Department of Commerce Patent and Trademark Office Notice of two-year exclusivity period; DAYPRO oxaprozin. Agency: Patent and Trademark Office, Commerce. Action: Notice of Receipt of Notice of Entitlement under Section 2105 of the FDA Export Reform and Enhancement Act of 1996 (Chapter 1A of Pub. L. No. 104-134). Summary: The Patent and Trademark Office has received notification from G. D. Searle & Co. that it claims entitlement under Section 2105 of the FDA Export Reform and Enhancement Act of 1996 (Chapter 1A of Pub. L. No. 104-134) for its drug product DAYPRO oxaprozin. For Information Contact: Karin Tyson by telephone at (703) 305-9285; by mail marked to her attention and addressed to the Assistant Commissioner for Patents, Box DAC, Washington, D.C. 20231; or by fax marked to her attention at (703) 308-6916. Supplementary Information: On April 25, 1996, the FDA Export Reform and Enhancement Act of 1996 (Act) (Chapter 1A of Pub. L. No. 104-134) was enacted. Section 2105 thereof grants specified exclusive rights to the owner of the right to market a specified nonsteroidal anti-inflammatory drug who has complied with the Act. The text of Section 2105 is as follows: (a) IN GENERAL -- Any owner on the date of enactment of this Act of the right to market a nonsteroidal anti-inflammatory 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 enactment of this Act, any owner granted an entitlement under subsection (a) shall notify the Commissioner of Patents and Trademarks and the Secretary of Health and Human Services of such entitlement. Not later than 7 days after receipt of such notice, the Commissioner and Secretary shall publish an appropriate notice of the receipt of such notice. On May 15, 1996, G. D. Searle & Co., filed a notice with the Commissioner of Patents and Trademarks of its claim for entitlement pursuant to Section 2105(c) of the Act. The notice states that G. D. Searle & Co. was the owner of the right to market the nonsteroidal anti-inflammatory drug oxaprozin on April 25, 1996, the date of enactment of the Act. Further, the notice states: that oxaprozin contains an agent that was patented and covered by U.S. Patent No. 3,578,671; that a New Drug Application (NDA) was filed on August 10, 1982, for oxaprozin and was reviewed for a period of more than 120 months; and that oxaprozin was approved as safe and effective by the Federal Food and Drug Administration on October 29, 1992. May 16, 1996 BRUCE A. LEHMAN Assistant Secretary of Commerce and Commissioner of Patents and Trademarks