Entitles the owner of the right to market a nonsteroidal anti-inflammatory drug that contains a previously patented active agent, that has been reviewed by the Food and Drug Administration (FDA) for more than 120 months as a new drug application, and that was approved as safe and effective by the FDA on October 29, 1992, to exclude others from making, using, offering for sale, selling, or importing into the United States such active agent for two years beginning October 29, 1997.
Applies the prohibition on infringement of patents to such entitlement. Prohibits submission of an application under the Federal Food, Drug, and Cosmetic Act for introduction into interstate commerce of a drug claimed in a patent, or the use of which is claimed in a patent, before the expiration of such entitlement.
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E1917)
Referred to the Committee on the Judiciary, and in addition to the Committee on Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on the Judiciary, and in addition to the Committee on Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on the Judiciary, and in addition to the Committee on Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health and Environment, for a period to be subsequently determined by the Chairman.
Referred to the Subcommittee on Courts and Intellectual Property.
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