This is the new MLex platform. Existing customers should continue to use the existing MLex platform until migrated.
For any queries, please contact Customer Services or your Account Manager. Dismiss

UPC second medical use ruling means off-label use alone won’t prove infringement

By Inbar Preiss ( May 15, 2025, 15:01 GMT | Comment) -- Sanofi and Regeneron have lost their infringement case against Amgen in the Unified Patent Court’s first ruling on a second medical use claim, though their patent was upheld as valid. The court found no evidence that Amgen’s cholesterol drug Repatha was being prescribed off-label for the patented use, nor that Amgen knew — or should have known — about such prescriptions. The judgment sets an early precedent that to prove infringement, rights holders must show not just potential, but actual or likely off-label use and the alleged infringer’s awareness of it.The Unified Patent Court this week handed down its first judgment on the infringement of a second medical use pharmaceutical patent claim, offering long-awaited guidance on how such claims — made to protect the use of a known substance for treating a new medical condition — will be handled under the new UPC system....

Prepare for tomorrow’s regulatory change, today

MLex identifies risk to business wherever it emerges, with specialist reporters across the globe providing exclusive news and deep-dive analysis on the proposals, probes, enforcement actions and rulings that matter to your organization and clients, now and in the longer term.


Know what others in the room don’t, with features including:

  • Daily newsletters for Antitrust, M&A, Trade, Data Privacy & Security, Technology, AI and more
  • Custom alerts on specific filters including geographies, industries, topics and companies to suit your practice needs
  • Predictive analysis from expert journalists across North America, the UK and Europe, Latin America and Asia-Pacific
  • Curated case files bringing together news, analysis and source documents in a single timeline

Experience MLex today with a 14-day free trial.

Start Free Trial

Already a subscriber? Click here to login

Related Sections