04-25204. Grant of Interim Extension of the Term of U.S. Patent No. 4,603,123; Piroxicam Betadex

AGENCY:

United States Patent and Trademark Office, DOC.

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 one-year interim extension of the term of U.S. Patent No. 4,603,123.

FOR FURTHER INFORMATION CONTACT:

Karin Ferriter by telephone at [phone]; 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 [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 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 October 25, 2004, patent owner Chiesi Farmaceutici S.p.A. timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,603,123. The patent claims the active ingredient piroxicam betadex in the human drug product Brexidol®. The application indicates that a New Drug Application for Brexidol® (piroxicam betadex) 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, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Since the regulatory review period is anticipated to continue beyond the expiration date of the patent November 13, 2004, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,603,123 is granted for a period of one year from the expiration date of the patent, i.e., until November 13, 2005.

Dated: November 4, 2004.

Jon W. Dudas,

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