[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Page 33106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing: Cloned 
Hepatitis C Virus (HCV) Genomes, Chimeras, and Derivatives Thereof

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

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by contacting Peter A. 
Soukas, J.D., at the Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 
20852-3804; telephone: 301/496-7056 ext. 268; fax: 301/402-0220; e-
mail: [email protected]. A signed Confidential Disclosure Agreement 
will be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Hepatitis C virus (HCV) is a single stranded 
RNA virus responsible for the majority of non-A non-B hepatitis. 
Hepatitis C virus (HCV) has a worldwide distribution and is a major 
cause of liver cirrhosis and hepatocellular carcinoma in the U.S., 
Europe, and Japan. For this reason, development of a vaccine against 
hepatitis C is of great importance. The present inventions claim full-
length sequences of HCV, HCV chimeras and HCV derivatives, and methods 
for using these full-length sequences for a variety of therapeutic and 
diagnostic applications, including vaccines.

Cloned Genomes of Infectious Hepatitis C Virus and Uses Thereof

Masayuki Yanagi, Jens Bukh, Suzanne U. Emerson, Robert H. Purcell 
(NIAID)
Serial No. 09/014,416 filed 27 Jan 1998, issued as U.S. Patent 
6,153,421 on 28 Nov 2000; Serial No. 09/662,454 filed 14 Sep 2000; 
Canadian Application 2295552; Australian Application 84889/98; European 
Application 98935702.5

    The current invention provides nucleic acid sequences comprising 
the genomes of infectious hepatitis C viruses (HCV) of genotype 1a and 
1b. It covers the use of these sequences, and polypeptides encoded by 
all or part of the sequences, in the development of vaccines and 
diagnostic assays for HCV and the development of screening assays for 
the identification of antiviral agents for HCV. Additional information 
can be found in Yanagi et al., (1997) Proc. Natl. Acad. Sci., USA 94, 
8738-8743 and Yanagi et al. (1998) Virology 244, 151-172.

Cloned Genome of Infectious Hepatitis C Virus of Genotype 2a and 
Uses Thereof

Jens Bukh, Masayuki Yanagi, Robert H. Purcell, Suzanne U. Emerson 
(NIAID)
DHHS Reference No. E-100-99/0, U.S. S/N 60/137,693 filed 04 Jun 1999; 
DHHS Reference No. E-100-99/1, PCT/US00/15466 filed 02 Jun 2000

    The current invention provides a nucleic acid sequence comprising 
the genome of infectious hepatitis C viruses (HCV) of genotype 2a. The 
encoded polyprotein differs from those of the infectious clones of 
genotypes 1a and 1b (U.S. Patent 6,153,421) by approximately thirty 
(30) percent. It covers the use of this sequence and polypeptides 
encoded by all or part of the sequence, in the development of vaccines 
and diagnostic assays for HCV and the development of screening assays 
for the identification of antiviral agents for HCV. Additional 
information can be found in Yanagi et al. (1999), Virology 262, 250-
263.

HCV/BVDV Chimeric Genomes and Uses Thereof

Jae-Hwan Nam, Jens Bukh, Robert H. Purcell, Suzanne U. Emerson (NIAID)
DHHS Reference No. E-102-99/0, U.S. S/N 60/137,817 filed 04 June 1999; 
DHHS Reference No. E-102-99/1, PCT/US00/15527 filed 02 Jun 2000

    The current invention provides nucleic acid sequences comprising 
chimeric viral genome of hepatitis C Virus (HCV) and bovine viral 
diarrhea viruses (BVDV). The chimeric viruses are produced by replacing 
the structural region or a structural gene of an infectious BVDV clone 
with the corresponding region or gene of an infectious HCV. It covers 
the use of these sequences and polypeptides encoded by all or part of 
the sequences in the development of vaccines and diagnostic assays for 
HCV and the development of screening assays for the identification of 
antiviral agents for HCV.

Infectious cDNA Clone of GB Virus B and Uses Thereof

Jens Bukh, Masayuki Yanagi, Robert H. Purcell, Suzanne U. Emerson 
(NIAID)
DHHS Reference No. E-173-99/0, U.S. S/N 60/137,694 filed 04 Jun 1999; 
DHHS Reference No. E-173-99/1, PCT/US00/15293 filed 02 Jun 2000

    The current invention provides nucleic acid sequences comprising 
the genomes of infectious GB virus B, the most closely related member 
of the Flaviviridae to hepatitis C virus (HCV). It also covers chimeric 
GBVB-HCV sequences and polypeptides for use in the development of 
vaccines and diagnostic assays for HCV and the development of screening 
assays for the identification of antiviral agents for HCV. Additional 
information can be found in Bukh et al. (1999), Virology 262, 470-478.

    Dated: June 11, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 01-15462 Filed 6-19-01; 8:45 am]
BILLING CODE 4140-01-P