[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Page 34897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9490]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2006-0033]


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

AGENCY: United States Patent and Trademark Office, 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 fourth 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 16, 2006, patent owner, L Oreal S.A., timely filed an 
application under 35 U.S.C. 156(d)(5) for a fourth 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 (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). Because it is apparent that the regulatory 
review period will continue beyond the extended expiration date of the 
patent (June 16, 2006), interim extension of the patent term under 35 
U.S.C. 156(d)(5) is appropriate. A fourth 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 extended expiration date of the 
patent, i.e., until June 16, 2007.

    Dated: June 12, 2006.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E6-9490 Filed 6-15-06; 8:45 am]
BILLING CODE 3510-16-P