[Federal Register Volume 74, Number 128 (Tuesday, July 7, 2009)]
[Notices]
[Page 32116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15863]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2009-0027]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,977,138; ISTODAX\TM\

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 an 
order granting interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 4,977,138.

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 Hatch-Waxman PTE, 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 June 12, 2009, Gloucester Pharmaceuticals, Inc., a licensee of 
Astellas Pharma Inc., the patent owner, timely filed an application 
under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. 
Patent No. 4,977,138. The patent claims the human drug product 
ISTODAXTM (romidepsin). The application indicates that a New 
Drug Application (NDA No. 22-393) for the human drug product 
ISTODAXTM (romidepsin) 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 one 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 original expiration 
date of the patent (July 6, 2009), an 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. 4,977,138 is granted for a period of one year from the 
original expiration date of the patent, i.e., until July 6, 2010.

    June 30, 2009.
John J. Doll,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. E9-15863 Filed 7-6-09; 8:45 am]
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