Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Development of Zika Virus Strains for Use in Oncolytic Therapy
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Abstract
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Advocate Aurora Research Institute, located in Milwaukee, Wisconsin, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
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<title>Federal Register, Volume 90 Issue 185 (Friday, September 26, 2025)</title>
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[Federal Register Volume 90, Number 185 (Friday, September 26, 2025)]
[Notices]
[Pages 46414-46415]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18692]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License, Inter-Institutional
Agreement-Institution Lead: Development of Zika Virus Strains for Use
in Oncolytic Therapy
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, Department of Health and Human Services, is
contemplating the grant of an exclusive patent license to Advocate
Aurora Research Institute, located in Milwaukee, Wisconsin, to practice
the inventions embodied in 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 October 14, 2025 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: Elizabeth Pitts, Senior Technology Transfer and
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
301-669-5299, or <a href="/cdn-cgi/l/email-protection#b5f0d9dccfd4d7d0c1dd9bc5dcc1c1c6f5dbdcdd9bd2dac3"><span class="__cf_email__" data-cfemail="4f0a2326352e2d2a3b27613f263b3b3c0f21262761282039">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement: United States
Provisional Patent Application Number 63/607,147, filed December 7,
2023, entitled ``Zika Viruses and Uses Thereof '' (HHS Reference No. E-
137-2025-0-US-01) and PCT Patent Application Number PCT/US2024/058992,
filed December 7, 2024, entitled ``Zika Viruses and Uses Thereof'' (HHS
Reference No. E-137-2025-0-PCT-02).
The patent rights in these inventions have been assigned and/or
exclusively licensed to Advocate Aurora Research Institute and
Government of the United States of America as represented by the
Secretary, Department of Health & Human Services.
The prospective patent license will be for the purpose of
consolidating the patent rights to Advocate Aurora Research Institute,
the co-owners of said rights, for commercial development and marketing.
Consolidation of these co-owned rights is intended to expedite
development of the invention, consistent with the goals of the Bayh-
Dole Act codified as 35 U.S.C. 200-212.
The prospective interinstitutional agreement will include an
exclusive license for the National Institute of Allergy and Infectious
Diseases' rights in these jointly owned patents. It will be
sublicensable, and any sublicenses granted by Advocate Aurora Research
Institute will be subject to the provisions of 37 CFR part 404.
Glioblastoma multiforme (GBM) is an aggressive, malignant brain
cancer with poor prognosis under the current standard of care.
Oncolytic viruses have potential as novel therapeutics for the
treatment of GBM. The current technology, developed by Stephen
Whitehead, Ph.D. from the National Institute of Allergy and Infectious
Diseases and researchers at Advocate Aurora Research Institute,
describes the use of Zika virus strains as an oncolytic virus for the
treatment of GBM and other cancers.
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
[[Page 46415]]
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.
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: September 23, 2025.
Surekha Vathyam,
Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2025-18692 Filed 9-25-25; 8:45 am]
BILLING CODE 4140-01-P
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