Last updated: September 8, 2025
Introduction
Patent AU2018376817, titled “Method for detecting multiple analytes in a sample using a multiplex immunoassay”, represents a significant intellectual property in the diagnostic and biomedical sectors. Understanding its scope, claims, and position within the Australian patent landscape is critical for stakeholders including pharmaceutical companies, diagnostic developers, and patent strategists. This analysis offers an exhaustive overview of the patent’s claims, the technological scope, and its landscape context.
Patent Overview and Context
Filed in 2018, AU2018376817 addresses multiplex immunoassay technologies, which have revolutionized diagnostic testing by enabling simultaneous detection of multiple analytes. As diagnostic complexity increases, the patent's placement within the broader multiplex assay landscape signifies its potential influence. It falls under the IPC class G01N33/68 (Detecting specific substances using immunoassays) and intersects with broader classifications such as G01N33/54 (Multiplexing techniques).
Australia's patent system offers a robust platform for biotechnological inventions, emphasizing novelty, inventive step, and sufficient disclosure. The patent’s strategic claims target both fundamental assay methods and specific implementation aspects, providing a potentially broad scope within its technical field.
Scope and Claims Analysis
Independent Claims
The patent primarily comprises three broad independent claims, each establishing the core inventive concept:
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Claim 1: Describes a method for detecting multiple analytes within a sample by employing a multiplex immunoassay, involving steps of immobilizing specific binding partners for each analyte onto a solid support, contacting the sample, and detecting bound analytes via specific labels.
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Claim 2: Focuses on specific arrangements of the assay components, such as the use of distinct capture molecules arranged spatially or via barcoded particles, for multiplexing.
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Claim 3: Encompasses a kit comprising the reagents and apparatus necessary to perform the claimed multiplex detection method.
Scope of the Claims
The claims are deliberately broad, emphasizing:
- The use of multiple capture agents (antibodies, aptamers, or other binding partners),
- The application of specific detection labels,
- The implementation on various solid supports (microarrays, bead-based systems),
- Kits that incorporate the assay reagents and detection systems.
This comprehensive approach aims to encompass all feasible embodiments of multiplex immunoassays that detect multiple analytes in a single sample.
Dependent Claims
Dependent claims narrow the scope by specifying certain features:
- Specific label types (fluorophores, nanoparticles),
- Particular solid support materials (nitrocellulose, microbeads),
- Specific detection methods (fluorescence, luminescence),
- Variations in sample preparation steps.
Implications for Patent Scope
The strategic breadth of these claims aims to cover both fundamental method embodiments and variations that practitioners commonly employ in multiplex diagnostics. However, the claims' scope may be challenged if prior art demonstrates similar multiplexing techniques, especially those using comparable reagents or configurations.
Patent Landscape in Australia
Regional Context
Australia's biotechnology patent landscape is characterized by a balanced approach to protecting innovative diagnostic methods. As in other jurisdictions, the landscape features notable filings from global diagnostics developers like Abbott, Roche, and Siemens, alongside academic institutions innovating in multiplex assays.
Key Competitors and Patent Art
AU2018376817 coexists within a crowded landscape where multiple patents focus on:
- Detection methods (e.g., lateral flow, bead-based),
- Multiplexing techniques (e.g., spatially separated arrays, encoded particles),
- Specific analyte detection systems (e.g., cytokines, hormones).
Similar Australian patents (e.g., AU2018104389, covering multiplex immunoassays for specific analytes) indicate active patenting activity around multiplex systems.
Legal Status and Opposition
As of the current status, AU2018376817 remains granted, with potential for post-grant oppositions by competitors claiming overlapping scopes. The patent's strength will depend heavily on the validity of its inventive step over the prior art, considering Australia’s adherence to strict novelty and inventive step standards.
Patent Extent and Market Impact
Its enforceability within Australia could influence licensing negotiations and potentially block competitors from deploying similar multiplex immunoassay platforms. Due to its broad claims, competitors might have to design around, which can be complex and resource-intensive.
Strategic Insights
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Broad Claims Evaluation: The patent's broad scope offers market exclusivity but also faces challenges from prior multiplex assays, emphasizing the necessity of clear inventive steps.
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Infringement Risks: Companies developing multiplex diagnostics should evaluate claim scope carefully to avoid infringement, especially if similar configurations are employed.
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Licensing and Commercialization: The patent presents a potentially valuable asset for licensing, particularly in the rapidly expanding diagnostics market, but assessments of validity and enforceability should precede negotiations.
Key Takeaways
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Patent AU2018376817 covers a broad multiplex immunoassay method and kit, with claims designed to encompass various embodiments within the multiplex detection field.
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Its scope includes specific arrangements of capture agents, labels, solid supports, and detection methods, potentially providing comprehensive market protection.
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The patent exists within a competitive Australian landscape featuring active innovations in multiplex diagnostics, warranting thorough freedom-to-operate analyses for market entrants.
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Due to its broad claims, enforceability and validity will depend on prior art and patent prosecution history. Strategic licensing or infringement prevention hinges on detailed claim interpretation and prior art analysis.
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Stakeholders should monitor patent status and potential oppositions, leveraging this patent’s scope to bolster commercial or defensive IP strategies in Australia.
FAQs
1. What is the primary innovation claimed in AU2018376817?
The patent claims a multiplex immunoassay method allowing the simultaneous detection of multiple analytes using specific binding partners and detection labels arranged on a solid support, with broad embodiments covering various assay configurations.
2. How does this patent compare to other multiplex assay patents in Australia?
It offers broader claims encompassing multiple assay components and configurations. However, it exists within an active patent landscape with similar patents, necessitating detailed prior art analysis to confirm novelty and inventive step.
3. Can this patent cover new multiplexing technologies like nanoparticle-based detection?
Yes, if the claims encompass labels such as nanoparticles and specific assay arrangements, it could potentially cover such advancements, depending on claim scope and prosecution history.
4. What are the enforcement challenges associated with broad claims like these?
Broad claims face potential validity challenges from prior art disclosures. Defenders might argue claims are overly broad or anticipated, especially if similar multiplex systems predate the patent filing.
5. How should potential licensees or competitors approach this patent?
They should perform detailed freedom-to-operate assessments, focusing on claim language and prior art. Licensing negotiations must consider the patent’s scope and jurisdictional enforceability, while designing around the claims if necessary.
References
- Australian Patent AU2018376817. “Method for detecting multiple analytes in a sample using a multiplex immunoassay.” — Official Patent Documentation.
- IPC Classification G01N33/68 — Detection of specific substances by immunologicals, particularly multiple analyte immunoassays.
- Patent landscape reports and analysis of Australian diagnostic patent filings, 2020–2022.
