In Astellas Pharma, Inc. v. Sandoz Inc., No. 23-2032 (Fed. Cir. Sept. 18, 2024), the Federal Circuit vacated the district court's judgment and remanded the case.
Astellas's '780 patent relates to a sustained release formulation for the drug mirabegron. Following a bench trial, which was limited to infringement and validity under 35 U.S.C. § 112, the district court held sua sponte thatthe '780 patent was invalid as directed to patent-ineligible subject matter under 35 U.S.C. § 101.
The Federal Circuit held the district court erred by disregarding the principle of party presentation and abused its discretion because patent eligibility was not raised below by Sandoz. The Federal Circuit stated that "[i]t is for the parties—not the court—to chart the course of litigation." While Sandoz argued during oral argument that it pleaded an invalidity defense under § 101 in its answer, the Federal Circuit noted this argument was not raised on appeal and was thus forfeited.
The Federal Circuit declined to grant reassignment to a different judge on remand. The Federal Circuit was not convinced that the presiding judge could not resolve the outstanding issues impartially and fairly, particularly since the Federal Circuit clarified the "proper course for adjudication" on remand.
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