Litigating the Drug Price Competition and Patent Term Restoration Act of 1984

Abstract

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act in honor of its sponsors Senator Orrin Hatch and Representative Henry Waxman, was enacted in an attempt to reconcile two seemingly contradictory policy goals. The Act represented a compromise between the interests of generic drug manufacturers and the competing interests of the "pioneer" drug manufacturers who research and develop novel drug products. Thus, the Act was designed to improve the availability of inexpensive generic drugs, while maintaining sufficient incentives for investment in new drug development. The Hatch-Waxman Act creates a complex statutory framework, such that many problems and debates have arisen surrounding its implementation. This paper gives an overview of the issues that have been litigated under the Hatch-Waxman Act in the nearly sixteen years since its enactment.