[Federal Register Volume 89, Number 77 (Friday, April 19, 2024)]
[Notices]
[Page 28791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08361]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License, Inter-Institutional
Agreement-Institution Lead: Polyvalent Vaccines and Methods for Making
Them
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, on behalf of the Centers for Disease Control and
Prevention, Department of Health and Human Services, is contemplating
the grant of an exclusive, sublicensable patent license to University
Health Network, located in Toronto, Canada, its rights to the
technologies and the patent applications listed in the SUPPLEMENTARY
INFORMATION section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases on or
before May 6, 2024 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: Ann Marie Flammang Ph.D., Senior Technology
Transfer Patent Specialist, Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852-9804, phone
number 301-761-6682, or [email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement: United States
Provisional Patent Application Number 63/278,467, filed November 11,
2021, entitled ``Polyvalent Vaccines and Methods for Making Them'' (HHS
Reference No. E-091-2024-0-US-01), and Patent Cooperation Treaty Patent
Application Number PCT/CA2022/051680, filed November 14, 2022, entitled
``Polyvalent Vaccines and Methods for Making Them'' (HHS Reference No.
E-091-2024-0-PC-01). All patent rights in these inventions have been
assigned to University Health Network, University of Liverpool, The
Governing Council of the University of Toronto, and Centers for Disease
Control and Prevention.
The prospective patent license will be for the purpose of
consolidating the patent rights to University Health Network, the co-
owners of said rights, for commercialization. Consolidation of these
co-owned rights is intended to expedite development of the technology,
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
University Health Network will be subject to the provisions of 37 CFR
part 404.
The technology is a strategy to overcome the challenge of virus
heterogeneity against hepatitis C virus (HCV). Using a model of
hypervariable region 1 (HRV1) genetic variability and observed
discrete, genotype-independent clusters, sequences were selected to
synthesize peptides for vaccination. The pentavalent mixture resulted
in an antibody response that was more broadly neutralizing than each
individual variant or pooled sera, indicating a synergistic interaction
among immune responses to related, but distinct, HVR1 variants. These
findings open a new path for the development of an HCV vaccine using
sequence complementary variants of genetically divergent HVR1 antigenic
epitopes. A method was developed for producing a multivariant vaccine
comprised of a plurality of peptides or the nucleic acids encoding
them.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 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
Insitute 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.
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.
Complete license applications submitted in response to this Notice
will be presumed to contain business confidential information and any
release of information in 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: April 15, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-08361 Filed 4-18-24; 8:45 am]
BILLING CODE 4140-01-P