UPC_CFI_505/2024 – Decision of 13 May 2025
The Düsseldorf Local Division ruled on an infringement action and counterclaim for revocation concerning EP 3 536 712 B1, a divisional patent directed to a specific second medical use of PCSK9 inhibitors for reducing lipoprotein(a) [Lp(a)] levels. While the Court upheld the validity of the patent, it dismissed the infringement claim for lack of sufficient evidence that the defendants’ product Repatha® is used in the claimed manner.
One particularly noteworthy procedural point in this decision concerns the Court’s rejection of the Defendants’ repeated reliance on “pleading ignorance” (in German civil procedure called: Bestreiten mit Nichtwissen), e.g. when contesting the standing of Claimant 1) as an exclusive licensee. The Düsseldorf Local Division held that such general denials did not fulfil the requirements of Rule 171.2 RoP, which states that facts which are not specifically contested shall be treated as admitted. The Düsseldorf Division stated further that Defendants apparently derived this objection from German procedural law, ignoring that the Rules of Procedure contain no corresponding provision.
The Defendants had questioned the authenticity and legal effectiveness of multiple license agreements, casting doubt on signatures, authority of signatories, and even on whether the submitted documents corresponded to the originals – yet without putting forward positive evidence or detailed reasoning. The Court found this tactic insufficient and emphasized that the UPC Rules of Procedure do not provide for a right to "plead ignorance" as a substitute for proper contestation.
This marks a clear divergence from German civil procedural law (Zivilprozessordnung – ZPO), where § 138(4) ZPO permits a party to declare lack of knowledge with respect to an allegation if the party has made reasonable efforts to obtain the necessary information and cannot, without its own fault, confirm or deny the fact. German courts typically accept such declarations if the relevant fact lies in the exclusive knowledge of the other party.
In contrast, the UPC has now adopted a stricter standard for factual contestation. General denials or evasive statements of non-admission will not suffice; a party must substantively engage with the factual allegation.
Second medical use claims require a “specific therapeutic use” under Art. 54(5) EPC. In this case, the claim was directed to the therapeutic reduction of elevated Lp(a) in patients at risk of cardiovascular or thrombotic occlusive disease and not on a statin regimen.
Infringement of second medical use claims under Art. 25 UPCA requires both an objective element (that the product is likely used for the claimed purpose) and a subjective element (that the alleged infringer knew or should have known about such use).
Inventive step was confirmed. Although PCSK9 inhibitors were known for lowering LDL-C, the Court found that their use to reduce Lp(a) levels was not obvious in view of the prior art due to prevailing scientific uncertainty regarding Lp(a) metabolism and the role of PCSK9. The Court in its 4th headnote:
“In terms of inventive step, the subject matter of the claim may be obvious if the skilled person would have been motivated to implement it as the next step in the view of the problem. A motivation to implement may be absent or negated if the skilled person is faced with many uncertainties or expected difficulties. If there is no motivation at all or a negated motivation, the subject matter of the claim is not obvious and involves an inventive step.”
