04-22705. Grant of Interim Extension of the Term of U.S. Patent No. 4,567,264; Ranolazine

AGENCY:

United States Patent and Trademark Office.

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 second one-year interim extension of the term of U.S. Patent No. 4,567,264.

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 March 29, 2004, patent owner Roche Palo Alto LLC, timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 4,567,264. The patent claims the active ingredient ranolazine (Ranexa^TM). The application indicates, and the Food and Drug Administration (FDA) has confirmed, that a New Drug Application for the human drug product ranolazine has been filed and is currently undergoing regulatory review before the FDA 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. Since it is apparent that the regulatory review period will continue beyond the extended expiration date of the patent (May 18, 2004), the term of the patent will be extended under 35 U.S.C. 156(d)(5) for an additional year.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,567,264 is granted for an additional period of one year from the extended expiration date of the patent, i.e., until May 18, 2005.

Dated: September 17, 2004.

Jon W. Dudas,

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