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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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: hus@od.nih.gov; Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

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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 Start Printed Page 7049preclinical 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.

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Dated: February 2, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E7-2486 Filed 2-13-07; 8:45 am]

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