[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Page 12696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation License: Live 
Attenuated Codon-Deoptimized Respiratory Syncytial Virus Vaccines

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404, that the National Institutes of Health (NIH), Department of Health 
and Human Services (HHS), is contemplating the grant of a worldwide 
exclusive evaluation option license to practice the inventions embodied 
in: HHS Ref. No. E-080-2013/0 and /1, ``Attenuation Of Human 
Respiratory Syncytial Virus By Genome Scale Codon-Pair 
Deoptimization,'' US Provisional Patent Applications 61/762,768 filed 
February 8, 2013 and 61/794,155 filed March 15, 2013, and PCT/US2014/
015274 filed February 7, 2014, to Codagenix, Inc., having its principle 
place of business in Stony Brook, New York.
    The United States of America is an assignee to the patent rights of 
these inventions.
    The contemplated exclusive license may be limited to a live 
attenuated codon-deoptimized respiratory syncytial virus vaccine. Upon 
the expiration or termination of the start-up exclusive evaluation 
license, Codagenix will have the right to execute a start-up exclusive 
patent commercialization license with no greater field of use and 
territory than granted in the evaluation license.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before March 
21, 2014 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: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The invention pertains to live attenuated 
respiratory syncytial viruses that can be used in prophylactic 
vaccines. The viruses are generated using codon-pair deoptimization 
techniques, resulting in attenuation based on hundreds or thousands of 
nucleotide substitutions with no differences at the amino acid level. 
The most notable strain has mutations in the NS1, NS2, N, P, M, SH, G, 
F, or L genes and referenced by the designation RSV MinFLC (SEQ ID No: 
5 in the patent application). Experimental growth data for 
representative viruses in mice and in African Green Monkeys 
demonstrated in vivo growth attenuation.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR 404. The prospective exclusive evaluation option license, and a 
subsequent exclusive patent commercialization license, may be granted 
unless within fifteen (15) days from the date of this published notice, 
the 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.
    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: March 3, 2014.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-04929 Filed 3-5-14; 8:45 am]
BILLING CODE 4140-01-P