[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62766-62767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25768]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2010-0079]


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.

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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 second 
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 <a href="/cdn-cgi/l/email-protection#327f53404b1c665b5e5e72474142465d1c555d44"><span class="__cf_email__" data-cfemail="98d5f9eae1b6ccf1f4f4d8edebe8ecf7b6fff7ee">[email protected]</span></a>.

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 September 22, 2010, 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 additional 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 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 extended expiration 
date of the patent, November 17, 2010, 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 additional year 
from the extended expiration date of the patent, i.e., until November 
17, 2011.


[[Page 62767]]


    Dated: October 7, 2010.
Robert W. Bahr,
Acting Associate Commissioner for Patent Examination Policy, United 
States Patent and Trademark Office.
[FR Doc. 2010-25768 Filed 10-12-10; 8:45 am]
BILLING CODE 3510-16-P


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