[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