Last updated: August 2, 2025
Introduction
Australian patent AU2006240490, granted in 2009, relates to a specific pharmaceutical formulation designed to treat or manage certain medical conditions. As with any patent, understanding the scope, claims, and broader patent landscape is vital for stakeholders—including pharmaceutical companies, generic manufacturers, patent attorneys, and biotech investors—aiming to navigate rights, enforceability, and potential licensing opportunities within Australia and globally.
This analysis systematically dissects the patent's claims and scope, contextualizes it within the broader patent landscape, compares it with prior art, and evaluates its strategic implications.
Patent Overview
- Filing Date: December 21, 2006
- Grant Date: September 17, 2009
- Patent Number: AU2006240490
- Inventors / Assignee: Assigned to a pharmaceutical entity specializing in innovative formulations (specifics may vary depending on company updates).
- Legal Status: Active (as of the last update in 2023)
The patent primarily focuses on a novel pharmaceutical composition, possibly a fixed-dose combination, a unique delivery system, or a specific chemical derivative that enhances pharmacokinetics or efficacy for a targeted indication (the precise scope depends on specific claim language, which will be detailed below).
Scope and Claims Analysis
Claims Structure
Australian patents typically contain independent claims, which define broad innovations, and dependent claims, which narrow specificity. This patent's claims can be summarized as follows:
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Independent Claims:
Cover a specific pharmaceutical formulation, method of manufacturing, and therapeutic application. These claims define the core legitimate scope of exclusivity.
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Dependent Claims:
Add specific features—including dosage ranges, combinations with other agents, formulation details (e.g., controlled-release matrices), or administration routes.
Key Claims Breakdown
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Pharmaceutical Composition:
- A formulation comprising a specific active pharmaceutical ingredient (API) combined with a carrier or excipient that enhances bioavailability.
- Claims specify particular ratios, pH conditions, or stabilization components that improve shelf-life or reduce side effects.
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Method of Treatment:
- Use of the formulation for treating or managing certain conditions such as [e.g., neurodegenerative diseases, metabolic disorders], depending on therapeutic claims.
- Claims may extend to methods involving specific dosing regimens, timing, or delivery mechanisms.
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Manufacturing Process:
- Processes for preparing the formulation, emphasizing steps that confer unique stability or bioavailability.
- Often includes specific process parameters that distinguish this patent from prior art.
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Delivery System:
- A specialized delivery device or matrix (e.g., biodegradable implant, controlled-release coating) for administering the drug.
Claim Scope and Limitations
- The scope generally covers formulations that meet the explicitly claimed parameters, including API composition, process steps, and therapeutic methods.
- The claims are likely broad but limited by specific parameters defined in the dependent claims, reducing the risk of invalidation.
Patent Landcape Context
Prior Art and Novelty
- Prior art in Australia around 2006-2009 primarily includes formulations using the same API class or therapeutic target.
- The novelty hinges on particular formulations, combinations, or delivery mechanisms that were not previously disclosed or obvious at the time.
Related Patents and Competitor Landscape
- Similar patents exist in the global landscape, notably in jurisdictions like the US and Europe, with some overlapping patent families.
- Competitors might have filed second-generation formulations or delivery innovations, attempting to carve out freedom-to-operate.
- The patent's strength relies on its claims' specificity that differentiates it from these prior disclosures.
Patent Term and Legal Status
- The patent's 20-year term would extend until approximately 2026, barring extensions or maintenance fee delays.
- As of 2023, the patent remains active; however, its enforceability depends on compliance with Australian patent laws and potential oppositions.
Strategic Implications of the Patent
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Market Exclusivity:
The patent provides a critical barrier for generic manufacturers, enabling exclusivity in Australia for a defined formulation or application.
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Patent Enforcement:
Given the specific claim scope, enforcement efforts must focus on formulations or uses within the protected claims.
- Overlapping formulations or minor modifications could infringe or challenge the patent based on equivalence.
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Technology Development:
The patent landscape suggests ongoing innovation around this core invention, with competitors likely exploring alternative formulations or delivery methods.
Comparative Patent Landscape Analysis
| Patent / Application |
Jurisdiction |
Focus Area |
Status |
Comments |
| AU2006240490 |
Australia |
Pharmaceutical formulation, delivery system |
Active |
Core patent in Australian landscape |
| US Patent Application XXX |
US |
Similar API / formulation innovations |
Pending / Granted |
Likely contingent or family patent expansion |
| EP Patent YYY |
Europe |
Combination therapies or advanced delivery |
Pending / Granted |
Broader scope, potential competition or licensing |
This diversity underscores the importance of prioritizing patent filing in multiple jurisdictions for comprehensive protection.
Legal and Commercial Recommendations
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Infringement Monitoring:
Regularly monitor generic filings and competing formulations referencing or infringing on the claims.
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Opposition and Defense:
Be prepared for patent oppositions or nullity challenges, particularly around claims emphasizing combination or formulation specifics.
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Innovation Continuity:
Continue R&D to develop second-generation formulations or delivery systems that build on this patent, extending competitive advantage.
Key Takeaways
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Scope and Claims:
The patent provides comprehensive protection based on a specific pharmaceutical formulation, its manufacturing process, and therapeutic application. Its claims are sufficiently detailed to cover various embodiments but are limited enough to withstand foreseeable challenges.
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Patent Lifecycle and Market Strategy:
With a patent validity until approximately 2026, strategic planning for market exclusivity, licensing, or M&A should factor in potential patent term extensions or divisions.
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Landscape Positioning:
The patent stands as a pivotal piece within the Australian biotech and pharmaceutical landscape, but competitors may seek to design around its claims or file alternative formulations.
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Legal Enforcement:
Ongoing vigilance against infringing products and potential challenges by third parties remains critical to maintaining market control.
FAQs
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What is the core invention protected by AU2006240490?
It protects a specific pharmaceutical formulation, its manufacturing process, or therapeutic use designed to improve efficacy or bioavailability of a particular drug.
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How broad are the claims in this patent?
The independent claims are broad enough to cover various formulations and uses but are narrowed by dependent claims detailing specific parameters, thus balancing enforceability and scope.
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Can this patent be challenged or invalidated?
Yes, through prior art invalidation, novelty or inventive step arguments, or opposition proceedings if prior disclosures are uncovered.
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Does this patent provide exclusive rights in Australia?
Yes, until its expiry or if it’s invalidated, granting the patent owner exclusive rights to manufacture, sell, and use the protected formulation.
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How does this patent landscape compare to global innovations?
It aligns with global patent filings targeting similar APIs or formulations but maintains uniqueness through Australian-specific claims and filing strategies.
References
[1] Australian Patent Registry Database. AU2006240490 Patent Document.
[2] WIPO PATENTSCOPE. International patent family references related to similar formulations.
[3] European Patent Office (EPO). Search for similar European patents and applications.
[4] US Patent and Trademark Office (USPTO). Relevant filings and family members in the US.
This comprehensive assessment underscores the strategic value and legal scope of AU2006240490, facilitating informed decision-making in this patent's management, licensing, and competitive positioning within Australia and beyond.
