[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Page 10126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03855]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No.: PTO-P-2013-0065]


Grant of Interim Extension of the Term of U.S. Patent No. 
5,610,059; Monovalent Lawsonia Intracellularis Bacterin Vaccine

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. 5,610,059.

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 [email protected].

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 December 27, 2013, the Arizona Board of Regents, on behalf of 
the University of Arizona, the patent owner of record, timely filed an 
application under 35 U.S.C. 156(d)(5) for an interim extension of the 
term of U.S. Patent No. 5,610,059. The patent claims the veterinary 
biological product monovalent Lawsonia intracellularis bacterin 
vaccine. The application indicates that Intervet, a licensee of the 
patent owner, submitted two Product License Applications (PLA) to the 
United States Department of Agriculture (USDA). In a letter dated April 
12, 2011, USDA acknowledged receipt of the PLA for a multi-valent 
vaccine and assigned the vaccine product code 49L5.RO. In a letter 
dated December 22, 2011, USDA acknowledged receipt of a PLA for a 
monovalent vaccine of Lawsonia intracellularis bacterin and assigned 
the vaccine product code 2799.20.
    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 original expiration date of the patent, March 11, 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. 5,610,059 is granted for a period of one year from the 
original expiration date of the patent.

    Dated: February 14, 2014.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2014-03855 Filed 2-21-14; 8:45 am]
BILLING CODE 3510-16-P