[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Page 16692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06069]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Option Exclusive License: The
Development of Liposomal Therapeutic Agents for the Treatment of Human
Epithelial Cancers and Liposarcomas
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 to ZoneOne
Pharma, Inc., of an exclusive evaluation option license to practice the
inventions embodied in the following US Patent (and all foreign
counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative
and Method of Treating Cancer Using Same'' [HHS Ref. E-050-2000/0-US-
15]. 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 worldwide, and the field of use may be limited to:
The pharmaceutical use in humans of 17-dimethylaminoethylamino-17-
demethoxygeldanamycin (``17-DMAG'') as a liposome-encapsulated drug,
alone or in combination with other agents, for the treatment of the
following types of cancer: ovary, pancreas, metastatic skin, head
and neck, colon, kidney, non-small cell lung, or liposarcoma.
Upon the expiration or termination of the exclusive evaluation
option license, ZoneOne Pharma, Inc., will have the exclusive right to
execute an exclusive commercialization license which will supersede and
replace the exclusive evaluation option license with no greater field
of use and territory than granted in the exclusive evaluation option
license.
DATES: Only written comments or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before April 2, 2013 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: Patrick McCue, Ph.D.,
Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-5560; Facsimile: (301)
402-0220; Email: [email protected].
SUPPLEMENTARY INFORMATION: This invention concerns 17-DMAG, the first
water-soluble analog of 17-AAG, a less toxic and more stable analog of
the antitumor antibiotic geldanamycin.
The prospective exclusive evaluation license is being considered
under the small business initiative launched on 1 October 2011, and
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR
404.7. The prospective exclusive evaluation license, and a subsequent
exclusive commercialization license, may be granted unless 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 within fifteen (15) days from the date of
this published notice.
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: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-06069 Filed 3-15-13; 8:45 am]
BILLING CODE 4140-01-P