The Unified Patent Court (UPC) has delivered its first judgment on second medical use pharmaceutical patent claims in a closely watched case between Sanofi/Regeneron and Amgen. While upholding the validity of Sanofi and Regeneron's patent, the court ruled against their infringement claims regarding Amgen's cholesterol drug Repatha.
The decision, issued by the Düsseldorf Local Division on May 15, 2025, establishes a significant precedent for how second medical use claims—which protect the use of known substances for treating new medical conditions—will be handled under the new UPC system.
Key Aspects of the Ruling
The court found no evidence that Amgen's Repatha was being prescribed off-label for the patented use claimed by Sanofi and Regeneron. Critically, the judgment determined that Amgen neither knew nor should have known about such prescriptions, a factor that proved decisive in the non-infringement finding.
This ruling clarifies that to prove infringement of second medical use claims, patent holders must demonstrate not merely the potential for off-label use but evidence of actual or likely off-label prescribing patterns. Additionally, they must establish the alleged infringer's awareness of such use.
"This marks a notable shift from the more conservative stance traditionally taken by some European national courts," noted legal experts familiar with the case. The decision introduces what some are calling a "foreseeability" test for infringement.
The Foreseeability Standard
The Düsseldorf Local Division adopted a patentee-friendly approach by establishing that infringement can be found if the generic manufacturer "knows or reasonably should have known" that their product would be used for the patented indication.
This standard balances the interests of innovator companies seeking to protect their investments in discovering new uses for existing drugs against the public interest in access to off-patent medications for established uses.
Background on the Dispute
The case emerges from the long-running dispute between Sanofi/Regeneron and Amgen in the anti-PCSK9 antibody space. Both companies have developed monoclonal antibodies targeting PCSK9 to reduce LDL cholesterol levels in patients with hypercholesterolemia.
Sanofi and Regeneron market Praluent (alirocumab), while Amgen produces Repatha (evolocumab). Both drugs represent significant advances in cholesterol management, particularly for patients who cannot achieve target LDL levels with statins alone.
Implications for Pharmaceutical Innovation
The ruling has significant implications for pharmaceutical companies investing in research to discover new therapeutic applications for existing compounds. Second medical use patents are crucial for incentivizing such research, as they provide exclusivity for novel applications even after the original compound patent expires.
Dr. Elena Martínez, a pharmaceutical patent specialist at Cambridge University, explained: "This decision strikes a balance between protecting innovation and preventing overreach. Companies will need stronger evidence of intentional infringement, which could influence how they monitor market activities and document off-label usage."
Industry Response
Pharmaceutical industry representatives have expressed mixed reactions to the ruling. Innovator companies have voiced concerns that the evidentiary burden may be too high, potentially undermining the value of second medical use patents.
Generic manufacturers, meanwhile, have welcomed the clarity provided by the decision, noting that it reduces uncertainty about potential liability for legitimate marketing of drugs for non-patented indications.
Broader UPC Context
This case represents an important early test of the UPC system, which began operations in June 2023 after decades of preparation. The court's approach to second medical use claims was among the most anticipated aspects of UPC jurisprudence, given the divergent national approaches that existed previously across Europe.
The ruling suggests the UPC may be developing a harmonized approach that draws from various national traditions while establishing its own distinct jurisprudence.
What's Next
Legal experts anticipate that Sanofi and Regeneron may appeal the decision to the UPC's Court of Appeal. The companies have not yet announced their intentions.
Meanwhile, pharmaceutical companies across Europe are likely to review their patent enforcement strategies in light of this precedent, particularly regarding the evidence they gather to support infringement claims for second medical use patents.
The case number is UPC_CFI_188/2024, and the full judgment is expected to be published on the UPC's website in the coming days.
