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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

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

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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 Karin.Ferriter@uspto.gov.

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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 Start Printed Page 49909subject 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.

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Dated: July 24, 2002.

James E. Rogan,

Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.

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[FR Doc. 02-19453 Filed 7-31-02; 8:45 am]

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