Mylan Pharmaceuticals Inc. v. Sebelius

Citation Number: 1:12-cv-524
Federal Court: District of Columbia
Brief of the Federal Trade Commission, as amicus curiae, submitted to the United States District Court for the District of Columbia, in a case challenging the Food and Drug Administration's decision giving the seller of a branded drug sole control of the 180-day exclusivity rights granted, under the Hatch-Waxman Act, to a first generic filer. The brief does not take a position on the FDA's interpretation and application of the governing statute and regulations, but explains the Commission's enforcement actions relating to the branded drug, Provigil, and describes the adverse effects on competition from allowing the branded drug seller to control the generic exclusivity period.