A bill to amend title 35 of the United States Code to extend the term of patents for agricultural and chemical products for the period during which they underwent regulatory review.
Agricultural Patent Reform Act - Amends the patent laws to extend the terms of patents which encompass specified products or methods for using a product, including methods of manufacturing which primarily use recombinant DNA technology or hybridoma technology, any of which are subject to certain nonpatent regulatory review periods. Sets forth the terms and conditions of such extension, including a five-year limitation on the extension and a 17-year maximum patent term for the earliest filing.
Directs the Commissioner of Patents to notify the appropriate Federal agency upon receipt from the product sponsor of a notice of extension to determine the applicable regulatory review period and whether, within that period, the sponsor acted with due diligence. Provides for notice and informal hearings for persons interested in such determinations.
Directs the Commissioner, upon a final determination of the applicable regulatory review period, to issue to the owner of record of a patent a certificate of extension stating the fact and length of the extension. Makes such certificate a part of the original patent.
Limits the application of such patent term extension to patents for: (1) any pesticide subject to regulation under the Federal Insecticide, Fungicide and Rodenticide Act; (2) any chemical substance or mixture subject to regulation under the Toxic Substances Control Act; and (3) any plant or plant product which is genetically altered and defined as a plant pest or potential plant pest and regulated under the Federal Plant Pest Act.
Provides for the protection of trade secret and other confidential information. Permits the setting of fees to cover the costs of review.
Permits the use, sale, or manufacture of a pesticide solely for testing for meeting certain regulatory requirements during the last two years of its patent, except where recombinant DNA or hybridoma technology is involved in its manufacture.
Prohibits anyone other than the original patent holder or licensee from applying for a patent for a pesticide covered by the first composition of matter patent, method of use patent, or method of manufacturing patent before the first patent term expires.
Introduced in House
Introduced in House
Referred to House Committee on The Judiciary.
Referred to Subcommittee on Courts, Civil Liberties, and the Administration of Justice.
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