Number: RS21129
Title: Pharmaceutical Patent Term Extensions: A Brief Explanation
Authors: Wendy H. Schacht and John R. Thomas, Resources, Science and Industry Division 
Abstract: The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the "Hatch-Waxman" Act, permits limited extensions to compensate for market time lost during the drug approval process undertaken by the FDA. Independent of the patent term, the FDA may provide market exclusivity to pharmaceuticals meeting specific conditions under the Hatch-Waxman Act, the Orphan Drug Act, and the Best Pharmaceuticals for Children Act.
Pages: 5
Date: Updated January 31, 2002