[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Pages 30448-30449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development of 
an Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment of 
Human Cancer

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of 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 U.S. Patents and Patent Applications listed 
in the Supplementary Information section of this notice to Atara 
Biotherapeutics Inc. (``Atara'') located in South San Francisco, CA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before July 13, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Rose M. Freel, Ph.D., Licensing and Patenting 
Manager, NCI Technology Transfer Center, 8490 Progress Drive, Suite 
400, Frederick, MD 21701; Telephone: (301)-624-8775; Facsimile: (240)-
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 30449]]

Intellectual Property

    United States Provisional Patent Application No. 61/040,005, filed 
March 27, 2008 and entitled ``Human Monoclonal Antibodies Specific for 
Mesothelin'' [HHS Reference No. E-079-2008/0-US-01];
    PCT Patent Application PCT/US2009/038228, filed March 25, 2009 and 
entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS 
Reference No. E-079-2008/0-PCT-02]; and US Patent No. 8,357,783, filed 
September 22, 2010, Issued January 22, 2013 and entitled ``Human Anti-
Mesothelin Monoclonal Antibodies'' [HHS Reference No. E-079-2008/0-US-
06].
    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 development of a mesothelin 
chimeric antigen receptor (CAR)-based immunotherapy using autologous or 
allogeneic T cells either transduced with a retroviral vector 
(including lentiviral vectors) or modified using a gene-editing 
technology, wherein the vector expresses a CAR comprising:
    (1) Single antigen specificity for binding to mesothelin, and
    (2) at least (a) the complementary determining region (CDR) 
sequences of the anti-mesothelin antibody known as m912, and (b) a T 
cell signaling domain; for the prophylaxis and treatment of mesothelin-
expressing human cancers.''
    This technology discloses a monoclonal antibody and methods of 
using the antibody for the treatment of mesothelin-expressing cancers, 
including mesothelioma, lung cancer, stomach/gastric cancer, ovarian 
cancer, and pancreatic cancer. The specific antibody covered by this 
technology is designated as m912, which is a fully human monoclonal 
antibody against mesothelin.
    Mesothelin is a cell surface antigen that is preferentially 
expressed on certain types of cancer. The m912 antibody selectively 
binds to the mesothelin on the surface of cancer cells and induces cell 
death of those cancer cells while leaving healthy cells unharmed. This 
selectivity may lead to fewer side effects due to decreased non-
specific killing of cells.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: June 21, 2018
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-13893 Filed 6-27-18; 8:45 am]
 BILLING CODE 4140-01-P