Grant of Interim Extension of the Term of U.S. Patent No. 4,977,138; ISTODAXTM, 32116 [E9-15863]
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Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices
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[FR Doc. E9–15960 Filed 7–6–09; 8:45 am]
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Grant of Interim Extension of the Term
of U.S. Patent No. 4,977,138;
ISTODAXTM
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VerDate Nov<24>2008
14:45 Jul 06, 2009
Jkt 217001
AGENCY: United States Patent and
Trademark Office.
ACTION: Notice of Interim Patent Term
Extension.
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
Mary.Till@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 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
PO 00000
Frm 00013
Fmt 4703
Sfmt 4703
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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[Federal Register Volume 74, Number 128 (Tuesday, July 7, 2009)]
[Notices]
[Page 32116]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 Mary.Till@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 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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