BIOGARAN v H. Lundbeck (CFI, 9 October 2026)

Dhenne Avocats · 17 October 2026

Our analysis

Summary

In a decision of 9 October 2026 (UPC_CFI_1587/2025), the Milan section of the Central Division dismissed Biogaran’s revocation action against EP 4 223 296, held by H. Lundbeck A/S and directed to nalmefene, to the extent that the patent is maintained in amended form. The decision clarifies the novelty test for a second medical use defined by a patient subgroup and the weight of an EPO Board of Appeal ruling before the UPC.

Facts and procedure

Biogaran relied on added matter, insufficiency, lack of novelty, lack of inventive step and invalid priority. At the opening of the oral hearing, Lundbeck applied unconditionally to delete dependent claims 7 and 9 to bring the patent into line with the text amended before the EPO Opposition Division after its preliminary opinion. That text, which corresponds to auxiliary request 4, was admitted under Rule 30.2 RoP read with Rules 49.2 and 50.2 RoP (paragraphs 5 to 8). Five late-filed documents and the attacks based on them were disregarded (paragraphs 15 to 22), and the remaining auxiliary requests were inadmissible (paragraph 23).

Question

Does the identification of a subgroup of alcohol-dependent patients suffice to make a second medical use of nalmefene novel?

Decision

Claim 1 validly enjoys priority from P2 (paragraph 102), so three documents cannot be cited under Article 54(2) EPC. The added matter objection failed: the first attack was insufficiently substantiated (paragraphs 108, 115 and 116), and claim 1 is directly and unambiguously derivable from embodiments E24 to E26 of WO’427 (paragraphs 119 to 126). All three insufficiency attacks were rejected (paragraphs 138, 156 and 180).

On novelty, a patient subgroup confers novelty only if it is physiologically or pathologically distinct, and merely singling out a subset is not enough (paragraph 183). The patent targets patients with a high drinking risk level who maintain that level after the observation period, which excludes those who reduce their intake spontaneously (paragraph 191). Karhuvaara et al. does not directly and unambiguously disclose that subgroup (paragraphs 209 to 214), so novelty was established (paragraph 220).

The objective technical problem is to identify, among alcohol-dependent patients, a subgroup in which nalmefene achieves a more marked reduction in consumption (paragraph 222). Board of Appeal decision T 0963/20 on the parent patent EP’564 has no res judicata effect before the UPC and can only be persuasive (paragraphs 224 and 225). Karhuvaara et al. and Lundbeck’s 2011 press release are realistic starting points (paragraphs 228 to 230), but neither points towards the claimed subgroup (paragraphs 233 and 234). The inventive step attacks therefore failed (paragraph 273). Biogaran bears the costs under Article 69(1) UPCA (paragraph 276) and must pay an interim award of costs of EUR 100,000 within three weeks (paragraphs 277 to 279).

Key points for practice

• A patient subgroup establishes novelty only where it is physiologically or pathologically distinct.
• A Board of Appeal decision on a parent patent does not bind the UPC, which treats it as persuasive authority only.
• Aligning the text defended before the UPC with the version the Opposition Division is minded to maintain may justify admitting an amendment filed at the hearing.

Provisions applied

Rules of Procedure

Rules 30.2, 49.2 and 50.2 RoP

UPC Agreement

Article 69(1) UPCA

European Patent Convention

Article 54(2) and (5) EPC

Case law cited

EPO Board of Appeal, T 0963/20, parent patent EP’564

Related decisions

• No other decision in these proceedings is currently in the database.

Prepared by Dhenne Avocats from the official decision, consulted on 17 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.