[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Notices]
[Page 40876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15270]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 2004-P-039]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,591,585; Atamestane

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States 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. 4,591,585.

FOR FURTHER INFORMATION CONTACT: Karin Ferriter by telephone at (703) 
306-3159; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Patent Ext., P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (703) 872-
9411, or by e-mail to [email protected].

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 five 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, and that the patent may be extended for interim 
periods of up to a year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On May 21, 2004, patent owner Schering Aktiengesellschaft, timely 
filed an application under 35 U.S.C. 156(d)(5) for an interim extension 
of the term of U.S. Patent No. 4,591,585. The patent claims the product 
atamestane. The application indicates that a New Drug Application for 
the human drug product atamestane has been filed and is currently 
undergoing regulatory review before the Food and Drug Administration 
for permission to market or use the product commercially.
    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, and 
that the patent should be extended for one year as required by 35 
U.S.C. 156(d)(5)(B). Since it is apparent that the regulatory review 
period will continue beyond the expiration date of the patent (June 18, 
2004), interim extension of the patent term under 35 U.S.C. 156(d)(5) 
is appropriate.
    An interim extension under 35 U.S.C. Sec.  156(d)(5) of the term of 
U.S. Patent No. 4,591,585 is granted for a period of one year from the 
expiration date of the patent, i.e., until June 18, 2005.

    Dated: June 24, 2004.
Jon W. Dudas,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. 04-15270 Filed 7-6-04; 8:45 am]
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