A bill to amend the patent law to restore the term of the patent grant in the case of certain products for the time of the regulatory review period preventing the marketing of the product claimed in a patent.
Agricultural Patent Reform Act of 1984 - 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, 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 25 year maximum patent term from the earliest filing.
Directs the Commissioner of Patents to notify the appropriate Federal agency upon receipt from a product sponsor of a notice of extension. Requires the notified agency 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. Permits the appropriate Secretary or Administrator to consider the failure of a product sponsor to submit data which such sponsor should have known was necessary to support an extension notice. Permits the appropriate Secretary or Administrator to establish fees to cover review costs.
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 and identifying the product and the use and the claim to which such extension is applicable. Makes such certificate a part of the original patent.
Restricts the disclosure of any data submitted during the regulatory review period which is designated as a trade secret or confidential.
Limits the application of such patent term extension to patents for: (1) any new animal drug or antibiotic subject to regulation under the Federal Food, Drug, and Cosmetic Act; (2) any veterinary biological product subject to regulation under the Virus-Serum- Toxin Act; (3) any pesticide subject to regulation under the Federal Insecticide, Fungicide, and Rodenticide Act; and (4) any chemical substance or mixture subject to regulation under the Toxic Substances Control Act.
Clean Bill H.R.6034 Forwarded by Subcommittee to Full Committee in Lieu.
Introduced in House
Introduced in House
Referred to House Committee on The Judiciary.
For Previous Action See H.R.5529.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended).
Reported to House (Amended) by House Committee on The Judiciary. Report No: 98-1122.
Reported to House (Amended) by House Committee on The Judiciary. Report No: 98-1122.
Placed on Union Calendar No: 633.
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