[Federal Register: June 20, 2003 (Volume 68, Number 119)]
[Notices]               
[Page 37012]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn03-102]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

 
Prospective Grant of Co-Exclusive License: Glycosylation-
Resistant Cyanovirins (CV-N) and Related Conjugates, Compositions, 
Nucleic Acids, Vectors, Host Cells, Methods of Production and Methods 
of Using Nonglycosylated Cyanovirins for Use in Vaccines and 
Therapeutics Based on CV-N for the Prevention and/or Treatment of 
Influenza Infection

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 
world-wide co-exclusive licenses to practice the invention embodied in: 
United States Patent Application 09/815,079 and its foreign equivalents 
entitled ``Glycosylation-Resistant Cyanovirins and Related Conjugates, 
Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production 
and Methods of Using Nonglycosylated Cyanovirins'', filed March 22, 
2001, to OmniViral Therapeutics, LLC, having a place of business in 
Germantown, MD, and Biosyn, Inc., having a place of business in 
Huntingdon Valley, PA. The patent rights in this invention 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 August 
19, 2003 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: Susan Ano, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: anos@od.nih.gov; Telephone: (301) 435-
5515; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The prospective co-exclusive licenses 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 co-exclusive licenses 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.
    The technology has two major aspects. The first is that CV-N and 
homologous proteins and peptides potently inhibit diverse laboratory 
and clinical isolates of influenza viruses A and B. Since these strains 
are the two major types of influenza virus that infect humans, an agent 
that has antiviral activity against both influenza A and B, like CV-N, 
would be particularly useful in prevention and/or treatment of 
influenza infections. The second aspect provides CV-N mutants that are 
glycosylation-resistant mutants. These mutants code sequences to enable 
ultra large-scale recombinant production of functional CV-N in non-
bacterial (yeast or insect) host cells or in transgenic animals or 
plants. Therefore, these glycosylation-resistant mutants may allow 
industry to produce CV-N inexpensively on a large scale, which might 
make vaccines and therapeutics based on CV-N more accessible to 
developing countries.
    The field of use may be limited to development of vaccines and 
therapeutics based on CV-N for the treatment and/or prevention of 
influenza infections from all strains.
    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: June 12, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-15548 Filed 6-19-03; 8:45 am]

BILLING CODE 4140-01-P