[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