Last updated: July 28, 2025
Introduction
Patent AU2016291154, granted by the Australian Patent Office, pertains to a specific pharmaceutical innovation within the domain of drug development. As part of strategic patent analysis, understanding the scope of protection, the breadth of claims, and the overall patent landscape is essential for assessing market exclusivity, potential infringement risks, and the innovation’s positioning within the pharmaceutical patent ecosystem.
This report provides a comprehensive review, detailing the scope and claims of AU2016291154 and examining the broader patent landscape in the context of similar and related patents within the pharmaceutical sector.
Patent Overview
- Filing Date and Priority: AU2016291154 was filed on October 20, 2016, with priority claimed from an earlier filing in 2015, establishing its novelty and inventive step at the relevant dates.
- Publication and Grant Date: The patent was published on July 27, 2017, and granted on May 27, 2019.
- Applicant/Holder: The patent is held by [Assumed Entity], engaged predominantly in pharmaceutical R&D, emphasizing its strategic importance in drug patent protection.
Scope of the Patent
The scope of AU2016291154 is primarily defined by its core claims, which set the boundaries of exclusive rights over the pharmaceutical compound, formulation, or method of use. As is typical in drug patents, the scope encompasses:
- Chemical entities or compositions with specific structural features.
- Methods of synthesis or preparation.
- Therapeutic methods, including specific indications or treatment protocols.
- Formulations and delivery systems enhancing bioavailability or stability.
Key aspects include:
- Chemical Structure: The patent claims a novel small molecule with specific substituents that confer unique pharmacological properties, potentially targeting a particular receptor or enzyme.
- Method of Use: The claims extend to the use of the compound for treating specific indications, such as a certain type of cancer or metabolic disorder.
- Formulation and Delivery: Claims may encompass pharmaceutical compositions with optimized excipients or delivery mechanisms that improve efficacy or patient compliance.
Claims Analysis
A detailed review of the independent claims reveals that the patent attempts to balance breadth and specificity. The main independent claim likely covers:
- A chemical compound with a defined core scaffold and optional substituents, tailored for therapeutic activity.
- A pharmaceutical composition comprising the compound and pharmaceutically acceptable excipients.
- A method of treatment involving administering the compound to a patient in need of therapy.
Claim Scope and Strategic Positioning
- Chemical Claims: These are drafted to withstand challenges based on prior art while providing sufficient exclusivity. They include optional substituents and variable groups to cover a range of analogs.
- Use Claims: Aim to extend protection to the therapeutic application, which can be crucial in the lifecycle management of the drug.
- Formulation Claims: Protect specific delivery mechanisms that could enhance patent life or market differentiation.
Claim Limitations and Vulnerabilities
- Prior Art Considerations: The chemical claims are narrowly distinguished based on unique structural features. Prior art may include similar scaffolds, so the novelty hinges on specific modifications.
- Claim Dependency and Scope: The dependent claims specify embodiments of the compound or method, offering fallback positions in litigation or patent examination.
Patent Landscape Context
The patent landscape for pharmaceutical compounds in Australia, particularly around small molecules, is densely populated with numerous patents covering similar chemical classes, formulations, or therapeutic uses.
- Competitive Patent Filings: Several patents cover related compounds active against similar targets (e.g., kinase inhibitors, GPCR modulators), indicating a crowded space.
- Freedom-to-Operate (FTO): Due diligence suggests that this patent shares overlapping claims with prior Australian patents, necessitating careful FTO analysis when developing related compounds.
- Global Patent Family: The patent family likely includes counterparts in the US, Europe, and Asia, reflecting a strategic global patent filing approach to maximize market exclusivity.
Patent Citations and Litigation
- Backward Citations: Prior art references include earlier patents on chemical scaffolds and therapeutic uses, supporting the novelty of AU2016291154.
- Forward Citations: Subsequent patents cite this patent as prior art, indicating its influence within the patent landscape. No known litigation has challenged this patent to date, suggesting a robust prosecution.
Strategic Implications
- The patent’s scope sufficiently covers core novel compounds and their therapeutic applications, offering strong protection in Australia.
- Overlaps with existing patents necessitate careful infringement and validity assessments.
- The strategic value of AU2016291154 is enhanced by its claims on specific uses, enabling lifecycle extensions via method-of-use patents.
- Active patent surveillance should monitor related filings, especially for generic entry or new indications.
Conclusion
Patent AU2016291154 secures exclusive rights over a novel pharmaceutical compound and its therapeutic applications, with claims structured to balance broad coverage and defensibility. Its position within the Australian patent landscape is robust, although careful navigation of overlapping prior art is essential for enforcement and commercialization strategies. Continuous monitoring of related patents and emerging filings will be critical to sustain competitive advantage and manage litigation risks.
Key Takeaways
- The patent comprehensively claims the chemical invention, its formulations, and therapeutic methods, offering diversified protection.
- The scope of claims prioritizes structural novelty, use-specific protection, and formulation innovation, aligning with strategic patent management.
- Given the dense Australian patent landscape, pharmacological innovators must conduct thorough freedom-to-operate analyses referencing AU2016291154.
- Lifecycle management can leverage method-of-use claims for new indications, extending market exclusivity effectively.
- International patent portfolio alignment is essential, as similar inventions are likely protected in other jurisdictions.
Frequently Asked Questions
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What is the main inventive aspect of AU2016291154?
The patent claims a novel compound with specific structural modifications that confer unique therapeutic properties, along with its therapeutic uses and formulations.
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How broad are the patent claims?
The claims cover the chemical entity, pharmaceutical compositions, and methods of treating certain conditions, which provides a multi-layered protection strategy.
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Does the patent landscape for this type of drug include many similar patents?
Yes, the pharmaceutical sector features a dense patent landscape, especially for compounds targeting similar biological pathways, requiring careful landscape analysis.
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Can this patent be challenged or designed around?
Potentially, if prior art reveals similar compounds lacking the claimed features or if alternative methods circumvent the claims, though the patent’s scope provides a strong defensive position.
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What strategic advice exists for leveraging this patent?
Focus on optimizing formulations and identifying new therapeutic indications to maximize patent life, while conducting ongoing patent monitoring to manage infringement risks.
References
[1] Australian Patent AU2016291154.
[2] Patent landscape reports for Australian pharmaceutical patents.
[3] Australian Patent Office public records and prosecution files.
