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UPC CFI 41/2025

Jan 22, 2025·EP1830843 · INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES

Action number: ACT 3186/2025

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Case details
Status
Case ClosedSet aside on appeal, Aug 13, 2025
Action
Provisional measures
Category
Provisional measures
Parties
Respondents
Representatives
Division
Lisbon LD
Judges
Technology
  • Chemistry
    Pharmaceuticals
Language
English
First decided
May 8, 2025
EPO Opposition
  • SANDOZ AG2013-08-07
Appealed
How this compares
The court's record for this kind of case, counted in first-instance rulings. A figure in brackets is the number of rulings a rate rests on.
Preliminary injunction grantedMedian days to first decision
All UPC54% (38/70)124
Lisbon LDLockedLocked
Judge Rute LopesLockedLocked
Judge Camille LignièresLockedLocked
Judge Petri RinkinenLockedLocked

At the UPC: BOEHRINGER INGELHEIM INTERNATIONAL GMBH (3 cases)·Zentiva Group (15 cases)

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Related cases
All proceedings on this patent

This dispute contains 2 other proceedings

UPC CFI 858/2025·UPC CoA 446/2025

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More cases: Lisbon LD·2025

Decisions
  • 2025-05-08
    Application for provisional measuresPublic

    Summary: 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.

    Show the legal issues (4)
    • Preliminary injunction in pharmaceutical patent case
    • Imminent infringement standard
    • Parallel exclusivity period (PEP) request as evidence of market entry
    • Marketing authorisation vs. market entry timing
Documents
Show all 151 documents
Document titleDatePublic
Outcome of the Order2025-05-26Not public
Declaration2025-05-26Public
Outcome of the Order2025-05-21Not public
Template-order2025-05-16Public
Declaration2025-05-16Public
Measures_DecisionOutcome_Notification.pdf2025-05-16Not public
Final order2025-05-08Public
Receipt2025-04-22Not public
Request to the Registrar for the recording of the oral hearing to be made available2025-04-22Not public
record2025-04-16Not public
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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