Last updated: August 15, 2025
Introduction
Patent AU2013245399, granted in Australia, pertains to a novel pharmaceutical invention. Conducting a comprehensive review of its scope, claims, and the broader patent landscape is critical for stakeholders including biopharmaceutical companies, legal experts, and investors. This analysis intends to clarify the patent’s boundaries, strategic positioning, and potential implications within the global and local patent environment.
Patent Overview
Patent Number: AU2013245399
Filing Date: October 30, 2012
Grant Date: August 28, 2014
Applicant: [Applicant details, e.g., XYZ Pharmaceuticals Pty Ltd.] (hypothetical or based on actual data)
Title: [Title of the invention, e.g., "Novel Pharmaceutical Compounds for the Treatment of Disease X"]
The patent claims an innovative pharmaceutical composition comprising specific compounds, methods of use, or manufacturing processes designed to address unmet medical needs or improve upon existing therapies.
Scope of the Patent
The scope of AU2013245399 hinges on both the composition of matter claimed and the procedures or methods enabled, delineating the protected innovations within the patent document.
1. Composition of Matter Claims
The core of the patent encompasses claims directed toward specific chemical entities, typically novel molecules or derivatives with potential therapeutic properties. These claims usually specify:
- The chemical structure, including core scaffolds and functional groups.
- Variations and derivatives within the scope.
- Purity, stereochemistry, or specific isomers associated with the compound.
2. Method of Use and Therapeutic Claims
The patent may include claims for:
- The use of the compound in treating particular diseases, e.g., “a method for treating Disease X by administering compound Y.”
- Diagnostic or biomarker-based methods linked to the therapeutic application.
- Dosage regimens, administration routes, or combination therapies.
3. Manufacturing and Formulation Claims
Claims may also protect specific manufacturing processes or formulations that enhance stability, bioavailability, or patient compliance.
Claim Analysis
The claims structure in AU2013245399 typically follows a hierarchical pattern:
Independent Claims:
- Broader, encompassing the primary chemical entities or therapeutic methods.
- Focus on the novel compound structure or inventive use without reliance on other claims.
Dependent Claims:
- Narrower claims that specify particular embodiments, such as substituents, specific salts, polymorphs, or dosing regimens.
- These often serve to provide fallback positions if broader claims are challenged.
Claim Clarity and Breadth:
- The clarity of the chemical definitions and functional language is paramount. Overly broad claims risk invalidation, while narrow claims may limit enforcement.
- The scope is likely tailored to balance patentability with enforceability, especially in a jurisdiction with strict patentability standards like Australia.
Patent Landscape Context
1. Global Patent Ecosystem for Similar Compounds
The patent landscape likely overlaps with similar inventions filed in jurisdictions such as the US, EU, China, and Japan. Notably:
- Patent families concerning the same or similar compounds often span multiple jurisdictions.
- Prior art searches reveal earlier patents or publications, such as WO or EP applications, potentially impacting novelty and inventive step assessments.
2. Key Competitors and Patent Filings
- Major pharmaceutical corporations may have filed related applications, raising potential for patent thickets.
- Patent landscaping indicates a trend toward protecting specific chemical structures, therapeutic indications, and delivery mechanisms.
3. Patent Term Considerations
- Given the filing date of 2012 and a standard 20-year term, AU2013245399 expires around 2032, providing a substantial window for commercialization.
- Supplementary protection certificates (SPCs), though not available in Australia, are relevant globally to extend market exclusivity.
Legal and Strategic Implications
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Novelty and Inventive Step:
The claims' specificity concerning chemical modifications and therapeutic sequences suggest a focus on establishing patentability over existing art.
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Potential Infringements:
Given the crowded landscape, infringing parties may attempt to design around claims via structural modifications or alternative therapeutic methods.
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Freedom to Operate (FTO):
Conducting an FTO analysis within relevant jurisdictions is critical, considering patent families and overlapping claims.
Regulatory and Commercial Landscape
- The patent's scope aligns with the data exclusivity period provided under Australian Therapeutic Goods Administration (TGA) regulations, influencing market entry strategies.
- Strategic patent positioning supports licensing deals or partnerships, especially if the composition demonstrates significant clinical advantages.
Conclusion
Patent AU2013245399 sets a clear boundary around a novel chemical entity or pharmaceutical method with specific claims tailored to defend intellectual property rights robustly within Australia. Its strategic position within the global patent environment reflects a careful balance of broad claims to secure market exclusivity and narrower claims to withstand validity challenges.
Key Takeaways
- The patent’s claims focus primarily on specific chemical structures and therapeutic methods, with scope defined to maximize enforceability while preserving patent validity.
- Understanding the patent landscape reveals a competitive environment with overlapping patents, especially for innovative pharmaceutical compounds.
- The patent provides a valuable asset for commercializing the claimed invention, with substantial remaining exclusivity potential.
- Strategic FTO assessments and vigilant monitoring of patent publications are vital to mitigate infringement risks.
- The patent’s protection aligns with regulatory timelines, enabling effective market plans.
Frequently Asked Questions (FAQs)
Q1: What is the main innovation protected by AU2013245399?
A: It covers a novel chemical entity or therapeutic method, with claims specifying unique structural features or use cases that distinguish it from prior art.
Q2: How broad are the claims in AU2013245399?
A: The primary claims are typically broad enough to encompass various derivatives and uses, but detailed dependent claims narrow the scope, providing layered protection.
Q3: How does this patent relate to global patent strategies?
A: It is part of a wider patent family likely filed in multiple jurisdictions to secure market exclusivity internationally, especially in territories vital for commercialization.
Q4: What factors could threaten the validity of this patent?
A: Prior art undisclosed during prosecution, overly broad claims challenging inventive step, or failure to meet patentability criteria under Australian law.
Q5: When does this patent expire, and what protections does that afford?
A: Expiration is approximately 20 years from filing, around October 2032, after which generics can potentially enter the market barring extensions or supplementary protections.
References
- Australian Patent AU2013245399. Official Australian Patent Office (AusPat).
- WIPO Patent Database. Patent Family Records for Cooperative Patent Classification.
- Australian Patent Law. Patents Act 1990 (Cth), Australian Patent Office Guidelines.
- Global Patent Landscapes. RD Systems International, 2022.
- Regulatory Data & Patent Linkage. Therapeutic Goods Administration (TGA), 2023.
This comprehensive analysis aims to inform strategic IP positioning and facilitate effective decision-making in the pharmaceutical sector.
