[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Page 73279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28966]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2014-0065]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,693,323; Recombinant Humanized Monoclonal Antibody (IgG<INF>1</INF>, 
Kappa)-Mepolizumab

AGENCY: United States Patent and Trademark Office, Commerce.

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. 5,693,323.

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 email to <a href="/cdn-cgi/l/email-protection#eca18d9e95c2b8858080ac999f9c9883c28b839a"><span class="__cf_email__" data-cfemail="430e22313a6d172a2f2f03363033372c6d242c35">[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 November 24, 2014, GlaxoSmithKline LLC and SmithKline Beecham 
Limited timely filed an application under 35 U.S.C. 156(d)(5) for an 
interim extension of the term of U.S. Patent No. 5,693,323. The patent 
claims the human biological product Mepolizumab, a recombinant 
humanized monoclonal antibody (IgG1, Kappa). The application indicates 
that a Biologics License Application, BLA 125526, for the human 
biological product 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, 
December 23, 2014, 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. 5,693,323 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: December 5, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2014-28966 Filed 12-9-14; 8:45 am]
BILLING CODE 3510-16-P


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