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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

Start a free trial to see how each one ended.

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
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
record2025-04-16Not public
Receipt2025-04-16Not public
Final order - CMS purposes2025-04-16Public
Template-Order2025-04-16Not public
Request recording oral hearing2025-04-15Not public
Response under Order April 2, 20252025-04-10Not public
Response under APP 15653.20252025-04-10Not public
Receipt2025-04-09Not public
Call for proposals under framework agreement - Part 32025-04-08Not public
Generic Procedural Appplication2025-04-08Not public
Decision and Final Report under Framework Agreement - Part 32025-04-08Not public
Decision and Final Report under Framework Agreement - Part 12025-04-08Not public
Decision and Final Report under Framework Agreement - Part 22025-04-08Not public
Decision and Final Report under Framework Agreement - Part 52025-04-08Not public
Decision and Final Report under Framework Agreement - Part 42025-04-08Not public
Call for proposals under framework agreement - Part 42025-04-08Not public
Call for proposals under framework agreement - Part 22025-04-08Not public
Call for Proposals under Framework Agreement (Reference: 1283/2025) - Part 12025-04-08Not public
Receipt2025-04-07Not public
Receipt2025-04-07Not public
Exhibit 22025-04-07Not public
Response under Order App 15653.2025 of April 2, 20252025-04-07Not public
Exhibit 1 - Permanent Certificate2025-04-07Not public
Response under Order of April 2, 20252025-04-07Not public
Exhibit 12025-04-07Not public
Applicant's note on award of costs2025-04-07Not public
Exhibit 272025-04-07Not public
Exhibit 262025-04-07Not public
BI reply to Zentiva evidence submission2025-04-04Not public
BI reply to Zentiva evidence submission2025-04-04Not public
BI reply to Zentiva evidence submission2025-04-04Not public
BI reply to Zentiva evidence submission2025-04-04Not public
BI reply to Zentiva evidence submission2025-04-04Not public
BI reply to Zentiva evidence submission2025-04-04Not public
Order2025-04-02Not public
Receipt2025-04-02Not public
Order2025-04-02Not public
Order2025-03-31Not public
Exhibit 25 - Defence SPMS2025-03-31Not public
Exhibit 20 - Declaration Vanessa Jacinto2025-03-31Not public
Application - written2025-03-31Not public
Exhibit 21 - Declaration Manuela Kreuder2025-03-31Not public
Exhibit 22 - Zentiva atos societarios2025-03-31Not public
Exhibit 25 - Defence SPMS2025-03-31Not public
Exhibit 24 - Defence Zentiva2025-03-31Not public
Exhibit 24 - Defence Zentiva2025-03-31Not public
Exhibit 23 - Article Prof. Marco Caldeira2025-03-31Not public
Exhibit 23 - Article Prof. Marco Caldeira2025-03-31Not public
Exhibit 22 - Zentiva atos societarios2025-03-31Not public
Receipt2025-03-31Not public
Order2025-03-31Not public
Application for Written Witnesses Statements2025-03-31Not public
Written Statement - Ana Lopes2025-03-31Not public
Written Statement - Ana Teixeira2025-03-31Not public
Receipt2025-03-31Not public
Generic Procedural Appplication2025-03-28Not public
Exhibit 1 - TPI Decision2025-03-28Not public
Receipt2025-03-24Not public
Exhibit 4 - Order 1771-B_20162025-03-21Not public
Exhibit 2 - Order 55_20132025-03-21Not public
Rejoinder2025-03-21Not public
Exhibit 1 - Proof of Judicial Certificate2025-03-21Not public
Exhibit 3 - Decree-law 19_20102025-03-21Not public
Receipt2025-03-13Not public
Reply to the Objection2025-03-12Not public
EXHIBIT 192025-03-12Not public
EXHIBIT 182025-03-12Not public
EXHIBIT 172025-03-12Not public
Acknowledgement-of-lodging2025-03-07Not public
Request remit to Objection filed 03.03.252025-03-07Not public
Summon-Oral-Hearing2025-03-06Not public
Order2025-03-06Public
Oral hearing2025-03-03Not public
Order 209.1(b) RoP2025-03-03Public
Oral hearing2025-03-03Not public
Template-Order2025-03-03Not public
Receipt2025-03-03Not public
Exhibit 2 - Case 57/25.1YHLSB (i)2025-03-03Not public
Exhibit 5 - Clarification Boehringer Ingelheim Portugal 30.01.20252025-03-03Not public
Exhibit 4 - Specifications Framework Agreement no 491/2023 - part 42025-03-03Not public
Exhibit 3 - Framework Agreement Nintedanib - part 22025-03-03Not public
Exhibit 1 - Certificate SPC 6792025-03-03Not public
Exhibit 4 - Specifications Framework Agreement no 491/2023 - part 12025-03-03Not public
Exhibit 4 Specifications Framework Agreement no 491/2023 - part 32025-03-03Not public
Exhibit 3 - Framework Agreement Nintedanib - part 32025-03-03Not public
Exhibit 3 - Framework Agreement Nintedanib - part 12025-03-03Not public
Exhibit 1 - Certificate SPC 6792025-03-03Not public
Objection provisional measures application2025-03-03Not public
Exhibit 4 Specifications Framework Agreement no 491/2023 - part 22025-03-03Not public
Exhibit 2 - Case 57/25.1YHLSB - part 22025-03-03Not public
Exhibit 2 - Case 57/25.1YHLSB - part 32025-03-03Not public
Acknowledgement of access to case2025-02-24Not public
Notification Of Service2025-02-10Not public
receipt confirmation2025-02-10Not public
Letter-for-Service2025-01-30Not public
Preliminary Order - R.2092025-01-29Not public
Preliminary Order - R.2092025-01-29Not public
Template-Order2025-01-29Not public
Preliminary Order - R.2092025-01-29Not public
Panel-Appointment2025-01-29Not public
Application-For-Measures-Receipt2025-01-23Not public
Formal-checks_Notification-of-positive-outcome2025-01-23Not public
Exhibit 8 - Decision of China National Intellectual Property Administration2025-01-23Not public
Exhibit 1- Boehringer Ingelheim Pharma GmbH & Co. KG authorized Boehringer Ingelheim International GmbH to file to proc2025-01-23Not public
Exhibit 14 - EP 1 830 843 B1opt-out and withdrawal of the opt-out2025-01-23Not public
Application for provisional measures2025-01-23Not public
Exhibit 11 - Zentiva: authorised and registered wholesale distributor of medicines2025-01-23Not public
Exhibit 15 - IQVIA DATA2025-01-23Not public
Exhibit 6 - EP 1 830 843 B1 decision of the OD of the EPO2025-01-23Not public
Exhibit 3 - EP 1 830 843 B12025-01-23Not public
Exhibit 12- Zentiva Generics SmPC and PL (PT and EN)2025-01-23Not public
Exhibit 2 - Ofev Summary of Product Characteristics and Package Leaflet2025-01-23Not public
Exhibit 4 - EP 1 830 843 B1 EPO registrar and national registrars2025-01-23Not public
Exhibit 9 - Zentiva Generics MAs: INFOMED extract (PT and ENG)2025-01-23Not public
Exhibit 16 - Written statement from Mariana Nascimento2025-01-23Not public
Response to the request for amendments2025-01-23Not public
Exhibit 7 - Decision of the Federal Court of Canada2025-01-23Not public
Proof of payment of court fees2025-01-23Not public
Exhibit 10 - Zentiva Generics: DCP procedure2025-01-23Not public
Exhibit 5 - Boehringer Ingelheim Pharma GmbH & Co. KG authorization2025-01-23Not public
Exhibit 13 - Notice no. 0689/2024 (PT and EN)2025-01-23Not public
Formal-checks_Request-for-correction2025-01-22Not public
Application-For-Measures-Acknowledgement2025-01-21Not public
Exhibit 6 - EP 1 830 843 B1 decision of the OD of the EPO2025-01-21Not public
Exhibit 14 - EP 1 830 843 B1opt-out and withdrawal of the opt-out2025-01-21Not public
Exhibit 10 - Zentiva Generics: DCP procedure2025-01-21Not public
Exhibit 3 - EP 1 830 843 B12025-01-21Not public
Exhibit 4 - EP 1 830 843 B1 EPO registrar and national registrars2025-01-21Not public
Exhibit 5 - Boehringer Ingelheim Pharma GmbH & Co. KG authorization2025-01-21Not public
Application for provisional measures2025-01-21Not public
Exhibit 12- Zentiva Generics SmPC and PL (PT and EN)2025-01-21Not public
Exhibit 15 - IQVIA DATA2025-01-21Not public
Exhibit 1- Boehringer Ingelheim Pharma GmbH & Co. KG authorized Boehringer Ingelheim International GmbH to file to proc2025-01-21Not public
Exhibit 16 - Written statement from Mariana Nascimento2025-01-21Not public
Exhibit 2 - Ofev Summary of Product Characteristics and Package Leaflet2025-01-21Not public
Proof of payment of court fees2025-01-21Not public
Exhibit 9 - Zentiva Generics MAs: INFOMED extract (PT and ENG)2025-01-21Not public
Exhibit 11 - Zentiva: authorised and registered wholesale distributor of medicines2025-01-21Not public
Exhibit 8 - Decision of China National Intellectual Property Administration2025-01-21Not public
Exhibit 13 - Notice no. 0689/2024 (PT and EN)2025-01-21Not public
Exhibit 7 - Decision of the Federal Court of Canada2025-01-21Not 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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