03-15692. Grant of Interim Extension of the Term of U.S. Patent No. 4,585,597; ANTHÉLIOS® SP Topical Cream (Mexoryl® SX (ecamsule))

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 one-year interim extension of the term of U.S. Patent No. 4,585,597.

FOR FURTHER INFORMATION CONTACT:

Karin Ferriter by telephone at [phone]; by mail addressed to Mail Stop Patent Ext., Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450; by fax 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 May 30, 2003, patent owner L'Oreal S.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. 4,585,597. The patent claims the active ingredient Mexoryl® SX (ecamsule) in the human drug product ANTHÉLIOS® SP Topical Cream (HELIOBLOCK® SX Cream), a method of use of the active ingredient, and a method of manufacturing the active ingredient. The application indicates, and the Food and Drug Administration has confirmed, that a New Drug Application for the human drug product Mexoryl® SX (ecamsule) 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. Since it is apparent that the regulatory review period will continue beyond the original expiration date of the patent (June 16, 2003), the term of the patent is extended under 35 U.S.C. 156(d)(5) for a term of one year, i.e., until June 16, 2004.

Dated: June 13, 2003.

James E. Rogan,

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