Neurotech International Limited (ASX:NTI), a clinical-stage biopharmaceutical firm specialising in paediatric neurological disorders, has revealed that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for two U.S. patent applications related to its leading drug candidate, NTI164. These applications, which cover methods for reducing neuroinflammation and treating Autism Spectrum Disorder (ASD), are anticipated to be formally granted in the upcoming months, pending routine administrative procedures. Upon grant, these patents are expected to secure NTI164's intellectual property rights in the U.S. through 2042, contingent on payment of maintenance fees. This development coincides with NTI164's progression through Phase 3 clinical trials for paediatric ASD, marking a significant milestone in the company’s long-term commercialisation plans.
Key Points
- Company: Neurotech International Limited (ASX:NTI)
- USPTO has issued Notices of Allowance for two U.S. patent applications (Nos. 18/698,605 and 19/335,945) concerning NTI164
- Patent No. 18/698,605 pertains to methods of reducing neuroinflammation with NTI164; Patent No. 19/335,945 relates to methods for treating Autism Spectrum Disorder (ASD)
- Formal patent grants are expected within months, subject to standard administrative completion
- Patents are projected to provide U.S. intellectual property protection for NTI164 through 2042, subject to maintenance fee payments
- NTI164 is currently undergoing Phase 3 clinical development for paediatric ASD treatment
- Investors should monitor for formal patent grants and ongoing Phase 3 clinical trial progress
USPTO Issues Notices of Allowance for Patent Applications 18/698,605 and 19/335,945
On 2 July 2026, Neurotech International announced that the USPTO has issued Notices of Allowance for two U.S. patent applications titled "Compositions and Methods for Treating Neurological Disorders," which directly relate to NTI164. This proprietary, multi-constituent, GMP-grade standardised formulation includes CBDA-rich extracts and select minor cannabinoids.
A Notice of Allowance indicates the USPTO’s determination that the patent applications meet patentability criteria. However, Neurotech emphasised that these patents will not be enforceable until formal grant, expected within months after standard administrative steps are completed. Investors should note that a Notice of Allowance is a positive step toward patent issuance but does not confer enforceable rights by itself.
Scope of the Two Allowed Patent Claims for NTI164
The two patent applications cover distinct, clinically significant aspects of NTI164’s therapeutic use. U.S. Patent Application No. 18/698,605 includes claims on methods for reducing neuroinflammation using NTI164, a key mechanism believed to underlie the drug’s therapeutic effects based on preclinical and earlier clinical data.
U.S. Patent Application No. 19/335,945 claims methods for treating Autism Spectrum Disorder, the primary indication for which NTI164 is in Phase 3 development. Securing patent protection specifically for ASD treatment methods could be crucial for future licensing, commercialisation, or partnership opportunities in the U.S. Together, these patents aim to reinforce Neurotech’s global intellectual property portfolio for NTI164.
NTI164 Patent Protection Expected Through 2042
Subject to maintenance fees, Neurotech expects these patents to protect NTI164’s intellectual property rights in the U.S. until 2042. This extended protection period offers a potentially lengthy exclusivity window during a critical commercialisation phase, assuming successful Phase 3 trial completion and regulatory approval.
In pharmaceuticals, patent exclusivity duration is a key factor influencing commercial value and investor interest. While the company did not disclose financial valuations linked to this expanded IP portfolio, the protection horizon to 2042 is significant for market potential in the U.S.
CEO Anthony Filippis Highlights U.S. IP Strategy Progress
Neurotech CEO and Managing Director Anthony Filippis described the Notices of Allowance as "further execution of our strategy to create value by protecting our assets and expanding our global IP portfolio." He stated that the USPTO’s determination that both applications fulfill patentability requirements marks "an important step in the progression of the Company’s U.S. intellectual property strategy for NTI164."
Filippis also outlined near-term company priorities: "As we enter the new financial year, we remain focused on achieving key milestones for NTI164 to address the urgent need for effective treatments for children diagnosed with ASD." This underscores the integration of patent milestones with clinical development efforts, with Phase 3 ASD trials central to upcoming activities.
NTI164’s Phase 3 Clinical Development for Paediatric ASD
NTI164 is in Phase 3 clinical trials targeting ASD in paediatric patients. The company previously completed a Phase II/III randomised, double-blind, placebo-controlled trial demonstrating clinically meaningful and statistically significant benefits across validated measures, alongside an excellent safety profile. Human ethics committee approval for the Phase 3 study has also been obtained.
The ongoing Phase 3 programme runs concurrently with the company’s IP expansion, both supporting long-term NTI164 value. Earlier clinical studies in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS), Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), and Rett Syndrome have shown statistically significant, clinically meaningful outcomes. This broad clinical scope highlights the strategic importance of robust U.S. patent protection.
NTI164 Composition and Mechanism of Action
NTI164 is a proprietary, multi-constituent, GMP-grade standardised oral formulation containing CBDA-rich extracts and select minor cannabinoids. Preclinical and early clinical data indicate its potential to modulate neuroinflammatory signalling, immune dysregulation, and upstream biological pathways implicated in neurodevelopmental disorders.
Emphasising CBDA-rich extracts—cannabidiolic acid, the acidic precursor to CBD—distinguishes NTI164 from other cannabinoid therapies. The company’s scientific rationale focuses on neuroinflammation and immune dysregulation as core pathological mechanisms in ASD, PANDAS/PANS, and Rett Syndrome. The newly allowed patent claims on neuroinflammation reduction directly align with NTI164’s proposed mechanism, reinforcing the coherence of its IP strategy.
Integration of Patent Allowances into Neurotech’s Global IP Portfolio
Neurotech views the Notices of Allowance as strengthening its NTI164 intellectual property portfolio. Although this announcement pertains specifically to U.S. patents, the reference to a "global IP portfolio" implies patent protection efforts in other jurisdictions. The company did not disclose details of its full global patent holdings or additional jurisdictions in this update.
For a clinical-stage biopharmaceutical, the strength and duration of patent protection are critical factors in attracting partnerships, licensing agreements, or strategic transactions. Given the U.S. is the largest pharmaceutical market globally, these patents represent a significant advance in Neurotech’s commercial readiness. Investors should watch for updates on patent grants and further IP filings as the portfolio expands.
Upcoming Milestones: Patent Grants and Phase 3 Progress
The next key milestone after the Notices of Allowance is the formal grant of the two U.S. patents, expected within months following administrative completion. Until then, the patents are not enforceable. Investors should look for company confirmation of official issuance for patent applications 18/698,605 and 19/335,945.
In parallel, advancing the Phase 3 ASD clinical trial—already cleared by human ethics committees—remains a core focus. CEO Filippis has emphasized achieving key NTI164 milestones in ASD treatment as a priority. Progress on clinical and regulatory fronts, alongside a strengthened U.S. IP position, will be closely monitored by investors. The immediate market reaction to the Notices of Allowance was not evident from public data.
Neurotech’s Commitment to Paediatric Neurological Disorders
Neurotech International identifies as a clinical-stage biopharmaceutical company primarily addressing paediatric neurological disorders, an area with significant unmet medical needs and limited approved treatment options, especially for ASD. Its pipeline centers on NTI164 as a broad-spectrum oral cannabinoid therapy, with clinical programmes covering ASD, PANDAS/PANS, and Rett Syndrome.
The announcement reiterates the company’s focus on "addressing the urgent need for effective treatments for children diagnosed with ASD," reflecting both clinical and patient advocacy motivations. For investors, the combination of an expanding IP portfolio, a Phase 3 programme supported by prior efficacy and safety data, and a clearly defined patient population with high unmet need constitutes important considerations in evaluating Neurotech’s risk-reward profile as it advances toward regulatory engagement in the U.S. and other markets.