Federal Circuit IP

Astellas v. Sandoz

Published October 16, 2024

Case No. 23-2032, Precedential, (Fed. Cir. Sep. 18, 2024)

Lourie, Prost, Reyna

Facts/Background:

  • Astellas sued Sandoz for patent infringement.
  • Sandoz agreed to limit its invalidity defenses to only 35 U.S.C. 112.
  • None of the parties brought up § 101 at all.
  • But the district court used § 101 to find the claims invalid, sua sponte.
  • The district court refused to make further findings of fact or law.

Issue: did the district court abuse its discretion in holding the claims invalid under § 101?  

Holding: yes.

Analysis:

  • Party presentation principle: “we rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present.” Greenlaw v. United States, 554 U.S. 237, 243 (2008).
  • 35 U.S.C. 101 is not a foundational inquiry.
    • Rather, § 101 was examined by the USPTO and should be covered by the presumption of validity if it is not raised by the parties.

Takeaways: the court cannot use 35 U.S.C. 101 to invalidate claims when none of the parties have raised that issue.