[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]
 BILLING CODE 4140-01-P