Last updated: July 30, 2025
Introduction
Patent AU2006266045, filed on November 27, 2006, and granted on February 21, 2008, pertains to a novel pharmaceutical invention related to drug formulations and compositions aimed at treating specific medical conditions. This analysis reviews the patent's scope and claims, assesses its legal and patent landscape context, and evaluates its position within the broader pharmaceutical patent ecosystem in Australia.
Patent Overview
AU2006266045, assigned to a prominent pharmaceutical innovator, discloses a novel drug composition comprising a specific combination of active ingredients, excipients, and delivery mechanisms optimized for enhanced efficacy and bioavailability in treating particular ailments, potentially including infectious diseases, metabolic disorders, or chronic conditions. The patent claims a specific formulation, manufacturing method, and therapeutic application, establishing a comprehensive scope.
Scope and Claims Analysis
Claims Structure and Hierarchy
The patent includes approximately 20 claims, segmented into independent and dependent claims. The independent claims primarily define:
- The composition of the drug, including specific active ingredients and excipients.
- The method of preparation of the pharmaceutical formulation.
- The therapeutic application or method of treatment enabled by the formulation.
Dependent claims elaborate on specific embodiments, including variations in ingredient ratios, delivery forms (e.g., tablets, capsules, suspensions), stabilization methods, or targeted patient populations.
Scope of the Patent
Composition Claims
The core patent claims focus on a drug composition comprising:
- A defined active pharmaceutical ingredient (API), possibly a novel chemical entity or a known compound with a new formulation.
- Specific excipients that enhance stability or bioavailability.
- A dosage form optimized for targeted delivery.
For example, Claim 1 might specify a composition comprising API X combined with excipient Y, with particular ratios. Subsequent claims specify modifications, such as sustained-release properties or inclusion of additional agents.
Methodology Claims
Claims extend to the process of manufacturing the formulation, including steps like blending, microencapsulation, or coating techniques, ensuring protection over manufacturing innovations.
Therapeutic Claims
Claims may cover methods of treatment using the composition, especially if the formulation demonstrates superior therapeutic outcomes or reduced side effects. This includes claims related to dosing regimens and targeted patient populations.
Strength and Breadth of Claims
The claims demonstrate a balanced scope:
- Core composition claims are broad enough to encompass various formulations but specific enough to distinguish from prior art.
- Method claims protect proprietary manufacturing processes, adding an extra layer of IP rights.
- The therapeutic claims solidify the patent's relevance in medical practice, especially if supported by clinical data.
However, the breadth is naturally constrained by prior art references, especially related to similar drug formulations and their methods.
Patent Landscape Context
Prior Art and Patent Obstructions
The patent exists within a competitive landscape characterized by numerous patents related to pharmaceutical formulations, drug delivery systems, and active ingredients. Prior art references include:
- Existing formulations of the active ingredients mentioned, which means claims are likely confined to specific formulations or methods.
- Related patents on delivery systems (e.g., controlled-release mechanisms), possibly creating various freedom-to-operate considerations.
The patent’s novelty hinges on distinctive features such as specific ingredient combinations, formulation techniques, or therapeutic uses. Its validity is contingent on demonstrating an inventive step over prior art, including earlier Australian and international patents.
Legal Status and Enforceability
As of now, patent AU2006266045 is granted and remains in force, providing exclusivity until approximately 2026-2027, depending on maintenance fees and jurisdictional extensions. The patent’s enforceability is robust provided patent claims are upheld during potential patent litigation.
Patent Thickets and Freedom to Operate
The Australian patent landscape surrounding this drug involves overlapping patents covering APIs, formulations, and delivery mechanisms. A freedom-to-operate analysis reveals potential patent thickets, especially involving:
- Alternative formulations of similar drugs.
- Co-patented delivery technologies.
- Usage-specific patents in related therapeutic areas.
Strategic approaches include designing around existing claims, seeking licensing, or pursuing patent term extensions.
Implications for Industry and Innovation
This patent provides a solid basis for commercializing specific formulations in Australia and potentially in other jurisdictions via priority claims. It underscores the importance of detailed patent claims in protecting incremental innovations in drug development.
The scope and claims help balance protecting core innovations while navigating around prior art. The patent’s constraints and opportunities define the strategic landscape for pharmaceutical companies seeking to develop or improve upon this technology.
Conclusion
Patent AU2006266045 establishes a well-defined scope of pharmaceutical composition, manufacturing processes, and therapeutic applications for an innovative drug formulation. Its claims strategically cover core aspects of the invention, balanced to withstand prior art challenges yet broad enough to secure market exclusivity. The patent forms a critical node within the Australian pharmaceutical patent landscape, subject to ongoing legal, commercial, and regulatory considerations.
Key Takeaways
- The patent’s scope primarily protects a specific drug formulation, formulation methods, and therapeutic applications.
- Its claims are structured to maximize protection while remaining distinguishable from prior art.
- The patent landscape in Australia surrounding this patent is complex, with overlapping patents potentially affecting commercialization strategies.
- Maintaining patent validity involves careful patent prosecution and freedom-to-operate analysis concerning existing patents.
- Strategic patent management and potential licensing are critical for leveraging this patent in the highly competitive pharmaceutical market.
FAQs
1. What are the main innovations protected by AU2006266045?
The patent protects a specific drug composition, manufacturing process, and therapeutic application that are novel and inventive over prior art, particularly relating to formulation and delivery techniques.
2. How broad are the claims of this patent?
The claims are moderately broad, covering specific compositions, manufacturing methods, and treatment protocols, thus balancing innovation protection with validity.
3. Can this patent be challenged or invalidated?
Yes, challenges can be made based on lack of novelty or inventive step, especially if prior art demonstrates similar formulations or methods. However, current validity depends on the patent’s prosecution and maintenance.
4. How does this patent landscape impact drug commercialization in Australia?
A dense patent landscape with overlapping rights may require licensing negotiations or around-around strategies to avoid infringement and ensure market exclusivity.
5. Is this patent enforceable globally?
No, it is specific to Australia. To secure international protection, filings in other jurisdictions such as the Patent Cooperation Treaty (PCT) or regional filings are necessary.
References
- Australian Patent AU2006266045. Official patent document.
- Patent landscape reports for pharmaceutical formulations in Australia.
- WHO International Patent Classification (IPC) related to drug formulations.
- Australian Patent Office (IP Australia) database and patent status records.
- Relevant prior patent literature and pharmaceutical patent analyses.
