[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Page 8330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Start-up Evaluation 
License for the Development of Theranostic Kits for Taxane-based 
Chemotherapy

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 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant to Taxor Diagnostics, 
LLC of an exclusive evaluation option license to practice the 
inventions embodied in the following US Patent, US Patent Application, 
and International Patent Application (and all foreign counterparts): US 
Patent No. 8,546,091, issued 01 October 2013, entitled, ``Akt 
Phosphorylation at SER473 as an Indicator for Taxane-based 
Chemotherapy'' [HHS Ref. E-191-2009/0-US-07]; US Patent Application 
serial no. 14/031,699, of the same name, filed 19 September 2013 [HHS 
Ref. E-191-2009/0-US-08]; and International (PCT) Patent Application 
no. PCT/US2010/035816, of the same name, filed 21 May 2010 [HHS Ref. E-
191-2009/0-PCT-02]. The patent rights in this invention have been 
assigned to the Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide, and the field of use may be limited to:

    1. Exclusive use of the Licensed Patent Rights to develop a test 
kit approved by the FDA as a Class III medical device under the 
Premarket approval (PMA) process, such test kit to be distributed in 
commerce for the purpose of identifying subgroups of breast cancer, 
colorectal cancer, and non-small cell lung cancer patients that may 
benefit from treatment with a taxane therapy; and
    2. Non-exclusive use of the Licensed Patent Rights to develop a 
test kit for which the FDA issues an order, in the form of a letter, 
which finds Licensee's device to be substantially equivalent to one 
or more similar legally marketed devices, and states that the 
Licensee's device can be marketed in the U.S. (i.e., 510(k) 
cleared), such test kit to be distributed in commerce for the 
purpose of identifying subgroups of breast cancer, colorectal 
cancer, and non-small cell lung cancer patients that may benefit 
from treatment with a taxane therapy.

    Upon the expiration or termination of the exclusive evaluation 
option license, Taxor Diagnostics, LLC 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 or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before March 4, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Patrick McCue, 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) 435-5560; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: The technology describes a method of 
identifying cancer patients that will respond favorably to and benefit 
from treatment with taxane-based therapy depending on the 
phosphorylation status of protein Akt-Serine 473 in patient's tumor 
biopsy sample.
    The prospective exclusive evaluation 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 
part 404. 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: February 9, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-03088 Filed 2-13-15; 8:45 am]
BILLING CODE 4140-01-P