[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55626-55627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of T Cell Therapies for Mesothelin-Expressing Cancers

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 Ares 
Immunotherapy, Inc. (``Ares''), a Delaware corporation.

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 October 21, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-078-2012: Anti-Mesothelin Chimeric Antigen Receptors

    1. United States Provisional Patent Application No. 61/614,612 
filed March 23, 2012 (NCI Reference E-078-2012-0-US-01);
    2. PCT Patent Application No. PCT/US2013/028980 filed March 5, 2013 
(NCI Reference E-078-2012-0-PCT-02);
    3. Australian Patent No. 2013235726 issued August 3, 2017 (NCI 
Reference E-078-2012-0-AU-03);
    4. Canadian Patent No. 2,868,121 issued June 1, 2021 (NCI Reference 
E-078-2012-0-CA-04);
    5. European Patent No. 2828290 issued August 15, 2018 (NCI 
Reference E-078-2012-0-EP-05);
a. Validated in: FR, DE and UK
    6. United States Patent No. 9,359,447 issued June 7, 2016 (NCI 
Reference E-078-2012-0-US-06);
    7. European Patent No. 3421489 issued May 5, 2021 (NCI Reference E-
078-2012-0-EP-07); and
a. Validated in: FR, DE and UK
    8. Canadian Patent Application No. 3,116,051 filed April 23, 2021 
(NCI Reference E-078-2012-0-CA-11).
    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:
    ``Development, manufacture and commercialization of T cell therapy 
products engineered to express the chimeric antigen receptor(s) claimed 
in the Licensed Patent Rights for the treatment of mesothelin-
expressing cancers in humans.''
    The E-078-2012 invention family discloses certain chimeric antigen 
receptors (CARs) targeting mesothelin. CARs are synthetic proteins 
comprised of extracellular antigen binding domains and intracellular 
signaling domains designed to activate the cytolytic functions of CAR-
expressing T cells upon antigen recognition.
    Mesothelin is a cell surface protein. Its expression is primarily 
restricted to mesothelial cells of the pleura, peritoneum, and 
pericardium; however, research has demonstrated that several cancers, 
including malignant mesothelioma, pancreatic, ovarian and lung 
adenocarcinoma, also express mesothelin under certain circumstances. 
Due to its limited expression in normal tissues, CARs targeting 
mesothelin may be useful in the development of T cell therapy products 
for the treatment of select cancers.
    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 from these license applications will be made only as 
required and upon a request under the

[[Page 55627]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: October 1, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-21846 Filed 10-5-21; 8:45 am]
BILLING CODE 4140-01-P