2026-10-09 - CD Milan - Biogaran v. H. Lundbeck - UPC-CFI-0001587/2025

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.

The Milan Central Division dismissed a generic company's revocation action against a second-medical-use patent defined by a patient subgroup, maintaining it in a form the proprietor had unconditionally limited to match its amendment before the EPO Opposition Division. Late-filed prior art and new attacks introduced in the rejoinder, partly drawn from the EPO's preliminary opinion, were excluded under the front-loaded procedure, and the Court held that an EPO Board of Appeal decision on a parent patent has no res judicata effect before the UPC. It held that a generic added-matter attack resting on the number of combinations in the parent application was insufficiently substantiated (while examining it anyway), that the patent was sufficiently disclosed although claim 1 recites no dose and the trials excluded some patients, and that a patient subgroup confers novelty under Art. 54(5) EPC where its defining characteristics are functionally linked to an improved therapeutic effect. Inventive step was upheld because no realistic starting point, alone or combined with over ten further documents, pointed to selecting the subgroup with a reasonable expectation of success; such a mosaic indicates hindsight.