[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