Recently, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Astellas Pharma, Inc. v. Sandoz Inc., No. 2023-2032 (Sept. 18, 2024), vacating and remanding the district court’s sua sponte finding of invalidity under 35 U.S.C. § 101.
Sandoz sued Astella and other generic drug manufacturers for infringement of U.S. Patent No. 10,842,780, directed to a sustained-release pharmaceutical composition. Sandoz’s invalidity contentions asserted invalidity under 35 U.S.C. §§ 102, 103, and 112, but not under 35 U.S.C. § 101. Sandoz further limited its invalidity defenses before trial, and neither party addressed patent eligibility at trial. In addressing Sandoz’s enablement defense in post-trial briefing, Astella described the inventive concept of the ’780 Patent as “discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.” Relying on Astella’s description, the district court sua sponte ruled that the asserted claims were directed to a law of nature and were invalid under 35 U.S.C. § 101.
The Federal Circuit vacated and remanded. The Court emphasized the long-standing principle of party presentation, i.e., the parties frame the issues for decision while the court decides those issues. Although the Court recognized that the party presentation principle is “supple, not ironclad,” it held that finding a patent invalid on a ground not raised by any party was an abuse of discretion. The Court explained that “[o]ne cornerstone” of patent litigation is a patent’s presumption of validity. This means that patent eligibility is not a threshold question that a court is required to determine; instead, a court must only determine whether the patent challenger has met its burden of establishing invalidity on the grounds raised in the litigation. The Court vacated and remanded for adjudication of the issues properly raised by the parties.
The Court denied Astella’s request that the case be reassigned on remand. The Court noted that reassignment is “an exceptional remedy” and explained that errors relating to the propriety of a district court’s analysis do not warrant reassignment. The Court explained that while the district court had expressed personal frustration regarding the pharmaceutical industry, those comments were directed to the entire industry (brand and generic manufacturers), and there was no indication that the judge “cannot resolve the outstanding issues impartially and fairly.”
