[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