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Notice

Prospective Grant of Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in Patent Applications USSN 61/021,596, filed Jan 16, 2008; 61/023,341, filed Jan 24, 2008; PCT/US2009/031329, filed Jan 16, 2009; and USSN 12/838,292, filed Jul 16, 2010; entitled “Influenza DNA Vaccination and Methods of Use Thereof”, by Rao et al (NIAID/VRC) (E-050-2008/0,1,2,3), to Newport Laboratories having a place of business in 1520 Prairie Drive, Worthington, MN 56187. The patent rights in this invention have been assigned to the United States of America.

DATES:

Only written comments and/or application for a license that are Start Printed Page 79204received by the NIH Office of Technology Transfer on or before January 20, 2012 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: ThalhamC@mail.nih.gov; Telephone: (301) 435-4507; Facsimile: (301) 402-0220.

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SUPPLEMENTARY INFORMATION:

The prospective worldwide exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The invention relates to compositions and methods of use as Veterinary Influenza Vaccines. Sustained outbreaks of highly pathogenic influenza in animals increase the risk of reassortment and adaption to humans. This technology describes DNA vaccines against influenza serotypes H5N1, H1N1, H3N2, and H3N8 for poultry, swine and equine. Particularly one vaccine, a trivalent combination of H5N1 immunogens, effectively protects against homologous and heterologous challenges. These vaccines can be delivered intramuscularly or through needle-free delivery mechanism. These veterinary influenza vaccines are specifically designed for poultry, swine and equine recipients, with the following advantages: (a) More efficient and versatile than the conventional inactivated whole-virus vaccines; (b) Can be precisely tailored to target one or more strains of avian, swine or equine outbreaks; (c) Adaptable to large scale immunization; (e) Shorter production time than the current egg-based technology; (f) Noninfectious and safe to manipulate and handle; (g) Needle-free device delivery elicits robust cellular immune response; and (h) Because they do not contain other viral proteins, a diagnostic test will enable vaccinated animals to be differentiated from naturally infected animals, key if governments mandate vaccination and a vital consideration for the international industry. Data are available for mice, chickens, pigs, and horses.

The field of use may be limited to “Veterinary Biological Products for Swine Influenza Vaccines”.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

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Dated: December 15, 2011.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 2011-32706 Filed 12-20-11; 8:45 am]

BILLING CODE 4140-01-P