[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Notices]
[Pages 18577-18578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Methods and 
Compositions for Adoptive Cell Therapy

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 Lyell 
Immunopharma, Inc. (``Lyell''), 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 April 17, 2020 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, 9609 Medical Center Drive, RM 
1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240) 276-5484; Facsimile: (240) 
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Group A

E-022-2017: Methods for Selecting Therapy for a Cancer Patient
    1. US Provisional Patent Application 62/418,461 filed November 7, 
2016 (E-022-2017-0-US-01);
    2. International Patent Application PCT/US2017/060304 filed 
November 7, 2017 (E-022-2017-0-PCT-02);
    3. European Patent Application 17805342.7 filed May 6, 2019 (E-022-
2017-0-EP-03); and
    4. United States Patent Application 16/347,778 filed May 6, 2019 
(E-022-2017-0-US-04).

Group B

E-250-2016: Methods of Preparing an Isolated or Purified Population of 
Thymic Emigrant Cells and Methods of Treatment Using the Same
    1. US Provisional Patent Application 62/433,591 filed December 13, 
2016 (E-250-2016-0-US-01);
    2. International Patent Application PCT/US2017/065986 filed 
December 13, 2017 (E-250-2016-0-PCT-02);
    3. European Patent Application 17825696.2 filed June 11, 2019 (E-
250-2016-0-EP-03); and
    4. United States Patent Application 16/468,890 filed June 12, 2019 
(E-250-2016-0-US-04).
E-132-2017: Methods of Preparing Hematopoietic Progenitor Cells In 
Vitro
    1. US Provisional Patent Application 62/583,240 filed November 8, 
2017 (E-132-2017-0-US-01); and
    2. International Patent Application PCT/US2018/059856 filed 
November 8, 2018 (E-132-2017-0-PCT-02).
E-133-2017: In Vitro Generation of Thymic Organoid From Human 
Pluripotent Stem Cells
    1. US Provisional Patent Application 62/560,908 filed September 20, 
2017 (E-133-2017-0-US-01); and
    2. International Patent Application PCT/US2018/051625 filed 
September 19, 2018 (E-133-2017-0-PCT-02).

[[Page 18578]]

E-091-2019: Methods of Producing T Cell Populations Using Induced 
Pluripotent Stem Cells
    1. US Provisional Patent Application 62/957,939 filed January 7, 
2020 (E-091-2019-0-US-01).

Group C

E-174-2012: Methods of Producing T Memory Stem Cell Populations
    1. International Patent Application PCT/US2012/053947 filed 
September 6, 2012 (E-174-2012-0-PCT-01);
    2. United States Patent 10,316,289 issued June 11, 2019 (E-174-
2012-0-US-02.; and
    3. United States Patent Application 16/410,327 filed May 13, 2019 
(E-174-2012-0-US-03).
    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 fields of use may be limited to the following:
Field of Use Applying to Intellectual Property Group A
    ``Manufacture and commercialization of companion diagnostics 
approved or cleared by the FDA or equivalent foreign regulatory agency 
for Licensee-proprietary T cell therapy products.''
Field of Use Applying to Intellectual Property Group B
    ``Manufacture and commercialization of adoptive T cell therapy 
products generated from autologously-derived, induced pluripotent stem 
cells for the treatment of cancer in humans.''
Field of Use Applying to Intellectual Property Group C
    ``Manufacture and commercialization of adoptive T cell therapy 
products isolated from peripheral blood for the treatment of cancer in 
humans.''
    E-022-2017 generally discloses methods of using certain gene 
signature profiles to identify cancer patients likely to respond to T 
cell immunotherapy.
    E-250-2016 generally discloses in vitro methodologies for 
generating induced pluripotent stem cell-based thymic emigrants and 
methods of using the same for the treatment of cancer.
    E-132-2017 generally discloses methods of generating multi-potent 
hematopoietic progenitor cells from induced pluripotent stem cells and 
methods of using the same for the treatment of cancer.
    E-133-2017 generally discloses methods of generating autologous 
thymic organoids from human pluripotent stem cells and methods of 
treating cancer using T cells produced by such organoids.
    E-091-2019 generally discloses methods of reprogramming tumor 
infiltrating lymphocytes into induced pluripotent stem cells and 
methods of treating cancer using such cells.
    E-174-2012 generally discloses a method of generating stem cell-
like memory T cells by stimulating naive T cells in the presence of 
GSK-3beta inhibitors, and methods of treating cancer using cells 
conditioned in such a manner.
    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 which 
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 Freedom of Information Act, 5 
U.S.C. 552.

    Dated: March 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-06922 Filed 4-1-20; 8:45 am]
BILLING CODE 4140-01-P