First Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011.
The current system of regulating the multi-billion-dollar pharmaceutical industry via market exclusivity comes from the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The statute creates the framework for controlling the entry of generic drugs by a notification and certification system that heavily relies on the "Approved Drug Products with Therapeutic Equivalence Evaluations," a publication commonly known as the "Orange Book." Ever since Congress passed the Hatch-Waxman Act and directed FDA to time generic drug entry based on patents, brand name and generic manufacturers alike have come up with innovative strategies to exploit the system. One major concern is the use of the generic exclusivity period to improperly delay further generic entry. After MedImmune and the MMA amendments, the Federal Circuit followed suit and liberalized standing requirements for generic manufacturer plaintiffs in declaratory judgment actions against brand name manufacturers. This article examines the changing role of declaratory judgment actions in challenging patents upon generic entry and the Constitutional constraints, evaluates alternative regulatory schemes to FDA's current system of enforcement, and discusses the effects of increased litigation in the ANDA world.