[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7048-7049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Field of Use: Development 
of a Live Microbicide for Preventing Sexual Transmission of HIV

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:
    (1) U.S. Patent No. 5,821,081, filed April 26, 1996, 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-117-1995/1-US-01) 
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, 
and James B. McMahon) (NCI);
    (2) U.S. Patent No. 5,843,882, filed April 27, 1995, issued Dec. 
01, 1998, entitled ``Antiviral Proteins and Peptides, DNA, DNA-coding 
Sequences Therefore, and Uses thereof `` (E-117-1995/0-US-01) 
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, 
and James B. McMahon) (NCI);
    (3) U.S. Patent No. 5,998,587, filed Nov. 13, 1997, issued Dec. 7, 
1999, entitled ``Anti-cyanovirin Antibody'' (E-117-1995/1-US-02) 
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, 
and James B. McMahon) (NCI);
    (4) U.S. Patent No. 6,015,876, filed Oct. 27, 1999, issued Jan. 18, 
2000, entitled ``Method of Using Cyanovirins'' (E-117-1995/0-US-02) 
(Inventor: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and 
James B. McMahon) (NCI);
    (5) U.S. Patent No. 6,780,847, filed March 22, 2001, issued August 
24, 2004, entitled ``Glycosylation-Resistant Cyanovirins and Related 
Conjugates, Compositions, Nucleic Acids, Vectors, Host Cells, Methods 
of Production and Methods of Using Nonglycosylated Cyanovirins'' (E-
074-1999/3-US-01) (Inventors: Michael R. Boyd, Barry O'Keefe, Toshiyuki 
Mori (NCI) and Angela Gronenborn (NIDDK));
    (6) U.S. Patent No. 7,048,935, filed July 1, 2002, issued May 23, 
2006, entitled ``Cyanovirin Conjugates and Matrix-Anchored Cyanovirin 
and Related Compositions and Methods of Use'' (E-074-1999/1-US-03) 
(Inventor: Michael R. Boyd (NCI);
    (7) U.S. Patent No. 7,105,169, filed September 12, 2001, issued 
September 12, 2006, entitled ``Cyanovirins Conjugates and Matrix-
Anchored Cyanovirins and Methods of Use'' (E-074-1999/1-US-02) 
(Inventor: Michael R. Boyd (NCI);
    (8) U.S. Patent No. 6,743,577, filed October 27, 1999, issued June 
1, 2004, entitled `` Methods of Using Cyanovirins to Inhibit Viral 
Infection'' (E-074-1999/0-US-03) (Inventor: Michael R. Boyd (NCI);

    (9) U.S. Patent No. 6,420,336, filed October 27, 1999, issued July 
16, 2002, entitled ``Methods Of Using Cyanovirins Topically To Inhibit 
Viral Infection'' (E-074-1999/3-US-01) (Inventor: Michael R. Boyd (NCI)
to Osel, Inc. (Hereafter Osel), having a place of business in Santa 
Clara of California. 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 
April 16, 2007 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 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.
    Cyanovirin-N (CV-N) is a novel, naturally occurring anti-HIV 
protein that was originally isolated from Nastoc ellipipsosporum, a 
blue-green algae. Cyanovirin is a protein with potent neutralizing 
activity against HIV1 and 2 by blocking the fusion reaction between HIV 
and CD4 target cells. Cyanorvirin is in the pre-IND development phase 
with several animal toxicology and irritation studies completed; 
initial chemical purification processes developed; and no human data to 
date. Dr. Boyd and his colleagues have demonstrated that a simple 
aqueous gel formulation of CV-N completely protected macaques against 
intravaginally or intarectally transmitted SHIV 89-9P (a chimeric 
simian/human immunodeficiency virus that causes ``AIDS'' in simians). 
Also importantly, there was no indication of any toxicity or other 
adverse effects of the CV-N to the macaques in these

[[Page 7049]]

preclinical microbicide evaluation studies. CV-N has the potential to 
become a microbicide useful in preventing sexual transmission of HIV. 
An effective anti-HIV microbicide could slow down the spread of the 
virus in the population, especially in the developing world, before an 
effective vaccine is available.
    The field of use may be limited to the topical use of commensal 
bacteria that express cyanovirin-N.
    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: February 2, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-2486 Filed 2-13-07; 8:45 am]
BILLING CODE 4140-01-P