Grant of Interim Extension of the Term of U.S. Patent No. 5,407,914; SURFAXIN® (lucinactant), 60240 [E9-27903]
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Federal Register / Vol. 74, No. 223 / Friday, November 20, 2009 / Notices
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[FR Doc. E9–27937 Filed 11–19–09; 8:45 am]
BILLING CODE 3510–DS–S
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2009–0052]
Grant of Interim Extension of the Term
of U.S. Patent No. 5,407,914;
SURFAXIN® (lucinactant)
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.
5,407,914.
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.
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 one year if the
regulatory review is anticipated to
extend beyond the expiration date of the
patent.
On October 6, 2009, Discovery
Laboratories Inc., on behalf of patent
owner Scripps Research Institute, timely
filed an application under 35 U.S.C.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00006
Fmt 4703
Sfmt 4703
156(d)(5) for an interim extension of the
term of U.S. Patent No. 5,407,914. The
patent claims the human drug product,
SURFAXIN® (lucinactant) and a method
of using SURFAXIN® (lucinactant). The
application indicates that a New Drug
Application, NDA No. 21–746, for the
human drug product SURFAXIN®
(lucinactant) 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 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 November
17, 2009, 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.
5,407,914 is granted for a period of one
year from the original expiration date of
the patent, i.e., until November 17,
2010.
Dated: November 16, 2009.
David J. Kappos,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. E9–27903 Filed 11–19–09; 8:45 am]
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[Federal Register Volume 74, Number 223 (Friday, November 20, 2009)]
[Notices]
[Page 60240]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27903]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2009-0052]
Grant of Interim Extension of the Term of U.S. Patent No.
5,407,914; SURFAXIN[supreg] (lucinactant)
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. 5,407,914.
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 one year if the regulatory review is anticipated to
extend beyond the expiration date of the patent.
On October 6, 2009, Discovery Laboratories Inc., on behalf of
patent owner Scripps Research Institute, timely filed an application
under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S.
Patent No. 5,407,914. The patent claims the human drug product,
SURFAXIN[supreg] (lucinactant) and a method of using SURFAXIN[supreg]
(lucinactant). The application indicates that a New Drug Application,
NDA No. 21-746, for the human drug product SURFAXIN[supreg]
(lucinactant) 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 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
November 17, 2009, 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. 5,407,914 is granted for a period of one year from the
original expiration date of the patent, i.e., until November 17, 2010.
Dated: November 16, 2009.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. E9-27903 Filed 11-19-09; 8:45 am]
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