Pub. L. 104-134, tit. II, ch. 1A, sec. 2105

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, the Commissioner and the Secretary shall publish an appropriate notice of the receipt of such notice.