[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48172-48173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of PKM2 Activators 
for the Treatment of Cancer

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 patent license to practice the inventions embodied in U.S. 
Provisional Patent Application No. 61/104,091, entitled ``Activators of 
Human Pyruvate Kinase,'' filed October 9, 2008, now abandoned [HHS Ref. 
No. E-326-2008/0-US-01]; PCT/US2009/60237 Application entitled ``Small 
Molecule Activators of Pyruvate Kinase,'' filed October 9, 2009, now 
abandoned [HHS Ref. No. E-326-2008/0-PCT-02]; EP Application No. 
09740795.1, entitled ``Small Molecule Activators of Pyruvate Kinase,'' 
filed October 9, 2009 [HHS Ref. No. E-326-2008/0-EP-05]; U.S. Non-
Provisional Application No. 13/123,297, entitled

[[Page 48173]]

``Small Molecule Activators of Pyruvate Kinase,'' filed April 8, 2011 
[HHS Ref. No. E-326-2008/0-US-07]; Australian National Application No. 
2009303335, entitled ``Small Molecule Activators of Pyruvate Kinase,'' 
filed October 9, 2010 [HHS Ref. No. E-326-2008/0-AU-03]; Canadian 
National Application, entitled ``Small Molecule Activators of Pyruvate 
Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-CA-04]; 
Japanese National Application, entitled ``Small Molecule Activators of 
Pyruvate Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-JP-
06]; U.S. Provisional Patent Application No. 61/329,158, entitled 
``Pyruvate Kinase M2 Activators for the Treatment of Cancer,'' filed 
April 29, 2010, now abandoned [HHS Ref. No. E-120-2010/0-US-01]; and 
PCT Application PCT/US2011/033852 entitled ``Pyruvate Kinase M2 
Activators for the Treatment of Cancer,'' filed April 26, 2011 [HHS 
Ref. No. E-120-2010/0-PCT-02] to Forma Therapeutics, Inc., having an 
office at 790 Memorial Drive, Cambridge, MA 02139. The patent rights in 
these inventions have been assigned to the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the use of PKM2 activators as human 
therapeutics for the treatment of cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 7, 2011 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: Steven Standley, PhD, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4074; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The fetal form of Pyruvate Kinase, called 
PKM2, is expressed in all cancer cells and imparts an important 
metabolic change on cancer cells which allows them to grow and divide 
rapidly. That is, PKM2 is normally inactive, which allows cancer cells 
to create an abundance of molecules for cellular growth and division. 
The products and methods sought in the prospective license activate 
PKM2 and result in inhibition of tumor development.
    This invention relates to products and methods of administering 
PKM2 activators of various types and methods of treating cancer and 
diseases susceptible to PKM2 activators.
    The prospective 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 license may be granted unless within thirty 
(30) days from the date of this published notice, 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.
    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 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: August 2, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-20003 Filed 8-5-11; 8:45 am]
BILLING CODE 4140-01-P