Sanofi & Regeneron v Amgen (UPC_CFI_195/2025)
Decision date:
06 August 2025
Osborne Clarke summary
- This was an infringement and revocation action concerning Sanofi's patent EP 857, which was parallel to proceedings between Sanofi and Amgen relating to Sanofi's EP 3 536 712. In the EP 712 action, the Düsseldorf LD found the patent valid but not infringed by Amgen's PCSK9 inhibitor product, Repatha.
- The EP 712 decision is under appeal, and Sanofi sought to stay these proceedings pursuant to Rule 295(m) RoP on the basis that infringement of EP 857 involves the same factual and legal questions.
- The court allowed the stay, finding that the stay was in accordance with the requirements of proper administration of justice. It held that it was reasonable to conserve the court's and the parties' resources until after a decision of the Court of Appeal in the EP 712 case. It stated that, if the Court of Appeal upheld the finding of non-infringement of EP 712, the Düsseldorf LD was likely to dismiss the present claim, so staying proceedings would avoid unnecessary expenditure in the meantime.
- On the other hand, if the Court of Appeal upheld the appeal it was "reasonable and fair" that Sanofi should be able to present new legal arguments, and Amgen would then have an opportunity at first instance to argue why the case should be approached differently.
- Contrary to Sanofi's arguments, the Düsseldorf LD did not consider a stay to be in conflict with the right to an effective legal remedy and a fair and public hearing within a reasonable time or the principles of proportionality, flexibility, fairness and equity. It noted that no (permanent) injunction had been granted against Amgen.
Issue
Curious about how UPC decisions might impact your business? Have questions about the UPC?
Reach out to our patents team for expert guidance and support.