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ACT 3186/2025

—·EP1830843: INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES

Case details
Status
—
Action
Provisional measures
Category
Provisional Measures
Parties
Claimants
Reps: Joana Catarina Piriquito Santos; Sara Nazaré; Beatriz Lima
Respondents
Reps: Patrícia Paias
Division
Lisbon LD
Judges
Technology
Organic Chemistry
Language
—
First decided
May 8, 2025
Decisions
  • 2025-05-08
    PI deniedPreliminary injunctionApplication for provisional measures

    Lisbon Local Division denied Boehringer Ingelheim International GmbH's application for a preliminary injunction against Zentiva Portugal, LDA concerning EP 1 830 843 (nintedanib for idiopathic pulmonary fibrosis). The court found no imminent infringement: Zentiva's receipt of marketing authorisations and filing of a parallel exclusivity period (PEP) request did not demonstrate that market entry was imminent before patent expiry. The PEP request was filed in the usual course of business and the Defendant was aware of the risk of PEP expiry. Value of case set at EUR 1,000,000.

    Legal issues:Preliminary injunction in pharmaceutical patent caseImminent infringement standardParallel exclusivity period (PEP) request as evidence of market entryMarketing authorisation vs. market entry timing
Documents
  • BD863190C8435CC47CD56CFA9BE61449_en.pdf2025-05-08ENGLISH
Plain-English summary

Boehringer Ingelheim International GmbH applied for a preliminary injunction before the Lisbon Local Division against Zentiva Portugal, LDA, concerning EP 1 830 843, a patent protecting the use of nintedanib (esylate) for treatment of idiopathic pulmonary fibrosis. The court dismissed the application, finding no imminent infringement: Zentiva's receipt of marketing authorisations and filing of a parallel exclusivity period request followed normal industry practice and did not demonstrate that market entry would occur before the patent's expiry.

Accepted arguments
What the court agreed with — by party.

  • No imminent infringement: receipt of marketing authorisations and filing of PEP request does not demonstrate market entry is imminent before patent expiry

    RespondentLegal basis: Art. 62(1) UPCA; Art. 25 UPCA

    Note: The Lisbon Local Division found that Zentiva's receipt of MAs and filing of a parallel exclusivity period (PEP) request followed usual pharmaceutical industry procedure and did not indicate that market entry would occur before expiry of EP 1 830 843.

  • Infarmed one-year commercialisation deadline in PEP notice does not indicate imminent infringement

    Respondent

    Note: The court accepted Zentiva's argument (supported by a written statement from its head of scientific affairs) that the PEP risk of expiry lies with the defendant, and that awareness of this risk alone does not indicate intended market entry timing.

Rejected arguments
What the court did not agree with — and why.

  • Imminent infringement established by Infarmed notice, receipt of marketing authorisations, and filing of PEP request

    ClaimantLegal basis: Art. 62(1) UPCA

    Reason: The court found that these steps followed normal pharmaceutical regulatory procedure and did not demonstrate that Zentiva had taken actions making infringement more likely than not to occur before patent expiry; the risk of PEP expiry is borne by the party that requested it prematurely.

Key legal principles
Doctrines and rules cited in the reasoning.
imminent infringement must arise directly from conduct of potential infringerpharmaceutical regulatory steps (marketing authorisation, PEP request) do not per se establish imminent infringementcosts follow the event under Art. 69 UPCA and Art. 14 Directive 2004/48

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