[Federal Register Volume 62, Number 71 (Monday, April 14, 1997)]
[Notices]
[Page 18099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9555]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Grant of Certificate of Interim Extension of the Term of U.S. 
Patent No. 4,197,297; CORLOPAM

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of Term Extension.

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SUMMARY: The Patent and Trademark Office has issued a certificate under 
35 U.S.C. 156(d)(5) for a one-year interim extension of the term of 
U.S. Patent No. 4,197,297 that claims the active ingredient, fenoldopam 
mesylate, in the human drug product ``CORLOPAM'' and methods 
of use of said active ingredient.

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: Section 156 of Title 35, United States Code, 
generally provides that the term of a patent may be extended for a 
period of up to 5 years if the patent claims a product, or a method of 
making or using a product, that has been subject to certain defined 
regulatory review. Under section 156, a patent is eligible for term 
extension only if regulatory review of the claimed product was 
completed before the original patent term expired.
    On December 3, 1993, section 156 was amended by Pub. L. 103-179 to 
provide that if the owner of record of the patent or its agent 
reasonably expects the applicable regulatory review period to extend 
beyond the expiration of the patent, the owner or its agent may submit 
an application to the Commissioner of Patents and Trademarks for an 
interim extension of the patent term. If the Commissioner determines 
that, except for permission to market or use the product commercially, 
the patent would be eligible for a statutory extension of the patent 
term, the Commissioner shall issue to the applicant a certificate of 
interim extension for a period of not more than one year.
    On March 21, 1997, Neurex Corporation, an agent of SmithKline 
Beecham Corporation, the owner of record of U.S. Patent No. 4,197,297, 
filed an application under 35 U.S.C. 156(d)(5) for interim extension of 
the term of U.S. Patent No. 4,197,297. The patent claims the active 
ingredient, fenoldopam mesylate, in the human drug product 
``CORLOPAM'' and methods of use of said active ingredient. 
The application indicates, and the Food and Drug Administration (FDA) 
has confirmed, that the product is currently undergoing a regulatory 
review under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) before the FDA for permission to market or use the 
product commercially. The original term of the patent expires on April 
8, 1997.
    Review of the application indicates that, except for permission to 
market or use the product commercially, the subject patent would be 
eligible for an extension of the patent term under 35 U.S.C. 156. Since 
it is apparent that the regulatory review period may extend beyond the 
date of expiration of the patent, interim extension of the patent term 
under 35 U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 4,197,297 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: April 7, 1997.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 97-9555 Filed 4-11-97; 8:45 am]
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