Grant of Interim Extension of the Term of U.S. Patent No. 5,693,323; Recombinant Humanized Monoclonal Antibody (IgG1, 73279 [2014-28966]

Download as PDF Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices Nominations should be sent to the web address specified below and must be received by January 9, 2015. ADDRESSES: Applications should be submitted electronically to noaa.sab.newmembers@noaa.gov. FOR FURTHER INFORMATION CONTACT: Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301– 734–1156, Fax: 301–713–1459, Email: Cynthia.Decker@noaa.gov); or visit the NOAA SAB Web site at https:// www.sab.noaa.gov. DATES: SUPPLEMENTARY INFORMATION: Individuals are sought with expertise in meteorology, operational weather and water forecasting, water resources and climate. Individuals with expertise in the physical sciences, social sciences, and communications in these fields will all be given consideration. Dated: December 5, 2014. Jason Donaldson, Chief Financial Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration. [FR Doc. 2014–28939 Filed 12–9–14; 8:45 am] BILLING CODE 3510–KD–P 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 (IgG1, Kappa)-Mepolizumab United States Patent and Trademark Office, Commerce. ACTION: Notice of interim patent term extension. AGENCY: 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 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 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 DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2014–0067] Grant of Interim Extension of the Term of U.S. Patent No. 5,496,801; Recombinant Human Parathyroid Hormone United States Patent and Trademark Office, Commerce. ACTION: Notice of interim patent term extension. AGENCY: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 73279 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. 5,496,801. SUMMARY: 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 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 29, 2014, NPS Pharmaceuticals, Inc., timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 5,496,801. The patent claims the human biological product recombinant human parathyroid hormone. The application indicates that Biologics License Application 125511 for the drug product, recombinant human parathyroid hormone, was filed on October 24, 2013, 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 the regulatory review period will continue beyond the extended 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. 5,496,801 is granted for a period of one year from the extended expiration date of the patent. SUPPLEMENTARY INFORMATION: E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Page 73279]
From the Federal Register Online via the Government Printing 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 (IgG1, 
Kappa)-Mepolizumab

AGENCY: United States Patent and Trademark Office, Commerce.

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. 5,693,323.

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 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 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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