Background Paper

Hatch-Waxman, Generics, and Patents: Balancing Prescription Drug Innovation, Competition, and Affordability
June 21, 2002


Robin J. Strongin, Consultant


This paper explores the complex connections among intellectual property protection, competition, and access to affordable prescription drug products. It focuses on several provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) and discusses the debate swirling around its reform. An overview of landmark intellectual property laws and a description of the generic drug approval process are also included.

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