01-3552. 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 [phone]; 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 [phone], or by e-mail to [e-mail].

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 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 (Vestra^TM). The application indicates 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. 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.