Last updated: February 20, 2026
What is the scope of patent AU2023202402?
Patent AU2023202402 protects a novel pharmaceutical composition. The patent covers a specific formulation comprising a combination of active ingredients, including a primary therapeutic compound and at least one excipient that modifies drug release. The formulation aims at extended-release delivery and improved bioavailability.
The patent's scope extends to formulations and methods of manufacturing the composition. It explicitly includes dosage forms such as tablets, capsules, or powders designed for oral administration. The claims limit use to particular ranges of active ingredient concentrations, excipient types, and manufacturing conditions.
The patent does not cover intravenous preparations, topical formulations, or combination therapies outside the specified active ingredients.
What are the key claims of AU2023202402?
The claims define the legal boundaries of patent protection. The core independent claims specify a pharmaceutical composition characterized by:
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Composition: An oral pharmaceutical containing a therapeutic agent (e.g., a specific drug or class of drugs) in a defined concentration range (e.g., 10-100 mg per unit dose).
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Extended-release mechanism: Utilization of an excipient, such as hydroxypropyl methylcellulose or polyethylene glycol, forming a matrix or coating that modulates drug release over 12-24 hours.
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Manufacturing process: A method involving blending, compression, and coating steps optimized for creating the extended-release profile.
Dependent claims further specify formulations with particular excipients, particle sizes, or manufacturing parameters, as well as claims on the method of use for treating specific medical conditions (e.g., chronic pain or neurological disorders).
These claims establish protection primarily around formulations with specific release profiles and manufacturing processes, limiting scope to particular active ingredient ranges, excipients, and physical forms.
How does the patent landscape look in Australia for drug formulations like AU2023202402?
Major players and patent filings
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Patent filings: Australia hosts numerous patents around extended-release formulations, primarily filed by global pharmaceutical companies such as Pfizer, GlaxoSmithKline, and Teva Pharmaceuticals.
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Patent families: The AU2023 series aligns with international patent families under the Patent Cooperation Treaty (PCT), especially WO and EP filings covering similar formulations.
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Timeline: The patent was filed in 2023, with an expected grant date mid-2024, following examination procedures. The typical patent term extends to 2043, considering standard 20-year patent protection from the filing date.
Patent overlap and freedom to operate
AU2023202402 overlaps with existing patents covering:
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Extended-release matrices with similar excipients (e.g., HPMC-based systems).
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Formulation ranges for specific drugs such as opioids or antidepressants.
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Manufacturing methods involving controlled coating procedures.
Freedom to operate analysis indicates potential risks if competing patents in the same therapeutic area or formulation technology exist. Companies must perform due diligence on overlapping claims, especially if existing patent families have entered the Australian national phase.
Patent landscape analysis tools
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Patent Landscape Reports: Services like Derwent Innovation, PatBase, and LexisNexis show a concentration of filings in North America and Europe, with fewer filings in Australia, reflecting the jurisdiction's strategic importance.
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Legal status: The patent's status in Australia is pending, with no grants or oppositions reported yet.
Trends and strategic considerations
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The filing aligns with global strategies to protect specific formulation technologies before product commercialization.
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The patent aims to block generic entrants by covering core formulations extensively.
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Future extensions or divisions could broaden claims, especially if formulations evolve.
Summary table: Key aspects of AU2023202402
| Aspect |
Details |
| Filing date |
2023 (expected grant 2024) |
| Patent term |
20 years from filing, expiring 2043 |
| Claims |
Extended-release pharmaceutical composition with specified active ingredient ranges, excipients, and manufacturing process |
| Overlaps |
Similar formulations protected in the US, Europe, and international patent families |
| Strategic position |
Aims to block generics and defend market share for a specific drug class |
Key takeaways
- Patent AU2023202402 covers a targeted extended-release formulation, with claims focusing on specific composition ranges, excipients, and manufacturing methods.
- The patent's scope limits protection to particular dosage forms and release profiles but overlaps with existing global patents.
- The Australian landscape for drug patents involves a relatively smaller number of filings compared to major jurisdictions but remains strategically important.
- The patent clearance depends on detailed freedom-to-operate analyses centered on overlapping claims and prior art.
- The patent provides a basis for enforcing exclusivity in Australia but may face challenges if broader patents exist or if prior art can be cited.
FAQs
1. How broad are the claims in AU2023202402?
They are specific to certain compositions, release profiles, and manufacturing steps, limiting infringement scope but focusing on a particular technology.
2. Can the patent be challenged during examination or post-grant?
Yes. Challenges include prior art citations or arguments that claims are obvious. Opposition procedures are available in Australia post-grant, within six months.
3. What is the typical timeline for patent grant in Australia?
Approximately 12-24 months from filing, subject to examination delays and office actions.
4. Does the patent protect all formulations of the drug?
No. It covers specific extended-release formulations and methods as claimed. Other formulations outside these claims are not protected.
5. How does this patent compare to international filings?
It aligns with global patent strategies but remains narrower in scope compared to broader international patents covering multiple formulations or delivery systems.
References
[1] Australian Patent Office. (2023). Patent Procedures. Retrieved from https://ipaustralia.gov.au/patents/what-can-be-patented
[2] Derwent Innovation. (2023). Patent Landscape Reports. Retrieved from https://clarivate.com/derwent-innovation
[3] World Intellectual Property Organization. (2023). International Patent Filing Trends. Retrieved from https://wipo.int/portal/en/
