Notice: Prospective Grant of Exclusive License: Avian Influenza Vaccines 
for Domesticated Poultry/Wild Birds To Be Provided to the National 
Veterinary Stockpile Program and Avian Influenza Vaccines To Be Sold as 
Veterinary Biological Products

Federal Register: Volume 76, Number 245 (Wednesday, December 21, 2011)
                  Page 79203

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 
ANQUAGEN, LLC having a place of business at 2329 N. Career Avenue, 
Suite 306, Sioux Falls, SD 57107. 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 
received by the NIH Office of Technology Transfer on or before January 
5, 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.

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 fifteen (15) 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 ``Avian influenza vaccines for 
domesticated poultry/wild birds to be provided to the National 
Veterinary Stockpile program and avian influenza vaccines to be sold as 
Veterinary Biological Products''.
    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.

    Dated: December 15, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-32701 Filed 12-20-11; 8:45 am]
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