No. EP 1 830 843 for nintedanib, the active ingredient in Ofev used to treat idiopathic pulmonary fibrosis.
Zentiva had obtained two marketing authorizations in August 2024 and completed Portugal's Prior Evaluation Procedure (PEP) in December 2024, establishing pricing, reimbursement, and acquisition conditions for public hospitals. Crucially, these steps were completed more than a year before the patent's scheduled expiry.
The Lisbon Local Division initially held that "merely obtaining marketing authorisations and completing administrative steps (such as a PEP) does not, in itself, establish a concrete risk of imminent infringement." However, the Court of Appeal disagreed, finding that completion of national procedures for health technology assessment, pricing, and reimbursement constituted a sufficient risk of patent infringement.
Four-Step Test for Imminent Infringement
The Court of Appeal established a comprehensive four-step analysis to assess imminent infringement in pharmaceutical cases, examining:
- Whether the generic manufacturer needed further administrative steps to commercialize the products
- Whether the characterization of pharmaceutical acquisition procedures as "precontractual" under national law affects infringement analysis
- Whether generic acquisition by public hospitals could only occur through public procurement procedures
- Whether the generic manufacturer was effectively hindered from participating in acquisition proceedings
Applying this test to Zentiva's situation, the Court found that once products were labeled as "blue" in the INFARMED database, they could be delivered immediately without further administrative barriers. The Court determined that "only self-restraint was preventing Zentiva starting to offer its product."
Early Regulatory Approval Signals Intent to Infringe
A critical factor in the Court's decision was Zentiva's inability to provide "any credible explanation" for obtaining PEP approval more than one year before patent expiry. The Court concluded that "the only way a completed PEP can be of any use for Zentiva from an objective point of view is for the offering of the generics."
The ruling clarified that while "the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one," completing pricing and reimbursement procedures crosses the threshold into actionable territory.
Broad Injunction Across UPC Territories
The preliminary injunction applies across all 17 UPC contracting states where the patent remains in force, not just Portugal where the initial regulatory steps occurred. This represents the broadest pharmaceutical injunction issued by the UPC system since its establishment.
Zentiva faces daily penalties of up to EUR 10,000 for each infringing package and was ordered to pay an interim award of EUR 199,000 plus Boehringer Ingelheim's legal costs. The Court noted this ruling "represents the first preliminary injunction granted in the pharmaceutical sector since the UPC's establishment, leaving no prior UPC case law from which to benchmark the level of monetary relief awarded."
Market Impact and Competitive Dynamics
The Court of Appeal recognized the significant market implications of generic competition, referencing its earlier decision in Sumi v Syngenta. The Court stated that "a move from a market situation where only one product is available, to one where there are two competing products can be expected to lead not just to price pressure but to a permanent price erosion."
The anticipated 30% price reduction from generic competition was identified as a key factor supporting the necessity for provisional measures, as such price erosion would create immediate and irreversible market impact for the patent holder.
Implications for European Generic Strategy
This decision fundamentally alters the landscape for generic drug launches across Europe under the UPC system. The ruling suggests that pharmaceutical companies seeking to launch generics must carefully time their regulatory submissions to avoid completing all commercialization steps significantly before patent expiry.
The four-step test provides clearer guidance for both patent holders and generic manufacturers in assessing the risk of preliminary injunctions. Patent holders now have stronger grounds for seeking injunctive relief when competitors complete pricing and reimbursement procedures well in advance of patent expiration without credible business justification.
