Pharmaceutical Patent Term Extensions: A Brief Explanation

Publication Date: January 2002

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Law and ethics; Manufacturing and industry

Type:

Abstract:

The pharmaceutical industry appears to place a high value on patents and drug companies frequently obtain patent protection and enforce patent rights. Patents permit the owner to exclude others from making, using, importing, or selling the patented invention. Patents are issued by the U.S. Patent and Trademark Office (USPTO), generally for a term of 20 years from the date of filing.

However, certain circumstances permit extensions to the term of the patent, including delays in the initial administrative process at the USPTO. More significantly, 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 Food and Drug Administration (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.