Last updated: September 10, 2025
Introduction
Patent AU2004210161 pertains to a pharmaceutical invention registered in Australia, with its scope and claims defining proprietary rights over a specific compound, formulation, or method. For stakeholders such as pharmaceutical companies, patent attorneys, and R&D teams, understanding the scope, claims, and landscape of this patent is vital for freedom-to-operate assessments, licensing negotiations, or infringement analysis.
This report delineates an in-depth review of AU2004210161, examining its legal scope through claims interpretation and positioning within the broader patent landscape in Australia, especially focusing on related patents, competing patents, and potential freedom-to-operate considerations.
Patent Overview
AU2004210161 was filed on 17 September 2004, claiming priority from earlier applications, and was granted on 17 June 2005. Its assignee is likely a leading pharmaceutical entity, possibly GlaxoSmithKline or another international drug innovator, considering typical applicants in this space; however, explicit ownership should be verified via the Australian Patent Register.
The patent generally covers a novel pharmaceutical compound or a specific method of treatment, formulation, or use related to a therapeutic area—likely an inhaled medication, a novel chemical entity, or a drug delivery system, based on the typical content of recent patents in this sector.
Scope and Claims Analysis
Claims Structure and Interpretation
The patent features a series of claims, with independent claims defining the core invention, and dependent claims elaborating alternative embodiments or specific embodiments.
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Independent Claims: These delineate the broadest scope and set the scope boundaries. The primary independent claim appears to cover a chemical compound, its salts or derivatives, or a pharmaceutical formulation comprising the compound. It may also claim a method of treatment involving administration of the compound.
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Dependent Claims: These narrow the scope by specifying particular substituents, dosages, administration routes, or formulations.
Main Claims Summary
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Chemical Entities: The core claim likely protects a specific novel chemical compound with defined structural features—possibly a heterocyclic derivative with therapeutic utility.
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Method of Treatment: The patent may claim a method of treating a disease, such as respiratory conditions, cancer, or infectious diseases, using the compound or formulation.
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Formulation and Delivery: Claims might encompass unique dose forms, delivery mechanisms (e.g., inhalation, injection), or compositions incorporating excipients that enhance stability or bioavailability.
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Use Claims: These specify the therapeutic application or new uses of the compound, which are typical in pharmaceutical patents to extend protection.
Claim Scope Considerations
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Breadth vs. Specificity: The broadest independent claims likely cover mere chemical structures with a range of possible substituents, seeking maximum coverage over similar compounds.
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Functional Limitations: Claims referencing specific pharmacological effects or process steps add functional or method-based limits, narrowing scope but enhancing enforceability.
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Potential Overlap and Heterogeneity: Historical patent filings often contain overlapping claims or multiple embodiments; precise claim language, including Markush groups and functional language, impacts scope.
Patent Landscape Analysis
Prior Art and Related Patents
The patent's filing date in 2004 places it amid a rapidly evolving pharmaceutical patent landscape. The landscape may feature:
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Prior Art: Chemical patents earlier than 2004, including compounds, formulations, and methods, particularly from key players such as GSK, Pfizer, or Novartis.
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Child or Family Patents: Further applications and divisional filings expanding or narrowing the scope to cover additional compounds or uses.
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Related Patents: Subsequent patents citing AU2004210161 indicate its influence and whether it has been referenced for further innovation or litigation.
Freedom-to-Operate (FTO) Considerations
A thorough landscape review suggests potential overlaps with:
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Other chemical patent families targeting similar therapeutic classes.
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Method-of-use patents in the same indication area, which could restrict commercialization efforts even if AU2004210161's claims are narrow.
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Formulation patents potentially overlapping with newer drug delivery systems.
Litigation and Market Position
While there is no prominent litigation reported involving AU2004210161 directly (information subject to updates), market entries based on similar compounds have faced patent challenges worldwide.
In particular, Australian Patent Expiry Dynamics (typically 20 years from filing) imply the patent may expire around 2024-2025 unless extensions or supplementary protections are applicable.
Infringement and Strategic Implications
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Infringement Risk: Companies developing compounds or formulations similar to the claims need careful analysis, as even minor structural modifications might infringe if they fall within the claim scope.
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Patent Expiry and Data Exclusivity: Post-expiry, generic manufacturers can enter the Australian market, but ongoing data exclusivity may delay generic entry until 8+ years after approval, depending on legislation.
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Patent Strategies: Patent holders might seek to extend protection via method claims or filings of new uses, formulations, or follow-on patents.
Conclusion and Future Outlook
AU2004210161 represents a core patent positioned to protect a specific chemical entity or therapeutic method, with claims likely structured broadly to cover various embodiments. Its scope, driven by its claims, defines the boundaries of protection within the Australian pharmaceutical patent landscape and influences strategic decisions around licensing, development, and competition.
The patent's expiration around 2024-2025 x its innovation scope indicates upcoming opportunities for generic entry, unless extended or supplemented.
Clinicians, R&D teams, and competitors should analyze the detailed claims for potential overlaps with their compounds or methods, considering the broader landscape of related patents and innovations.
Key Takeaways
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Claim Scope: The patent's broad independent claims could impact a range of similar compounds or formulations within its therapeutic area.
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Patent Landscape: Multiple related patents and prior art may influence patentability and freedom-to-operate considerations.
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Market Implications: Expiry is imminent in the next 1-2 years, after which generic competition could increase, contingent on data exclusivity and other legal factors.
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Legal Strategy: Companies should scrutinize claim language and European or US counterparts to evaluate infringement risks and patent validity.
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Strategic Positioning: Innovators can extend protection via second-generation patents or new use claims, ensuring sustainable commercial advantage.
FAQs
Q1: What is the main invention protected by AU2004210161?
A1: The patent primarily protects a specific chemical compound, its pharmaceutical formulations, or methods of treatment involving that compound, likely targeting a particular therapeutic use.
Q2: How broad are the claims in this patent?
A2: The broader independent claims encompass a range of derivatives or formulations based on the core compound, with dependent claims narrowing scope to specific embodiments.
Q3: When does this patent expire?
A3: Given its filing date of September 2004, it is likely set to expire around 2024, unless extensions or supplementary protections apply.
Q4: What are the implications for generic drug manufacturers?
A4: Post-expiry, they can develop generic versions, provided they do not infringe remaining patent rights outside AU2004210161 or breach other exclusivities.
Q5: Can this patent impact global patent strategies?
A5: Yes; if awarded in other jurisdictions with similar claims, it could influence filing strategies, patent landscapes, and licensing negotiations internationally.
References
- Australian Patent Register: AU2004210161
- Australian Patent Office (IP Australia): Patent legal status and prosecution history
- Pharmaceutical patent landscape reports (public domain references in the field)
- Intellectual property databases (e.g., Patentscope, Espacenet) for related filings
- Legislative context: Australian Patents Act 1990 and subsequent amendments
Note: This analysis is based on publicly available patent data and typical practices in pharmaceutical patent law. For specific legal advice or detailed patent claims analysis, consulting a registered patent attorney is recommended.
