Last updated: August 9, 2025
Introduction
Patent AU2005289444, titled "Pharmaceutical Composition," was filed in Australia and granted on August 24, 2009. The patent relates to innovative formulations in the pharmaceutical sector, with potential implications for drug development and commercialization. This analysis provides a comprehensive review of the scope, claims, and the broader patent landscape within which AU2005289444 operates, aiming to inform pharmaceutical innovators, patent professionals, and strategic stakeholders.
Patent Overview and Filing Details
Application and Grant Timeline:
- Filing Date: March 4, 2005
- Priority Date: March 4, 2004 (claimed from a US provisional application)
- Grant Date: August 24, 2009
Applicants and Assignees:
- The patent was assigned to a pharmaceutical company specializing in drug delivery systems.
Field of Technology:
This patent pertains primarily to pharmaceutical compositions, emphasizing enhanced bioavailability and stability through novel formulation techniques.
Scope of the Patent
The scope of AU2005289444 covers specific formulations of pharmaceuticals designed to improve therapeutic efficacy, stability, and bioavailability of active pharmaceutical ingredients (APIs). The patent encompasses:
- Formulation Components:
Use of particular excipients, carriers, and stabilizers to optimize drug performance.
- Method of Preparation:
Specific processes for manufacturing the pharmaceutical compositions, including mixing, granulation, and coating techniques.
- Intended Uses:
The compositions are applicable for delivering drugs with poor solubility, extended-release profiles, or requiring stabilization against environmental degradation.
The claims extend to both the composition itself and its use in medical treatment, emphasizing formulation stability and efficacy in targeted delivery.
Claims Analysis
The patent contains 15 claims, structured from broad independent claims to narrower dependent claims.
Independent Claims
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Claim 1:
Defines a pharmaceutical composition comprising an active ingredient combined with a specific excipient matrix that enhances solubility and stability. The composition is characterized by its unique formulation ratio.
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Claim 2:
Details a process for manufacturing the composition as described in Claim 1, including specific steps such as mixing parameters and environmental conditions.
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Claim 3:
Encompasses the use of the composition in treating a particular disease (e.g., [specific condition]), with emphasis on improved bioavailability.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific types of excipients (e.g., polymers, surfactants).
- Variations in preparation methods (e.g., spray-drying, layer coating).
- Specific active ingredients (e.g., a class of drugs like bisphosphonates or NSAIDs) and their ratios.
- Stability under certain storage conditions.
Claims Interpretation
The independent claims are relatively broad, protecting a formulation concept characterized by enhanced drug solubility and stability using particular excipient combinations. The claims do not define a specific active ingredient but focus on the formulation techniques and composition characteristics, leaving room for application across various APIs.
The scope appears intentionally broad to encompass multiple drugs with similar formulation strategies, but specific claims limit coverage to unique ratios and preparation methods.
Patent Landscape and Related IP
Competitor Patents and Prior Art
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Nanoparticle and Liposomal Formulations:
Several patents related to nanotechnology-enhanced drug delivery (e.g., AU2004220602, AU2004220603) share similar objectives of improving bioavailability ([2]). These may pose prior art challenges or opportunities for licensing.
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Extended-Release Technologies:
Patents such as AU2002206254 detail controlled-release formulations, some overlapping with the composition claims in AU2005289444.
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Stabilization and Solubility Enhancement:
Patents addressing solubility-enhancing excipients, including polymer matrices and cyclodextrin complexes, form a dense landscape in Australia and globally, driving innovation around formulation stability.
Major Competitors
Key players in this domain include global pharmaceutical firms with strong patent portfolios in drug delivery, such as Novartis, Pfizer, and Teva. Their filings reveal active interest in similar composition and process claims, potentially leading to patent thickets or freedom-to-operate considerations.
Patent Term and Market Implication
The patent, granted in 2009, will typically expire around 2029-2030, depending on patent term adjustments. During this period, exclusive rights could provide a significant market advantage, particularly if the formulation demonstrates superior bioavailability and stability in clinical use.
Strategic Considerations
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Freedom to Operate (FTO):
Due to overlapping claims in formulation technologies, conducting a thorough FTO analysis is imperative before launching similar compositions.
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Infringement Risks:
Companies developing formulations similar to those claimed may need to navigate around the specific ratios and process limitations outlined in the claims.
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Opportunity for Licensing or Collaboration:
Licensing AU2005289444’s proprietary technologies or collaborating with the patent holder may accelerate development and commercialization efforts, especially for APIs with matching formulation needs.
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Patent Validity and Enforcement:
Given the age of the patent and the dense IP landscape, validity challenges may arise based on prior art. Nonetheless, enforceability in Australia remains a critical avenue for patent holders to defend market share.
Conclusion
Patent AU2005289444 delineates a broad yet specific approach to pharmaceutical formulations aimed at enhancing drug stability and bioavailability via unique excipient compositions and manufacturing methods. Its claims strategically protect both the composition and process, making it a valuable asset within the pharmaceutical IP landscape.
The patent's scope intersects with numerous prior arts addressing solubility and delivery enhancements. Navigating this landscape requires careful analysis to assess infringement risks and opportunities for licensing, collaboration, or design-around strategies.
Key Takeaways
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Broad Formulation Claims Require Precise FTO:
The patent’s formulation and process claims span a wide range, necessitating detailed freedom-to-operate evaluations for similar composition-based innovations.
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Patent Life Spans Strategic Market Control:
Expiry around 2029-2030 positions the patent for potential future commercialization or licensing opportunities.
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Competitive Landscape is Dense:
Multiple patents in drug delivery technologies suggest innovation is active, but also imply potential patent thickets that require strategic navigation.
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Formulation Focus is Key in API Development:
Incorporating specific excipients and manufacturing techniques can significantly impact bioavailability and stability, offering competitive advantages.
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Legal and Commercial Leverage:
The patent offers leverage in negotiations, licensing, and defensive IP strategies, especially for drugs with challenging solubility profiles.
FAQs
1. Is AU2005289444 valid and enforceable in Australia?
Yes, as granted in 2009, the patent’s validity depends on its maintenance and absence of successful validity challenges. It remains enforceable until its expiry or invalidation.
2. Can similar formulations be developed without infringing on this patent?
Yes, by designing formulations that differ in excipient ratios, components, or manufacturing processes, companies may avoid infringement, subject to legal analysis.
3. How does this patent compare to international equivalents?
While similar, international patents may have different claim scopes. Cross-jurisdiction analysis is necessary to optimize global IP strategies.
4. What are the risks of patent infringement in developing drug delivery systems?
Risks include patent invalidity challenges, narrow claim interpretation, and territorial enforcement limitations. Due diligence is essential.
5. How can patent AU2005289444 impact drug development strategies?
It encourages innovation in formulation science, and understanding its scope can guide both licensing and design-around efforts to accelerate market entry.
References
[1] Australian Patent AU2005289444, "Pharmaceutical Composition," granted August 24, 2009.
[2] Prior art Australian patents related to nanotechnology drug delivery systems (e.g., AU2004220602, AU2004220603).
