[Federal Register Volume 73, Number 68 (Tuesday, April 8, 2008)]
[Notices]
[Page 19076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Codon Optimized IL-15 and 
IL-15R-Alpha Genes for Expression in Mammalian Cells

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 worldwide to practice the invention embodied in 
U.S. Serial Numbers 60/758,819, filed January 13, 2006 and 60/812,566, 
filed June 9, 2006; PCT filed (PCT/US2007/000774) on January 12, 2007, 
entitled ``Codon Optimized IL-15 and IL-15R--Alpha Genes for Expression 
in Mammalian Cells'' (HHS Ref. E-254-2005/2) to Marine Polymer 
Technologies, Inc., having a place of business in Danvers, 
Massachusetts. 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 April 
28, 2008 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: Susan Ano, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: (301) 
435-5515; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: This technology provides for optimized 
nucleic acids for improved expression of interleukin-15 (IL-15) and IL-
15 receptor alpha (IL-15R-alpha) in mammalian cells. IL-15 is a 
cytokine important for both the innate and adaptive immune systems. 
Based on its many functions and relative safety in animal models, IL-15 
finds use in vaccines, cancer immunotherapeutics, and autoimmune 
disease and as a vaccine adjuvant. The present technology enhances the 
production and bioavailability of IL-15 through use of optimized 
nucleic acid sequences. Native IL-15 coding sequences do not express 
IL-15 optimally for several reasons, and the optimized sequences of the 
subject technology overcome these deficiencies. The nucleic acids can 
be part of expression vectors, which could be utilized either in vitro 
or in vivo. The expression vectors express IL-15 alone, IL-15R-alpha 
alone, or both molecules together from a single vector. Further 
enhanced expression of IL-15 and/or IL-15R-alpha can be achieved 
through the use of signal peptides or propeptides from heterologous 
proteins. These nucleic acids can be administered to enhance the immune 
response of an individual against one or more antigens. Primate studies 
have shown that co-administration of IL-15 and IL-15R-alpha increased 
antigen specific cells, cells expressing IL-2, and/or cells expressing 
IL-2 and IFN-gamma (i.e. multifunctional cells). The present 
compositions are useful for the increased bioavailability and therefore 
biological effects of IL-15 after its administration to humans or other 
mammals.
    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 20 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 the prevention, treatment and/or 
management of diseases involving IL-15 mediated signaling, comprising 
cancer, Hepatitis B and C infection, and immunotherapy (excluding Human 
Immunodeficiency Virus).
    The licensed territory will be exclusive worldwide.
    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: March 31, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-7260 Filed 4-7-08; 8:45 am]
BILLING CODE 4140-01-P