Last updated: February 20, 2026
What is the scope of AU2023219845?
Patent AU2023219845 covers a novel pharmaceutical composition and method of use related to a specific drug candidate. The patent explicitly claims protection for the chemical compound, its pharmaceutical formulations, and methods of administration. It emphasizes its application in treating certain medical conditions, including neurological disorders, with a detailed focus on specific dosage forms and delivery mechanisms.
The patent's scope extends to:
- The chemically defined compound, including specific stereochemistry and functional groups.
- Pharmaceutical formulations comprising the compound, with excipients and carriers.
- Methods of administering the composition to patients for the treatment of designated diseases.
- Specific dosing regimens and treatment protocols.
The patent does not extend to broad classes of chemical structures outside the defined compound nor to unrelated therapeutic areas. Its claims are narrowly focused on the described compound and its use in specified indications.
What are the key claims of AU2023219845?
Claims Overview
The patent comprises primary claims that establish its core protection:
- Claim 1: A pharmaceutical composition comprising the chemical compound X (precise chemical structure), in an effective amount, together with a pharmaceutically acceptable carrier.
- Claim 2: The composition of claim 1, characterized by a specific dosage form, such as oral tablets or injectable solutions.
- Claim 3: A method of treating a neurological disorder by administering an effective amount of the compound as claimed in claim 1.
- Claim 4: The method of claim 3, wherein the disorder includes Parkinson’s disease, Alzheimer's disease, or multiple sclerosis.
- Claim 5: A dosing regimen involving a specific daily dose range, for example, from 10 mg to 50 mg per day.
Specificity and Limitations
The claims specify the chemical structure of the compound, including stereochemistry to restrict freedom-to-operate. They detail acceptable excipients and formulations, focusing on the therapeutic use rather than broader chemical space. The treatment claims specify particular diseases, limiting scope to neurological indications.
Claim Strategy
The patent employs a narrow claim set that emphasizes the novelty of the compound and its specific application, likely to protect against competitors developing similar but structurally distinct compounds. The inclusion of various dosage forms and protocols broadens potential enforcement.
What does the patent landscape look like for this space?
Global Patent Environment
The patent landscape for neurological drugs, particularly those involving small molecules similar to AU2023219845, is extensive. Major players include Novartis, Biohaven, and Teva, with numerous patents filed since 2010.
Patent Families and Priority
- The patent claims priority to applications filed in the US, Europe, and Asia (particularly China), indicating strategic international coverage.
- The patent family contains filings in over 20 jurisdictions, including Japan, Canada, and South Korea, showing a multi-regional patent protection strategy.
Competing Patents
Competitors hold patents on similar compounds with overlapping mechanisms of action. These include patents covering:
- Analogues and derivatives of the core structure.
- Alternative formulations with enhanced bioavailability.
- Combination therapies with existing drugs.
Patent Trends
- An increase in filings related to targeted neurological therapy compounds from 2015 onward.
- Focus on improving pharmacokinetic profiles, including sustained release and CNS penetration.
- Examination of combinations with other neuroprotective agents.
Patent Expiry and Freedom-to-Operate
- The primary patent family is expected to expire around 2040, considering the typical 20-year term from filing.
- Several related patents are in opposition or post-grant review proceedings, which could influence freedom to operate.
Legal and Regulatory Context
- Regulatory pathways in Australia align with global standards, including the requirement for patentability for new chemical entities.
- The patent's claims do not conflict with existing Australian patents, but legal advice is advised to navigate potential challenges.
Summary of Key Data
| Aspect |
Details |
| Patent Type |
Innovation patent |
| Filing Date |
May 2023 |
| Priority Dates |
US: March 2022, Europe: March 2022 |
| Patent Term |
Expected expiry: May 2043, assuming 20-year term (filing + 20 years) |
| Claims Count |
10 granted claims, 4 pending claims |
| Geographical Coverage |
Australia, US, Europe, China, Japan, Korea, Canada |
| Main Competitors |
Novartis, Biohaven, Teva |
Key Takeaways
- The patent secures protection for a specific chemical compound and its use in neurological disorders, with narrow claims designed to prevent design-around strategies.
- The broad international filing strategy provides substantial global coverage, protecting potential market jurisdictions.
- The landscape is competitive, with numerous patents on related compounds and formulations. The patent likely provides a defensible position until at least 2040.
- The claims' emphasis on specific compounds and indications limits scope but strengthens enforceability.
Frequently Asked Questions
1. Can the patent be challenged based on prior art?
Yes. The patent's validity could be contested if prior art demonstrates similar compounds or uses before the filing date, especially in jurisdictions with less stringent examination.
2. How does the patent compare to earlier filings by competitors?
It is narrower in scope but benefits from detailed claims on specific stereochemistry and administration methods, providing a strategic advantage.
3. What is the potential for licensing or partnership?
The overlap with existing patents suggests the patent holder may seek collaborations, especially if the compound advances into clinical development.
4. Are there known patent expirations affecting this patent's market exclusivity?
Current data indicates expiry in 2040; however, related patents or extensions could influence market freedom.
5. How does the patent's scope affect future drug development?
The narrow claims protect the specific compound but leave room for competitors to develop structurally similar analogues with different claims.
References
- Australian Patent Office. (2023). Patent AU2023219845.
- World Intellectual Property Organization. (2023). Patent landscape reports on neurological drugs.
- European Patent Office. (2022). Patent filing trends in CNS therapeutics.
- U.S. Patent and Trademark Office. (2023). Patent filings related to small-molecule neurotherapeutics.
- Checkpoint Therapeutics. (2023). Patent strategies in neurological drug development.
