[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Page 16406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-up Exclusive Evaluation Option Patent 
License: ``The Development and Use of Diazeniumdiolated and Hybrid 
Diazeniumdiolated Compounds for the Treatment of Ovarian Cancer in 
Humans''

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of a Start-up Exclusive Evaluation Option 
License to practice the inventions embodied in the Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to Tar Meta Biosciences, Inc. (``TarMeta'') located in King of 
Prussia, PA, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before April 19, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Start-up Exclusive Evaluation 
Option License should be directed to: Kathleen Higinbotham, Senior 
Technology Transfer Manager, NCI Technology Transfer Center, Riverside 
5, Suite 400, 8490 Progress Dr., Frederick, MD 21701, Telephone: (301)-
624-8775; Facsimile: (301)-631-3027 Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    (1) E-025-2010/0 entitled ``Nitric Oxide-based Cancer 
Therapeutic Agents For Lung Cancers With Elevated Levels Of Reactive 
Oxygen Species (ROS) And/or Low Levels Of Antioxidant Defense/DNA 
Repair Mechanisms.''
    (a) United States Provisional Patent Application No. 61/261,175 
filed November 13, 2009;
    (b) PCT Application No. PCT/US2010/056446 filed November 12, 
2010;
    (c) United States Patent Application No. 13/509,431 filed June 
01, 2012, US Patent 9,205,091 issued December 08, 2015;
    (d) Australian Patent Application No. 2010319398 filed May 09, 
2012;
    (e) Canadian Patent Application No. 2,780,633 filed May 10, 
2012;
    (f) European Patent Application No. 10778814.3 filed May 14, 
2012;
    (2) E-220-2011/0 entitled ``Hybrid Diazeniumdiolated Compounds, 
Pharmaceutical Compositions, And Method Of Treating Cancer.''
    (a) United States Provisional Patent Application No. 61/549,862, 
filed October 21, 2011;
    (b) PCT Application No. PCT/US2012/060785 filed October 18, 
2012;
    (c) United States Patent Application No. 14/352,096 filed April 
16, 2014, US Patent 9,168,266 issued October 27, 2015;
    (d) Australian Patent Application No. 2012326105 filed April 14, 
2014;
    (e) Canadian Patent Application No. 2,852,682 filed April 14, 
2014;
    (f) European Patent Application No. 12841601.3 filed April 14, 
2014, European Patent 2768824 issued December 07, 2016;
    (i) German Patent 602012026435.7 issued December 07, 2016;
    (ii) French Patent 2768824 issued December 07, 2016; and
    (iii) UK Patent 2768824 issued December 07, 2016.

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to ``The development and use of 
diazeniumdiolated and hybrid diazeniumdiolated compounds for the 
treatment of ovarian cancer in humans.''
    The present inventions describe the use of diazeniumdiolate-based 
nitric oxide (NO)-releasing compounds wherein the cancer cell has an 
elevated level of reactive oxygen species (ROS), as well as the use of 
hybrid prodrug molecules that combine a diazeniumdiolated compound and 
a poly(ADP-ribose) polymerase (PARP) inhibitor in cancer cells to 
produce synergistic effects, whether alone or as an adjuvant for other 
therapies. The hybrid prodrug is expected to enhance cytotoxicity by 
creating DNA damage with NO and preventing its repair with the PARP 
inhibitor. The prodrug and the hybrid are activated by glutathione S-
transferase and are predicted to be effective in cancers with reactive 
oxygen species (ROS), both of which are elevated in many cancers. In 
addition, the prodrug and hybrid may have synergy with therapeutics 
(such as proteasome inhibitor bortezomib and doxorubicin) which act 
through generation of ROS. Taken together, these features suggest that 
the prodrug and hybrid may have therapeutic applications in cancer 
patients whose tumors include high levels of ROS.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Start-up Exclusive Evaluation Option License 
will be royalty bearing, and the prospective exclusive license may be 
granted unless within fifteen (15) days from the date of this published 
notice, the National Cancer Institute 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.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Start-up Exclusive Evaluation Option 
License Agreement. 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: March 21, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-06545 Filed 4-3-17; 8:45 am]
 BILLING CODE 4140-01-P