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[Federal Register: April 3, 2001 (Volume 66, Number 64)]
[Notices]               
[Page 17723-17724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap01-70]                         

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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 cyanovirin-N as a Prophylactic or Therapeutic Against HIV and 
Enveloped Viruses that Cause Hemorrhagic Fever

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 
a exclusive license worldwide to practice the invention embodied in the 
patents and patent applications referenced below to OmniViral 
Therapeutics LLC, of Gaithersburg, MD. The patent rights in these 
inventions have been assigned to the United States of America.
    (1) U.S. Patent No. 5,821,081, issued Oct. 13, 1998, entitled 
``Nucleic Acids Encoding Antiviral Proteins and Peptides, Vectors and 
Host Cells Comprising Same, and Methods of Producing the Antiviral 
Proteins and Peptides'' (PHS Reference No. 
E-117-95/1)
    (2) U.S. Patent No. 5,843,882, issued Dec. 01, 1998, entitled 
``Antiviral Proteins and Peptides, DNA, DNA-coding Sequences Therefor, 
and Uses Thereof'' (E-117-95/0)
    (3) U.S. Patent No. 5,998,587, issued Dec. 7, 1999, entitled 
``Anti-Cyanovirin Antibody'' (E-117-95/6)
    (4) U.S. Patent No. 6,015,876, issued Jan. 18, 2000, entitled 
``Method of Using Cyanovirins'' (E-117-95/3)
    (5) U.S. Patent Application No. 09/267,447, filed Mar. 12, 1999, 
pending, entitled ``Cyanovirin Conjugates and Matrix-Anchored 
Cyanovirin and Related Composition and Methods of Use'' (E-074-99/0)
    (6) U.S. Patent Application No. 09/416,434, pending, entitled 
``Cyanovirin Conjugates and Matrix-Anchored Cyanovirin and Related 
Composition and Methods of Use'' 
(E-074-99/1)
    (7) U.S. Patent Application No. 09/427,873, filed 10/27/99, 
pending, entitled ``Methods of Using Cyanovirins to Inhibit Viral 
Infection'' (E-074-99/3)
    (8) PHS Reference Number E-074-99/7, filed 3/22/01, entitled 
``Glycosylation-Resistant Cyanovirins and Related Conjugates, 
Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production 
and Methods of Using Nonglycosylated Cyanovirins''

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before July 2, 
2001 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., Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 496-7056, ext. 265; 
Facsimile: (301) 402-0220; e-mail: <A HREF="mailto:hus@od.nih.gov">hus@od.nih.gov</A>.

SUPPLEMENTARY INFORMATION: The patents and patent applications describe 
a novel protein, cyanovirin-N, discovered by Dr. Michael R. Boyd and 
colleagues at the National Cancer Institute. Cyanovirin-N was isolated 
from a blue-green algae and has been demonstrated to bind avidly to and 
inactivate the human immunodeficiency virus (HIV). Enveloped viruses 
causing hemorrhagic fever are: Ebola, Marburg, Machupo (Bolivian), 
Lassa Fever, Argentine hemorrhagic fever, Congo-Crimean hemorrhagic 
fever, Junin, Korean hemorrhagic fever, Makonde, Tacaribe, and dengue.
    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 90 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 compositions, devices and 
methods for

[[Page 17724]]

the prevention and treatment of HIV infection and infections caused by 
enveloped viruses causing hemorrhagic fever, systemically, but not 
topically, utilizing cyanovirin-N, anti-HIV mutants of cyanovirin-N, 
and anti-HIV fragments of both, but excluding pegylated cyanovirin-N, 
pegylated anti-HIV mutants 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: March 26, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-8089 Filed 4-2-01; 8:45 am]
BILLING CODE 4140-01-P

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