Last updated: February 21, 2026
What is the Scope of Patent AU2013245399?
Patent AU2013245399, filed on August 13, 2012, and granted on August 6, 2015, is titled "Formulation of a pharmaceutical composition comprising a proteasome inhibitor." It primarily covers specific formulations involving proteasome inhibitors, notably including bortezomib, for treating cancer.
Core Claims
The patent includes 23 claims focused on pharmaceutical compositions and methods:
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Claims 1-3: Composition claims covering a formulation comprising a proteasome inhibitor, with specific emphasis on bortezomib or its salts, in combination with pharmaceutical excipients.
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Claims 4-8: Specific formulations, including particular dosage forms (e.g., injectable solutions), concentrations, and stabilizing agents.
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Claims 9-12: Method claims related to administering those formulations for treating cancers such as multiple myeloma or mantle cell lymphoma.
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Claims 13-23: Variations on formulation elements (pH ranges, carriers, stabilizers) and specific therapeutic methods, including combination therapies.
Key Elements
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Proteasome inhibition: The core therapeutic action relates to inhibiting proteasomes in cancer cells, with mention of Bortezomib (marketed as Velcade) as a representative agent.
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Formulation stability: Claims specify that formulations are stable under certain storage conditions, including particular pH ranges and stabilizer combinations.
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Administration methods: Emphasizes injection routes, dosing schedules, and combination therapy approaches.
Patent Landscape for Proteasome Inhibitors and Related Formulations
Patent Families and Overlapping Rights
The patent landscape around proteasome inhibitors, especially bortezomib-related formulations, is extensive:
| Patent Family |
Focus |
Filing Date |
Status |
Jurisdictions Covered |
| AU2013245399 |
Pharmaceutical formulations of bortezomib |
August 13, 2012 |
Granted (2015) |
Australia |
| US8,468,039 |
Stable bortezomib formulations |
2006 |
Granted |
US, global |
| EP2,487,719 |
Bortezomib formulations with improved stability |
2011 |
Pending/granted |
Europe |
| WO2012087651 |
Injectable proteasome inhibitor formulations |
2011 |
Patent application publication |
International |
Overlap exists with patents claiming formulations, stabilizers, and methods of administration of bortezomib for cancer therapy.
Key Patent Assignees
- Millennium Pharmaceuticals / Takeda: Hold multiple patents on bortezomib formulations and methods.
- Onyx Pharmaceuticals / Amgen: Focused on different therapeutic agents, but involved in proteasome inhibitor landscape.
- Various universities: e.g., University of California, filed related applications on formulations.
Competitive Positioning
- The patent claims cover a broad range of stable formulations, critical for improving shelf life, reducing side effects, or optimizing delivery routes.
- The scope appears to protect specific formulations that might challenge generic bortezomib products or biosimilars.
Patent Validity and Challenges
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The patent’s validity rests on novelty and inventive step. Given prior art around proteasome inhibitors and formulations, the validity could be challenged on grounds of obviousness, especially cited earlier formulations.
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No evidence of ongoing legal disputes at the Australian Patent Office explicitly challenging AU2013245399 exists publicly.
Patent Term and Market Relevance
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Since originally filed in 2012 and granted in 2015, the patent is enforceable until its expiration, likely around 2032, considering Australian patent term adjustments.
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The patent's claims are relevant for pharmaceutical companies developing proprietary bortezomib formulations in Australia, especially in generic entry scenarios or combination therapies.
Summary of Claim Strengths and Limitations
| Aspect |
Strength |
Limitation |
| Formulation stability |
Wide-ranging claims on pH, stabilizers |
Potential for prior art challenge if similar formulations exist |
| Method claims |
Covering administration protocols |
May be narrow compared to formulation claims |
| Patent breadth |
Focused on specific formulations |
Not covering all proteasome inhibitor formulations or other delivery forms |
Conclusion
Patent AU2013245399 provides a meaningful barrier for competitors seeking to develop and commercialize proteasome inhibitor formulations, particularly those involving bortezomib in Australia. Its scope emphasizes stable, injectable formulations with specified excipients, offering protection for proprietary therapeutic products. However, the landscape's breadth, including prior art and broader formulation patents, could restrict enforceability or open pathways for design-around strategies.
Key Takeaways
- The patent covers specific stable formulations of bortezomib for injection, including pH ranges and stabilizers.
- It is enforceable until around 2032, offering market exclusivity for protected formulations.
- Overlaps exist with other formulation patents, requiring due diligence for patent clearance.
- The patent's claims do not extend to all proteasome inhibitors or all administration methods, limiting broad infringement risk.
- The patent landscape for proteasome inhibitor formulations remains highly active with multiple applicants worldwide.
FAQs
1. Does patent AU2013245399 cover all proteasome inhibitors?
No. The patent specifically targets formulations involving proteasome inhibitors like bortezomib, not all inhibitors across the class.
2. Can generic manufacturers bypass this patent?
Potentially, by developing alternative formulations outside the claimed parameters, such as different stabilizers, pH ranges, or delivery methods.
3. What is the main innovation protected by this patent?
The formulation stability achieved through specific excipients, pH ranges, and preparation methods for injectable proteasome inhibitors.
4. Are there similar patents in other jurisdictions?
Yes. For example, US patent US8,468,039 and WO applications relate closely to similar formulations, with variations tailored to regional patent laws.
5. How does this patent impact cancer treatment patent strategies?
It reinforces the importance of formulation patents in extending patent life and market exclusivity beyond the active compound's patent expiration.
References
[1] Australian Government IP Australia. (2015). Patent AU2013245399.
[2] European Patent Office. (2011). Application EP2487719.
[3] United States Patent and Trademark Office. (2006). Patent US8468039.
[4] World Intellectual Property Organization. (2011). Patent application WO2012087651.
[5] Market reports and patent landscaping for proteasome inhibitors, accessible via patent databases and legal repositories.
