'Authorized Generics' Can Frustrate Patent Challenges by Generic Manufacturers

摘要

The Food and Drug Administration (FDA) has concluded that brand companies' marketing of so-called "authorized generics" during a generic company's 180-day exclusivity period is permissible under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FDCA).To no avail, generic companies have strenuously argued to the FDA that authorized generics are designed for the sole purpose of dissuading generic manufacturers from challenging invalid or unenforceable patents purportedly covering brand drugs. Frustrated by strong competition from authorized generics, generic companies are currently challenging the legality of the FDA's decision under the Administrative Procedure Act (APA) and federal antitrust laws. An authorized generic is the same as the brand drug, but it is sold by the brand company at a lower price, usually through a licensed distributor. Marketed as a competitor to a generic version approved pursuant to an Abbreviated New Drug Application (ANDA), the brand company may sell an authorized generic during the ANDA applicant's 180-day exclusivity period.