Grant of Interim Extension of the Term of U.S. Patent No. 4,585,597; ANTHÉLIOS ®

AGENCY:

United States Patent and Trademark Office, Department of 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. 4,585,597.

FOR FURTHER INFORMATION CONTACT:

Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Patent Ext., P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755, or by e-mail to Mary.Till@uspto.gov.

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 17, 2005, patent owner L'Oreal S.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. 4,585,597. The patent claims the active ingredient Mexoryl^® SX (ecamsule), in the human drug product ANTHELIOS^® 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, 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 (June 16, 2005), 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. 4,585,597 is granted for a period of one year from the expiration date of the patent, i.e., until June 16, 2006.