03-9924. Prospective Grant of Exclusive License: The Systemic In Vivo Use of the Domain-Swapped Dimer of Cyanovirin (DeltaQ50-CVN) as a Prophylactic or Therapeutic Against HIV and Enveloped Viruses That Cause Hemorrhagic Fever; the Ex Vivo Use of ...

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 an exclusive license worldwide to practice the invention embodied in:

U.S. Patent Application, S/N 60/359,360, filed: 2/25/2002, entitled “An Obligate Domain-swapped Dimer of Cyanovirin with Enhanced Anti-viral Activity” (PHS Reference No. E-096-2002)

to OmniViral Therapeutics LLC, of Germantown, MD. 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 June 23, 2003 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., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The patent application describes a novel protein, obligate domain-swapped dimer of Cyanovirin-N (CVN), discovered by Dr. Carole A. Bewley at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The obligate domain-swapped dimer of Cyanovirin-N (CVN) displays enhanced anti-HIV activity relative to the wild-type CVN monomer and offers a great advantage over wild-type CVN because it is extremely easy to purify large quantities to greater than 98% homogeneity. So, it may open the possibility that an effective drug treatment for the human immunodeficiency virus (HIV) could reach underdeveloped countries.

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.

The field of use may be limited to:

1. Compositions, devices and methods for the prevention and treatment of HIV infection and infections caused by enveloped viruses causing hemorrhagic fever, systemically, but not topically, utilizing obligate domain-swapped dimer of Cyanovirin-N, anti-HIV mutants of obligate domain-swapped dimer of Cyanovirin-N, and anti-HIV fragments of both;

2. Compositions, devices and methods for the ex vivo removal or inactivation of HIV from fluid samples, utilizing obligate domain-swapped dimer of Cyanovirin-N, anti-HIV mutants of obligate domain-swapped dimer of Cyanovirin-N, and anti-HIV fragments of both;

but excluding pegylated obligate domain-swapped dimer of Cyanovirin-N, pegylated anti-HIV mutants of obligate domain-swapped dimer 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: April 11, 2003.

Steven M. Ferguson,

Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer.