[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25876-25877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Option License 
Agreement: Activators of Human Pyruvate Kinase To Treat Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This 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 of a Start-up Exclusive 
Evaluation Option License Agreement to TeamedOn International, LLC., a 
company having a place of business in Rockville, MD, to practice the 
inventions embodied in the following applications:

1. U.S. Provisional Patent Application No. 61/104,091, filed October 
9, 2008
    HHS Ref. No.: E-326-2008/0-US-01
    Titled: Activators of Human Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, Amanda 
P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
2. PCT Application No. PCT/US2009/60237, filed October 9, 2009

[[Page 25877]]

    HHS Ref. No.: E-326-2008/0-PCT-02
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
3. Australian Patent Application No. 2009303335, filed October 9, 
2009
    HHS Ref. No.: E-326-2008/0-AU-03
Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
4. Canadian Patent Application No. 2,740,148, filed October 9, 2009
    HHS Ref. No.: E-326-2008/0-CA-04
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
5. European Patent Application No. 09740795.1, filed October 9, 2009
    HHS Ref. No.: E-326-2008/0-EP-05
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
6. Japanese Patent Application No. 531221-2011, filed October 9, 
2009
    HHS Ref. No.: E-326-2008/0-JP-06
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
7. U.S. Patent Application No. 13/123,297, filed October 9, 2009
    HHS Ref. No.: E-326-2008/0-US-07
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
8. U.S. Patent Application No. 13/433,656, filed March 29, 2012
    HHS Ref. No.: E-326-2008/0-US-08
    Titled: Activators of Pyruvate Kinase
    Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, 
Amanda P. Skoumbourdis, Jian- Kang Jiang, and Matthew Boxer (NCATS)

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective Start-up Exclusive Evaluation Option License Agreement may 
be worldwide, and the field of use may be limited to ``Use of PK-M2 
activators for treatment of cancer in humans.''
    Upon the expiration or termination of the Start-up Exclusive 
Evaluation Option License Agreement, TeamedOn International will have 
the exclusive right to execute a Start-up Exclusive Patent License 
Agreement which will supersede and replace the Start-up Exclusive 
Evaluation Option License Agreement, with no greater field of use and 
territory than granted in the Start-up Exclusive Evaluation Option 
License Agreement.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
21, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated Start-up 
Exclusive Evaluation Option License Agreement should be directed to: 
Suryanarayana Vepa, Ph.D., J.D., Senior Licensing and Patenting 
Manager, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5020; Facsimile: (301) 402-0220; Email: 
[email protected]. A signed confidentiality nondisclosure agreement 
will be required to receive copies of any patent applications that have 
not been published or issued by the United States Patent and Trademark 
Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: The fetal form of Pyruvate Kinase, called 
PK-M2, is expressed in all cancer cells but is normally inactive. The 
products and methods sought in the prospective evaluation option 
license agreement activate PK-M2 and result in inhibition of tumor 
development. This invention relates to products and methods of 
administering PK-M2 activators of various types and methods of treating 
cancer and diseases susceptible to PK-M2 activators. The prospective 
Start-up Exclusive Evaluation Option License Agreement is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR Part 404. The prospective Start-up Exclusive Evaluation Option 
License Agreement and a subsequent Start-up Exclusive Patent License 
Agreement may be granted unless the NIH receives written evidence and 
argument, within fifteen (15) days from the date of this published 
notice, that establishes that the grant of the contemplated Start-up 
Exclusive Evaluation Option License Agreement 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: May 2, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-10309 Filed 5-5-14; 8:45 am]
BILLING CODE 4140-01-P