Prospective Grant of Exclusive Patent License: Development and Commercialization of Regulatory T-Cell Therapies for the Treatment of Multiple Sclerosis (MS)
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Abstract
The National Institute of Allergy and Infectious Diseases, 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 TeraImmune, Inc. ("TeraImmune") located in Gaithersburg, Maryland, USA.
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<title>Federal Register, Volume 87 Issue 16 (Tuesday, January 25, 2022)</title>
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[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Page 3832]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development and
Commercialization of Regulatory T-Cell Therapies for the Treatment of
Multiple Sclerosis (MS)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Institute of Allergy and Infectious Diseases, 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 TeraImmune, Inc. (``TeraImmune'') located in Gaithersburg,
Maryland, USA.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Allergy and Infectious
Diseases' Technology Transfer and Intellectual Property Office on or
before February 9, 2022 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Dr. Yogikala Prabhu, Technology Transfer and
Patent Specialist, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, 5601
Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804 Telephone:
(301) 496-2644; Facsimile: (240) 627-3117; Email:
<a href="/cdn-cgi/l/email-protection#88f8fae9eae0fdf1e7c8e6e1e9e1eca6e6e1e0a6efe7fe"><span class="__cf_email__" data-cfemail="eb9b998a89839e9284ab85828a828fc5858283c58c849d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
<bullet> U.S. Patent 9,481,866, entitled ``Methods of Producing T Cell
Populations Enriched for Stable Regulatory T-Cells'' [HHS Reference No.
E-279-2011/0-US-02]
<bullet> U.S. Patent 11,060,059, entitled ``Methods of Producing T Cell
Populations Enriched for Stable Regulatory T-Cells'' [HHS Reference No.
E-279-2011/0-US-03]
<bullet> U.S. Divisional Application No. 17/371,589--filed July 9,
2021, entitled ``Methods of Producing T Cell Populations Enriched for
Stable Regulatory T-Cells'' [HHS Reference No. E-279-2011/0-US-04]
The patent and patent application rights in these inventions have
been assigned 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: ``Use of the Licensed Patent Rights
to develop and commercialize Treg cell therapies for the treatment of
multiple sclerosis (MS).''
The technology is directed to a method for producing or growing
cell populations that are enriched for stable, highly suppressive
regulatory T cells (Tregs). Tregs are critical in regulating immune
system processes that maintain tolerance to self-antigens and prevent
immune mediated diseases. The method takes a population of cells
comprising stable, regulatory T cells and enriched for specific CD
markers, cultures these cells in the presence of interleukin-2, an
anti-CD3 antibody, an anti-CD28 antibody, and oligodeoxynucleotides of
specified length having a phosphorothioate backbone, and yields the
expansion of the initial population of regulatory T-cells. The expanded
Tregs may then be used for the treatment of immune-mediated diseases.
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, unless the
National Institute of Allergy and Infectious Diseases 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.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization license.
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: January 19, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-01330 Filed 1-24-22; 8:45 am]
BILLING CODE 4140-01-P
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