03-15548. 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 ...

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 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: [e-mail]; Telephone: [phone]; Facsimile: [phone].

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.