[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Notices]
[Page 27787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12729]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Grant of Interim Extension of the Term of U.S. Patent No. 
4,567,264; Ranolazine

AGENCY: 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. 4,567,264.

FOR FURTHER INFORMATION CONTACT: Karin Ferriter by telephone at 
(703)306-3159; by mail marked to her attention and addressed to Mail 
Stop Patent Ext., Commissioner for Patents, 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 March 5, 2003, patent owner Roche Palo Alto LLC, timely filed an 
application under 35 U.S.C. 156(d)(5) for an interim extension of the 
term of U.S. Patent No. 4,567,264. The patent claims the active 
ingredient ranolazine (RanexaTM). The application indicates 
that a New Drug Application for the human drug product ranolazine 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. Since 
it is apparent that the regulatory review period will continue beyond 
the original expiration date of the patent (May 18, 2003), the term of 
the patent is extended under 35 U.S.C. 156(d)(5) for a term of one 
year, i.e., until May 18, 2004.

    Dated: May 9, 2003.
James E. Rogan,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 03-12729 Filed 5-20-03; 8:45 am]
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