Justia Regulation Tracker

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[Federal Register: November 10, 2009 (Volume 74, Number 216)]
[Notices]               
[Page 58003]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no09-48]                         

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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2009-0048]

 
Grant of Interim Extension of the Term of U.S. Patent No. 
4,971,802; MIFAMURTIDE

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 third one-year interim 
extension of the term of U.S. Patent No. 4,971,802.

FOR FURTHER INFORMATION CONTACT: Raul Tamayo by telephone at (571) 272-
7728; by mail marked to his attention and addressed to the Commissioner 
for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 
22313-1450; by fax marked to his attention at (571) 273-7728, or by e-
mail to Raul.Tamayo@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 September 30, 2009, IDM Pharma, agent/licensee of patent owner 
Novartis, timely filed an application under 35 U.S.C. 156(d)(5) for a 
third interim extension of the term of U.S. Patent No. 4,971,802. 
Claims of the patent cover muramyl tripeptide phosphatidyl 
ethanolamine, which is labeled as the active ingredient in the human 
drug product Mifamurtide. The application indicates, and the Food and 
Drug Administration has confirmed, that a New Drug Application for the 
human drug product Mifamurtide 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 (November 20, 2009), interim extension of the patent term under 
35 U.S.C. 156(d)(5) is appropriate.
    A third interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 4,971,802 is granted for a period of one year from the 
extended expiration date of the patent, i.e., until November 20, 2010.

    Dated: October 30, 2009.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. E9-26998 Filed 11-9-09; 8:45 am]

BILLING CODE 3510-16-P