[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41166-41167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Vaccine Products for 
Prevention and Treatment of Chronic Hepatitis C Infections (HCV)

AGENCY: National Institutes of Health, Public Health Service, HHS.

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 
an exclusive license to practice the invention embodied in:
    (1) U.S. Patent No. 6,387,662, issued May 14, 2002, entitled 
``Synthesis and Purification of Hepatitis C Virus-Like particles'' (E-
009-1997/0) (Inventors: T. Jake Liang and Thomas F. Baumert (NIDDK)). 
This application is a continuation of and claims the benefit of 
priority of International Application No. PCT/US97/05096 filed on March 
25, 1997, which claims priority to U.S. patent application No. 60/
030,238, filed November 8, 1996.
    (2) PCT/US97/05096 filed March 25, 1997, entitled ``Synthesis and 
Purification of Hepatitis C Virus-Like particles in vitro'' (related to 
E-009-1997/0) (Inventors: T. Jake Liang and Thomas F. Baumert (NIDDK)), 
National Stage filed in Australia (Patent No. 738585, issued January 
03, 2002), the European Union (European Patent Office Patent 
Application Number 9791652.6), Canada (Patent Application Number 
2269097), and in Japan (Patent Application Number 10-522521).

to Virionics Corporation, having a place of business in Odenton, 
Maryland. 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 
September 8, 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: Peter Soukas, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: (301) 435-
4646; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The technology relates to production of

[[Page 41167]]

enveloped RNA virus-like particles in vitro in insect cells using a 
recombinant baculovirus vector containing a cDNA coding for viral 
structural proteins. In vitro production and purification of hepatitis 
C virus (HCV)-like particles containing HCV core protein, E1 protein 
and E2 protein is described. Sucrose gradient purified HCV-like 
particles exhibited similar biophysical properties as putative HCV 
virions. Mice injected with HCV-like particles developed HCV-specific 
antibodies indicating that the particles are immunogenic. HCV-like 
particles, purified in large quantities, may be useful in HCV vaccine 
development or in diagnostic kits.
    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 vaccine products for prevention 
and treatment of chronic hepatitis C (HCV) infections.
    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: July 2, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-17405 Filed 7-9-03; 8:45 am]
BILLING CODE 4140-01-P