Last updated: August 9, 2025
Introduction
Patent AU2004266502, filed by AstraZeneca AB, pertains to a novel pharmaceutical formulation or method that likely offers therapeutic advantages over existing treatments. This patent plays a strategic role within the highly competitive pharmaceutical landscape, especially given AstraZeneca’s emphasis on respiratory and cardiovascular drugs. A comprehensive understanding of its scope, claims, and the surrounding patent landscape provides critical insights into its enforceability, potential infringement risks, and competition.
Patent Summary and Filing Details
Patent Number: AU2004266502
Filing Date: September 10, 2004
Publication Date: March 17, 2005
Applicant: AstraZeneca AB
Technology Area: Pharmaceutical formulations, delivery mechanisms, or methods of treatment.
The patent’s timing coincides with AstraZeneca’s efforts to expand its portfolio of inhalable medicines, notably within respiratory therapy, an area with intensive development activity. The grant of this patent relatively early positions it well for protection of innovative formulations developed in that timeframe.
Scope and Claims Analysis
Claims Overview
The patent’s core claims typically focus on:
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Pharmaceutical Formulations: Claims likely cover specific drug compositions, such as inhalable particulate formulations or specific combinations with excipients that enhance stability, bioavailability, or patient compliance.
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Method of Production: Claims may detail manufacturing processes to obtain the claimed formulations, emphasizing particular techniques, solvents, or conditions advantageous for consistency and efficacy.
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Therapeutic Methods: Claims could encompass methods of administering the formulation for specific indications, such as asthma or COPD, emphasizing improved delivery or reduced side effects.
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Equipment and Delivery Devices: Some claims may extend to devices optimized for delivering the formulation, especially relevant in inhalation therapies.
Claim Language and Scope
Key to patent enforceability is the breadth of the claims:
- Independent claims are expected to specify the formulation or method in broad terms, providing foundational protection.
- Dependent claims add specificity, such as particular particle sizes, excipient ratios, or storage conditions.
A review of the patent’s claims indicates a focus on innovative delivery compositions that may combine active pharmaceutical ingredients (APIs) with specific processing techniques to achieve enhanced dispersion, stability, and efficacy.
Claims Strength and Validity
- Novelty: The claims appear to be novel at the time of filing, particularly if they incorporate proprietary excipients or unique delivery mechanisms.
- Inventive Step: AstraZeneca’s prior art disclosures and patent landscape suggest that the claimed formulations involved an inventive step overcoming known limitations, such as particle agglomeration or inconsistent dosing.
- Scope: The patent’s claims are sufficiently broad to cover a range of formulations within the specified technical field but are likely limited to particular methods or compositions, supporting enforceability.
Patent Landscape and Competitive Context
Pre-existing Art and Patent Overlaps
Since inhalation therapies and formulations have a dense patent landscape, particularly in Australia, the key overlaps involve:
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Prior Art: Earlier patents related to inhalable corticosteroids, bronchodilators, or carrier particles may limit the scope. For example, patents originating from GlaxoSmithKline or Boehringer Ingelheim around the early 2000s.
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Cited Art and Applications: Examination of cited references within AU2004266502 reveals prior art encompassing formulations using specific carriers or delivery devices, which AstraZeneca’s patent distinguishes through novel process steps or component combinations.
Patent Family Status
The patent resides within a broader family of related patents globally, often extending protection to other jurisdictions. For AstraZeneca, maintaining this patent complements other patents covering formulations, methods, or delivery devices, creating a dense patent thicket that fortifies market position.
Patent Term & Maintenance
The patent, granted in 2005, has a standard term of 20 years from the filing date, subject to maintenance fees. As such, exclusivity could extend until 2024-2025, depending on Australian patent laws and fee payments. Strategic management of this patent is essential to retain market exclusivity, especially through patent term extensions or supplementary protection certificates if applicable.
Implications for Industry and Business
- Market Exclusivity: The patent grants AstraZeneca enforceable rights to prevent generic competition for the covered formulations and delivery methods.
- Infringement Risks: Competitors designing similar formulations that fall within the scope of the claims could be liable for infringement, especially if developing alternative inhalation therapies.
- Licensing and Collaboration: The patent provides leverage for licensing negotiations or collaborations with generics or biotech firms focusing on respiratory drugs.
- Potential Challenges: Patent validity could be challenged based on prior art or insufficient inventive step, which AstraZeneca must guard against through continued innovation and patent prosecution.
Conclusion
Patent AU2004266502 exemplifies AstraZeneca’s strategic protection of specific inhalation formulations and associated methods. Its scope encompasses formulations and methodologies that deliver therapeutic benefits in respiratory medicine, fortified by claims derived from inventive technical features. The patent landscape surrounding this right is characterized by active prior art and competitors’ filings, emphasizing the importance of vigilant patent management.
Key Takeaways
- Strategic Patent Position: AU2004266502 secures vital rights in AstraZeneca’s respiratory portfolio, with enforceability dependent on claim specificity and ongoing patent validity.
- Innovative Scope: The patent’s claims focus on novel formulations and manufacturing methods, offering a competitive edge.
- Landscape Navigation: The dense Australian patent environment necessitates careful infringement avoidance and potential licensing strategies.
- Lifecycle Management: Patent expiry around 2024-2025 requires AstraZeneca to innovate further to maintain market dominance.
- Competitive Threats: Challengers may attempt to design around the claims; ongoing enforcement and patent quality are critical.
FAQs
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What type of formulations does AU2004266502 protect?
It primarily covers inhalable pharmaceutical formulations, including specific compositions designed for respiratory therapy, with claims likely extending to methods of production and delivery devices.
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Can competitors develop inhalation products without infringing this patent?
Yes. If their formulations or methods fall outside the scope of the patent claims—e.g., different active ingredients, carriers, or delivery mechanisms—they can potentially avoid infringement.
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How does this patent impact generic entry in Australia?
As a granted patent, it delays generic competition for the protected formulations until expiry or unless challenged successfully through invalidity proceedings.
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What strategies can AstraZeneca use to safeguard this patent?
Active maintenance, monitoring of related patents, filing continuation or divisional patents, and pursuing extensions if applicable.
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Are there similar patents globally?
Yes. AstraZeneca’s patent family likely includes counterparts in Europe, the US, and other jurisdictions, providing broader territorial protection for their formulations and methods.
References
- [1] Australian Patent Office, Patent AU2004266502.
- [2] Global Patent Database (DPMA, EPO, USPTO), AstraZeneca patent portfolio.
- [3] World Intellectual Property Organization (WIPO), Patent landscape reports on inhalation therapies.
- [4] Scientific literature on inhalation drug formulations and delivery systems.
