[Federal Register Volume 68, Number 119 (Friday, June 20, 2003)]
[Notices]
[Pages 36973-36974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15692]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office


Grant of Interim Extension of the Term of U.S. Patent No. 
4,585,597; ANTH[Eacute]LIOS[reg] SP Topical Cream (Mexoryl[reg] SX 
(ecamsule))

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of interim patent term extension.

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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 (703) 
306-3159; by mail addressed to Mail Stop Patent Ext., Commissioner for 
Patents, PO Box 1450, Alexandria, VA 22313-1450; by fax at (703) 872-
9411, or by e-mail to [email protected].

[[Page 36974]]


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[reg] SX (ecamsule) in the human drug product 
ANTH[Eacute]LIOS[reg] SP Topical Cream (HELIOBLOCK[reg] 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[reg] 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.
[FR Doc. 03-15692 Filed 6-19-03; 8:45 am]
BILLING CODE 3510-16-P