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UPC CFI 1587/2025
Nov 14, 2025·EP4223296 Unitary patent · NALMEFENE FOR REDUCTION OF ALCOHOL CONSUMPTION IN SPECIFIC TARGET POPULATIONS
- Case details
- StatusCase Closed (Patent upheld as amended)ActionRevocationCategoryMain revocation action
- Parties
- Claimants
- BIOGARANOperating co.
Respondents- H. Lundbeck A/SOperating co.
Representatives- Benoît Strowel-Hoyng Rokh Monegier
- Amandine Métier-Hoyng Rokh Monegier
- Alix Fourmaux-Hoyng Rokh Monegier
- Nathalie Rodriguez Arigon-Hoyng Rokh Monegier
- Division
- Milan CD
- Technology
- ChemistryPharmaceuticals
- Language
- English
- First decided
- Oct 9, 2026
- EPO Opposition
- Alfred E. Tiefenbacher (GmbH & Co. KG)Admissible2025-10-27
- BIOGARANAdmissible2025-10-29
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.
| Patent revoked | Median days to first decision | |
|---|---|---|
| All UPC | 37% (34/91) | 124 |
| Milan CD | Locked | Locked |
| Judge Andrea Postiglione | Locked | Locked |
| Judge Anna-Lena Klein | Locked | Locked |
| Judge Eric Enderlin | Locked | Locked |
At the UPC: BIOGARAN (2 cases)·H. Lundbeck A/S (2 cases)
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Related cases
All proceedings on this patentThis dispute contains 1 other proceedings
Decisions
- 2026-10-09RevocationPublic
Summary: The Milan central division dismissed Biogaran's revocation action of EP 4223296 in so far as the patent is maintained in the amended form (Lundbeck's unconditional Auxiliary Request 4, deleting dependent claims 7 and 9). The added matter, sufficiency and inventive step attacks were held unfounded. Biogaran bears Lundbeck's costs, with an interim award of EUR 100,000, and the value of proceedings is set at EUR 2 million.
Show the legal issues (5)
- Added matter (Art. 123(2) EPC / Art. 138(1)(c) EPC) in a divisional
- Sufficiency of disclosure for a patient-subgroup medical use
- Inventive step and ex post facto analysis
- Admissibility of late attacks and unconditional amendment (AR4, R. 30 RoP)
- Interim award of costs (R. 119 RoP)
Documents
| Document title | Date | Public |
|---|---|---|
| Publication of decision | 2026-10-09 | Not public |
| Case closed | 2026-10-09 | Not public |
| Decision | 2026-10-09 | Not public |
| Decision | 2026-10-09 | Public |
| Communication | 2026-10-08 | Not public |
| Other Documents | 2026-09-15 | Not public |
| Receipt | 2026-09-14 | Not public |
| Cover sheet | 2026-09-14 | Not public |
| Document | 2026-09-14 | Not public |
| Oral procedure opened | 2026-09-02 | Not public |
| Interim procedure closed | 2026-09-02 | Not public |
| Other Documents | 2026-09-02 | Not public |
| Summons to oral hearing | 2026-09-02 | Not public |
| Order | 2026-09-02 | Not public |
| Hearing recording reference document | 2026-08-27 | Not public |
| Communication | 2026-08-25 | Not public |
| Other Documents | 2026-08-25 | Not public |
| Interim procedure opened | 2026-08-07 | Not public |
| Written procedure closed | 2026-08-07 | Not public |
| Order | 2026-08-07 | Not public |
| Order | 2026-08-07 | Not public |
| Receipt | 2026-07-15 | Not public |
| Cover sheet | 2026-07-15 | Not public |
| Further pleadings | 2026-07-15 | Not public |
| Receipt | 2026-07-08 | Not public |
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| Exhibit Defendant | 2026-07-08 | Not public |
| Further pleadings | 2026-07-08 | Not public |
| Communication | 2026-07-01 | Not public |
| Receipt | 2026-06-27 | Not public |
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| Document | 2026-06-27 | Not public |
| Communication | 2026-06-22 | Not public |
| Receipt | 2026-06-19 | Not public |
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| Application document Defendant | 2026-06-19 | Not public |
| Receipt | 2026-06-08 | Not public |
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| Statement of rejoinder | 2026-06-08 | Not public |
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| Statement of rejoinder | 2026-05-08 | Not public |
| Communication | 2026-04-20 | Not public |
| Receipt | 2026-04-17 | Not public |
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| Summons to oral hearing | 2026-04-17 | Not public |
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| Order | 2026-04-14 | Not public |
| Order | 2026-04-14 | Not public |
| Receipt | 2026-04-09 | Not public |
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| Application to Amend Patent Defence | 2026-04-09 | Not public |
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| Statement of reply | 2026-04-09 | Not public |
| Summons to oral hearing | 2026-03-17 | Not public |
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| Receipt | 2026-03-02 | Not public |
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| Document | 2026-03-02 | Not public |
| Communication | 2026-02-24 | Not public |
| Receipt | 2026-02-09 | Not public |
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| Application to Amend Patent | 2026-02-09 | Not public |
| Statement of defence | 2026-02-09 | Not public |
| Publication | 2025-12-12 | Not public |
| Publication | 2025-12-12 | Not public |
| Service Receipt/Service Document | 2025-12-11 | Not public |
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| Statement of claim | 2025-11-14 | Not public |
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Accepted arguments
What the court agreed with — by party.
Added matter requires a specific comparison with the original disclosure; numerous embodiments alone do not show extension
RespondentLegal basis: Art. 123(2) and 138(1)(c) EPCSkilled person can select a safe and effective dose without undue burden, so the dosage need not be in the independent claim
RespondentLegal basis: Sufficiency of disclosureThe obviousness attack is an ex post facto mosaic with no pointer to combine the documents
RespondentLegal basis: Art. 56 EPC
Rejected arguments
What the court did not agree with — and why.
Patent is invalid for added matter, insufficiency and lack of inventive step
ClaimantLegal basis: Art. 138(1) UPCA, EPCLate additional attacks based on EPO opposition arguments in the Rejoinder
ClaimantLegal basis: Recital 5 Preamble RoP