In its ruling on EP 3 536 712 B1, the Düsseldorf Local Division of the UPC for the first time outlined crucial criteria for patent infringement based on second medical use claims. Central to the case was whether marketing a PCSK9 inhibitor for lowering lipoprotein(a) constitutes patent infringement, even if this specific indication is not explicitly mentioned in the product’s SmPC.
The court initially referred to the established German approach—especially the principle of “preparation-free liability”—and raised the evidentiary bar: To establish infringement, both a “marketed or foreseeable use” for the patented therapy and corresponding knowledge or negligent ignorance on the part of the supplier must be demonstrated. The judges emphasized that a thorough assessment of all circumstances of the specific case is required, with a special focus on actual prescription practices and market behavior.
This decision highlights significant parallels with German legal practice but sets new standards in evidence and legal certainty, providing transparency for pharmaceutical companies dealing with skinny label products and off-label uses. The ruling marks a key step toward harmonized enforcement of patent rights within the UPC and serves as a vital reference point for the life sciences sector throughout Europe.
