01-8091. Prospective Grant of Exclusive License: The use of cyanovirin-N in a Topical Microbicide To Prevent the Transmission of HIV and Other Sexually Transmitted Diseases

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 a exclusive license worldwide to practice the invention embodied in the patents and patent applications referenced below to Biosyn, Inc., of Philadelphia, PA. 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) U.S. Patent Application No. 09/417,797, filed 10/27/99, pending, entitled “Methods of Using Cyanovirins Topically to Inhibit Viral Infection” (E-074-99/4)

(9) 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: [phone], ext. 265; Facsimile: [phone]; e-mail: [e-mail].

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).

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 the prevention of infection by HIV and other sexually transmitted pathogens, topically, but not systemically, 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.