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Overview · Filed: —

ACT_3186/2025

INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES

Provisional measuresProvisional MeasuresLisbon LDApplication for provisional measures—
OverviewDecisionsReasoningCitationsDocumentsTimeline
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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