Skip to content
LexBuild

Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Development of Zika Virus Strains for Use in Oncolytic Therapy

---
identifier: "/us/fr/2025-18692"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Development of Zika Virus Strains for Use in Oncolytic Therapy"
title_number: 0
title_name: "Federal Register"
section_number: "2025-18692"
section_name: "Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Development of Zika Virus Strains for Use in Oncolytic Therapy"
positive_law: false
currency: "2025-09-26"
last_updated: "2025-09-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2025-18692"
document_type: "notice"
publication_date: "2025-09-26"
agencies:
  - "Health and Human Services Department"
  - "National Institutes of Health"
fr_citation: "90 FR 46414"
fr_volume: 90
comments_close_date: "2025-10-14"
fr_action: "Notice."
---

#  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.

**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 *[email protected].*

**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  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.