[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Page 67743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of FDA 
Approved HIV Resistance Diagnosis Kit

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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 invention embodied in U.S. Patent 
No. 5,714,313, issued February 03, 1998, entitled ``Simple Method For 
Detecting Inhibitors Of Retroviral Replication'' (HHS Ref. E-054-1991/
1-US-01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and 
Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), 
having a place of business in France. The patent rights in these 
inventions have been assigned to the United States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
January 29, 2008 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: Sally Hu, Ph.D., M.B.A., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: 
(301) 435-5606; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The subject technology discloses a DNA 
vector comprised of a selectable marker gene inserted into a 
retrotransposon for use in identifying and selecting cells in which 
retrotransposition has occurred. This novel method uses a 
retrotransposon comprised of a retroviral reverse transcriptase/RNAse H 
gene domain, which creates a unique restriction enzyme site wherever 
reverse transcription occurs. This novel system offers a means of 
identifying compounds or agents that can inhibit retrotransposition or 
retroviral replication. Previous methods developed to detect 
retrotransposition have not been able to accurately identify DNA in 
which reverse transcription has occurred. Certain types of 
retrotransposition are similar to retroviral replication. Thus, this 
method is applicable to identifying antiretroviral compounds as well as 
inhibitors of retrotransposition.
    The field of use may be limited to the development of FDA approved 
HIV resistance diagnosis kit through the combination of the subject 
technology and AmiKana's proprietary yeast based HIV protease 
phenotyping procedure (Patent Publication No. WO2006000693).
    The prospective 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 60 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.
    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: November 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-23191 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P