Neurelis Inc. v. Califf

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _________________________________________ ) NEURELIS, INC., ) ) Plaintiff, ) ) v. ) ) SARA BRENNER, et al., 1 ) ) Case No. 24-cv-1576 (APM) Defendants, ) ) and ) ) AQUESTIVE THERAPEUTICS, INC., ) ) Intervenor-Defendant. ) _________________________________________ ) MEMORANDUM OPINION I. INTRODUCTION Congress enacted the Orphan Drug Act (“ODA”) to encourage pharmaceutical companies to develop treatments for rare diseases that affect a small portion of the population. Among the Act’s various economic incentives is a seven-year period of…