[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Page 50425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20057]



National Institutes of Health

Prospective Grant of Exclusive License: Development of Brachyury 
Tumor Associated Antigens as Cancer Vaccines for Colorectal Cancer

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 patent 
license to practice the inventions embodied in the following U.S. 
Patents and Patent Applications to Bavarian Nordic Immunotherapeutics 
(``BNIT'') located in Mountain View, CA, USA.
    Intellectual Property: U.S. Provisional Patent Application No. 61/
701,528 [HHS Ref. No. E-054-2011/0-US-01] filed September 17, 2012, 
entitled ``Methods and Compositions for the Treatment of Cancer,'' as 
well as all international applications, continuation applications and 
divisional applications.
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use will be limited to the use of Licensed Patent Rights 
for development of pox virus-based immunotherapeutics for colorectal 

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 18, 2013 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. Licensing and 
Patenting Manager, Cancer Branch, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5587; Facsimile: (301) 
435-4013; Email: [email protected].

SUPPLEMENTARY INFORMATION: Cancer immunotherapy is a recent approach 
where tumor associated antigens (TAAs), which are primarily expressed 
in human tumor cells and not expressed or minimally expressed in normal 
tissues, are employed to generate a tumor-specific immune response. 
Specifically, these antigens serve as targets for the host immune 
system and elicit responses that result in tumor destruction.
    The technology relates to the development of cancer vaccines 
utilizing pox virus vectors encoding proteins involved in regulating 
the epithelial-to-mesenchymal transition (EMT) during vertebrate 
development, as a cancer antigen. Dr. Jeffrey Schlom et al. at NCI have 
demonstrated for the first time that a T-box transcription factor and a 
molecule implicated in EMT, namely the Brachyury protein, appears to be 
highly expressed in metastasizing tumor cells, and could be a potential 
target for human T-cell mediated cancer immunotherapy, such as for 
tumors of the lung, intestine, stomach, kidney, bladder, uterus, ovary, 
testis, colon and chronic lymphocytic leukemia.
    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 404.7. 
The prospective exclusive license may be granted unless within thirty 
(30) 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 404.7.
    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 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: August 13, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-20057 Filed 8-16-13; 8:45 am]