[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Notices]
[Pages 73792-73793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected].

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