Biogaran v. H. Lundbeck A/S, UPC Central Division, Milan section, 9 October 2026, Case no. UPC_CFI_1587/2025
The use of nalmefene to treat alcohol-dependent patients was known. EP ‘296 is a second medical use patent, directed at the definition of a subgroup of alcohol-dependent patients who respond better to said nalmefene.
Biogaran sought revocation of EP ‘296 at the Central Division Milan. It’s attack failed.
Objective technical problem
“54. In the Court’s view, the objective technical problem could be formulated as the identification of the subgroup of alcohol-dependent patients who derive an improved therapeutic benefit from treatment with nalmefene. This formulation reflects the technical contribution disclosed in the patent while avoiding any pointer to the claimed solution.”
Added matter
Biogaran based its added matter attack on the argument that embodiments E1-E135 disclosed in parent application WO’427 give rise to millions of possible combinations and that the subject-matter of EP’296 therefore does not comply with Article 138(1)(c) EPC.
The Court disagreed:
“111. […] [T]he 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.
“112. BIOGARAN was therefore required to specify which features of EP’296 were absent from WO’427 (and only WO’427 since no arguments have been put forward as to the other parent
applications) or resulted from an impermissible generalisation or extension of its disclosure.
“113. The mere fact that the original application contains numerous embodiments and theoretically allows a very large number of combinations does not, in itself, 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.
“114. As an impartial body, the Court cannot further develop or investigate an objection stated only in general terms. Doing so would amount to an inadmissible ex officio examination of a ground for invalidity raised by a party.”
The Court, citing the present uncertainty as to the degree of specificity required for an added matter attack, and pending further guidance from the Court of Appeal, nevertheless carried out an ex officio assessment and carried out a comparative examination of WO’427 and EP’296. It found the added matter attack unfounded.
Sufficiency
The Court considered that the invention was sufficiently disclosed.
Novelty, inventive step
The Court considered the patent to be both novel and inventive. With respect to inventive step it held that Biogaran’s attack suggests hindsight as it drew on more than ten disclosures. Absent pointers, the skilled person has no reason to combine them:
“255. The mere fact that relevant features are disclosed separately and in different contexts, and could in principle be combined, is insufficient: absent a pointer, the skilled person has no reason to combine them. An inventive-step objection cannot therefore be sustained by reconstructing the claimed solution with knowledge of the patent.
“256. The fact that this attack relies on the combination of such a large number of prior-art documents suggests hindsight. 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.
The Decision can be read here.
