Hatch-Waxman Related Provisions of the Medicare Prescription Drug Bills (H.R. 1 and S. 1): A Side-by-Side Comparison

Publication Date: September 2003

Publisher: Library of Congress. Congressional Research Service

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Research Area: Health

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Abstract:

The Congress is currently debating changes to the Medicare program. H.R. 1, the Medicare Prescription Drug and Modernization Act, and S. 1, the Prescription Drug and Medicare Improvements Act, as passed by each respective body on June 27, 2003, contain provisions that would amend P.L. 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act). The Hatch-Waxman Act made several significant changes to the patent laws designed to encourage innovation in the pharmaceutical industry while facilitating the speedy introduction of lower-cost generic drugs. The two bills currently under consideration would address Hatch-Waxman related issues of drug patents listed in the Orange Book, patent challenges by generic firms, and the award of market exclusivity, among other things. This report provides a thematic side-byside comparison of the proposed changes contained in H.R. 1 and S. 1 that would affect the Hatch-Waxman legislation. The paper will be updated as events warrant.