[Federal Register Volume 68, Number 77 (Tuesday, April 22, 2003)]
[Notices]
[Page 19843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9925]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Use of the Domain-
Swapped Dimer of Cyanovirin (deltaQ50-CVN) 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 
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 Biosyn, Inc., of Philadelphia, 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 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., Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5606; Facsimile: (301) 
402-0220, e-mail: [email protected].

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 compositions, devices and 
methods for the prevention of infection by HIV and other sexually 
transmitted pathogens, topically, but not systemically, utilizing the 
obligate domain-swapped dimer cyanovirin-N, anti-HIV mutants of the 
obligate domain-swapped dimer cyanovirin-N, and anti-HIV fragments of 
both, but excluding pegylated the domain-swapped dimer cyanovirin-N, 
pegylated anti-HIV mutants of the dimer 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.
[FR Doc. 03-9925 Filed 4-21-03; 8:45 am]
BILLING CODE 4140-01-P