[Federal Register Volume 68, Number 77 (Tuesday, April 22, 2003)]
[Notices]
[Pages 19843-19844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Systemic In Vivo Use 
of the Domain-Swapped Dimer of Cyanovirin (DeltaQ50-CVN) as a 
Prophylactic or Therapeutic Against HIV and Enveloped Viruses That 
Cause Hemorrhagic Fever; the Ex Vivo Use of the Domain-Swapped Dimer of 
Cyanovirin (DeltaQ50-CVN) To Remove or Inactivate HIV in Fluid Samples

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

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 worldwide to practice the invention embodied in:

U.S. Patent Application, S/N 60/359,360, filed: 2/25/2002, entitled 
``An Obligate Domain-swapped Dimer of Cyanovirin with Enhanced Anti-
viral Activity'' (PHS Reference No. E-096-2002)

to OmniViral Therapeutics LLC, of Germantown, MD. 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 which are 
received by the NIH Office of Technology Transfer on or before June 23, 
2003 will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Sally Hu, Ph.D., M.B.A.,

[[Page 19844]]

Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 
(301) 435-5606; Facsimile: (301) 402-0220, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The patent application describes a novel 
protein, obligate domain-swapped dimer of Cyanovirin-N (CVN), 
discovered by Dr. Carole A. Bewley at the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK). The obligate 
domain-swapped dimer of Cyanovirin-N (CVN) displays enhanced anti-HIV 
activity relative to the wild-type CVN monomer and offers a great 
advantage over wild-type CVN because it is extremely easy to purify 
large quantities to greater than 98% homogeneity. So, it may open the 
possibility that an effective drug treatment for the human 
immunodeficiency virus (HIV) could reach underdeveloped countries.
    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:
    1. Compositions, devices and methods for the prevention and 
treatment of HIV infection and infections caused by enveloped viruses 
causing hemorrhagic fever, systemically, but not topically, utilizing 
obligate domain-swapped dimer of Cyanovirin-N, anti-HIV mutants of 
obligate domain-swapped dimer of Cyanovirin-N, and anti-HIV fragments 
of both;
    2. Compositions, devices and methods for the ex vivo removal or 
inactivation of HIV from fluid samples, utilizing obligate domain-
swapped dimer of Cyanovirin-N, anti-HIV mutants of obligate domain-
swapped dimer of Cyanovirin-N, and anti-HIV fragments of both;

but excluding pegylated obligate domain-swapped dimer of Cyanovirin-N, 
pegylated anti-HIV mutants of obligate domain-swapped dimer of 
Cyanovirin-N and pegylated anti-HIV fragments of both.
    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: April 11, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-9924 Filed 4-21-03; 8:45 am]
BILLING CODE 4140-01-P