UPC CFI 41/2025
22. Jan. 2025·EP1830843 · INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES
Hauptaktenzeichen: ACT 3186/2025
- Verfahrensdetails
- StatusCase ClosedIn der Berufung aufgehoben, 13. Aug. 2025VerfahrensartEinstweilige VerfügungKategorieEinstweilige Maßnahmen
- Parteien
- Kläger
- BOEHRINGER INGELHEIM INTERNATIONAL GMBHUnternehmen
Vertreter- Joana Piriquito Santos-NLP - Nazaré, Lima, Piriquito Santos & Associados
- Sara Nazaré-NLP - Nazaré, Lima, Piriquito Santos & Associados
- Beatriz Lima-NLP - Nazaré, Lima, Piriquito Santos & Associados
- Division
- Lisbon LD
- Technologie
- ChemistryPharmaceuticals
- Sprache
- English
- Erste Entscheidung
- 8. Mai 2025
- EPA-Einspruch
- SANDOZ AG2013-08-07
- Berufung
- Aufgehoben durch UPC CoA 446/2025 · 13. Aug. 2025
| Einstweilige Verfügung erlassen | Median Tage bis zur ersten Entscheidung | |
|---|---|---|
| Gesamt-UPC | 54% (38/70) | 124 |
| Lisbon LD | Gesperrt | Gesperrt |
| Richter Rute Lopes | Gesperrt | Gesperrt |
| Richter Camille Lignières | Gesperrt | Gesperrt |
| Richter Petri Rinkinen | Gesperrt | Gesperrt |
Vor dem UPC: BOEHRINGER INGELHEIM INTERNATIONAL GMBH (3 Verfahren)·Zentiva Group (15 Verfahren)
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- 2025-05-08Application for provisional measuresÖffentlich
Zusammenfassung: 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.
Rechtsfragen anzeigen (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
| Dokumenttitel | Datum | Öffentlich |
|---|---|---|
| Outcome of the Order | 2025-05-26 | Nicht öffentlich |
| Declaration | 2025-05-26 | Öffentlich |
| Outcome of the Order | 2025-05-21 | Nicht öffentlich |
| Template-order | 2025-05-16 | Öffentlich |
| Declaration | 2025-05-16 | Öffentlich |
| Measures_DecisionOutcome_Notification.pdf | 2025-05-16 | Nicht öffentlich |
| Final order | 2025-05-08 | Öffentlich |
| Receipt | 2025-04-22 | Nicht öffentlich |
| Request to the Registrar for the recording of the oral hearing to be made available | 2025-04-22 | Nicht öffentlich |
| record | 2025-04-16 | Nicht öffentlich |
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.
No imminent infringement: receipt of marketing authorisations and filing of PEP request does not demonstrate market entry is imminent before patent expiry
BeklagterRechtsgrundlage: Art. 62(1) UPCA; Art. 25 UPCAHinweis: 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
BeklagterHinweis: 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.
Imminent infringement established by Infarmed notice, receipt of marketing authorisations, and filing of PEP request
KlägerRechtsgrundlage: Art. 62(1) UPCABegründung: 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.
Weitere Fälle zu diesem Grundsatz ansehen.