Articles

The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition

Current Topics in Medicinal Chemistry
Winter 2010

Sokal, Allen M.

Article

This article, by Finnegan partner Allen Sokal reviews the congressional goals and background of the Hatch-Waxman Act and examines the statutory provisions applicable to drug products that are directed to fulfilling the congressional goals.  The authors discuss how Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. They state that the Act contains important provisions directed to fulfilling each goal, including provisions favorable to either branded drug or generic drug manufacturers. In the article Sokal and Gerstenblith provide a framework for understanding the main provisions of the Act that achieve the primary congressional goals.