Prospective Grant of Exclusive Patent License: “Griffithsin Compositions for Treatment and Prevention of Anti-Viral Infections”, 73792-73793 [2021-28196]

Download as PDF 73792 Federal Register / Vol. 86, No. 246 / Tuesday, December 28, 2021 / Notices Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Conference Rooms C, D&E, and F&G, 31 Center Drive, Bethesda, MD 20892. Contact Person: Karl F. Malik, Ph.D., Director Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Boulevard, Room 7329, MSC 5452, Bethesda, MD 20892, (301) 594–4757 malikk@ niddk.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.niddk.nih.gov/fund/divisions/DEA/ Council/coundesc.htm., where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: December 21, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. Name of Committee: National Institute on Aging Special Emphasis Panel; Age-related metabolites, mitochondrial and synaptic degeneration & rescue in Aging and Alzheimer’s disease. Date: March 23, 2022. Time: 11:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Video Meeting). Contact Person: Anita H. Undale, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–827– 7428, anita.undale@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: December 21, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–28091 Filed 12–27–21; 8:45 am] BILLING CODE 4140–01–P 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. Notice. [FR Doc. 2021–28097 Filed 12–27–21; 8:45 am] ACTION: BILLING CODE 4140–01–P SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting khammond on DSKJM1Z7X2PROD with NOTICES would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which VerDate Sep<11>2014 22:45 Dec 27, 2021 Jkt 256001 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 directed to: Taryn Dick, Ph.D., MBA, Licensing and Patenting Manager at Telephone: (301) 631–3007 or Email: taryn.dick@nih.gov. 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 (E029–2022–1–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 E:\FR\FM\28DEN1.SGM 28DEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 246 / Tuesday, December 28, 2021 / Notices 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 coowned rights is intended to expedite development of the inventions, consistent with the goals of the BayhDole 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 VerDate Sep<11>2014 22:45 Dec 27, 2021 Jkt 256001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 73793 Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Najma Begum, Ph.D., Scientific Review Officer Review Branch, DEA, NIDDK, National Institutes of Health, 6707 Democracy Boulevard, ROOM 7349, Bethesda, MD 20892–5452 (301) 594–8894, begumn@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: December 21, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings [FR Doc. 2021–28101 Filed 12–27–21; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel RFA DK–21–503: Limited Competition for the Continuation of EDIC Study Research Center (Collaborative U01, Clinical Trial Not Allowed. Date: February 14, 2022. Time: 11:00 a.m. to 1:30 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: National Institutes of Health, Democracy II 6707, Democracy Blvd, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Najma Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 6707 Democracy Boulevard, ROOM 7349, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR10–202: High Impact Interdisciplinary Science in NODDK Research Areas (RC2 Clinical Trial Optional)Kidney Diseases. Date: February 18, 2022. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Democracy II, 6707 Democracy Blvd. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–P National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; SBIR Contract Review Panel. Date: February 2, 2022. Time: 9:00 a.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20892. Contact Person: Rahat (Rani) Khan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20892, 301–594–7319, khanr2@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
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