Astellas Pharma, Inc. v. Sandoz Inc.

Case Name: Astellas Pharma, Inc. v. Sandoz Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374 (Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, J.) (Appeal from D. Del., Bataillon, J.) 

Drug Product and Patent(s)-in-Suit: Myrbetriq® (mirabegron); U.S. Patent No. 10,842,780 (“the ’780 patent”)

Nature of the Case and Issue(s) Presented: During the development of Myrbetriq, a drug that treats overactive bladder (“OAB”), Astellas discovered that immediate-release formulations of mirabegron exhibited an undesirable “food effect,” meaning that the bioavailability of the drug was affected by the presence or absence of food in the stomach. Astellas developed sustained-release formulations of mirabegron, which got around the food effect, and claimed those formulations in the ’780 patent.

On the day the ’780 patent issued, Astellas sued each of Sandoz, Zydus, Lupin, and Lek for patent infringement based on their respective submissions of ANDAs seeking to market generic versions of Myrbetriq. Sandoz raised multiple defenses, but did not pursue an invalidity defense under 35 U.S.C. § 101 during the discovery phase of the litigation. Before trial, Sandoz limited its invalidity defenses to only those arising under § 112. No other defenses were tried or raised during trial and post-trial briefing. However, the district court issued a final decision holding the asserted of the ’780 patent invalid as directed to patent-ineligible subject matter under 35 U.S.C. § 101. Following the entry of judgment, Sandoz moved pursuant to Rule 52(b) for the court to make additional findings of fact and conclusions of law on the issues actually presented at trial, which the court denied. Astellas appealed and the Federal Circuit vacated and remanded the district court’s judgment.

Why Astellas Prevailed: The principle of party presentation governs. “By rendering its decision on a ground not raised by any party at any stage of the proceedings, and by expressly declaring that it ‘sits not [as] an arbiter to resolve the disputes on the parties’ favored terrain,’ the district court disregarded the longstanding principle of party presentation and, in doing so, abused its discretion.” While, at times, it may be appropriate for a court to take a “modest initiating role” in the shape of the litigation, this was not such a scenario.

The district court interpreted Astellas’ “zealous defense” on issues of § 112 as conceding that the ’780 patent is enabled because it claims invalid subject matter: a natural law applied via routine, conventional, and well-known methods. It then used that “concession” to hold the patent invalid on a ground never advanced by Sandoz. That was an abuse of discretion. “It is for the parties—not the court—to chart the course of the litigation.” The district court believed that patent eligibility was a threshold inquiry that it had a duty to address—even if the parties did not—but the presumption of validity afforded to patents applied to that inquiry.

Next, Astellas requested that the case be reassigned to a different district court judge on remand. Astellas argued that the district court’s failure to abide by the party presentation principle is alone enough to warrant reassignment. Second, Astellas pointed to several statements that the district court made as evidencing bias toward the pharmaceutical industry that, in the district court’s opinion, has “colluded to protect weak or invalid patents and share in the startling profits.” But the Federal Circuit denied Astellas’ request. While agreeing that the statements made by the district court are irrelevant and understanding Astellas’ concern that the district court’s commentary may evidence a personal frustration with the pharmaceutical industry as a whole, the Federal Circuit trusted that the district court “can and will take an objective, measured, and thorough look into the legal issues and evidence of record to resolve only those disputes that exist between the parties.”