Precedential and Key Federal Circuit Opinions
1. ASTELLAS PHARMA v. SANDOZ INC. [OPINION] (2023-2032, 2023-2063, 2023-2089, 9/18/24) (Lourie, Prost, Reyna)
Lourie, J. The Court vacated and remanded the district court’s finding that the asserted claims are invalid under 35 U.S.C. § 101 as directed to an ineligible natural law. Because no party had raised an invalidity challenge under § 101, the Court found the district court abused its discretion by disregarding the principle of party presentation.
The asserted patent covers a sustained release form of Astellas’ drug Myrbetriq®, which is used to treat an overactive bladder. Sandoz’s invalidity contentions asserted invalidity under 35 U.S.C. §§ 102, 103, and 112. Later, as part of a joint pre-trial stipulation, Sandoz agreed to limit its invalidity defenses to § 112 defenses.
In its post-trial briefing, Astellas stated that “in the context of enablement under § 112, the ‘inventive concept of the [asserted patent] was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.’” The district court used this statement as a concession that Astellas agreed the asserted claims are directed to “invalid subject matter: a natural law applied via routine, conventional, and well-known methods.” Although Sandoz did not assert invalidity based on § 101, the district court determined the asserted claims were invalid under § 101 and denied Sandoz’s invalidity defense under § 112.
Following the entry of judgment, Sandoz, the prevailing party, moved pursuant to Federal Rule of Civil Procedure 52(b), asking the district court to make additional findings, including on its § 112 defenses, because no § 101 defense was presented at trial. As anticipated, Astellas appealed the district court’s finding of invalidity on § 101.
On appeal, the Court held that the district court abused its discretion by disregarding the principle of party presentation, which allows parties to shape the course of litigation, and unilaterally finding the asserted claims invalid under § 101—a legal theory no party raised. In other words, because invalidity under § 101 was not advanced by either party during the litigation, the Court explained the district court cannot sua sponte determine the asserted patent is invalid under § 101 based on statements by Astellas during post-trial briefing when no party raised a § 101 defense.
