Notice2024-06128
Prospective Grant of an Exclusive Patent License: Adoptive T Cell Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated Protein Kinase (MAPK) Inhibitor
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 22, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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 Poolbeg Pharma (UK) Limited, incorporated in the United Kingdom.
Full Text
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<title>Federal Register, Volume 89 Issue 57 (Friday, March 22, 2024)</title>
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[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Page 20486]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Adoptive T Cell
Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated
Protein Kinase (MAPK) Inhibitor
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 Poolbeg Pharma
(UK) Limited, incorporated in the United Kingdom.
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 8, 2024 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: <a href="/cdn-cgi/l/email-protection#e3828d879acd8196918886a38d8a8bcd848c95"><span class="__cf_email__" data-cfemail="fa9b949e83d4988f88919fba949392d49d958c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 62/570,708
filed October 11, 2017, entitled ``Methods of Producing T Cell
Populations Using P38 MAPK Inhibitors'' [HHS Reference No. E-002-2018-
0-US-01];
2. International Patent Application No. PCT/US2018/055206 filed
October 10, 2018, entitled ``Methods of Producing T Cell Populations
Using P38 MAPK Inhibitors'' [HHS Reference No. E-002-2018-0-PCT-02];
and
3. United States Patent Application No. 16/754,926 filed April 9,
2020, entitled ``Methods of Producing T Cell Populations Using P38 MAPK
Inhibitors'' [HHS Reference No. E-002-2018-0-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 the United
States of America, and the field of use may be limited to the
following:
``The treatment of cancer in humans using adoptive T cell therapy
products produced through the use of a pharmacological p38 MAPK
inhibitor.''
The E-002-2018 patent family is primarily directed to a method of
producing populations of T cells for the treatment of cancer wherein
the cells are cultured (e.g., expanded) in the presence of a p38
mitogen-activated protein kinase (MAPK) inhibitor. In oncology, many
investigational adoptive cell therapies rely on antigen-specific T
cells isolated from the patient in need of treatment. However, these
cells often exist in a terminally differentiated and exhausted state,
or enter such a state following manipulation ex vivo, and are unable to
mount a robust immune response following reinfusion. Recent evidence
suggests that inhibition of P38 MAPK signaling in T cells during ex
vivo expansion can ameliorate this performance defect. It is hoped that
this modified cell manufacturing approach will enhance treatment
efficacy. The exclusive field of use which may be granted to Poolbeg
applies to only certain T cell manufacturing methods which rely on
pharmacologic P38 MAPK inhibitors. Accordingly, the proposed scope of
rights which may be conveyed under the license covers a portion of the
possible applications of E-002-2018.
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 Freedom of Information Act, 5
U.S.C. 552.
Dated: March 19, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-06128 Filed 3-21-24; 8:45 am]
BILLING CODE 4140-01-P
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