[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3062-3063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of 
Regulatory T-Cell Therapies for the Treatment of Hemophilia A (HA)

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 Rockville, 
Maryland.

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 3, 2020 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--issued November 1, 2016, entitled 
``Methods of Producing T Cell Populations Enriched for Stable 
Regulatory T-Cells'' [HHS Reference No. E-279-2011/0-US-02]
 U.S. Divisional Application No.15/284,840--filed October 4, 
2016, entitled ``Methods of Producing T Cell Populations Enriched for 
Stable Regulatory T-Cells'. [HHS Reference No. E-279-2011/0-US-03]

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory will be the United 
States and the field of use will be limited to: ``Human cell-based 
therapeutics for the treatment of Hemophilia A in patients that have 
inhibitory Factor VIII antibodies.''
    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.

[[Page 3063]]

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 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 6, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-00721 Filed 1-16-20; 8:45 am]
BILLING CODE 4140-01-P