Page:United States Statutes at Large Volume 110 Part 2.djvu/467

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PUBLIC LAW 104-134—APR. 26, 1996 110 STAT. 1321-320 under section 801(d)(3) or any finished product made from such article (except for export in accordance with section 801(e) or 802 or section 351(h) of the Public Health Service Act), or the failure to export or destroy any component, part or accessory not incorporated into a drug, biological product or device that will be exported in accordance with section 801(e) or 802 or section 351(h) of the Public Health Service Act.". SEC. 2104. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS. Subsection (h) of section 351 of the Public Health Service Act (42 U.S.C. 262) is amended to read as follows: "(h) A partially processed biological product which— "(1) is not in a forai applicable to the prevention, treatment, or cure of diseases or injuries of man; "(2) is not intended for sale in the United States; and "(3) is intended for further manufacture into final dosage form outside the United States, shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et. seq.) if the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice requirements or meets international manufacturing standards as certified by an international standards organization recognized by the Secretary and meets the requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).". SEC. 2105. (a) IN GENERAL. —Any owner on the date of enactment of this Act of the right to market a nonsteroidal antiinflammatory drug that— (1) contains a previously patented active agent; (2) has been reviewed by the Federal Food and Drug Administration for a period of more than 120 months as a new drug application; and (3) was approved as safe and effective by the Federal Food and Drug Administration on October 29, 1992, shall be entitled, for the 2-year period beginning on October 29, 1997, to exclude others from making, using, offering for sale, selling, or importing into the United States such active agent, in accordance with section 154(a)(1) of title 35, United States Code. (b) INFRINGEMENT.— Section 271 of title 35, United States Code shall apply to the infringement of the entitlement provided under subsection (a). No application described in section 271(e)(2)(A) of title 35, United States Code, regardless of purpose, may be submitted prior to the expiration of the entitlement provided under subsection (a). (c) NOTIFICATION.— Not later than 30 days after the date of the enactment of this Act, any owner granted an entitlement under subsection (a) shall notify the Commissioner of Patents and Trademarks and the Secretary for Health and Human Services of such entitlement. Not later than 7 days after the receipt of such notice. Publication, the Commissioner and the Secretary shall publish an appropriate notice of the receipt of such notice.