Neurotech International Ltd Receives US Allowance Notices for NTI164 Applications
US patent office clears two Neurotech applications for NTI164
The United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for two Neurotech International (ASX: NTI) US patent applications covering its lead asset, NTI164. Neurotech is a clinical-stage biopharmaceutical company focused on paediatric neurological disorders.
Announced on 2 July 2026, both applications share the title “Compositions and Methods for Treating Neurological Disorders”. Importantly, these are Notices of Allowance rather than granted patents. Formal grant is expected within the coming months, subject to completion of standard administrative processes.
Once granted, the patents are expected to provide intellectual property protection for NTI164 through to 2042, subject to the payment of applicable maintenance fees. The two applications carry the numbers 18/698,605 and 19/335,945.
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What the two patents cover
The two allowed applications address distinct but complementary aspects of NTI164.
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Application No. 18/698,605 — allowed claims cover methods of reducing neuroinflammation using NTI164
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Application No. 19/335,945 — allowed claims specifically directed to methods of treating autism spectrum disorder (ASD)
The ASD-specific claims align directly with NTI164’s current Phase 3 development programme, tying the intellectual property directly to the lead clinical indication.
The ASD-specific claims align directly with the Phase 3 Beyond Harmony trial, a multi-centre, randomised, double-blind, placebo-controlled study that opened for patient screening at Monash Children’s Hospital as its first activated site.
| Milestone | Application No. | Claim Focus | Status | Investor Impact |
|---|---|---|---|---|
| Notice of Allowance | 18/698,605 | Reducing neuroinflammation using NTI164 | Allowed, grant expected within coming months | Broadens IP coverage of NTI164’s mechanism |
| Notice of Allowance | 19/335,945 | Treating autism spectrum disorder (ASD) | Allowed, grant expected within coming months | Aligns IP with Phase 3 lead indication |
Why patent protection matters for a clinical-stage biotech
A USPTO Notice of Allowance is a determination that a patent application meets the requirements for patentability. It is a step that precedes formal grant, and the patents will not be enforceable until they are formally granted.
For a clinical-stage biopharmaceutical company, intellectual property sits at the core of asset value.
The 2042 expiry horizon matters because it offers a long runway of potential protection for an asset still progressing through trials. Once granted, this would give NTI164 an extended window of exclusivity as it advances through late-stage development.
Anthony Filippis, CEO and Managing Director
“These Notices of Allowance represent further execution of our strategy to create value by protecting our assets and expanding our global IP portfolio.”
Filippis described the USPTO’s determination that both applications satisfy the requirements for patentability as an important step in the progression of the Company’s US intellectual property strategy for NTI164.
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NTI164 and the road ahead
NTI164 is described as a proprietary, multi-constituent, GMP-grade standardised formulation containing CBDA-rich extracts and select minor cannabinoids. It is currently in Phase 3 clinical development for ASD in paediatric patients, and the Company has received human ethics committee clearance for the Phase III study.
Neurotech has completed a Phase II/III randomised, double-blind, placebo-controlled clinical trial in ASD, reporting statistically significant and clinically meaningful benefits across a number of clinically-validated measures alongside excellent safety. The Company has also completed and reported statistically significant and clinically meaningful Phase I/II trials in ASD, PANDAS/PANS and Rett Syndrome.
The next step is the formal grant of both patents, which is expected within the coming months. As the Company enters the new financial year, Filippis stated the focus remains on achieving key milestones for NTI164 to address the urgent need for effective ASD treatments in children.
For investors, three items stand out as near-term signposts:
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Formal grant of the two US patents (expected within coming months)
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Progress of the Phase 3 ASD clinical programme
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Further global IP portfolio expansion
Taken together, the Notices of Allowance strengthen the intellectual property position around NTI164 as it advances through late-stage development.
For investors exploring the broader pipeline context behind Neurotech’s IP expansion strategy, our detailed coverage of Neurotech’s Rett syndrome collaboration with the University of Sydney examines how mechanistic research in orphan indications supports both regulatory submissions and future IP filings.
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