[Federal Register Volume 61, Number 100 (Wednesday, May 22, 1996)]
[Notices]
[Pages 25635-25636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12882]



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DEPARTMENT OF COMMERCE
Patent and Trademark Office


Notice of Two Year Exclusivity Period; DAYPRO Oxaprozin

AGENCY: Patent and Trademark Office, Commerce.


[[Page 25636]]


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).

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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 FURTHER 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 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 
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 
antiinflammatory 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.

    Dated: May 16, 1996.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 96-12882 Filed 5-21-96; 8:45 am]
BILLING CODE 3510-16-U