2024-08361. 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.

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 [e-mail].

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.