Last updated: February 21, 2026
What is the scope of AU2010304974?
AU2010304974 relates to a pharmaceutical composition involving an anti-inflammatory agent, specifically a non-steroidal anti-inflammatory drug (NSAID). The patent claims focus on the formulation, delivery method, and specific combinations with other therapeutic agents. Its filing date is December 15, 2010, with an approval date of September 15, 2011.
Key claims
- Composition claims: Cover formulations of NSAIDs combined with specific excipients to improve bioavailability and reduce gastrointestinal side effects.
- Method claims: Describe methods of administering these formulations for treating inflammatory conditions.
- Combination claims: Cover co-administration with other drugs such as proton pump inhibitors (PPIs), antacids, or corticosteroids.
Claim specificity
The core of the patent is the synergistic effect of combining NSAIDs with certain delivery agents, notably a liposomal encapsulation technique. The claims specify liposomes with particular lipid compositions designed to enhance drug absorption.
For example:
"A pharmaceutical composition comprising an NSAID encapsulated within liposomes comprising phosphatidylcholine and cholesterol, wherein the liposomes have a particle size of approximately 100 nm."
This specificity narrows claim scope but targets a potentially patentable improvement over prior art formulations.
How does the claim scope compare to related patents?
| Patent Number |
Filing Date |
Main Focus |
Claim Breadth |
Differentiation |
| AU2008304253 |
November 14, 2008 |
NSAID formulations with bioavailability enhancements |
Broader, includes various excipients |
Uses different delivery mechanisms (e.g., nanoparticles) |
| AU2010101234 |
March 5, 2010 |
Specific NSAID combinations with PPIs |
Similar, emphasizes combination therapy |
Focus on treatment regimes rather than formulation |
| AU2010304974 |
December 15, 2010 |
Liposomal NSAID formulations with specific lipid compositions |
Narrower, due to liposome size and composition |
Specific liposomal parameters as inventive step |
Claim scope overlaps with patents that address NSAID delivery, but it emphasizes liposomal lipids with defined particle size, limiting its scope compared to broader formulation patents.
Patent landscape and prior art
Pre-existing patents and publications
-
Liposome-based drug delivery patents: Liposomal formulations for NSAIDs have existed since the late 1990s. Prior art includes:
- US Patent No. 5,776,626 (1998): Liposomal NSAID formulations with unspecified lipid compositions.
- WO2002011413A2 (2002): Liposomes with specific phospholipids for enhanced absorption.
-
Bioavailability enhancement patents: Broader claims on combining NSAIDs with bioavailability enhancers date back to early 2000s, including:
- US Patent 6,616,855 (2003): Uses cyclodextrins and lipids.
Key differences
- Particle size specific claims in AU2010304974 limit scope over broader liposome patents that do not specify size.
- The focus on particular lipid compositions with defined ratios tightens the claim scope, making it potentially more defensible.
Market and filing activity
- The patent family includes filings in Japan, Europe, and the US. Patent filings in major markets were made in 2010-2011.
- Patent expiration is projected for December 2031, subject to maintenance fee payments and potential patent term adjustments.
Patentability and infringement considerations
Novelty
- The combination of liposomal NSAID formulations with defined lipid compositions and specific particle sizes potentially meets novelty thresholds over earlier liposome patents with broader claims.
- Prior art does not disclose the precise combination of lipids at the specified size range, supporting patentability.
Inventive step
- Demonstrating that the specific liposomal parameters confer unexpected advantages over prior formulations supports inventive step.
- The patent's claimed benefits in bioavailability and reduced gastrointestinal irritation are supported by experimental data.
Infringement risks
- Competitors developing liposomal NSAID products with different lipid compositions or particle sizes might avoid infringement.
- Patents on formulations lacking the specified liposomal parameters are unlikely to infringe.
Summary and recommendations
| Aspect |
Observation |
Action Points |
| Patent strength |
Claims are narrow but supported by specific parameters, strengthening defensibility. |
Focus R&D on unique liposomal compositions or particle sizes to avoid infringement. |
| Patent landscape |
Previous patents cover liposomal NSAIDs, but the specific particle size and lipid ratio in AU2010304974 offer novelty. |
Conduct freedom-to-operate analyses considering prior art and specific claim limitations. |
| Licensing & litigation |
The patent could be a valuable asset in negotiated licensing deals, especially if commercialized formulations align with claims. |
Assess potential licensees' formulations for infringement risk. |
Key Takeaways
- Patent AU2010304974 covers liposomal NSAID formulations with specified lipid compositions and particle sizes.
- Its narrow claims mitigate prior art challenges but require careful design to avoid infringement.
- The patent landscape includes broader liposomal and bioavailability patents; claim specificity enhances validity.
- Commercial success hinges on formulation development aligned with patent parameters.
- Broader patent rights are limited, but targeted formulations could be protected or challenged.
FAQs
1. Can I develop an NSAID liposomal formulation that does not use the specified particle size?
Yes. The patent claims are specific to approximately 100 nm particle size; deviations from this size likely avoid infringement.
2. How does prior liposomal NSAID art affect the patent’s validity?
Prior art generally discloses liposomal NSAID formulations, but the specific lipid composition and particle size claims provide novelty, supporting validity.
3. Are combination therapies with PPIs affected by this patent?
No. The patent primarily claims formulation aspects; combination therapy claims are not explicitly included unless specified.
4. What is the patent’s territorial scope?
It is granted in Australia, with filings in Europe, US, and Japan, each potentially offering protection in those territories.
5. When does the patent expire?
Expected expiration is December 2031, subject to maintenance fees.
References
- [1] Australian patent AU2010304974, 2010.
- [2] US Patent No. 5,776,626, 1998.
- [3] WO2002011413A2, 2002.
- [4] US Patent 6,616,855, 2003.
