[20020131]RS21129_药品专利期限延长：简要说明.pdf

Congressional Research Service The Library of CongressCRS Report for CongressReceived through the CRS WebOrder Code RS21129January 31, 2002Pharmaceutical Patent Term Extensions: ABrief ExplanationWendy H. SchachtSpecialist in Science and TechnologyResources, Science, and Industry DivisionJohn. R. ThomasVisiting Scholar in Economic Growth and EntrepreneurshipResources, Science, and Industry DivisionSummaryThe pharmaceutical industry appears to place a high value on patents and drugcompanies frequently obtain patent protection and enforce patent rights. Patents permitthe owner to exclude others from making, using, importing, or selling the patentedinvention. 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 circumstancespermit extensions to the term of the patent, including delays in the initial administrativeprocess at the USPTO. More significantly, the Drug Price Competition and Patent TermRestoration Act of 1984, commonly known as the “Hatch-Waxman” Act, permitslimited extensions to compensate for market time lost during the drug approval processundertaken by the Food and Drug Administratio