[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Notices]
[Page 40876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15272]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 2004-P-041]


Grant of Second Interim Extension of the Term of U.S. Patent No. 
4,585,597; 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 second 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, P.O. Box 1450, Alexandria, VA 22313-1450; by fax at (703) 872-
9411, 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 April 30, 2004, patent owner, L'Oreal S.A., timely filed an 
application under 35 U.S.C. 156(d)(5) for a second interim extension of 
the term of U.S. Patent No. 4,585,597. The patent claims the active 
ingredient MexorylTMSX (ecamsule) in the human drug product 
ANTH[Eacute]LIOSTMSP, a method of use of the ecamsule, and a 
method of manufacturing ecamsule. The application indicates, and the 
Food and Drug Administration has confirmed, that a New Drug Application 
for the human drug product ANTH[Eacute]LIOSTMSP (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. The patent was previously extended for a term of 
one year.
    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 extended expiration date of the patent (June 16, 2004), the term of 
the patent is extended under 35 U.S.C. 156(d)(5) for an additional term 
of one year, i.e., until June 16, 2005.

    Dated: June 24, 2004.
Jon W. Dudas,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. 04-15272 Filed 7-6-04; 8:45 am]
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