[Federal Register Volume 66, Number 29 (Monday, February 12, 2001)]
[Notices]
[Pages 9823-9824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3552]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office


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

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of Interim Patent Term Extension.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office has issued a 
certificate under 35 U.S.C. 156(d)(5) for a third one-year interim 
extension of the term of U.S. Patent No. 4,229,449.

FOR FURTHER INFORMATION CONTACT: Karin Tyson by telephone at (703) 306-
3159; by mail marked to her attention and addressed to the Assistant 
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 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, and that the patent may be extended for interim 
periods of up to a year if the

[[Page 9824]]

regulatory review is anticipated to extend beyond the expiration date 
of the patent.
    On November 17, 2000, patent owner Pharmacia & Upjohn, S.p.A., 
filed an application under 35 U.S.C. 156(d)(5) for a third interim 
extension of the term of U.S. Patent No. 4,229,449. The patent claims 
the active ingredient roboxetine mesylate (VestraTM). The 
application indicates a New Drug Application for the human drug product 
roboxetine mesylate (VestraTM) has been filed and is 
currently undergoing regulatory review before the Food and Drug 
Administration for permission to market or use the product 
commercially. The original term of the patent expired on January 8, 
1999, and has been previously extended under 35 U.S.C. 156(d)(5) to 
January 9, 2001.
    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 extend beyond the 
extended expiration date of the patent, the term of the patent is 
extended under 35 U.S.C. 156(d)(5) for a term of one year from January 
9, 2001.

    Dated: January 19, 2001.
Q. Todd Dickinson,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 01-3552 Filed 2-9-01; 8:45 am]
BILLING CODE 3510-16-P