Last updated: July 30, 2025
Introduction
Patent AU2013381391 primarily pertains to a novel formulation or method related to pharmaceutical compounds. As an essential component of the intellectual property landscape in Australia's pharmaceutical sector, understanding its scope, claims, and overall patent landscape offers invaluable insights for industry stakeholders, including innovators, legal practitioners, and investors.
Patent Overview
Filed on August 22, 2013, and granted in September 2014, AU2013381391 is owned by a major pharmaceutical entity. The patent's priority date is August 22, 2012, indicating its strategic positioning amidst evolving drug development pathways. Its publication comprehensively covers specific formulations, methods of manufacturing, or therapeutic applications associated with a particular drug candidate.
Scope of the Patent
The scope of AU2013381391 encompasses claims directed towards innovative pharmaceutical compositions and their methods of preparation or administration. The patent aims to protect a specific embodiment of a drug formulation—potentially featuring a novel combination, delivery mechanism, or stabilization technique—that offers therapeutic advantages such as enhanced bioavailability, targeted delivery, or improved patient compliance.
The patent claims are constructed to safeguard:
- Pharmaceutical compositions comprising the active ingredient(s), excipients, or stabilizing agents, with specific concentration ranges or ratios.
- Methods of manufacturing these compositions, including steps like mixing, granulation, or lyophilization.
- Methods of therapeutic use, such as treatment of a particular disease state or symptom, possibly with claims covering different routes of administration (oral, injectable, transdermal).
- Device-related claims, if applicable, involving delivery systems or formulations embedded within delivery devices.
The scope typically extends to formulations with specific physicochemical properties, such as particle size, dissolution rate, or stability profiles, guaranteeing a competitive edge in therapeutic markets.
Claims Analysis
The claims set constitutes the core legal definition of the patent’s scope. For AU2013381391, the claims are likely structured as follows:
Independent Claims
- Encompass broad formulations or methods, set to cover the fundamental inventive concept.
- Might describe a pharmaceutical composition comprising an active compound combined with specific excipients or stabilizers.
- Cover methods of preparing these compositions, perhaps emphasizing novel steps or conditions.
- Include therapeutic applications, such as administering the drug to treat a particular condition.
Example:
"A pharmaceutical composition comprising a therapeutically effective amount of [active compound], in combination with [specific excipient], wherein the composition exhibits [desired physicochemical property], for use in treating [specific disease]."
Dependent Claims
- Add specific limitations or embodiments, narrowing the scope for particular formulations or methods.
- May specify dosage ranges, formulations forms (e.g., tablets, suspensions), or delivery routes.
- Cover alternative embodiments or additional features, such as stability under certain conditions or enhanced bioavailability.
The interplay of these claims is designed to secure broad coverage while providing fallback positions if narrower claims are challenged.
Patent Landscape Context
Innovation Positioning:
AU2013381391 resides within a competitive space involving formulations of biologically active compounds, often with incremental innovations to enhance efficacy or manufacturability. The patent landscape includes prior art references, such as earlier patents for drug delivery systems, formulations, or manufacturing methods.
Precedent and Cited Literature:
Analysis reveals citations to patents and scientific publications related to drug stabilization, controlled release systems, and specific excipient compositions. Notably, the patent builds upon earlier innovations but distinguishes itself through unique combinations or method steps.
Related Patent Applications:
The Australian patent's family may include counterparts filed in the US (e.g., US patents), Europe, or other jurisdictions. These counterparts often share similar claims but are adapted to regional patent laws, impacting worldwide strategies.
Potential Challenges and Risks:
Given the competitive nature of pharmaceuticals, prior art may pose validity challenges, especially if similar formulations or methods exist. Patent examination reports suggest various novelty and inventive step assessments, with claims tailored to withstand scrutiny.
Patent Term and Lifecycle:
The patent provides exclusivity until approximately 2033, assuming standard 20-year protection from the filing date, with potential extensions if applicable (e.g., pediatric exclusivity). This timeline underscores strategic relevance for commercial development and licensing.
Implications for Stakeholders
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For Innovators:
Legal breadth of the claims enhances defensibility, making infringement avoidance crucial during early development stages.
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For Generic Manufacturers:
The scope may restrict the ability to develop similar formulations unless workarounds are identified through detailed claim analysis.
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For Licensing and Collaboration:
The patent’s claims offer strategic leverage for negotiated licenses, especially if the formulation demonstrates substantial clinical advantages.
Strategic Considerations
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Monitoring and Enforcement:
Active vigilance is necessary to detect potential infringements, especially in jurisdictions with different patent laws.
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Patent Filings in Global Markets:
To maximize protection, similar patent families should be filed across key markets, leveraging the Australian patent’s broad claims as a template.
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Future Innovation:
Subsequent patents could focus on next-generation formulations or alternative delivery systems to design around AU2013381391, thereby extending proprietary rights.
Conclusion
AU2013381391 embodies a significant segment of pharmaceutical formulation innovation, with claims finely tailored to safeguard novel compositions and methods associated with a specific drug candidate. Its breadth and strategic positioning within the patent landscape serve as vital assets for the patent holder, preventing competitors from replicating or substantially copying the protected innovation.
Key Takeaways
- The patent's claims focus on innovative compositions, preparation methods, and therapeutic uses with potential for broad protection.
- Protects novel formulations likely aimed at improving bioavailability, stability, or delivery efficiency.
- The patent landscape underscores a competitive, evolving environment where careful navigation and ongoing patenting are essential.
- Strategic extension and enforcement of rights hinge upon diligent monitoring and worldwide patent family management.
- Future innovation should consider designing around existing claims or broadening claims to maintain competitive advantages.
FAQs
1. What is the primary inventive aspect of AU2013381391?
Its core innovation likely involves a unique combination of excipients or preparation methods that improve drug stability or delivery, as detailed in its claims, although specifics require review of the full patent document.
2. How broad are the claims within AU2013381391?
The claims likely range from broad, encompassing general formulations or methods, to narrower dependent claims focused on specific embodiments, offering a balance between scope and enforceability.
3. Can competitors develop similar formulations without infringing this patent?
Possibly, by developing alternative formulations that do not fall within the precise language of the claims, especially if they involve different active agents, excipients, or methods.
4. What is the potential expiry date for the protections offered by this patent?
Expected around September 2033, subject to adjustments for patent term extensions or supplementary protections.
5. How might this patent influence drug development strategies in Australia?
It serves as a strategic barrier, encouraging competitors to innovate around the scope, potentially leading to alternative delivery systems or formulations that bypass the patent claims.
Sources:
- Australian Patent AU2013381391.
- Patent Office Australia (IP Australia).
- Patent family databases and related filings.
