[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10081-10082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Autologous 
Therapy for the Treatment of Autoimmune Disease Using Chimeric Antigen 
Receptors Targeting CD19

AGENCY: National Institutes of Health, HHS.

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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Kyverna 
Therapeutics (``Kyverna'') located in Berkeley, CA.

[[Page 10082]]


DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before March 5, 2021 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: David A Lambertson, Ph.D., Senior Technology 
Transfer Manager, at Telephone (240)-276-5530 or Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    The following represents the intellectual property to be licensed 
under the prospective agreement:
    (A) U.S. Provisional Patent Application 62/006,313 entitled 
``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-
US-01], PCT Patent Application PCT/US2015/033473 entitled ``Chimeric 
Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-PCT-02], 
Australian Patent 2015270912 entitled ``Chimeric Antigen Receptors 
Targeting CD-19'' [HHS Ref. E-042-2014-0-AU-03], Canadian Patent 
Application 2951045 entitled ``Chimeric Antigen Receptors Targeting CD-
19'' [HHS Ref. E-042-2014-0-CA-04], Chinese Patent Application 
201580033802.5 entitled ``Chimeric Antigen Receptors Targeting CD-19'' 
[HHS Ref. E-042-2014-0-CN-05], European Patent 3149044 entitled 
``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-
EP-06] (validated in Germany [HHS Ref. E-042-2014-0-DE-19], Spain [HHS 
Ref. E-042-2014-0-ES-20], France [HHS Ref. E-042-2014-0-FR-21], the 
United Kingdom [HHS Ref. E-042-2014-0-GB-22], Italy [HHS Ref. E-042-
2014-0-IT-23], and Ireland [HHS Ref. E-042-2014-0-IE-24], and lodged in 
Hong Kong [E-042-2014-0-HK-16]), Israeli Patent Application 249305 
entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-
042-2014-0-IL-07], Indian Patent Application 291647041047 entitled 
``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-
IN-08], Japanese Patent Application 2016-571017 entitled ``Chimeric 
Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-JP-09], 
South Korean Patent Application 2016-7036828 entitled ``Chimeric 
Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-KR-10], 
Mexican Patent Application MX/a/2016/015834 entitled ``Chimeric Antigen 
Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-MX-11], New Zealand 
Patent Application 727167 entitled ``Chimeric Antigen Receptors 
Targeting CD-19'' [HHS Ref. E-042-2014-0-NZ-12], Saudi Arabian Patent 
Application 516380406 entitled ``Chimeric Antigen Receptors Targeting 
CD-19'' [HHS Ref. E-042-2014-0-SA-13], Singaporean Patent Application 
11201609960Q entitled ``Chimeric Antigen Receptors Targeting CD-19'' 
[HHS Ref. E-042-2014-0-SG-14], United States Patent 10,287,350 entitled 
``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-
US-15], United States Patent Application 16/360,281 entitled ``Chimeric 
Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-US-17], New 
Zealand Patent Application 764530 entitled ``Chimeric Antigen Receptors 
Targeting CD-19'' [HHS Ref. E-042-2014-0-NZ-18], European Patent 
Application 20197459.9 entitled ``Chimeric Antigen Receptors Targeting 
CD-19'' [HHS Ref. E-042-2014-0-EP-25], Australian Patent Application 
2020267211 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS 
Ref. E-042-2014-0-AU-26], and Japanese Patent Application XXX entitled 
``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014-0-
JP-27], and all continuing U.S. and foreign patents/patent applications 
for the technology family.
    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 following:

    ``The development, production and commercialization of an anti-
CD19 targeting chimeric antigen receptor (CAR)-based immunotherapy 
using autologous (meaning one individual is both the donor and the 
recipient) T lymphocytes transfected using a lentivirus, wherein the 
vector expresses a CAR having at least:
    (1) The complementary determining region (CDR) sequences of the 
anti-CD19 antibody known as Hu19;
    (2) a CD8a hinge and transmembrane domain;
    (3) and a CD28z T cell signaling domain;
    for the treatment of autoimmune diseases.''

    This technology discloses the development of chimeric antigen 
receptors that recognize the CD19 cell surface protein. CD19 is 
expressed on the cell surface of several autoimmune disease cells, 
including lupus nephritis. For many autoimmune diseases there are no 
FDA-approved therapies, underscoring that there is an unmet need. The 
development of an autoimmune disease therapeutic targeting CD19 will 
benefit public health by providing a treatment for patients who may not 
have any options.
    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 
completed 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: February, 4, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-03222 Filed 2-17-21; 8:45 am]
BILLING CODE 4140-01-P