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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# ACTION:

Notice.

# 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                               ( print 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:                         *sstand@od.nih.gov.*

# 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