[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65699-65700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26606]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of
Chemopreventive Treatments for Head and Neck Squamous Cell Carcinoma
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, Department
of Health and Human Services, is contemplating the grant of an
exclusive evaluation option license to practice the inventions embodied
in PCT Patent Application No. PCT/US2009/054478, U.S. Patent
Application No. 13/059,335 and foreign equivalents thereof entitled
``Chemopreventive of Head and Neck Squamous Cell Carcinoma'' (HHS Ref.
No. E-302-2008/0) and PCT Patent Application No. PCT/IL2010/000694,
U.S. Patent Application No. 13/391,756 and foreign equivalents thereof
entitled ``Prevention and Treatment of Oral and Lips Diseases Using
Sirolimus and Derivatives Sustained Release Delivery Systems for Local
Application to the Oral Cavity'' (HHS Ref. No. E-282-2009/0) to
Rapamycin Holdings, Inc., which is located in San Antonio, TX. 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 use of the Licensed
Patent Rights for the prevention and treatment of head and neck
cancers.
Upon the expiration or termination of the exclusive evaluation
option license, Rapamycin Holdings, Inc. 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.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 14, 2012 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: In head and neck squamous cell carcinoma
(HNSCC), a cancer occurring mostly in the mouth, it is frequently
observed that the Akt/mTOR pathway is abnormally activated. Therefore,
inhibiting this signaling pathway may help in treating this disease.
Rapamycin and its analogs are known to inhibit the activity of mTOR so
in principle they could serve as therapeutics for treating HNSCC.
This technology describes a method of potentially preventing or
treating HNSCC through the inhibition of mTOR activity. The proof of
this principle was demonstrated by rapid regression of mouth tumors in
mice afflicted with Cowden syndrome with the administration of
rapamycin. Like HNSCC, development of this disease is linked to over
activation of the Akt/mTOR pathway. Furthermore, the therapeutic
potential of rapamycin was demonstrated using mice in experiments that
model chronic exposure to tobacco, which promotes the development of
HNSCC. Therefore, inhibitors of mTOR have considerable potential in the
prevention and treatment of HNSCC. Moreover, using a local, sustained-
release oral drug delivery system for early intervention to prevent
potentially malignant or
[[Page 65700]]
premalignant lesions developing into HNSCC, could deliver the
inhibitors of mTOR with reduced systemic side effects and a lower
required drug dose.
The prospective exclusive license and any further license
applications received as objections to this Notice of Intent to Grant
an 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 evaluation option license is being considered under the small
business initiative launched on 1 October 2011, and will comply with
the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 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 404.7 within fifteen (15) days from the date of
this published notice. A previous Notice of Intent to Grant an
Exclusive License for the instant technology was published in 77 FR
28614, Tuesday, May 15, 2012.
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: October 25, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-26606 Filed 10-29-12; 8:45 am]
BILLING CODE 4140-01-P