[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Page 12982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05581]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2015-0009]


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 January 15, 2015, the Arizona Board of Regents, on behalf of the 
University of Arizona, the patent owner of record, timely filed a 
second 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 original 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 extended expiration date of the patent, March 11, 2015, 
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 
extended expiration date of the patent.

    Dated: March 2, 2015.
Andrew Hirshfeld,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2015-05581 Filed 3-11-15; 8:45 am]
 BILLING CODE 3510-16-P