Otsuka Pharmaceutical Co., Ltd. v. Burwell

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ) OTSUKA PHARMACEUTICAL CO., ) LTD., et al., ) ) Plaintiffs, ) ) v. ) Civil Action No. 15-cv-1688 (KBJ) ) SYLVIA MATHEWS BURWELL, in her ) official capacity as Secretary of the ) United States Department of Health and ) Human Services, et al., ) ) Defendants, ) ) and ) ) ALKERMES, INC., et al., ) ) Intervenor-Defendants. ) ) MEMORANDUM OPINION To incentivize the development and marketing of safe, effective, and affordable drug products, the Federal Food, Drug, and Cosmetic Act (“FDCA”),

21 U.S.C. § 321

et seq., provides a variety of…