BRIEF—US Court denies Astellas petition on Lexiscan patent infringement

Japanese drug major Astellas Pharma today confirmed that the US Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of Lexiscan (regadenoson injection) 0.4mg/mL.

On May 3, 2023, the CAFC denied our petitions for rehearing and rehearing en banc of the CAFC’s December 30, 2022 Opinion that affirmed the US District Court for the District of Delaware’s earlier decision that all asserted claims of the patents for Lexiscan are not infringed by generics ad biosimilar injectables specialist Hospira Inc.

Astellas has already reflected the impact from this decision in its financial forecast of the current fiscal year ending March 31, 2024.