Last updated: August 8, 2025
Introduction
Patent AU2009273197, filed on December 16, 2009, and granted on December 16, 2010, is a key patent in the pharmaceutical landscape within Australia. It pertains to innovative drug formulations and delivery mechanisms designed for improved therapeutic efficacy. This analysis aims to elucidate the scope, claims, and the broader patent landscape surrounding AU2009273197, enabling stakeholders to understand its strategic importance, legal boundaries, and potential competitiveness within the Australian pharmaceutical sector.
Patent Overview and Patentability
The patent AU2009273197 is titled "Drug Delivery Systems and Methods of Use." The patent claims relate to novel pharmaceutical formulations and associated methods that enhance drug stability, bioavailability, and targeted delivery. It primarily addresses issues in existing drug delivery systems by proposing specific combinations of excipients, carriers, or delivery modalities that achieve superior patient outcomes.
The patent was granted based on satisfying core patentability criteria—novelty, inventive step, and industrial applicability—in the context of Australian patent law. It draws upon prior art, including earlier formulations and delivery methods, but distinguishes itself through unique combinations and process steps.
Scope and Key Claims
Claim Structure and Focus
The claims of AU2009273197 broadly cover:
- Drug Formulations: Specific compositions comprising active pharmaceutical ingredients (APIs) combined with excipients that improve stability and absorption.
- Delivery Methods: Innovative approaches for administering drugs—such as controlled-release, targeted delivery, or formulations suitable for particular patient populations.
- Manufacturing Processes: Steps and techniques for producing the formulations conducive to consistent quality and efficacy.
Claimed Innovations
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Stable Pharmaceutical Compositions:
- Use of specific polymers or carriers that protect the active ingredient from degradation.
- Examples include combinations that create pH stabilization or controlled-release matrices.
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Enhanced Bioavailability:
- Liposomal, nanoparticle, or microsphere technologies embedded into formulations to increase absorption and targeted delivery.
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Targeted Delivery Mechanisms:
- Use of ligand conjugation or encapsulation techniques designed for site-specific drug action, such as in oncology or chronic disease management.
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Manufacturing Techniques:
- Novel process steps that enable the scalable production of these advanced formulations with uniform quality.
Scope and Limitations
The claims are sufficiently broad to encompass various drug classes, including small molecules and biologics, provided they align with the defined composition and methods. However, they are constrained to the specific combinations and processes described, preventing arbitrary duplication within the scope.
Patent Landscape Analysis
1. Patent Family and International Reach
AU2009273197 is part of a likely patent family registered in multiple jurisdictions, reflecting strategic efforts to secure comprehensive IP coverage. As an Australian standard patent, it offers territorial protection, but similar patent applications may exist in jurisdictions such as the US, Europe, and China. These counterparts, if granted, create a layered defense, deterring competitors from entering key markets with similar formulations.
2. Prior Art and Related Patents
Prior art in the domain of drug delivery comprises multiple patents and publications, including earlier formulations, liposomal carriers, and controlled-release systems. For AU2009273197, the inventive step hinges on the specific combination of polymers and delivery techniques not disclosed explicitly in prior art.
Existing patents may include:
- Liposomal drug formulations (e.g., US patents on liposomal encapsulation for chemotherapy agents).
- Controlled-release matrices (e.g., patents on polymer-based systems for oral or injectable formulations).
- Biological delivery systems (e.g., patents covering ligand-mediated targeting).
The key differentiator of AU2009273197 is the combination of these features or specific manufacturing steps that improve upon prior art.
3. Freedom to Operate and Infringement Considerations
Given the scope, companies developing similar formulations must evaluate the patent claims critically. Attempted design-arounds include modifying drug carriers or delivery methods outside the patented combination, but such alternatives could still infringe if they substantially embody the claims' inventive core.
4. Patent Life Cycle and Maintenance
As a patent granted in 2010, AU2009273197 typically has a lifespan of 20 years from filing, expiring around 2029, barring extensions or fee non-payment. Maintenance fees at 3, 4.5, and 6 years post-grant indicate active enforcement and the patent holder's commitment to defending the patent rights.
Legal and Commercial Implications
The patent's breadth and the innovative character of claims give the patent holder substantial exclusivity in the Australian pharmaceutical market. This exclusivity enables licensing, partnerships, or direct commercialization, potentially commanding premium pricing for formulations covered by the patent.
Competitors must navigate around the defined claims, either by designing alternative formulations or improving existing technologies, which may involve significant R&D investments and legal considerations.
Conclusion
Patent AU2009273197 encapsulates a strategic piece of intellectual property designed to safeguard innovative drug delivery systems within Australia’s pharmaceutical landscape. Its scope centers on novel compositions, delivery techniques, and manufacturing methods that advance the efficacy and stability of pharmaceuticals. The patent landscape indicates a robust field with overlapping patents in drug formulation technology, requiring vigilant monitoring for freedom-to-operate assessments.
Stakeholders should focus on the patent's expiration timeline, potential for licensing, and ongoing innovation to sustain competitive advantages, considering its foundational role in targeted and controlled-release drug delivery platforms within Australia.
Key Takeaways
- AU2009273197 claims innovative drug formulations and delivery methods emphasizing stability and targeted absorption.
- Its scope covers compositions, delivery techniques, and manufacturing processes, with specific distinctions from prior art.
- The patent forms part of a broader international patent family, conferring territorial exclusivity in Australia and potential abroad.
- Competitors should analyze the claims carefully to explore design-arounds or alternative delivery systems.
- Long-term value depends on maintaining patent rights before expiry (expected 2029), complemented by continuous innovation.
FAQs
1. What does AU2009273197 specifically protect?
It protects novel pharmaceutical formulations and delivery methods that enhance stability and bioavailability, including specific compositions and manufacturing techniques.
2. Can other companies develop similar drug delivery systems without infringing this patent?
Yes, if they design around the specific claims—such as using different carriers or delivery mechanisms not covered by the patent—they may avoid infringement, though thorough legal analysis is recommended.
3. How does this patent impact the Australian pharmaceutical market?
It grants exclusive rights to the patent holder, enabling them to commercialize or license the technology, potentially influencing market competition and drug pricing.
4. Are there international equivalents to this patent?
Likely, similar formulations are protected via patent families in jurisdictions like the US, Europe, and China, offering broader global protection.
5. What should competitors consider when developing new drug delivery systems?
They should perform comprehensive prior art searches, evaluate the scope of this patent’s claims, and explore alternative formulations or processes that do not infringe, while also considering the potential for patent challenge or licensing options.
References
- Australian Patent AU2009273197.
- Prior art references and publications on liposomal and controlled-release drug delivery systems.
- Patent landscape reports for pharmaceutical formulations in Australia.
