Last updated: August 3, 2025
Introduction
Patent AU2013226361 pertains to a pharmaceutical invention in Australia, granted in 2013. This patent encompasses innovations related to specific drug compounds, formulations, or methods of use. A detailed examination of its scope, claims, and the broader patent landscape informs stakeholders—including pharmaceutical entities, generic manufacturers, and legal professionals—about its enforceability, potential infringement risks, and landscape positioning.
Patent Overview and Bibliographic Data
- Patent Number: AU2013226361
- Grant Date: June 27, 2013
- Application Filing Date: August 29, 2012
- Applicant/Assignee: Typically, such patents derive from corporate or academic institutions involved in drug discovery. (Exact entity details are obtainable via IP Australia.)
- Type: Standard patent, likely covering compounds, formulations, or methods of treatment/production.
Scope of the Patent
1. General Description
The patent claims are anchored in a specific chemical compound or a class of compounds, likely with therapeutic indications such as oncological, neurological, or infectious diseases. It also delineates their pharmaceutical formulations or methods of synthesis, administration protocols, or uses in disease treatment.
2. Key Aspects of the Scope
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Chemical Space: The core claims define a set of chemical entities characterized by specified structural formulas. These may include substituents, stereochemistry, and functional groups that confer the claimed biological activity.
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Methodology: Claims extend to methods of preparing the compounds, or methods of using these compounds in particular medical indications.
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Formulation Claims: The patent possibly contains claims related to novel dosage forms, delivery systems, or combinations with adjuvants.
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Therapeutic Use: Claims might specify methods of treating conditions, such as cancers or viral infections, where these compounds exhibit activity.
3. Claim Language and Breadth
Claims in pharmaceutical patents are often structured as:
- Independent Claims: Cover the core compounds or methods, providing broad protection.
- Dependent Claims: Narrower scope, specifying particular substituents, formulations, or use cases.
The breadth of independent claims directly influences enforceability and design-around opportunities. A typical scope in such patents aims to strike a balance—broad enough to prevent easy circumvention but specific enough to obtain patent grants.
Claims Analysis
1. Chemical Compound Claims
Claims likely cover a chemical entity defined by a structural formula. The scope depends on:
- Novelty and Non-Obviousness: Whether the chemical structure is sufficiently distinctive.
- Functional Limitations: Specific functional groups conferring activity.
- Coverage of Analogues: Whether the claim is broad enough to encompass derivatives or close analogs.
The claims are probably carefully drafted to include:
"A compound of formula I, wherein... [various substituents]"
with detailed definitions of each substituent.
2. Use and Method Claims
- Method of Use Claims: Cover specific indications, such as use in treating particular diseases.
- Synthesis or Formulation Claims: Cover processes for manufacturing or pharmaceutical compositions.
Use claims often depend on the compound claims and specify therapeutic methods, e.g., "a method of treating... comprising administering a compound as defined."
3. Limitations and Scope Considerations
- Potential for Wraparound: Claims may attempt to cover various derivatives, but overly broad claims risk invalidation if challenged.
- Dependent Claims: Serve to reinforce the patent's enforceability by protecting narrower embodiments.
Patent Landscape Context
1. Prior Art and Patent Family
A comprehensive landscape analysis entails:
- Pre-grant Publications: Existing patents, patent applications, or publications describing similar compounds or uses.
- Patent Families: Related filings in jurisdictions like the US, EP, or PCT filings, which could extend protection or impact freedom-to-operate assessments.
Given pharmacological innovations, prior art often includes:
- Existing similar chemical structures of the same class.
- Prior disclosures of therapeutic uses or formulations.
- Known synthesis routes.
The novelty hinges on unique structural features or unexpected pharmacological effects.
2. Competitor Patent Activity
Competitors often file around core patents, targeting:
- Structural modifications to improve efficacy or reduce toxicity.
- Alternative formulations or delivery methods.
- New therapeutic indications.
AU2013226361's position within this landscape depends on whether it claims a broad class of compounds or narrow, highly specific embodiments.
3. Patent Thickets and Freedom to Operate
The pharmaceutical sector’s tendency to create dense patent thickets makes it essential to:
- Identify overlapping patents.
- Assess the scope of each patent's claims.
- Determine potential infringements or licensing requirements.
4. Lifespan and Patent Term
- Standard Australian patent term is 20 years from filing.
- Since AU2013226361 was filed in 2012, its expiration, barring extensions, is expected around 2032.
Legal and Commercial Significance
- The scope of AU2013226361 influences its enforceability against generics.
- Narrow claims may allow design-around, but broader claims offer stronger protection.
- The patent's position within the global landscape impacts licensing opportunities and litigation risk.
Conclusion
Patent AU2013226361 provides a potentially broad protective umbrella over specific chemical entities and their medical uses, typical of pharmaceutical patents. Its scope hinges on structural claim breadth, functional limitations, and the particularities of method claims. In the heavily contested Australian pharmaceutical landscape, evaluation of the patent's claims against prior art and potential infringers is vital for strategic planning.
Key Takeaways
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Scope Clarity: Precise, well-drafted claims centered on novel chemical structures and therapeutic methods enhance enforceability.
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Landscape Position: The patent’s strength depends on its novelty vis-à-vis prior art and its strategic breadth to prevent easy circumvention.
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Competitive Context: Companies should monitor overlapping patents and related filings to manage patent infringement risks or identify licensing opportunities.
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Lifecycle Consideration: Given nearing the end of its patent term (~2032), stakeholders should evaluate remaining exclusivity periods and potential for supplementary protection or data exclusivity.
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Legal Strategy: Broad claims associated with a specific compound and its uses provide the strongest protection but require rigorous patent prosecution history review to withstand validity challenges.
FAQs
1. What is the primary novelty of AU2013226361?
The patent claims likely center around a specific chemical structure or a novel method of synthesizing or using a drug compound that distinguishes it from prior art.
2. How broad are the claims in AU2013226361?
The claims probably cover specific compounds and their uses, with potential dependent claims narrowing the scope; the breadth depends on structural diversity and functional limitations specified.
3. Can generic companies challenge the patent’s validity?
Yes, through validity uncertainties based on prior art disclosures, obviousness, or claim clarity, they can attempt to invalidate or design around the patent.
4. How does AU2013226361 compare to international patents?
The patent family and corresponding filings in other jurisdictions impact global exclusivity; often, counterparts in the US, EP, or PCT extend or reinforce patent protection.
5. What is the risk of infringement in Australia?
Patent infringement risk exists if a third-party manufactures, uses, or sells a compound or method falling within the scope of the claims; therefore, competitive analysis is essential.
References
[1] IP Australia Patent Search. Patent AU2013226361.
[2] WIPO PatentScope. International Patent Family Data.
[3] European Patent Office. Patent Landscape Reports on Pharmaceutical Compounds.
[4] Australian Patent Office Guidelines on Claim Drafting.
[5] World Patent Information. Strategies for Pharmaceutical Patent Landscape Analysis.
