[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48355-48356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Griffithsin,
Glycosylation-Resistant Griffithsin, and Related Conjugates as
Biotherapeutics for the Treatment of HIV and HCV Infections
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 (HHS), is contemplating the
grant of an exclusive license to practice the inventions embodied in:
1. U.S. Provisional Patent Application Serial No. 60/576,056, filed
on June 1, 2004, entitled ``Griffithsin, Glycosylation-Resistant
Griffithsin, and Related Conjugates, Compositions, Nucleic Acids,
Vectors, Host Cells, Methods of Production And Methods of Use'',
converted to PCT/US2005/18778, filed May 27, 2005, and entered national
stage in U.S. (patent application serial number 11/569,813), Canada
(patent application serial number 2,567,728), Australia (patent
application serial number 2005250429), Europe (patent application
serial number 05804849.7), Japan (patent application serial number
2007-515398), Israel (patent application serial number 179236), New
Zealand (patent number 2006/09573), and South Africa (patent
application serial number 2006/09573) (HHS reference E-106-2003/0) from
Dr. Barry O'Keefe et al. (NCI).
2. U.S. Provisional Patent Application Serial No. 60/741.403, filed
on
[[Page 48356]]
December 1, 2005, entitled ``Antiviral Activity Of Griffithsin Against
SARS And HCV'', converted to PCT/US2006/045930, filed December 1, 2006,
and entered national stage in U.S. (patent application serial number
12/095,697), and Europe (patent application serial number 06838737.2)
(HHS reference E-025-2006/0) from Dr. Barry O'Keefe et al. (NCI).
To Rodos Biotarget GmbH (Rodos here after) having a place of business
in Germany. The patent rights in these inventions 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 9, 2010 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: Sally Hu, PhD, M.B.A., Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; E-mail: [email protected]; Telephone:
(301) 435-5606; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION:
The first invention, E-106-2003, provides for isolated and purified
Griffithsin protein and antibodies, plus related purified nucleic
acids. Griffithsin is a novel, potent anti-HIV protein isolated from an
aqueous extract of the red algae Griffithsia and Griffithsin inhibits
viral binding, fusion and entry into the host cells by binding to viral
envelope gp120. In addition, E-106-2003 also provides the methods of
producing Griffithsin and methods of inhibiting a viral infection
(incl. HIV), as well as vaccine development, and screening assays.
The second invention, E-025-2006, follows its predecessor patent
application (E-106-2003) and claims new indications in particular for
severe acute respiratory syndrome (SARS) and Hepatitis C. More
specifically, the subject invention provides for a composition of an
anti-viral polypeptide, Griffithsin, glycosylation-resistant
Griffithsin, and related conjugates, compositions, nucleic acids,
vectors, host cells, antibodies and methods of production and use.
Based on the above two inventions, Griffithsin can be developed as
an HIV entry inhibitor therapeutically or prophylactically against
retroviral infections and also can be developed as an inhibitor against
non-retroviruses infectious such as influenza virus, including H5N1,
SARS, Hepatitis C, and Ebola, measles, varicella, human herpes viruses
and others. In addition, Griffithsin can be used in combination with
other anti-viral agents to treat patients who have drug-resistant
virus.
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 30 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 prospective exclusive license will enter an agreement with
University of Canterbury in Christchurch of New Zealand complying with
the U.S. Government's policy of the U.N. CBD for sharing in a fair and
equitable way the results of research and development and the benefits
arising from the commercial and other utilization of genetic researches
with the ``Source Country'' providing such resources (U.N. CBD; Article
15.7: http://www.cbd.int/convention/convention.shtml).
The field of use may be limited to the development of non-
encapsulated and encapsulated Griffithsin for use in treating human
viral infections where those viral infections are human
immunodeficiency virus (HIV) or hepatitis C virus (HCV).
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: August 3, 2010 .
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-19680 Filed 8-9-10; 8:45 am]
BILLING CODE 4140-01-P