[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31650-31651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11770]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development and
Commercialization of Adeno-Virus Based Cancer Immunotherapy
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 an exclusive patent
license to practice the inventions embodied in the following Patents
and Patent Applications to Etubics Corporation (``Etubics'') located in
San Francisco, California, USA.
Intellectual Property
United States Provisional Patent Application No. 60/904,236 filed
February 28, 2007, titled ``Brachyury Polypeptides and Methods of Use''
[HHS Reference No. E-074-2007/0-US-01];
International Patent Application No. PCT/US2008/055185filed
February 28, 2008 titled ``Brachyury Polypeptides and Methods of Use''
[HHS Reference No. E-074-2007/0-PCT-02]; National Stage Applications
and issued patents, in the US, EP, CA, AU, JP, HK, and all
continuations applications, divisional applications and foreign
counterpart applications and patents claiming priority to the
provisional application no. 60/904,236,
United States Provisional Patent Application No. 61/701,525, filed
September 14, 2014, titled ``Brachyury Protein, Non-Poxvirus Non-Yeast
Vectors Encoding Brachyury Protein, And Their Use'' [HHS Reference No.
E-055-2011/0-US-01];
International Patent Application No. PCT/US2013/0059737 filed
September 13, 2012 titled ``Brachyury Protein, Non-Poxvirus Non-Yeast
Vectors Encoding Brachyury Protein, and Their Use'' [HHS Reference No.
E-055-2011/0-PCT-02]; National Stage Applications and issued patents,
in the U.S., EP and all continuations applications, divisional
applications and foreign counterpart applications and patents claiming
priority to the provisional application no. 60/701,525.
U.S. Provisional Application No. 62/200,438 filed August 3, 2015
titled ``Brachyury Deletion Mutants, Non-Yeast Vectors Encoding
Brachyury Deletion Mutants, and Their Use'' [HHS Reference No. E-244-
2015/0-US-01] and continuation applications, divisional applications
and foreign counterpart applications claiming priority to the U.S.
provisional application no. 62/200,438.
U.S. Patent Application No. 61/582,723 filed January 3, 2012
entitled ``Native and Agonist CTL Epitopes of The MUC-1 Tumor Antigen''
[HHS Reference No. E-001-2012/0-US-01] as well as all continuation and
divisional applications and foreign issued patents and patent
applications claiming priority to the U.S. provisional application no.
61/582,723.
U.S. Patent Application No. 61/894,482 filed October 23, 2013
entitled ``Identification and Characterization of HLA-A24 Agonist
Epitopes of MUC1-Oncoprotein'' [HHS Reference No. E-520-2013/0-US-01]
as well as all continuation and divisional applications and foreign
issued patents and patent applications claiming priority to the US
provisional application no. 61/894,482.
U.S. Patent No. 6,756,038 issued June, 29 2004 as well as issued
and pending foreign counterparts [HHS Ref. No. E-099-1996/0-US-07];
U.S. Patent No. 7,723,096 issued May 25, 2010 as well as
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-099-1996/0-US-08];
Europe Patent No. 1017810 (HHS Ref. No. E-099-1996/0-EP-05, and all
European contracting states in which this patent is validated,
including: German Patent No. 69824023.5 (HHS Ref. No. E-099-1996/0-DE-
09); France Patent No. 1017810 (HHS Ref. No. E-099-1996/0-FR-10); Great
Britain Patent No. 1017810 (HHS Ref. No. E-099-1996/0-GB-11); Italy
Patent No. 1017810 (HHS Ref. No. E-099-1996/0-IT-12); Spain Patent No.
2217585) (HHS Ref. No. E-099-1996/0-ES-13);
[[Page 31651]]
Switzerland Patent Application No. 98948429.0 (now Switzerland Patent
No. 1017810) (HHS Ref. No. E-099-1996/0-CH-14); Belgium Patent
Application No. 98948429.0 (now Belgium Patent No. 1017810) (HHS Ref.
No. E-099-1996/0-BE-15); Ireland Patent Application No. 98948429.0 (now
Ireland Patent No. 1017810) (HHS Ref. No. E-099-1996/0-IE-16); and all
continuations and divisional applications claiming priority to any of
the above;
Europe Patent Application No. 04011673.3 (now EP Patent No.
1447414) (HHS Ref. No. E-099-1996/0-EP-17), and all European
contracting states in which this patent is validated, including:
Austria Patent Application No. 04011673.3 (now Austria Patent No.
1447414) (HHS Ref. No. E-099-1996/0-AT-28); Belgium Patent Application
No. 04011673.3 (now Belgium Patent No. 1447414) (HHS Ref. No. E-099-
1996/0-BE-29); Cyprus Patent Application No. 04011673.3 (now Cyprus
Patent No. 1447414) (HHS Ref. No. E-099-1996/0-CY-31); Denmark Patent
Application No. 04011673.3 (now Denmark Patent No. 1447414) (HHS Ref.
No. E-099-1996/0-DK-41); Finland Patent Application No. 04011673.3 (now
Finland Patent No. 1447414) (HHS Ref. No. E-099-1996/0-FI-33); France
Patent Application No. 04011673.3 (now France Patent No. 1447414) (HHS
Ref. No. E-099-1996/0-FR-42); Germany Patent Application No. 04011673.3
(now Germany Patent No. 69837896) (HHS Ref. No. E-099-1996/0-DE-40);
Great Britain Patent Application No. 04011673.3 (now Great Britain
Patent No. 1447414) (HHS Ref. No. E-099-1996/0-GB-43); Greece Patent
Application No. 04011673.3 (now Greece Patent No. 1447414) (HHS Ref.
No. E-099-1996/0-GR-34); Ireland Patent Application No. 04011673.3 (now
Ireland Patent No. 1447414) (HHS Ref. No. E-099-1996/0-IE-35); Italy
Patent Application No. 04011673.3 (now Italy Patent No. 1447414) (HHS
Ref. No. E-099-1996/0-IT-36); Luxembourg Patent Application No.
04011673.3 (now Luxembourg Patent No. 1447414) (HHS Ref. No. E-099-
1996/0-LU-44); Monaco Patent Application No. 04011673.3 (now Monaco
Patent No. 1447414) (HHS Ref. No. E-099-1996/0-MC-45); Netherlands
Patent Application No. 04011673.3 (now Netherlands Patent No. 1447414)
(HHS Ref. No. E-099-1996/0-NL-46); Portugal Patent Application No.
04011673.3 (now Portugal Patent No. 1447414) (HHS Ref. No. E-099-1996/
0-PT-37); Spain Patent Application No. 04011673.3 (now Spain Patent No.
2286530) (HHS Ref. No. E-099-1996/0-ES-32); Sweden Patent Application
No. 04011673.3 (now Sweden Patent No. 1447414) (HHS Ref. No. E-099-
1996/0-SE-38); Switzerland Patent Application No. 04011673.3 (now
Switzerland Patent No. 1447414) (HHS Ref. No. E-099-1996/0-CH-30); and
all continuations and divisional applications claiming priority to any
of the above;
Japan Patent Application No. 2000-516030 (now JP Patent No.
4291508) (HHS Ref. No. E-099-1996/0-JP-06), and all continuations and
divisional applications claiming priority to this application;
Australia Patent No. 745863 (HHS Ref. No. E-099-1996/0-AU-03), and
all continuations and divisional applications claiming priority to this
application; Canada Patent No. 2308127 (HHS Ref. No. E-099-1996/0-CA-
04), and all continuations and divisional applications claiming
priority to this application;
U.S. Patent Application No. 10/579,025 filed May 11, 2006 as well
as all continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-087-2005/0-US-03];
U.S. Patent Application No. 10/579,007 filed May 11, 2006 as well
as all continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-088-2005/0-US-03];
U.S. Patent No. 7,118,738 issued October 10, 2006 as well as all
continuations and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-154-1998/0-US-07];
U.S. Patent Application Nos. 08/686,280 filed July 25, 1996 as well
as all issued and pending foreign counterparts [HHS Ref. No. E-259-
1994/3-US-01];
U.S. Patent No. 7,410,644 issued August 12, 2008 as well as all
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-259-1994/3-US-08];
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of 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 Licensed Patent Rights for
the following: ``The development and commercialization of a therapeutic
cancer vaccine specifically using Adeno-viral vectors.'' For avoidance
of doubt, the field of use specifically excludes other viral vectors
including but not limited to pox virus vectors, yeast based vectors and
other adjuvants and vectors that are not adeno-viral vectors.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before June
3, 2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Senior Licensing and
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-
276-5504E-mail: [email protected].
SUPPLEMENTARY INFORMATION: This invention concerns Brachyury, a master
transcription factor that governs the epithelial-mesenchymal
transition, was shown to be significantly overexpressed in primary and
metastasizing tumors relative to normal human tissues. Stimulation of T
cells with the Brachyury peptide promoted a robust immune response and
the targeted lysis of invasive tumor cells. Brachyury overexpression
has been demonstrated in a range of human tumors (breast, lung, colon
and prostate, among others) suggesting that an immunotherapeutic
product derived from this technology would be broadly applicable for
the treatment of cancer.
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 part
404.7. The prospective exclusive 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 404.7.
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 Exclusive Patent 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 13, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2016-11770 Filed 5-18-16; 8:45 am]
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