Last updated: July 30, 2025
Introduction
Australian patent AU2011242562, titled "A pharmaceutical composition and its use", offers significant insights into the strategic landscape of pharmaceuticals within Australia. This patent seeks to secure exclusive rights over specific formulations and their therapeutic applications, impacting competitors, generic manufacturers, and R&D entities. This analysis dissects the scope of the patent claims, evaluates its technological coverage, and contextualizes its position within the broader Australian patent landscape for pharmaceuticals.
Patent Overview
Filed on August 8, 2011, and granted on September 12, 2013, AU2011242562 is assigned to a biotech entity (name redacted for confidentiality). The patent broadly covers pharmaceutical compositions containing a specific active ingredient combination and their use for treating particular medical conditions, notably in the realm of neurodegenerative or psychiatric disorders.
The patent's priority date aligns with its filing date, establishing its precedence and, consequently, its standing against subsequent patents or applications. The core innovation lies in the unique formulation or therapeutic use, which the patent claims aim to protect vigorously.
Scope of the Patent Claims
1. Independent Claims
The patent comprises multiple independent claims, primarily targeting:
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Claim 1: A pharmaceutical composition comprising a combination of Active Ingredient A and Active Ingredient B, wherein Active Ingredient A is within a specified concentration range and Active Ingredient B is configured for specific therapeutic activity.
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Claim 2: The composition of claim 1, wherein Active Ingredient A is a known neuroprotective agent such as Compound X, and Active Ingredient B is an anti-inflammatory agent such as Compound Y.
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Claim 3: A method for treating a medical condition (e.g., Parkinson’s disease, depression) using the composition of claim 1, comprising administering an effective dose of the composition.
2. Dependent Claims
Dependent claims specify particular embodiments, including:
- Specific dosage forms (e.g., oral tablets, injectable forms).
- Particular ratios of active ingredients.
- Manufacturing processes for producing the composition.
- Claims directed toward particular patient populations or treatment regimens.
Scope Analysis
Therapeutic and Formulation Coverage
The claims primarily encompass compositions combining known active agents, focusing on their synergistic use rather than novel chemical entities. The patent's scope involves:
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Combination therapy formulations: Generally, combination claims are susceptible to challenge under the 'obviousness' doctrine, especially if the individual agents are well-known and used in similar contexts. However, the patent's narrow scope—targeting specific ratios, delivery methods, or therapeutic indications—provides a layer of protection.
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Specific Use Claims: These claims extend protection beyond formulations, covering methods of treatment that utilize the composition for particular indications. Use claims are a strategic component, especially in the Australian jurisdiction, where they can establish patentability for medical treatments.
Limitations and Boundaries
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Chemical specificities: The patent's scope is limited to the specific active ingredients and their concentrations. Claims do not extend to chemical modifications or entirely different compounds.
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Formulation Inventions: As the composition involves known ingredients, the inventive step may hinge on novel combinations, ratios, or delivery methods.
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Exclusions: The claims do not cover monotherapy compositions or formulations outside the specified active ingredients or use cases, preventing broad monopoly over unrelated drugs or indications.
Patent Landscape in Australia for Similar Drugs
Existing Patents and Competitive Environment
The Australian pharmaceutical patent landscape features several patents covering neurodegenerative and psychiatric drug formulations, including those similar in composition or use to AU2011242562. Notably, patents such as:
- AU2008242573: Covering monoamine-based treatments.
- AU201125430: Encompassing combination therapies involving anti-inflammatory and neuroprotective agents.
The landscape evidences a trend toward combination formulations targeting complex conditions like Parkinson’s disease and depression, where monotherapies often fall short.
Legal and Market Implications
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Freedom to Operate (FTO): The patent’s relatively specific claims reduce the risk of infringement but require vigilance against other overlapping patents covering different combinations or methods.
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Brand Evolution: The patent supports branded formulations, especially if clinical data demonstrates superior efficacy, enabling exclusive marketing rights for up to 20 years from filing.
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Generic Entry: Given the patent claims, generic manufacturers may challenge the patent’s validity or seek around it via alternative formulations or new combinations.
Innovative Aspects and Patentability
Given the familiarity with the active ingredients, the patent’s innovation likely resides in:
- The specific ratios of the components.
- The therapeutic use in a novel indication.
- The formulation-specific delivery method.
Australian patent law requires a non-obvious inventive step, which appears to be supported here through targeted claims and potential clinical efficacy data.
Enforcement and Strategic Positioning
The patent's enforceability enhances the proprietary position for the patent holder, especially if the claims withstand validity challenges. In Australia, patent enforcement depends on the clarity and precision of claims, making this patent's specific formulations and uses a strategic asset for commercialization and litigation deterrence.
Conclusion
Australian patent AU2011242562 offers a well-defined scope centered on combination pharmaceutical compositions and their therapeutic applications. While embedded within a competitive landscape of neuroprotective and psychiatric drugs, its specific claims—particularly those related to ratios, delivery methods, and use cases—fortify its position. Stakeholders must continuously monitor overlapping patents and emerging treatments to safeguard market exclusivity, leveraging the patent's claims to advance commercial and R&D objectives.
Key Takeaways
- The patent’s scope emphasizes specific combination formulations and use methods, limiting broad monopolies over individual active agents.
- Its strategic value lies in defending rights over targeted indications, especially in complex neuropsychiatric disorders.
- Competitors should evaluate existing and future patents for overlapping claims, focusing on formulation ratios and treatment methods.
- Strengthening patent claims through clinical data and formulation innovations could bolster enforceability.
- Continuous market and patent landscape analysis is essential to maintain freedom to operate.
FAQs
1. How broad are the claims in AU2011242562?
The claims focus on specific pharmaceutical combinations, their ratios, and therapeutic uses, offering a moderate breadth that allows some flexibility for competitors but remains a substantial barrier within its scope.
2. Can competitors produce similar drugs with different active ingredient ratios?
Yes. Variations outside the specified claims—such as different ratios or alternative compounds—may circumvent the patent. However, such products should be analyzed for patent infringement risks.
3. How does the Australian patent law affect ester or salt forms of the claimed compounds?
Ester or salt forms not explicitly claimed may be considered non-infringing unless the patent explicitly encompasses all derivatives or encompasses a broad concept covering such forms.
4. What is the enforceability outlook for AU2011242562?
Given precise claims and strategic formulation, enforceability depends on patent validity, clarity of claims, and diligent patent infringement monitoring. Challenges based on prior art or obviousness are common in combination patents.
5. How does this patent compare with international counterparts?
While similar in covering combination therapies, international patents may vary in claim scope, with some jurisdictions requiring different standards for use and formulation claims. Cross-jurisdiction patent strategy should consider these variations for global protection.
Sources
[1] Australian Patent AU2011242562.
[2] Australian Patent Office Guidelines on Pharmaceutical Patents.
[3] Comparative Analysis of Neuroprotective Combination Drugs Patents.
