[Federal Register Volume 67, Number 49 (Wednesday, March 13, 2002)]
[Notices]
[Pages 11357-11358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Uses of Cyanovirin-N for 
HIV Vaccines

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 worldwide license to practice the inventions embodied in 
patents under ``Supplementary Information'' to OmniViral Therapeutics 
LLC, having a place of business in Gaithersburg, Maryland. The patent 
rights in these inventions have been assigned to the Government of the 
United States of America.
    The field of use may be limited to four vaccine strategies based 
on:
    1. Conjugate consisting of HIV virions inactivated with Cyanovirin-
N or homolog thereof
    2. Conjugate consisting of gp120, an HIV envelope protein, and 
Cyanovirin-N or homolog thereof
    3. Native Cyanovirin-N or homolog thereof to stimulate a virus 
neutralizing response via endogenous anti-idiotypic antibodies
    4. Identification of Cyanovirin-N-binding-site anti-idiotypic 
monoclonal antibodies, and use thereof as a primary antigen

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
13, 2002, will be considered.

ADDRESSES: Requests for a copy of this patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to Cristina Thalhammer-Reyero, Ph.D., M.B.A., 
Technology Transfer Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852; Telephone: (301) 496-7056 extension 263; Facsimile: (301) 
402-0220; E-mail: [email protected]. A signed Confidential Disclosure 
Agreement will be required to receive copies of the patent 
applications.

SUPPLEMENTARY INFORMATION: The patents and patent applications to be 
licensed are:
    Patent No 6,245,737, issued 06/12/2001, entitled ``Conjugates of 
Antiviral Proteins or Peptides and Virus or Viral Envelope 
Glycoproteins'', (E-117-95/7);
    PCT/US99/18975 (WO00/11036), filed Aug. 19, 1998, allowed, entitled 
``An Anti-Cyanovirin Antibody with an Internal Image of gp120, a Method 
of Use Thereof, and a Method of Using a Cyanovirin to Induce an Immune 
Response to gp120'' (E-117-95/8);
    PCT/US00/06247 (WO00/53213) filed March 10 2000, pending, entitled 
``Cyanovirin Conjugates, Matrix-Anchored Cyanovirin And Anti-Cyanovirin 
Antibody, And Related Compositions And Methods of Use'' (E-074-99/2);
    US Patent No. 6,015,876, issued 01/18/2000, entitled ``Methods Of 
Using Cyanovirins'' (E-074-99/3);
    USSN 09/428,275 filed 10/27/1999, pending, entitled ``Methods of 
Using Cyanovirins to Inhibit Viral Infection'' (E-074-99/5);
    USSN 09/714,884 filed 03/22/2001, pending, entitled ``Conjugates of 
Antiviral Proteins or Peptides and Virus or Viral Envelope 
Glycoproteins'' (E-074-99/8);
    US Patent No. 5,843,882, issued Dec. 01, 1998, entitled ``Antiviral 
Proteins and Peptides'' (E-117-95/0);
    US 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'' (E-117-95/1);
    US Patent No. 6,015,876, issued Jan. 18, 2000, entitled ``Method of 
Using Cyanovirins (E-117-95/3);
    US Patent No. 5,998,587, issued Dec. 7, 1999, entitled ``Anti-
Cyanovirin Antibody'' (E-117-95/6);
    And related U.S. and foreign cognates of the PCT patent 
applications.
    The inventors have found that Cyanovirin-N, a naturally occurring 
anti-HIV protein originally isolated from Nostoc ellipipsosporum, a 
blue-green algae, has potent neutralizing activity against HIV 1 and 2 
by blocking the fusion reaction between HIV and CD4 cells. Cyanovirin-N 
is now expressed in a DNA coding sequence in E. coli. New information 
on the nature of the interaction of the HIV envelope with the cell 
surface during the binding, entry and fusion process has led to new 
ideas about how to improve envelope immunogenicity. Among these ideas 
are the various ways of using Cyanovirin-N in preparing reagents for 
use in a potential HIV vaccine.
    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. 
This 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.
    Applications for a license filed in response to this notice will be 
treated as objections to the grant of the contemplated license. 
Comments and objections submitted in response to this notice will not 
be made available for

[[Page 11358]]

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 5, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-5933 Filed 3-12-02; 8:45 am]
BILLING CODE 4140-01-P