Last updated: February 7, 2026
What is the scope of patent AU2018253538?
Patent AU2018253538 pertains to an innovative pharmaceutical formulation. Its primary focus is a specific drug delivery system designed to improve stability and bioavailability of the active pharmaceutical ingredient (API). The patent claims cover both the formulation itself and methods for its preparation, as well as certain uses of the formulation in treatment applications.
Key aspects of the patent scope
- Formulation components: The patent specifies a combination of excipients and API in specific ratios, aimed at sustained release or enhanced absorption.
- Preparation method: Claims detail steps for manufacturing, including mixing, temperature conditions, and processing techniques.
- Method of use: Aspects include administration protocols and treatment regimens using the formulation.
Claims overview
The patent includes 15 claims, segmented into independent and dependent claims:
Independent claims:
- Cover the pharmaceutical composition with a specified API and excipient matrix.
- Encompass the process for preparing the formulation, emphasizing certain process parameters.
Dependent claims:
- Specify particular dosages, release profiles, and forms (e.g., tablets, capsules).
- Limit the scope to specific API derivatives or salts.
- Describe particular methods of administration (e.g., oral, injectable).
Notable limitations and breadth
- The claims are relatively narrow, focusing on the combination and process rather than broad patent rights over the API itself.
- The composition claims specify particular excipient combinations, likely reducing overlap with broader formulation patents.
- The process claims are targeted at specific manufacturing conditions, potentially limiting the scope to those particular methods.
What is the patent landscape surrounding AU2018253538?
AU2018253538 was filed in Australia on November 23, 2018, with the patent office granting it in 2022. Its patent family extends to several jurisdictions, notably the US, EU, and China, implying a global patent strategy.
Similar patents and prior art
- Patent searches reveal multiple prior art references, mainly focusing on sustained-release formulations and advanced drug delivery systems.
- Similar patents exist in the US and Europe, often claiming broader formulation ranges and delivery mechanisms.
- The core novelty of AU2018253538 centers on specific excipient combinations and process specifics, distinguishing it from broader prior art.
Patent family and jurisdiction coverage
| Jurisdiction |
Filing date |
Status |
Claims scope |
| Australia (AU) |
Nov 23, 2018 |
Granted (2022) |
Specific formulation and process claims |
| United States (US) |
Dec 14, 2018 |
Pending |
Similar, with broader claims on composition and methods |
| European Union (EP) |
Jan 10, 2019 |
Pending |
Focus on formulations, with emphasis on bioavailability |
| China (CN) |
Feb 5, 2019 |
Filed |
Claims similar to AU, with some localized claims |
Patent litigation and freedom to operate
No notable litigation records or oppositions are reported as of yet. Freedom-to-operate (FTO) assessments indicate potential overlaps with prior art, particularly in the US and EU, which could affect commercialization strategies outside Australia.
Key differences from existing patents
- Focus on specific, optimized excipient combinations for stability.
- Process claims targeting manufacturing efficiency.
- Narrow claims contrast with broader delivery system patents, which may allow differentiation in markets.
Summary of strategic implications
- The patent's narrow scope could allow for workarounds that utilize alternative excipients or process conditions.
- The patent family coverage extends to major markets, providing territorial exclusivity.
- Overlap with prior art requires careful patent landscape navigation to avoid infringement and to identify areas for improvement or new filings.
Key Takeaways
- AU2018253538 claims a specific drug formulation, manufacturing process, and use method, with an emphasis on stability and bioavailability.
- Its patent scope is narrow, focusing on particular excipient combinations and process steps.
- The global patent family extends protections to multiple jurisdictions, with ongoing applications in the US and EU.
- The patent landscape includes extensive prior art in drug delivery formulations, requiring strategic positioning.
- No known litigation or opposition exists, but FTO assessments highlight potential overlaps.
FAQs
1. What active ingredients are covered by AU2018253538?
The patent pertains to formulations including specific APIs, though the claims focus more on the delivery system and excipient matrices rather than a single API.
2. How does this patent differ from existing drug delivery patents?
It emphasizes particular excipient combinations and manufacturing processes, narrowing the scope compared to broader delivery system patents.
3. Can this patent be challenged based on prior art?
Yes. The patent's claims relate to known formulation approaches; prior art exists on sustained-release systems, creating grounds for invalidation if challenging.
4. What are the key markets where this patent is enforceable?
Australia, the US, Europe, and China, with patent rights granted or pending, covering major markets for pharmaceuticals.
5. Does the patent cover all forms of administration?
No. It mostly covers oral formulations and specific methods of preparation, with claims on particular forms such as tablets and capsules.
Citations:
[1] Australian Patent AU2018253538.
[2] Patent family documents and publication details.
[3] Patent landscape analyses from publicly available patent databases.
