81_FR_31747 81 FR 31650 - Prospective Grant of Exclusive Patent License: Development and Commercialization of Adeno-Virus Based Cancer Immunotherapy

81 FR 31650 - Prospective Grant of Exclusive Patent License: Development and Commercialization of Adeno-Virus Based Cancer Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 97 (May 19, 2016)

Page Range31650-31651
FR Document2016-11770

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.

Federal Register, Volume 81 Issue 97 (Thursday, May 19, 2016)
[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31650-31651]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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



                                                  31650                          Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices

                                                  356: Major Opportunities for Research in                  Contact Person: Sung Sug Yoon, Ph.D.,               And Their Use’’ [HHS Reference No. E–
                                                  Epidemiology of Alzheimer’s Disease and                 Scientific Review Officer, Center for                 055–2011/0–US–01];
                                                  Cognitive Resilience (R01).                             Scientific Review, National Institutes of                International Patent Application No.
                                                    Date: June 14, 2016.                                  Health, 6701 Rockledge Drive, Room 3152,              PCT/US2013/0059737 filed September
                                                    Time: 1:00 p.m. to 4:00 p.m.                          Bethesda, MD 20892, sungsug.yoon@nih.gov.
                                                    Agenda: To review and evaluate grant
                                                                                                                                                                13, 2012 titled ‘‘Brachyury Protein, Non-
                                                                                                          (Catalogue of Federal Domestic Assistance             Poxvirus Non-Yeast Vectors Encoding
                                                  applications.                                           Program Nos. 93.306, Comparative Medicine;
                                                    Place: National Institutes of Health,                                                                       Brachyury Protein, and Their Use’’
                                                                                                          93.333, Clinical Research, 93.306, 93.333,
                                                  Rockledge II, 6701 Rockledge Drive,                     93.337, 93.393–93.396, 93.837–93.844,
                                                                                                                                                                [HHS Reference No. E–055–2011/0–
                                                  Bethesda, MD 20892, (Virtual Meeting).                  93.846–93.878, 93.892, 93.893, National               PCT–02]; National Stage Applications
                                                    Contact Person: George Vogler, Ph.D.,                 Institutes of Health, HHS)                            and issued patents, in the U.S., EP and
                                                  Scientific Review Officer, Center for                                                                         all continuations applications,
                                                  Scientific Review, National Institutes of                 Dated: May 12, 2016.
                                                                                                                                                                divisional applications and foreign
                                                  Health, 6701 Rockledge Drive, Room 3140,                Carolyn Baum,
                                                  MSC 7770, Bethesda, MD 20892, (301) 237–
                                                                                                                                                                counterpart applications and patents
                                                                                                          Program Analyst, Office of Federal Advisory           claiming priority to the provisional
                                                  2693, voglergp@csr.nih.gov.                             Committee Policy.
                                                    Name of Committee: Surgical Sciences,                                                                       application no. 60/701,525.
                                                  Biomedical Imaging and Bioengineering
                                                                                                          [FR Doc. 2016–11771 Filed 5–18–16; 8:45 am]              U.S. Provisional Application No. 62/
                                                  Integrated Review Group; Surgery,                       BILLING CODE 4140–01–P                                200,438 filed August 3, 2015 titled
                                                  Anesthesiology and Trauma Study Section.                                                                      ‘‘Brachyury Deletion Mutants, Non-
                                                    Date: June 15–16, 2016.                                                                                     Yeast Vectors Encoding Brachyury
                                                    Time: 8:00 a.m. to 5:00 p.m.                          DEPARTMENT OF HEALTH AND                              Deletion Mutants, and Their Use’’ [HHS
                                                    Agenda: To review and evaluate grant                  HUMAN SERVICES                                        Reference No. E–244–2015/0–US–01]
                                                  applications.                                                                                                 and continuation applications,
                                                    Place: Hilton Austin, 500 E 4th St, Austin,           National Institutes of Health                         divisional applications and foreign
                                                  TX.
                                                    Contact Person: Weihua Luo, MD, Ph.D.,                                                                      counterpart applications claiming
                                                                                                          Prospective Grant of Exclusive Patent
                                                  Scientific Review Officer, Center for                                                                         priority to the U.S. provisional
                                                                                                          License: Development and
                                                  Scientific Review, National Institutes of                                                                     application no. 62/200,438.
                                                                                                          Commercialization of Adeno-Virus                         U.S. Patent Application No. 61/
                                                  Health, 6701 Rockledge Drive, Room 5114,
                                                  MSC 7854, Bethesda, MD 20892, (301) 435–
                                                                                                          Based Cancer Immunotherapy                            582,723 filed January 3, 2012 entitled
                                                  1170, luow@csr.nih.gov.                                                                                       ‘‘Native and Agonist CTL Epitopes of
                                                                                                          AGENCY:    National Institutes of Health,
                                                    Name of Committee: Oncology 2—                        HHS.                                                  The MUC–1 Tumor Antigen’’ [HHS
                                                  Translational Clinical Integrated Review                                                                      Reference No. E–001–2012/0–US–01] as
                                                  Group; Drug Discovery and Molecular                     ACTION:   Notice.                                     well as all continuation and divisional
                                                  Pharmacology Study Section.                                                                                   applications and foreign issued patents
                                                    Date: June 16–17, 2016.                               SUMMARY:    This notice, in accordance
                                                                                                                                                                and patent applications claiming
                                                    Time: 8:00 a.m. to 5:00 p.m.                          with 35 U.S.C. 209 and 37 CFR part 404,
                                                    Agenda: To review and evaluate grant                                                                        priority to the U.S. provisional
                                                                                                          that the National Institutes of Health,
                                                  applications.                                                                                                 application no. 61/582,723.
                                                                                                          Department of Health and Human                           U.S. Patent Application No. 61/
                                                    Place: The Dupont Hotel, 1500 New                     Services, is contemplating the grant of
                                                  Hampshire Avenue NW., Washington, DC                                                                          894,482 filed October 23, 2013 entitled
                                                  20036.
                                                                                                          an exclusive patent license to practice               ‘‘Identification and Characterization of
                                                    Contact Person: Jeffrey Smiley, Ph.D.,                the inventions embodied in the                        HLA–A24 Agonist Epitopes of MUC1-
                                                  Scientific Review Officer, Center for                   following Patents and Patent                          Oncoprotein’’ [HHS Reference No. E–
                                                  Scientific Review, National Institutes of               Applications to Etubics Corporation                   520–2013/0–US–01] as well as all
                                                  Health, 6701 Rockledge Drive, Room 6194,                (‘‘Etubics’’) located in San Francisco,               continuation and divisional
                                                  MSC 7804, Bethesda, MD 20892, 301–594–                  California, USA.
                                                  7945, smileyja@csr.nih.gov.                                                                                   applications and foreign issued patents
                                                    Name of Committee: Bioengineering                     Intellectual Property                                 and patent applications claiming
                                                  Sciences & Technologies Integrated Review                                                                     priority to the US provisional
                                                                                                            United States Provisional Patent                    application no. 61/894,482.
                                                  Group; Biomaterials and Biointerfaces Study             Application No. 60/904,236 filed
                                                  Section.                                                                                                         U.S. Patent No. 6,756,038 issued June,
                                                    Date: June 16–17, 2016.
                                                                                                          February 28, 2007, titled ‘‘Brachyury                 29 2004 as well as issued and pending
                                                    Time: 8:00 a.m. to 5:00 p.m.                          Polypeptides and Methods of Use’’                     foreign counterparts [HHS Ref. No. E–
                                                    Agenda: To review and evaluate grant                  [HHS Reference No. E–074–2007/0–US–                   099–1996/0–US–07];
                                                  applications.                                           01];                                                     U.S. Patent No. 7,723,096 issued May
                                                    Place: Admiral Fell Inn, 888 South                      International Patent Application No.                25, 2010 as well as continuation and
                                                  Broadway, Baltimore, MD 21231.                          PCT/US2008/055185filed February 28,                   divisional applications, and issued and
                                                    Contact Person: Joseph D Mosca, Ph.D.,                2008 titled ‘‘Brachyury Polypeptides
                                                  Scientific Review Officer, Center for                                                                         pending foreign counterparts [HHS Ref.
                                                  Scientific Review, National Institutes of
                                                                                                          and Methods of Use’’ [HHS Reference                   No. E–099–1996/0–US–08];
                                                  Health, 6701 Rockledge Drive, Room 5158,                No. E–074–2007/0–PCT–02]; National                       Europe Patent No. 1017810 (HHS Ref.
                                                  MSC 7808, Bethesda, MD 20892, (301) 408–                Stage Applications and issued patents,                No. E–099–1996/0–EP–05, and all
                                                  9465, moscajos@csr.nih.gov.                             in the US, EP, CA, AU, JP, HK, and all                European contracting states in which
                                                    Name of Committee: Healthcare Delivery                continuations applications, divisional                this patent is validated, including:
                                                  and Methodologies Integrated Review Group;              applications and foreign counterpart                  German Patent No. 69824023.5 (HHS
                                                  Nursing and Related Clinical Sciences Study             applications and patents claiming                     Ref. No. E–099–1996/0–DE–09); France
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Section.                                                priority to the provisional application               Patent No. 1017810 (HHS Ref. No. E–
                                                    Date: June 16–17, 2016.                               no. 60/904,236,                                       099–1996/0–FR–10); Great Britain
                                                    Time: 8:00 a.m. to 5:00 p.m.
                                                    Agenda: To review and evaluate grant
                                                                                                            United States Provisional Patent                    Patent No. 1017810 (HHS Ref. No. E–
                                                  applications.                                           Application No. 61/701,525, filed                     099–1996/0–GB–11); Italy Patent No.
                                                    Place: Bethesda North Marriott Hotel &                September 14, 2014, titled ‘‘Brachyury                1017810 (HHS Ref. No. E–099–1996/0–
                                                  Conference Center, 5701 Marinelli Road,                 Protein, Non-Poxvirus Non-Yeast                       IT–12); Spain Patent No. 2217585) (HHS
                                                  Bethesda, MD 20852.                                     Vectors Encoding Brachyury Protein,                   Ref. No. E–099–1996/0–ES–13);


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                                                                                 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices                                                  31651

                                                  Switzerland Patent Application No.                      Patent No. 2286530) (HHS Ref. No. E–                  adjuvants and vectors that are not
                                                  98948429.0 (now Switzerland Patent                      099–1996/0–ES–32); Sweden Patent                      adeno-viral vectors.
                                                  No. 1017810) (HHS Ref. No. E–099–                       Application No. 04011673.3 (now                       DATES: Only written comments and/or
                                                  1996/0–CH–14); Belgium Patent                           Sweden Patent No. 1447414) (HHS Ref.                  applications for a license which are
                                                  Application No. 98948429.0 (now                         No. E–099–1996/0–SE–38); Switzerland                  received by the NIH Office of
                                                  Belgium Patent No. 1017810) (HHS Ref.                   Patent Application No. 04011673.3                     Technology Transfer on or before June
                                                  No. E–099–1996/0–BE–15); Ireland                        (now Switzerland Patent No. 1447414)                  3, 2016 will be considered.
                                                  Patent Application No. 98948429.0                       (HHS Ref. No. E–099–1996/0–CH–30);
                                                                                                                                                                ADDRESSES: Requests for copies of the
                                                  (now Ireland Patent No. 1017810) (HHS                   and all continuations and divisional
                                                                                                                                                                patent application, inquiries, and
                                                  Ref. No. E–099–1996/0–IE–16); and all                   applications claiming priority to any of
                                                                                                                                                                comments relating to the contemplated
                                                  continuations and divisional                            the above;
                                                                                                             Japan Patent Application No. 2000–                 exclusive license should be directed to:
                                                  applications claiming priority to any of                                                                      Sabarni K. Chatterjee, Ph.D., M.B.A.
                                                  the above;                                              516030 (now JP Patent No. 4291508)
                                                                                                          (HHS Ref. No. E–099–1996/0–JP–06),                    Senior Licensing and Patenting
                                                    Europe Patent Application No.                                                                               Manager, NCI Technology Transfer
                                                  04011673.3 (now EP Patent No.                           and all continuations and divisional
                                                                                                          applications claiming priority to this                Center, 9609 Medical Center Drive, RM
                                                  1447414) (HHS Ref. No. E–099–1996/0–                                                                          1E530 MSC 9702, Bethesda, MD 20892–
                                                  EP–17), and all European contracting                    application;
                                                                                                             Australia Patent No. 745863 (HHS                   9702 (for business mail), Rockville, MD
                                                  states in which this patent is validated,                                                                     20850–9702 Telephone: (240)-276–5530;
                                                                                                          Ref. No. E–099–1996/0–AU–03), and all
                                                  including: Austria Patent Application                                                                         Facsimile: (240)-276–5504E-mail:
                                                                                                          continuations and divisional
                                                  No. 04011673.3 (now Austria Patent No.                                                                        chatterjeesa@mail.nih.gov.
                                                                                                          applications claiming priority to this
                                                  1447414) (HHS Ref. No. E–099–1996/0–                                                                          SUPPLEMENTARY INFORMATION: This
                                                                                                          application; Canada Patent No. 2308127
                                                  AT–28); Belgium Patent Application No.                                                                        invention concerns Brachyury, a master
                                                                                                          (HHS Ref. No. E–099–1996/0–CA–04),
                                                  04011673.3 (now Belgium Patent No.                                                                            transcription factor that governs the
                                                                                                          and all continuations and divisional
                                                  1447414) (HHS Ref. No. E–099–1996/0–                                                                          epithelial-mesenchymal transition, was
                                                                                                          applications claiming priority to this
                                                  BE–29); Cyprus Patent Application No.                                                                         shown to be significantly overexpressed
                                                                                                          application;
                                                  04011673.3 (now Cyprus Patent No.                          U.S. Patent Application No. 10/                    in primary and metastasizing tumors
                                                  1447414) (HHS Ref. No. E–099–1996/0–                    579,025 filed May 11, 2006 as well as                 relative to normal human tissues.
                                                  CY–31); Denmark Patent Application                      all continuation and divisional                       Stimulation of T cells with the
                                                  No. 04011673.3 (now Denmark Patent                      applications, and issued and pending                  Brachyury peptide promoted a robust
                                                  No. 1447414) (HHS Ref. No. E–099–                       foreign counterparts [HHS Ref. No. E–                 immune response and the targeted lysis
                                                  1996/0–DK–41); Finland Patent                           087–2005/0–US–03];                                    of invasive tumor cells. Brachyury
                                                  Application No. 04011673.3 (now                            U.S. Patent Application No. 10/                    overexpression has been demonstrated
                                                  Finland Patent No. 1447414) (HHS Ref.                   579,007 filed May 11, 2006 as well as                 in a range of human tumors (breast,
                                                  No. E–099–1996/0–FI–33); France                         all continuation and divisional                       lung, colon and prostate, among others)
                                                  Patent Application No. 04011673.3                       applications, and issued and pending                  suggesting that an immunotherapeutic
                                                  (now France Patent No. 1447414) (HHS                    foreign counterparts [HHS Ref. No. E–                 product derived from this technology
                                                  Ref. No. E–099–1996/0–FR–42);                           088–2005/0–US–03];                                    would be broadly applicable for the
                                                  Germany Patent Application No.                             U.S. Patent No. 7,118,738 issued                   treatment of cancer.
                                                  04011673.3 (now Germany Patent No.                      October 10, 2006 as well as all                          The prospective exclusive license will
                                                  69837896) (HHS Ref. No. E–099–1996/                     continuations and divisional                          be royalty bearing and will comply with
                                                  0–DE–40); Great Britain Patent                          applications, and issued and pending                  the terms and conditions of 35 U.S.C.
                                                  Application No. 04011673.3 (now Great                   foreign counterparts [HHS Ref. No. E–                 209 and 37 CFR part 404.7. The
                                                  Britain Patent No. 1447414) (HHS Ref.                   154–1998/0–US–07];                                    prospective exclusive license may be
                                                  No. E–099–1996/0–GB–43); Greece                            U.S. Patent Application Nos. 08/                   granted unless within fifteen (15) days
                                                  Patent Application No. 04011673.3                       686,280 filed July 25, 1996 as well as all            from the date of this published notice,
                                                  (now Greece Patent No. 1447414) (HHS                    issued and pending foreign counterparts               the NIH receives written evidence and
                                                  Ref. No. E–099–1996/0–GR–34); Ireland                   [HHS Ref. No. E–259–1994/3–US–01];                    argument that establishes that the grant
                                                  Patent Application No. 04011673.3                          U.S. Patent No. 7,410,644 issued                   of the license would not be consistent
                                                  (now Ireland Patent No. 1447414) (HHS                   August 12, 2008 as well as all                        with the requirements of 35 U.S.C. 209
                                                  Ref. No. E–099–1996/0–IE–35); Italy                     continuation and divisional                           and 37 CFR part 404.7.
                                                  Patent Application No. 04011673.3                       applications, and issued and pending                     Complete applications for a license in
                                                  (now Italy Patent No. 1447414) (HHS                     foreign counterparts [HHS Ref. No. E–                 the prospective field of use that are filed
                                                  Ref. No. E–099–1996/0–IT–36);                           259–1994/3–US–08];                                    in response to this notice will be treated
                                                  Luxembourg Patent Application No.                          The patent rights in these inventions              as objections to the grant of the
                                                  04011673.3 (now Luxembourg Patent                       have been assigned and/or exclusively                 contemplated Exclusive Patent License
                                                  No. 1447414) (HHS Ref. No. E–099–                       licensed to the government of the                     Agreement. Comments and objections
                                                  1996/0–LU–44); Monaco Patent                            United States of America. The                         submitted to this notice will not be
                                                  Application No. 04011673.3 (now                         prospective exclusive license territory               made available for public inspection
                                                  Monaco Patent No. 1447414) (HHS Ref.                    may be worldwide and the field of use                 and, to the extent permitted by law, will
                                                  No. E–099–1996/0–MC–45);                                may be limited to the use of Licensed                 not be released under the Freedom of
                                                  Netherlands Patent Application No.                      Patent Rights for the following: ‘‘The
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                Information Act, 5 U.S.C. 552.
                                                  04011673.3 (now Netherlands Patent                      development and commercialization of
                                                  No. 1447414) (HHS Ref. No. E–099–                       a therapeutic cancer vaccine specifically               Dated: May 13, 2016.
                                                  1996/0–NL–46); Portugal Patent                          using Adeno-viral vectors.’’ For                      Richard U. Rodriguez,
                                                  Application No. 04011673.3 (now                         avoidance of doubt, the field of use                  Associate Director, Technology Transfer
                                                  Portugal Patent No. 1447414) (HHS Ref.                  specifically excludes other viral vectors             Center, National Cancer Institute.
                                                  No. E–099–1996/0–PT–37); Spain Patent                   including but not limited to pox virus                [FR Doc. 2016–11770 Filed 5–18–16; 8:45 am]
                                                  Application No. 04011673.3 (now Spain                   vectors, yeast based vectors and other                BILLING CODE 4140–01–P




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Document Created: 2018-02-07 15:01:53
Document Modified: 2018-02-07 15:01:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation81 FR 31650 

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