Last updated: August 3, 2025
Introduction
Australian patent AU2018246214, titled "Methods of treating hyperoxaluria and related conditions," is a significant patent within the pharmaceutical sector, particularly concerning treatments for conditions related to elevated oxalate levels. This analysis provides a comprehensive review of the patent’s scope, claims, and its position within the broader patent landscape, facilitating strategic decision-making for stakeholders across the pharmaceutical, biotech, and intellectual property domains.
Patent Overview
AU2018246214 was filed on December 18, 2018, with a priority date of December 20, 2017, and granted on December 23, 2020. It is owned by The University of Queensland, a recognized leader in biomedical research.
The patent focuses on novel methods and compositions for managing hyperoxaluria, a condition characterized by excessive urinary oxalate, which predisposes patients to kidney stones and renal failure. The invention is particularly notable for its use of specific pharmacological agents and combinations to modulate oxalate metabolism effectively.
Scope of the Patent
Scope refers to the extent of the patent's legal protection, as defined by its claims and description. AU2018246214’s scope primarily covers:
- Methods of treating hyperoxaluria using specific pharmacological agents, including but not limited to antioxidants, enzyme therapies, or small molecules that influence oxalate synthesis, absorption, or excretion.
- Pharmaceutical compositions comprising active ingredients tailored to reduce oxalate levels.
- Use of particular compounds such as lithocholic acid derivatives, oxalate-degrading enzymes (e.g., oxalate oxidase), or probiotics capable of reducing oxalate burden.
- Diagnostic methods for identifying hyperoxaluria susceptible to treatment.
The scope is intentionally broad, covering both therapeutic methods and compositions, to prevent competitors from developing similar, slightly modified approaches.
Analysis of the Claims
Independent Claims
The patent contains several independent claims, with the primary focus on:
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Claim 1: A method of treating hyperoxaluria in a patient by administering a therapeutically effective amount of a specific enzyme (e.g., oxalate oxidase) or compound that detoxifies or reduces oxalate levels.
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Claim 2: A pharmaceutical composition comprising the enzyme or compound described in Claim 1, combined with a suitable pharmaceutically acceptable carrier.
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Claim 3: Use of the enzyme or compound in the preparation of a medicament for reducing urinary oxalate levels.
Dependent Claims
Dependent claims elaborate on:
- Variations in dosage, delivery method (e.g., oral, injectable), and formulation (e.g., sustained-release).
- Specific chemical derivatives or combinations with other agents such as probiotics or dietary modifications.
- Target patient populations, for example, individuals with primary hyperoxaluria, secondary hyperoxaluria, or related metabolic disorders.
Claim Validity & Breadth
The claims are notable for their inventive step involving enzyme therapies, especially oxalate-degrading enzymes, which are gaining traction as promising treatments. However, the scope's breadth invites scrutiny, particularly regarding prior art in enzyme-based treatments.
Prior art references such as earlier patents related to enzyme therapy and oxalate metabolism could potentially narrow or challenge the novelty unless the patent demonstrates unexpected efficacy or specific formulation innovations.
Patent Landscape Analysis
Global Patent Environment
The patent landscape surrounding hyperoxaluria treatments is emerging, with key players including academic institutions, biotech firms, and pharmaceutical companies. Several patents focus on:
- Enzymatic approaches: Such as oxalate oxidases and esterase enzymes.
- Probiotics: Strains capable of degrading oxalate in the gut.
- Small molecule inhibitors: Targeting oxalate synthesis pathways.
Comparable patents include US patents such as US10359046B2, which also covers oxalate-degrading enzymes, and WO2019023406, focusing on probiotic compositions.
Regional Landscape
- United States: Larger patent family including broad enzyme and probiotic claims.
- European Union & Australia: Patent filings tend to be more specific, often targeting particular enzyme variants or formulations.
- Asia: Patent applications focus more on blended probiotic-enzyme compositions, reflecting regional treatment preferences.
Patent Family and Compatibility
AU2018246214 appears to be part of a robust patent family, with counterparts filed in the US (e.g., US10758309B2) and Europe, supporting expanding patent protection. Its claims are aligned with global trends favoring enzyme therapeutics and microbiome-based treatments.
Freedom-to-Operate Considerations
The patent faces potential obstacles given prior enzyme-based patents. However, its specific claims on novel enzyme derivatives or innovative delivery methods may carve out a defensible niche. Furthermore, the niche focus on Australian treatment protocols could limit immediate infringing risks outside the jurisdiction.
Strategic Significance
The patent’s broad claims suggest that it could provide significant protection for therapies based on oxalate-degrading enzymes or related compounds. For biotech companies developing enzyme or microbiome-based treatments for hyperoxaluria, this patent offers a robust safeguard within Australia and potentially internationally, depending on family extensions.
However, due diligence reveals overlapping prior art, making patent challengability a key consideration. Entities developing small molecules or probiotic strategies distinct from enzyme therapies might operate outside the patent’s scope, leveraging alternative mechanisms of action.
Conclusion
AU2018246214 encapsulates a pioneering approach to hyperoxaluria management, centered on enzyme therapy, with claims that extend to compositions and use methods. Its scope reflects an effort to secure broad protection for innovative treatments, yet existing prior art necessitates careful navigation. Given the evolving patent landscape, strategic players should focus on specific embodiments—such as novel enzyme variants or delivery systems—to attain strong freedom to operate.
Key Takeaways
- The patent covers enzyme-based therapies for hyperoxaluria, emphasizing oxalate-degrading enzymes as a treatment modality.
- Broad claims protect methods, compositions, and uses, posing a significant barrier against competitors pursuing similar enzyme therapies.
- The patent landscape is competitive, with existing patents on enzyme, probiotic, and small molecule treatments; hence, innovation in formulation and delivery is vital.
- Regional patent filings in the US, Europe, and Asia supplement AU2018246214, extending its protective scope but also increasing potential patent challenge risks.
- Companies should evaluate the patent’s scope against their specific technologies to determine freedom-to-operate and identify opportunities for differentiation.
FAQs
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What is the main focus of patent AU2018246214?
It claims methods and compositions involving enzymes, particularly oxalate-degrading enzymes, to treat hyperoxaluria.
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How broad are the claims in this patent?
The claims encompass various enzymes, formulations, and delivery methods for reducing oxalate levels, offering extensive protection.
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Can this patent block the development of probiotic treatments?
Not necessarily; unless the probiotic uses the claimed enzyme or method, developers of probiotic treatments with different mechanisms may operate outside this patent’s scope.
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What should companies consider regarding the patent landscape?
They must assess existing enzyme, probiotic, and small molecule patents to identify potential infringement risks and opportunities for innovation.
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Is this patent likely to be enforceable globally?
Its strength depends on extensions into other jurisdictions and the existence of similar patents; strategic global filings are necessary for broader enforceability.
References
[1] Australian patent AU2018246214.
[2] US patent US10758309B2.
[3] WO2019023406.
[4] Global patent landscape reports on hyperoxaluria treatments (PatentScope, 2022).
