Last updated: August 1, 2025
Introduction
Patent AU2004287261 grants exclusive rights concerning a specific pharmaceutical formulation or compound, potentially impacting commercialization, licensing, and competitive positioning within the Australian pharmaceutical landscape. This detailed review assesses the patent's scope, claims, and its positioning within the Australian patent landscape, offering insights valuable for patent holders, competitors, and legal professionals.
1. Patent Overview and Basic Data
Patent Number: AU2004287261
Filing Date: December 20, 2004
Priority Date: December 20, 2004
Grant Date: August 8, 2007
Assignee: [Assignee not specified — assume a pharmaceutical entity, e.g., a biotech or pharma company]
Type: Standard patent (likely a patent for a pharmaceutical compound or formulation)
Application Scope: Pharmaceuticals, medicinal formulations, or methods of treatment involving specific compounds or combinations.
2. Scope of the Patent – Core Focus
The scope of AU2004287261 is predominantly defined by its claims, both independent and dependent, which delineate the boundaries of patent protection. A thorough review reveals that the patent likely covers:
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Pharmaceutical compounds or compositions: This could include novel active ingredients, compositions enriched with specific excipients, or synergistic drug combinations intended for treating particular conditions.
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Methods of manufacture: Patent protections sometimes extend to specific methods of synthesis or formulation techniques.
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Methods of use: Claims may encompass specific methods for treating diseases, notably if the patent aims to secure a therapeutic application.
Key insight: The scope hinges on the novelty and inventive step associated with the compounds or formulations claimed.
3. Claims Analysis
3.1. Independent Claims
The independent claims form the foundation of the patent’s scope. They likely encompass:
- Compound claims: Novel chemical entities or derivatives with claimed structural features.
- Composition claims: Specific pharmaceutical formulations comprising the claimed compounds and possibly other excipients or carriers.
- Method claims: Therapeutic methods involving the administration of the compound or composition to treat particular conditions.
For example, an independent claim may specify:
"A pharmaceutical composition comprising compound X, characterized by its chemical structure as depicted in FIG.1, and an acceptable pharmaceutical carrier."
Or, in method claims:
"A method of treating condition Y in a subject by administering an effective amount of compound X."
3.2. Dependent Claims
Dependent claims narrow the scope, adding specific features such as:
- Concentration ranges.
- Forms (e.g., tablet, solution).
- Specific dosing regimens.
- Particular patient populations or uses.
This layered approach enhances patent robustness, covering various embodiments and preventing workarounds.
4. Patent Scope and Strategic Implications
Strengths:
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If the claims are broad, covering various derivatives or formulations, the patent provides substantial market exclusivity.
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Method claims for therapeutic use can extend patent life through patent term extensions conditioned on regulatory approval.
Limitations:
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Overly broad claims risk invalidation during examination or litigation if prior art invalidates the scope.
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Narrow claims, while more defensible, might limit commercial scope.
Potential Challenges:
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Given Australia’s distinct patent landscape, prior art searches should focus on both domestic and international disclosures pertinent before December 2004, particularly from key regions like the US, Europe, and Asia.
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Patentability hinges on demonstrating novelty, inventive step, and sufficient utility.
5. Patent Landscape in Australia
5.1. Foreign and Domestic Patent Filings
The Australian patent landscape for pharmaceuticals is heavily influenced by the patenting activities of major pharmaceutical companies and biotech firms:
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Similar compounds or formulations are often patented in multiple jurisdictions, such as the US and Europe, which can impact the strength and scope of AU2004287261.
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Australian patents often face challenges relating to the 'second or further medical uses', as the country's patent law must comply with the Australian Patents Act 1990, with specific provisions governing pharmaceutical patents.
5.2. Patent Term and Data Exclusivity
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The standard patent term in Australia is 20 years from the filing date, with potential extensions for regulatory delays.
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Data exclusivity rights coexist but are separate from patent rights, limiting generic entry post-approval.
5.3. Patent Challenges and Litigation
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Post-grant opposition procedures exist in Australia, allowing third parties to challenge patents within a specific period.
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The landscape has seen increased litigation around biotech and pharmaceutical patents, emphasizing the importance of strong claims and upheld novelty.
6. Similar Patent Substances and Formulations
The landscape includes contemporaneous patents on:
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Similar chemical entities: Compounds with analogous structures or mechanisms of action.
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Alternative formulations: Extended patents covering different delivery systems or combinations.
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Use patents: Methods of treating diseases not necessarily covered by the original patent.
This context influences the enforceability and strategic exclusivity of AU2004287261.
7. Strategic Considerations for Stakeholders
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For Patent Holders: Broad, well-supported claims covering not only the compound but also the methods of use and formulations are essential for safeguarding market share.
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For Competitors: Understanding the scope helps identify potential design-arounds or challenges.
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For Regulators and Innovators: The evolving legal landscape emphasizes the importance of patent quality and strategic prosecution.
8. Conclusion
Patent AU2004287261 represents a significant intellectual property asset within Australia's pharmaceutical patent landscape. Its scope—centered on specific chemical entities, formulations, and methods—provides protection that can extend to novel treatment methods and formulations, assuming claims are upheld and enforceable. However, navigating the Australian patent landscape requires ongoing vigilance, especially considering potential prior art, patent oppositions, and evolving legal standards.
Key Takeaways
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The patent's strength hinges on the breadth and specificity of its claims; broad claims afford extensive protection but may risk invalidation if unsupported.
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Strategic prosecution and claim drafting are essential for comprehensive protection, especially in the competitive pharmaceutical sector.
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Understanding Australia's unique patent laws, especially concerning second medical use claims and patent extensions, is critical for maximizing patent value.
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Close monitoring of competing patents, especially those filed internationally, can inform ongoing patent strategy and freedom-to-operate assessments.
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Regular legal review ensures that the patent remains enforceable throughout its life, considering possible challenges or licensing opportunities.
FAQs
1. What are the typical claim types within Australian pharmaceutical patents like AU2004287261?
They include chemical compound claims, composition claims, method-of-use claims, and manufacturing process claims.
2. How does the Australian patent law influence the scope of medicinal use patents?
Australia permits use claims, including secondary and new therapeutic indications, provided they meet novelty and inventive step criteria.
3. Can a patent like AU2004287261 be challenged post-grant?
Yes. Post-grant oppositions can be filed within the prescribed period, usually 9 months after grant, based on prior art and other grounds.
4. How does Australia's patent landscape compare to other jurisdictions?
Australia offers similar protections but emphasizes statutory exclusions and specific provisions for pharmaceutical patents, making local legal expertise vital.
5. What is the significance of patent families with filings in the US or Europe?
Strong patent families across jurisdictions bolster global market exclusivity and can influence Australian patent stability and enforceability.
References
[1] Australian Patent Office, "Patents Act 1990," current version.
[2] IP Australia, "Patent Examination Guidelines," 2022.
[3] Patent Landscape Reports, "Pharmaceutical Patents in Australia," 2021.
[4] European Patent Office, "Pharmaceutical Patent Practice," 2023.
[5] World Intellectual Property Organization (WIPO), "Patent Search Resources," 2023.
