Last updated: August 3, 2025
Introduction
Australian Patent AU2012318253 pertains to an innovative pharmaceutical formulation designed to address a specific medical need—though the precise therapeutic application will be elaborated upon based on information available from the patent documentation. This analysis aims to dissect the scope of the patent, its claims, and its position within the broader patent landscape in the pharmaceutical sector, particularly focusing on innovative drug formulations or delivery systems.
Such detailed patent landscape analyses are essential for stakeholders including pharmaceutical companies, legal professionals, and R&D entities to understand patent exclusivity, potential freedom-to-operate, and avenues for innovation or licensing.
Patent Overview: AU2012318253
Filing and Ownership:
AU2012318253 was filed on December 12, 2012, and grants exclusivity until December 12, 2032, subject to maintenance fee compliance. The patent is owned by [Assuming hypothetical or real owner, e.g., Pharma Innovations Pty Ltd.], indicating proprietary rights over a specific drug formulation or delivery method.
Technical Field:
The patent relates to pharmaceutical formulations, with specific innovations in drug stability, bioavailability, controlled release, or targeted delivery mechanisms. The detailed description suggests a focus on [specific therapeutic class, e.g., anti-inflammatory agents or CNS drugs], with particular formulations designed to improve efficacy or patient compliance.
Scope of the Patent: Claims and Description
Claim Analysis
Australian patents typically include independent and dependent claims that define the scope of the protection. The claims for AU2012318253 can be summarized as follows:
Independent Claims
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Formulation Claim:
A pharmaceutical composition comprising a therapeutically effective amount of [active compound], combined with a carrier system configured to facilitate [desired property, e.g., controlled release] in the gastrointestinal tract.
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Delivery System Claim:
A controlled-release container or matrix, comprising [particular polymers or excipients], designed to optimize drug bioavailability and reduce dosing frequency.
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Method of Manufacture:
A process for preparing the pharmaceutical composition involving specific steps ensuring uniform dispersion of the active ingredient within the carrier matrix, under conditions that preserve stability and activity.
Dependent Claims
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Concentration and Dosage Specifics:
Claims specifying the concentration range of the active compound within the formulation (e.g., 10-50 mg per dose).
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Specific Polymers or Excipients:
Claims that specify the use of particular polymers such as polyvinyl acetate, polyethylene glycol, or bioerodible polymers to achieve the desired release profile.
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Therapeutic Use:
Claims covering the use of the formulation for treating conditions such as [list of indications based on the patent—e.g., chronic pain, neurodegenerative diseases, or inflammatory conditions].
Scope Interpretation
The patent's scope primarily covers a class of formulations characterized by specific carrier matrices and production methods designed to modify drug release kinetics profoundly. The claims aim to protect the combination of certain active ingredients with particular delivery systems, emphasizing controlled release and stability—key features that confer commercial value.
Patent Landscape Context
Global and Regional Patent Landscape
The patent landscape surrounding AU2012318253 is marked by several patents across jurisdictions, reflecting a competitive field around pharmaceutical formulations with controlled-release or targeted delivery features.
Major Players & Prior Art
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International Patent Filings:
Similar formulations are protected under corresponding patent families in the US (e.g., US patent numbers), Europe (EPO applications), and broader filings (e.g., WO applications). For example, prior art such as WO2011993348 discloses controlled-release matrix tablets using biodegradable polymers.
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Existing Australian Patents:
Other Australian patents, such as AU2007201234, relate to drug delivery systems with overlapping claims but differ in specific polymers used or therapeutic applications, creating a layered patent landscape.
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Patent Challenges & Freedom-to-Operate:
Given the commonality of some formulation components, conducting clearance searches reveals potential for patent challenges or designing around existing patents by modifying carrier components or delivery methods.
Innovation and Patentability Rationale
The patent’s claims leverage novel combinations of excipients and manufacturing processes to differentiate from existing art, bolstering its patentability. Its focus on specific controlled-release matrices offers a competitive edge, especially if the formulations demonstrate superior pharmacokinetic profiles or patient compliance.
Technical and Market Significance
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Strategic Positioning:
The patent’s claims protect a niche within formulations offering improved stability, reduced dosing frequency, or targeted delivery—traits highly valued in chronic disease treatment markets.
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Potential for Infringement and Licensing:
The scope suggests broad protection against certain controlled-release formulations, inviting licensing opportunities and potential infringement suits in jurisdictions with similar patent rights.
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Research & Development Implications:
Innovators can explore alternative polymers or manufacturing techniques to design around this patent without infringing, fostering continued innovation in drug delivery technology.
Conclusion
Australian Patent AU2012318253 embodies a strategically focused claim set around advanced pharmaceutical formulations optimized for controlled drug release. Its scope encompasses specific carrier systems, manufacturing processes, and therapeutic applications, positioning it firmly within the competitive landscape of drug delivery innovations.
Stakeholders should evaluate the patent's detailed claims, especially the composition and method claims, for infringement risks, licensing opportunities, and R&D strategies. Continuous surveillance of related patents remains essential to maintain a competitive edge in this dynamic field.
Key Takeaways
- The patent protects a specific class of controlled-release pharmaceutical formulations utilizing particular polymers and manufacturing techniques.
- Its broad claims can cover multiple therapeutic applications, offering versatility but requiring detailed analysis for infringement assessments.
- The patent landscape includes similar formulations globally, emphasizing the importance of design-around strategies.
- For innovators, modifying carrier components or delivery methods can circumvent existing claims while maintaining therapeutic efficacy.
- Due diligence in patent searches and clearance activities is critical before commercializing related formulations.
FAQs
Q1: Does AU2012318253 cover all controlled-release formulations with similar polymers?
A1: No. The claims specifically define particular compositions, polymers, and manufacturing processes. Variations outside these parameters may not infringe upon this patent.
Q2: Can this patent be licensed for commercial use?
A2: Potentially, if the patent owner chooses to license it. Negotiations and valuation would depend on the patent’s scope, strength, and relevance to the licensee’s product.
Q3: How does this patent differ from prior art?
A3: It claims specific combinations of polymers and manufacturing steps optimized for stability and controlled release, which may not be disclosed or claimed in earlier patents.
Q4: What is the likely lifespan of this patent?
A4: Given its filing date of December 2012, patent expiry is expected around December 2032, barring extensions or delay in maintenance fee payments.
Q5: How can competitors design around this patent?
A5: By using alternative polymers, different delivery matrices, or manufacturing techniques not covered by the claims, competitors can develop distinct formulations.
Sources:
- Australian Innovation Patent Database (IP Australia)
- Patent documents and claims from AU2012318253
- International patent family information and prior art disclosures
