Hatch-Waxman Act: Overview

Practical Law Company
March 2013

This article provides an overview of the Hatch-Waxman Act system in the United States. The article details the innovator and generic drug approval process, including patent and non-patent exclusivity, and experimental use “safe harbor.” The article also discuss the system of “Paragraph IV” patent litigation created by the Act in depth, ranging from the initial submission of an ANDA through final remedies or settlement.

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