Genus Lifesciences, Inc. v. Azar

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA GENUS LIFESCIENCES, INC., Plaintiff, v. ALEX M. AZAR II, et al., Case No. 1:20-cv-00211 (TNM) Defendants, LANNETT CO., INC., Intervenor-Defendant. MEMORANDUM OPINION In the pharmaceutical development arena, Congress created a “winner-take-all” prize. Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the first developer of a “new chemical entity” (“NCE”)—a drug approved for the first time in the United States—receives a coveted period of exclusivity (“NCE exclusivity”). During that time, competing drugs generally cannot can enter…