Number: RL32377
Title: The Hatch-Waxman Act: Legislative Changes in the 108th Congress Affecting Pharmaceutical Patents
Authors: Wendy H. Schacht, Resources, Science, and Industry Division; and John R. Thomas, Resources, Science, and Industry Division 
Abstract: As a result of the debate over the cost of prescription drugs, the 108th Congress passed P.L. 108-173, the Medicare Prescription Drug and Modernization Act of 2003. Title XI of the legislation amends the Hatch-Waxman Act and makes changes to the process of patent challenges by generic firms designed to decrease the time needed to bring generic pharmaceuticals to the marketplace. The provisions are intended to encourage more generic options to innovator drugs and to help ease some of the uncertainty surrounding the marketing of generic products. However, several issues may remain of interest to Congress as Title XI of P.L. 108-173 is implemented. Certain concerns may be raised as a consequence of the changes in law; others may arise from the original legislation. Still additional issues may result from legal challenges and decisions of the court interpreting the law.
Pages: 14
Date: April 30, 2004