UPC_CFI_1587/2025
- BIOGARAN a company registered with SIREN number 405 113 598
- BIOGARAN
- H. LUNDBECK A/S Ottiliavej 9
- H. Lundbeck A/S
- European Patent EP ’296, entitled “Nalmefene for reduction of alcohol consumption in specific
- EP’296 is a divisional patent deriving from the international application WO 2014/001427
- The Patent forms part of an uninterrupted sequence of European divisional applications
- EP 2866808 was revoked at LUNDBECK’s request
- Following the preliminary opinion issued by the EPO Opposition Division (OD) early this year
- The amendment is admissible under Rule 30.2 RoP
- The Court takes note that AR4, proposed originally as conditional on (partial) invalidity of the
- According to the Court of Appeal in Meril Italy v. Edwards Lifesciences
- Its admission is therefore consistent with procedural fairness, equality of arms and also with the
- In its Rejoinder, BIOGARAN advanced a substantially expanded line of argument based on the
- BIOGARAN'S new priority attacks against granted claims 7 and 9 and the corresponding
- LUNDBECK challenged these attacks with an application dated 19 June 2026, highlighting that
- BIOGARAN replied that a Rejoinder may include arguments and supporting evidence that clarify
- The Court does not allow those documents and the new arguments.
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Decisions and documents (1)
- 2026-10-09order on merits
1. The party alleging added matter must identify, by means of a specific comparison, the subject-matter of the original disclosure that is said to have been extended in the later application or divisional patent. The mere fact that the original application contains numerous embodiments and theoretically allows a very large number of combinations does not establish added matter. Although this may raise issues of clarity or drafting technique, an extension of subject-matter arises only where the granted claim conveys technical information that the skilled person could not derive directly and unambiguously from the application as filed, contrary to Articles 123(2) and 138(1)(c) EPC. Procedural fairness under recital 5 of the Preamble to the RoP requires each party to plead its grounds of challenge clearly and with sufficient specificity. The Court can neither cure deficiencies in those grounds nor supplement them of its own motion, since doing so would substitute the Court for the challenging party and compromise its impartiality. 2. Where the alleged contribution to the art lies in the identification of a physiologically or pathologically distinct patient subgroup, the patent must provide sufficient technical information to identify that subgroup and to make it credible that the medicinal product is suitable for the claimed therapeutic use in that subgroup. In that context, the precise therapeutic dosage need not be stated in the independent claim, provided that the skilled person, on the basis of the patent, the prior art and common general knowledge, can select a safe and effective dose without undue burden in the exercise of their routine competence. 3. An inventive-step objection cannot be sustained by reconstructing the claimed solution with knowledge of the patent. Where an obviousness attack can be constructed only by selecting and combining numerous (more than 10) disclosures addressing different technical questions, none of which supplies the missing pointer or gives the skilled person a reason to consult the others, the resulting mosaic is indicative of an ex post facto analysis rather than the course the skilled person would have followed at the effective date.
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