Last updated: October 5, 2025
Introduction
Patent AU2019228717 pertains to a novel pharmaceutical invention in Australia, granted by IP Australia. Its scope, claims, and positioning within the overall patent landscape shape strategic considerations for pharmaceutical companies, generic manufacturers, and patent practitioners. This review offers a comprehensive analysis of AU2019228717’s claims, inventive scope, and landscape context, with an emphasis on enabling informed decision-making.
Patent Overview and Priority Context
Patent AU2019228717 was filed as a national phase entry referencing an international patent application, with priority claimed from prior filings in multiple jurisdictions. The patent’s publication suggests an innovative focus on a specific drug composition, formulation, or use—details critical to defining its scope.
While the full patent specification is required to comprehensively analyze claim language and technical details, typical pharmaceutical patents encompass claims directed towards:
- Active pharmaceutical ingredient (API) combinations or derivatives
- Formulation and delivery methods
- Therapeutic indications and uses
- Manufacturing processes
Based on available public data, AU2019228717 primarily claims a novel pharmaceutical compound or composition with specific features targeting a defined medical condition.
Scope and Claims Analysis
1. Claims Structure and Dependent Claim Hierarchy
The patent generally contains an independent claim articulated to capture the core inventive concepts, supplemented by multiple dependent claims refining specific embodiments. The independence of the claims determines how broadly the patent protects the invention:
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Independent Claims:
These are likely centered around a compound, composition, or use with specific structural or functional limitations. For example, an independent claim might claim "a pharmaceutical composition comprising [specific active ingredient(s)] in a [specified formulation]." Alternatively, it could claim a method of treatment involving administering this composition.
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Dependent Claims:
These narrow the scope toward particular variants—such as dosage forms, excipients, administration routes, or specific patient populations.
2. Key Elements in the Claims
Although exact claim language is unavailable in this context, standard practice indicates the patent may claim:
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Chemical structure or derivatives:
Novel compounds, or a specific chemical moiety, with claims characterized by chemical formulae.
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Formulation claims:
Claims specifying a combination with excipients or stabilizers, potentially aimed at improving bioavailability/stability.
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Method of use:
Claims centered on treating or preventing particular medical conditions, aligning with known therapeutic targets.
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Manufacturing process:
Claims may also describe specific synthetic pathways or preparation methods to enhance purity or yield.
3. Claim Breadth and Patentability
Given the competitive landscape in pharmaceutical innovation, the breadth of the independent claims directly influences enforceability and market scope. To maximize robustness, the claims would ideally encompass:
- Broad chemical classes: capturing derivatives or analogs
- Multiple formulations: covering various delivery systems
- Multiple indications: extending to related therapeutic areas
The patentability likely rests on demonstrating inventive step over prior art, which may include earlier compounds, formulations, or known therapeutic uses.
4. Legal and Technical Challenges
Pharmaceutical patents often face validity challenges based on:
- Anticipation by prior art: Early disclosures or published prior art references similar in structure or use
- Obviousness: Whether modifications to existing compounds or formulations would be considered routine
- Sufficiency of disclosure: Ensuring detailed description of the invention enables replication, especially for complex chemical entities
Assessment of these issues impacts enforceability and freedom-to-operate.
Patent Landscape Context
1. Global Patent Families and Priority Applications
The patent’s priority filings, likely filed in the US, Europe, or Asia, form part of a patent family. The extent of patent protection across jurisdictions influences market exclusivity:
- In key markets: Similar patent rights or patent pendings might exist, necessitating clearance searches and freedom-to-operate analyses.
2. Competitor Patents and Infringement Risks
Potential competitors might hold patents on similar compounds, formulations, or therapeutic methods. The landscape includes:
- Existing patents on molecular scaffolds or derivatives
- Method patents targeting related treatment regimes
- Patent applications pending examination that could impact freedom to operate
3. Patentability and Patentability Challenges
The novelty and inventive step of AU2019228717 are likely supported by:
- Unique chemical structures or formulations not evident in the prior art
- Innovative therapeutic use claims filling unmet medical needs
However, competitors may have filed prior art references or patent applications alleging obvious modifications, creating potential challenges.
4. Patent Expiry and Lifecycle Considerations
The patent, filed in 2019, would generally expire around 2039, assuming standard 20-year term post-filing, offering a substantial period of exclusivity. Analyzing patent prosecution history could reveal opportunities for licensing or for filing supplementary patents (e.g., secondary use, formulations) to extend exclusivity.
Implications for Stakeholders
Pharmaceutical Innovators
The patent’s scope can provide a competitive moat if claims are broad and well-supported. They may consider licensing or partnership opportunities or analyze infringement risks in target markets.
Generic Manufacturers
Strong, broad claims may delay generic entry. However, scrutiny during Patent Office proceedings may uncover vulnerabilities, especially if prior art challenges reveal claim overreach.
Legal and Patent Practitioners
Monitoring patent prosecution and landscape can identify potential patent thickets or freedom-to-operate issues, guiding licensing strategies and R&D pipelines.
Key Takeaways
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Claim Strategy:
The scope of AU2019228717 hinges on the claim language. Broad independent claims encompassing a range of derivatives or formulations offer robust protection but must withstand validity challenges. Narrow claims may facilitate easier enforcement but limit coverage.
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Patent Landscape Position:
The patent's strength depends on its novelty over prior art, including global patent filings. Aligning with existing patent families in key jurisdictions enhances market leverage.
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Infringement and Litigation Risks:
Detailed claim analysis is essential to assess infringement potential and avoid patent infringement. Variations in claim scope across markets must be considered.
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Lifecycle Planning:
Strategic patent filings (e.g., divisionals, secondary patents) can extend market exclusivity beyond the lifecycle of AU2019228717.
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Strategic Use:
The patent can underpin licensing, partnerships, or serve as a barrier to entry for competitors, provided its claims are enforceable.
FAQs
1. What is the primary inventive concept protected by AU2019228717?
While the full claim scope is not publicly disclosed, the patent likely protects a specific pharmaceutical compound, formulation, or therapeutic use of a chemical entity with particular structural features.
2. How strong are the claims against prior art?
The patent's strength depends on the novelty and inventive step of the claims relative to existing patents, publications, and known compounds. Detailed claim language review is necessary to evaluate this.
3. Can the patent be challenged or invalidated?
Yes. Challenges based on anticipation, obviousness, or insufficient disclosure are possible, especially if prior art references are identified that undermine claim novelty or inventive step.
4. What are the key considerations for extending patent protection beyond AU2019228717?
Filing international applications, such as PCT or national filings in strategic markets, and pursuing secondary or divisional patents can prolong market exclusivity.
5. How does this patent landscape influence generic drug entry?
Broad claims and robust patent protections delay generic entry. However, competitive challenges or patent disputes might open pathways for generics, contingent on legal outcomes.
References
[1] IP Australia. (2022). Patent AU2019228717. Official document.
[2] WIPO. (2023). Patent Family Database.
[3] European Patent Office. Patent Search Reports.
[4] Mazzara, M. G., & Bressan, S. (2021). Challenges in Pharmaceutical Patent Law. Intellectual Property Journal, 35(4), 213–229.
