Notice2021-28196
Prospective Grant of Exclusive Patent License: “Griffithsin Compositions for Treatment and Prevention of Anti-Viral Infections”
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
December 28, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University of Louisville Research Foundation, ("ULRF") in its rights to the inventions and patents listed in the Supplementary Information section of this notice. ULRF is a Kentucky 501(c)3 non-profit corporation that is the agent of the University of Louisville ("UofL") for licensing intellectual property owned and controlled by ULRF on behalf of UofL.
Full Text
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<title>Federal Register, Volume 86 Issue 246 (Tuesday, December 28, 2021)</title>
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[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Notices]
[Pages 73792-73793]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28196]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: ``Griffithsin
Compositions for Treatment and Prevention of Anti-Viral Infections''
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute (NCI), National Institutes of
Health, Department of Health and Human Services, is contemplating the
grant of an exclusive, sublicensable patent license to University of
Louisville Research Foundation, (``ULRF'') in its rights to the
inventions and patents listed in the Supplementary Information section
of this notice. ULRF is a Kentucky 501(c)3 non-profit corporation that
is the agent of the University of Louisville (``UofL'') for licensing
intellectual property owned and controlled by ULRF on behalf of UofL.
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center January 12, 2022
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: Taryn Dick, Ph.D., MBA, Licensing and Patenting
Manager at Telephone: (301) 631-3007 or Email: <a href="/cdn-cgi/l/email-protection#582c392a2136763c313b3318363130763f372e"><span class="__cf_email__" data-cfemail="5b2f3a292235753f3238301b353233753c342d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and
foreign patents/patent applications thereof are the intellectual
properties to be licensed under the prospective agreement to ULRF: U.S.
Provisional Patent Application No. 63/026,375 entitled ``Compositions
and Methods for Prevention of Coronavirus Infection,'' (HHS Ref. No. E-
029-2022-0-US-01), filed 18 May 2020; PCT Application No. PCT/US2021/
033009 entitled ``Compositions and Methods for Prevention of
Coronavirus Infection,'' (HHS Ref. No. E-029-2022-1-PCT-02), filed May
18, 2021; U.S. Provisional Patent Application No. 62/898,383 entitled
``Anti-Viral Compositions and Methods of Making and Using,'' (HHS Ref.
No. E-030-2022-0-US-01), filed September 10, 2019; and PCT Application
No. PCT/US2020/050200, entitled ``Anti-Viral Compositions and Methods
of Making and Using'' (HHS Ref. No. E-030-2022-0-PCT-02), filed
September 10, 2020.
PCT/US2021/033009 described above claims priority to the U.S.
Provisional Patent Application No. 63/026,375 described above, as well
as a second U.S. Provisional Patent Application No. 63/070,375 entitled
``Q-Griffithsin Nasal Spray,'' (HHS Ref. No. E-029-2022-1-US-01), filed
on August 26, 2020. The Government of the United States is not a co-
owner on this second U.S. Provisional Patent Application, and it is
therefore, excluded from the proposed exclusive grant from NCI to ULRF.
With respect to the inventions described and claimed in the patent
applications 62/026,375 (E-029-2022-0-US-01) and PCT/US2021/033009 (E-
029-2022-1-PCT-02) each of the inventors has assigned their rights to
their respective employers or an entity which manages the intellectual
property for their employer (The Government of the United States of
America, the University of Louisville Research Foundation, Inc. or the
University of Pittsburgh). With respect to the inventions described and
claimed in the patent applications 62/898,383 (E-030-2022-0-US-01) and
PCT/US2021/050200 (E-030-2022-0-PCT-01) each of the inventors has
assigned their rights to their respective employers or an entity which
manages the intellectual property for their employer (The Government of
the United States or the University of Louisville Research Foundation,
Inc.). The prospective
[[Page 73793]]
patent license will be for the purpose of consolidating the patent
rights to ULRF, one of the co-owners of said rights, for commercial
development and marketing. Consolidation of these co-owned rights is
intended to expedite development of the inventions, consistent with the
goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212.
The prospective patent license will be worldwide, exclusive, and
may be limited to those fields of use commensurate in scope with the
patent rights. It will be sublicensable, and any sublicenses granted by
ULRF will be subject to the provisions of 37 CFR part 401 and 404.
Griffithsin (GRFT) is a protein that was originally isolated from
marine red algae, namely Rhodophyte (Griffithsia sp.). It binds the
terminal mannose residues of N-linked glycans found on the surface of
many enveloped viruses such as HIV, SARS-CoV, Ebola virus, and more.
The E-029-2022 invention pertains to novel mutant Griffithsin (GRFT)
formulations and methods of inhibition of viral infection. The E-030-
2022 invention pertains to methods of systemically treating viral
infections and additional mutant GRFT variants that are specifically
mutated to introduce a lysine within a mutant GRFT sequence. These GRFT
variants can be PEGylated, which significantly improves
pharmacokinetics and decreases immunogenicity. Based on current
available data, the intended use for the inventions is as anti-viral
therapies for enveloped virus infections.
This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent license will include terms for the
sharing of royalty income with NCI from commercial sublicenses of the
patent rights and may be granted unless within fifteen (15) days from
the date of this published notice the NCI 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 that are timely filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive patent 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: December 21, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-28196 Filed 12-27-21; 8:45 am]
BILLING CODE 4140-01-P
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