[Federal Register Volume 67, Number 148 (Thursday, August 1, 2002)]
[Notices]
[Pages 49908-49909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19453]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 2002-P-004]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,229,449; Roboxetine Mesylate

AGENCY: Patent and Trademark Office, Commerce.

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 fourth one-year interim 
extension of the term of U.S. Patent No. 4,229,449.

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, Box Patent Ext., Washington, DC, 20231; 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 November 20, 2001, patent owner Pharmacia & Upjohn, S.p.A., 
timely filed an application under 35 U.S.C. 156(d)(5) for a third 
subsequent interim extension of the term of U.S. Patent No. 4,229,449. 
The patent claims the active ingredient roboxetine mesylate 
(Vestra(TM)). The application indicates that a New Drug Application for 
the human drug product roboxetine mesylate (Vestra(TM)) 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

[[Page 49909]]

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 an 
additional year as required by 35 U.S.C. 156(d)(5)(B). Since it is 
apparent that the regulatory review period has continued beyond the 
extended expiration date of the patent (January 9, 2002), the term of 
the patent is extended under 35 U.S.C. 156(d)(5) for an additional term 
of one year, i.e., until January 9, 2003.

    Dated: July 24, 2002.
James E. Rogan,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 02-19453 Filed 7-31-02; 8:45 am]
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