[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Page 3832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

 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]
 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]
 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