[Federal Register Volume 71, Number 64 (Tuesday, April 4, 2006)]
[Notices]
[Page 16766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4832]



[[Page 16766]]

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DEPARTMENT OF COMMERCE

 Patent and Trademark Office

[Docket No. PTO-P-2006-0021]


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, Department of 
Commerce.

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 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 [email protected].

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[reg] SX (ecamsule), in the 
human drug product ANTHELIOS[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, 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.

    Dated: March 29, 2006.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E6-4832 Filed 4-3-06; 8:45 am]
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