[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Page 32110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Human Monoclonal 
Antibodies, Their Fragments and Derivatives as Biotherapeutics for the 
Treatment of HIV Infections

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 (HHS), is contemplating the 
grant of an exclusive license to practice the inventions embodied in: 
U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 
(E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6, 
2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0-
EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/
0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144-
2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930 
(E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled 
``Novel broadly cross-reactive HIV neutralizing human monoclonal 
antibodies selected from Fab phage display libraries using a novel 
strategy based on alternative antigen panning,'' Inventors: Dimiter S. 
Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, 
Inc., having a place of business in Baltimore, Maryland. 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 
August 1, 2006 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 invention (E-144-2002/0) 
identifies four antibodies, designed 4B1-4, 4B1-10, 4H4, and 5H22 (M12, 
M14, M16, and M18). These four antibodies were isolated from a human 
Fab phage display library using alternating antigen panning (AAP). All 
four antibodies bind to recombinant HIV envelope glycoproteins (Env) 
gp12089.6, gp120JR-FL and gp120IIIB 
with high affinity. Moreover, 4B1-10 binding to gp 120 or gp 140 is 
significantly enhanced in the presence of the receptor CD4.
    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.
    The field of use may be limited to the development of human 
monoclonal antibodies for use as a therapeutic or preventative in HIV 
infection either alone or in combination with other compounds.
    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: May 25, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-8628 Filed 6-1-06; 8:45 am]
BILLING CODE 4140-01-P