[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40118-40119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Evaluation Option Exclusive License: 
Development of Granulysin Immunotherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of an exclusive evaluation 
option license to practice the inventions embodied in U.S. Provisional 
Patent Application. No. 61/250,601, filed October 12, 2009, HHS Ref. 
No.: E-158-2009/0-US-01, Titled: ``Granulysin Immunotherapy''; 
International Application No. PCT/US2010/052036, filed October 8, 2010, 
HHS Ref. No.: E-158-2009/0-PCT-02, Titled: ``Granulysin 
Immunotherapy''; U.S. Patent Application No. 13/501,726, filed April 
12, 2012, HHS Ref. No.: E-158-2009/0-US-06, Titled: ``Granulysin 
Immunotherapy'', and foreign equivalents thereof to Orpheden 
Therapeutics, Inc. (``Orpheden''), a Delaware corporation doing 
business principally in the state of Illinois. The patent rights in 
these inventions have been assigned to the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide and the field of use may be limited to the development of 
15kD granulysin as set forth in the Licensed Patent Rights for the 
treatment of human cancers.
    Upon the expiration or termination of the exclusive evaluation 
option license, Orpheden will have the exclusive right to execute an 
exclusive commercialization license which will supersede and replace 
the exclusive evaluation option license with no greater field of use 
and territory than granted in the exclusive evaluation option license.

[[Page 40119]]


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
28, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Whitney A. Hastings, Ph.D., Licensing 
and Patenting Manager, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Granulysin is a cytolytic and 
proinflammatory molecule expressed by activated human cytotoxic T 
lymphocytes (CTLs) and natural killer (NK) cells when they are attached 
to disease cells including infection, cancer, transplantation, 
autoimmunity, skin and reproductive maladies. Granulysin is made in a 
15-kDa form that is cleaved into a 9-kDa form at both the amino and the 
carboxy termini. Granulysin is broadly cytolytic against tumors and 
microbes. It has been implicated in many of diseases and studies 
suggest that granulysin may be a useful therapeutic directly 
contributing to immunity against foreign molecules for a wide variety 
of diseases.
    This technology describes the use of 15 kD granulysin for enhancing 
immune responses.
    Investigators at the NIH have discovered that 15 kD granulysin 
activates monocytes and induces them to differentiate into mature 
dendritic cells and activates allospecific T cells.
    The proof of this principle was demonstrated by mice expressing 
granulysin in vivo showing markedly improved anti-tumor responses, with 
increased numbers of activated dendritic cells and cytokine-producing T 
cells. Furthermore, current data suggest that dendritic cells matured 
with 15 kD granulysin are superior to the well-established GM-CSF 
induction. There appears to be a significant market opportunity for use 
of the 15 kD granulysin for the ex vivo dendritic cell maturation and 
adoptive immunotherapy.
    The prospective exclusive evaluation option license, and a 
subsequent exclusive commercialization license, may be granted unless 
the 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 part 404 within fifteen (15) days from the 
date of this published notice.
    Complete 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 evaluation option 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16267 Filed 7-10-14; 8:45 am]
BILLING CODE 4140-01-P