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UPC CoA 446/2025
May 23, 2025·EP1830843 +1 more: INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES
- Case details
- StatusCase ClosedActionAppealCategoryMain Appeal
- Parties
- ClaimantsReps: Joana Piriquito Santos (Piriquito Santos & Associados)
- Division
- Court of Appeal
- Technology
- Organic Chemistry
- Language
- English
Decisions
- 2025-08-13PI grantedAppeal RoP220.1
The Court of Appeal set aside the Lisbon Local Division's refusal to grant provisional measures and ordered a preliminary injunction against Zentiva Portugal prohibiting the making, offering, placing on the market or use of nintedanib products (Nintedanib Zentiva 100mg and 150mg soft capsules) for idiopathic pulmonary fibrosis in 17 UPC Contracting Member States while EP 1 830 843 remains in force. The court held that completion of national HTA/pricing/reimbursement procedures constitutes imminent infringement. Zentiva was ordered to pay EUR 199,000 as an interim award of costs. The request for an information order was denied.
Legal issues:Imminent infringement in generic medicines contextMarketing authorisation vs HTA/pricing procedures as imminent infringementOrder to communicate information under Art. 67 UPCANational law as source of law under Art. 24 UPCAProvisional measures in pharmaceutical patent disputesDamages: 199,000
Documents
| Document title | Date | Public |
|---|---|---|
| Acknowledgement-of-lodging | 2025-08-14 | Not public |
| Acknowledgement-of-lodging | 2025-08-14 | Not public |
| Headnote-and-Keywords | 2025-08-14 | Not public |
| DecisionOutcome | 2025-08-14 | Not public |
| Final order | 2025-08-14 | Public |
| Decision-On-Appeal-On-Measures-Outcome | 2025-08-13 | Not public |
| Final order | 2025-08-13 | Public |
| Hearing reference | 2025-07-23 | Not public |
| Hearing reference | 2025-07-23 | Not public |
| Receipt | 2025-07-21 | Not public |
| Exhibit 2 | 2025-07-19 | Not public |
| Application - new framework agreement | 2025-07-19 | Not public |
| Exhibit 1 | 2025-07-19 | Not public |
| Interim-Procedure-Closure | 2025-06-30 | Not public |
| Summon-Oral-Hearing | 2025-06-30 | Not public |
| Summons to OH | 2025-06-30 | Public |
| Interim-Conference-Decision | 2025-06-30 | Not public |
| Receipt | 2025-06-26 | Not public |
| Boehringer Statement of Response | 2025-06-25 | Not public |
| Generic application | 2025-06-25 | Not public |
| Boehringer Statement of Response | 2025-06-25 | Not public |
| Application in response to order re. OH 20.06.2025 | 2025-06-20 | Not public |
| Comments pursuant to RoP 264 | 2025-06-20 | Not public |
| Receipt | 2025-06-20 | Not public |
| OH request follow up BI vs Zentiva | 2025-06-20 | Not public |
| OH request follow up BI vs Zentiva | 2025-06-20 | Not public |
| Response to the Order of the Court issued on 16 June 2025 | 2025-06-20 | Not public |
| Application in Response to CoA Order OH | 2025-06-20 | Not public |
| Request for OH availability | 2025-06-16 | Not public |
| Acknowledgement-of-lodging | 2025-06-12 | Not public |
| Panel-Appointment | 2025-06-12 | Not public |
| Receipt | 2025-06-12 | Not public |
| Acknowledgement-of-lodging | 2025-06-12 | Not public |
| Requirements-OK-Cross-Appeal | 2025-06-12 | Not public |
| Panel-Appointment | 2025-06-12 | Not public |
| Acknowledgement-of-lodging | 2025-06-11 | Not public |
| Exhibit 1 - Decision and Final Report under Framework Agreement - Part 1 | 2025-06-11 | Not public |
| Exhibit 1A - Payment of Court Fees | 2025-06-11 | Not public |
| Exhibit 1 - Decision and Final Report under Framework Agreement - Part 3 | 2025-06-11 | Not public |
| Exhibit 1 - Call for proposals under Framewrok Agreement - Part 1 | 2025-06-11 | Not public |
| Exhibit 1 - Decision and Final Report under Framework Agreement - Part 2 | 2025-06-11 | Not public |
| Exhibit 1 - Decision and Final Report under Framework Agreement - Part 5 | 2025-06-11 | Not public |
| Exhibit 1 - Call for proposals under Framework agreement - Part 2 | 2025-06-11 | Not public |
| Exhibit 1 - Call for proposals under Framework agreement - Part 3 | 2025-06-11 | Not public |
| Exhibit 1 - Decision and Final Report under Framework Agreement - Part 4 | 2025-06-11 | Not public |
| Statement and Grounds of Cross-appeal | 2025-06-11 | Not public |
| Exhibit 1 - Call for proposals under Framework Agreement - Part 4 | 2025-06-11 | Not public |
| Exhibit 1 - Generic application 08.04.2025 | 2025-06-11 | Not public |
| Exhibit 2 - Statement Onsynergy | 2025-06-11 | Not public |
| Acknowledgement-of-lodging | 2025-06-10 | Not public |
| Exhibit 1 - Part 4 | 2025-06-10 | Not public |
| Statement of Response | Cross-Appeal | 2025-06-10 | Not public |
| Exhibit 1 - Part 3 | 2025-06-10 | Not public |
| Exhibt 1- Part 1 | 2025-06-10 | Not public |
| Exhibit 1 - Part 7 | 2025-06-10 | Not public |
| Exhibit 1A | 2025-06-10 | Not public |
| Exhibit 1 - Part 8 | 2025-06-10 | Not public |
| Exhibit 1 - Part 10 | 2025-06-10 | Not public |
| Exhibit 1 - Part 6 | 2025-06-10 | Not public |
| Exhibit 1 - Part 2 | 2025-06-10 | Not public |
| Exhibit 1 - Part 9 | 2025-06-10 | Not public |
| Exhibit 2 | 2025-06-10 | Not public |
| Exhibit 1 - Part 5 | 2025-06-10 | Not public |
| Acknowledgement-of-lodging | 2025-05-26 | Not public |
| Panel-Appointment | 2025-05-26 | Not public |
| Receipt | 2025-05-26 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-26 | Not public |
| Acknowledgement-of-lodging | 2025-05-23 | Not public |
| Exhibit 1A | 2025-05-23 | Not public |
| Statement of Appeal and Statement of Grounds of Appeal | 2025-05-23 | Not public |
| Exhibit 2A | 2025-05-23 | Not public |