[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9248-9249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03410]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Pre-Clinical Evaluation 
and Commercial Development of Human Therapeutics for Liver Cancer and 
Ovarian Cancer Within the Scope of the Licensed Patent Rights

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 of an exclusive 
evaluation option license to practice the inventions covered under the 
scope of the following patents and patent applications:
     United States Patent No. 8,207,142 issued Jun 26, 2012 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
US-06);
     EP Patent No. 1418949 issued June 19, 2013, entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-EP-02) and 
validated in Great Britain, Germany and France;
     Australia Patent No. 2002322805 issued February 21, 2008 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
AU-03);
     Australia Patent No. 2008200601 issued November 25, 2010 
entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-
AU-07);
     Canada Patent No. 2,454,147 issued May 21, 2013 entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-CA-04);
     Japan Patent Application No. 2003-517229 filed July 30, 
2002 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-
2001/2-JP-05); and
     Japan Patent No. 5416660 issued November 22, 2013 entitled 
``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-JP-08)

to Metheor Therapeutics, Corporation (``METHEOR'') a U.S. based company 
located in Shoreline, WA, USA. 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

[[Page 9249]]

worldwide and the field of use may be limited to the pre-clinical 
evaluation and commercial development of human therapeutics for liver 
cancer and ovarian cancer within the scope of the Licensed Patent 
Rights. Upon expiration or termination of the exclusive evaluation 
option license, METHEOR will have the right to execute a start-up 
exclusive patent commercialization license which will supersede and 
replace the exclusive evaluation option license with no broader field 
of use and territory than granted in the exclusive evaluation option 
license.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
March 5, 2014 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: Sabarni K. Chatterjee, 
Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5587; 
Facsimile: (301) 402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: The present inventions relate to a potent 
inhibitor of DNA methylation (Zebularine) that can specifically 
reactivate silenced tumor suppressor genes. This agent can be used to 
inhibit methylation and thereby combat certain cancers that have been 
linked to hypermethylation. This agent has also been shown in initial 
animal testing to be active orally and is more stable than some other 
agents in this same area of therapy and is a suitable candidate for 
further pre-clinical and clinical development as an anti-cancer agent 
to be used as monotherapy and/or as an adjunct to existing anti-cancer 
therapeutics.
    METHEOR has indicated its interest in developing Zebularine as 
novel epigenetic modifiers and drugs for oncologic 
indications. Pre-clinical research and clinical development 
will primarily focus on determining the safety and efficacy of the lead 
compound for liver and ovarian cancers.
    The prospective exclusive evaluation option license 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 exclusive evaluation option license, 
and a subsequent exclusive patent commercialization license, may be 
granted unless within fifteen (15) 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 part 404.
    Any additional, properly filed, and 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 12, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-03410 Filed 2-14-14; 8:45 am]
BILLING CODE 4140-01-P