[Federal Register Volume 69, Number 190 (Friday, October 1, 2004)]
[Notices]
[Page 58933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22146]



[[Page 58933]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: ``Anthrax Toxin Fusion 
Proteins and Uses Thereof,'' ``Anthrax Toxin Fusion Proteins and 
Related Methods,'' and ``Targeting Agents to the MHC Class I Processing 
Pathway with an Anthrax Toxin Fusion Protein''

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

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), that the Food and Drug Administration and the 
Department of Health and Human Services is contemplating the grant of 
an exclusive license to practice the inventions embodied in ``Anthrax 
toxin fusion proteins and uses thereof'', by Leppla et al., issued as 
U.S. patent 5,591,631 on January 7, 1997; ``Anthrax toxin fusion 
proteins and related methods'' by Leppla et al., issued as U.S. patent 
5,677,274 on October 14, 1997; and ``Targeting agents to the MHC class 
I processing pathway with an anthrax toxin fusion protein'' by Klimpel 
et al. filed internationally as PCT/US97/16452, and claiming priority 
to U.S. provisional patent application 60/025,270, filed September 17, 
1996 to Avant Immunotherapeutics, Inc., which is located in Needham, 
MA. The patent rights in these inventions have been assigned to the 
United States of America. This technology is currently licensed to 
Avant Immunotherapeutics, Inc. on a non-exclusive basis in the area of 
immune diseases.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to vaccines and immunotherapeutics for 
the prevention or treatment of the following human and animal diseases: 
Human immunodeficiency, hepatitis B virus and hepatitis C virus.

DATES: Only written comments and/or license applications that are 
received by the National Institutes of Health on or before November 30, 
2004 will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: Brenda J. Hefti, Technology Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804. Telephone: 
(301) 435-4632; Facsimile: (301) 402-0220; and e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In this technology, an anthrax binary toxin 
system provides antigen access to MHC Class I processing pathway. The 
Bacillus antracis binary toxin consists of two proteins, a protective 
antigen (PA) combines with lethal factor (LF) to make anthrax toxin. In 
this system PA binds to the protein receptor on the target cell, is 
cleaved to produce the PA63 fragment, PA63 binds to LF and the binary 
anthrax toxin is endocytosed and transported into the cell to be 
processed by the MHC Class I processing pathway. Advantages of this 
system include its ability to accommodate large fusion proteins and the 
fact that anthrax toxin is not widely used for immunization.
    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 Part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the NIH 
receives written evidence and argument that establish that the grant of 
the license would not be consistent with the requirements of 35 U.S.C. 
209 and 37 CFR 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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: September 27, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-22146 Filed 9-30-04; 8:45 am]
BILLING CODE 4140-01-P