The Hatch-Waxman Act: Legislative Changes in the 108th Congress Affecting Pharmaceutical Patents
Publication Date: April 2004
Publisher: Library of Congress. Congressional Research Service
Author(s):
Research Area: Law and ethics; Manufacturing and industry
Type:
Abstract:
Congressional interest in the cost of prescription drugs, particularly for the elderly, has focused attention on several areas where the federal government has programs and policies associated with the development and accessibility of pharmaceuticals in the marketplace. One of the most prominent legislative actions in this area is P .L 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act) . This law makes several significant changes to the patent laws as they apply to pharmaceutical products in an attempt to balance the need for innovative new drugs and the availability of less expensive generic products . The Hatch-Waxman Act establishes several practices that make it easier for generic drugs to reach the market while permitting brand name companies to recover a portion of their intellectual property rights lost during the pharmaceutical approval process .
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