[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Notices]
[Pages 14331-14332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development, 
Production, and Commercialization of Ebola Neutralizing Single 
Monoclonal Antibody for the Treatment of Ebola Virus Disease in Humans

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 U.S. and European 
Patents and Patent Applications listed in the Supplementary Information 
section of this Notice to Ridgeback Biotherapeutics, L.P., located in 
Miami, Florida.

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 March 30, 2021 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: Daniel Lee, J.D., Technology Transfer and Patent 
Specialist, National Institute of Allergy and Infectious Diseases 
Technology Transfer and Intellectual Property Office by email 
([email protected]) or phone (301-761-6327).

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-045-2015: Neutralizing Antibodies to Ebolavirus Glycoprotein and 
Their Use

    1. United States Provisional Patent Application No. 62/087,087, 
filed 3 December 2014 (HHS Reference No. E-045-2015-0-US-01);
    2. International Patent Application No. PCT/US2015/060733, filed 13 
November 2015 (HHS Reference No. E-045-2015-0-PCT-02);
    3. European Patent Application No. 15797815.6, filed 13 November 
2015 (HHS Reference No. E-045-2015-0-EP-03); and
    4. United States Patent No. 10,273,288, issued 30 April 2019 (HHS 
Reference No. E-045-2015-0-US-05).
    The patent and patent application 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: Development, 
production, and commercialization of Ebola neutralizing monoclonal 
antibody mAb114, as a single antibody not in combination with other 
monoclonal antibodies, for the treatment of Ebola virus disease in 
humans.
    This technology discloses the discovery, isolation, production, and 
advancement in the development of recombinant neutralizing antibodies 
specific to the Ebola virus glycoprotein, varying Ebola virus 
glycoprotein recognition profiles, and increasing neutralization 
potency for a therapeutic in a patient diagnosed with Ebola virus.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
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 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 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.


[[Page 14332]]


    Dated: February 26, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-05235 Filed 3-12-21; 8:45 am]
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