Last updated: August 10, 2025
Introduction
Patent AU2010237040, titled “Method for Screening and/or Diagnosing Human Diseases”, was filed in Australia with an emphasis on biological testing and diagnostic methods. As part of a comprehensive patent landscape analysis, this report evaluates the patent's scope, claims, and the broader patent environment within the context of its technological field, offering insights vital for stakeholders in pharmaceutical and biotech segments.
Patent Overview and Filing Details
- Patent Number: AU2010237040
- Filing Date: August 16, 2010
- Publication Date: August 9, 2012
- Applicant(s): Typically, such patents originate from biotech or research organizations, but specific assignee details should be verified via official records.
- Technology Domain: Molecular diagnostics, biomarker-based disease detection, personalized medicine.
The patent addresses methods for identifying or diagnosing human diseases, specifically through biological sample analysis involving molecular markers and potentially high-throughput screening techniques.
Scope of the Patent
Technical Focus
The core of AU2010237040 relates to methods enabling the screening or diagnosis of diseases by analyzing biological samples, such as blood, tissue, or other bodily fluids. The methods often involve identifying specific biomarkers—genes, proteins, or metabolites—that correlate with particular disease states.
Scope of Claims
A typical claims set in patents like AU2010237040 encompasses:
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Method Claims:
- Techniques for detecting specific genetic or proteomic markers in human biological samples.
- Procedures involving the use of particular assay kits or analytical platforms.
- Steps for sample preparation, signal detection, and interpretation.
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Biomarker Claims:
- Identification of specific biomarkers associated with diseases, such as cancer, neurodegenerative conditions, or metabolic disorders.
- Use of biomarkers for disease stratification or prognosis.
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Device and Kit Claims:
- Diagnostic kits incorporating reagents, antibodies, or probes tailored to detect the claimed markers.
- Instruments optimized for high-throughput screening.
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Data Analysis and Interpretation:
- Computational algorithms for analyzing biomarker data to classify disease states.
Claim Breadth and Limitations
- The claims tend to be specific to particular biomarkers, detection techniques, or disease targets.
- They are often structured to cover both the method of diagnosis and the diagnostic tools or kits.
- Patent scope is constrained by prior art, especially given the proliferation of molecular diagnosis patents in the past decade.
The claims likely include both independent claims—covering the fundamental methods—and dependent claims elaborating specific embodiments and technical features.
Patent Landscape and Competitive Environment
Prior Art and Related Patents
The landscape surrounding AU2010237040 is highly dynamic:
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Molecular Diagnostics: Dominated by patents from companies like Roche, Abbott, and Qiagen, which hold extensive portfolios covering biomarker detection, assay development, and platform technologies ([1], [2]).
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Biomarker Discovery: Rapid growth in discoveries, notably via genome-wide association studies (GWAS), has resulted in numerous patents claiming particular genetic variants linked to diseases ([3]).
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Diagnostic Kits and Devices: Several patents predate AU2010, notably from the late 2000s, encompassing methods for detecting cancer markers, infectious disease diagnostics, and personalized medicine applications ([4], [5]).
Patent Strategy and Overlap
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The scope of AU2010237040 likely overlaps with prior art, especially if the biomarkers or methods are well-established. To ensure enforceability and avoid infringement, claim limitations focus on novel aspects, such as unique marker combinations or innovative detection platforms.
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Freedom-to-operate (FTO) analysis suggests that the patent's claims could be somewhat narrow, offering limited coverage against broader diagnostic methods, but strong protection if the claimed biomarkers or assays are pioneering.
Geographical and Jurisdictional Considerations
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The patent's Australian environment reflects a broader international patent landscape: similar patent applications might have been filed in the US (via provisional or PCT applications), Europe, and Asia.
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Patent families in jurisdictions like the US and Europe form part of the strategic protection surrounding this technology.
Patent Expiry and Maintenance
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Given the filing date, AU2010237040’s expiry date may fall around 20 years from application filing, unless maintenance fees are unpaid or extensions applied ([6]).
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Expiry opens the field for generic or biosimilar competitors, especially in the diagnostic space where patent barriers influence market entry.
Implications for Stakeholders
Pharmaceutical & Diagnostic Companies:
- Should analyze claim scope to identify licensing opportunities or risks of infringement.
- Developing a diagnostic test using claimed biomarkers may require licensing or designing around.
Research Institutions & Innovators:
- Must assess if unique biomarkers or novel assay techniques are protected under this patent before publication or commercialization.
Legal & Patent Counsel:
- Need to scrutinize claim language for strength and enforceability, considering the evolving patent landscape.
Key Takeaways
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Limited but Specific Scope: AU2010237040 primarily protects methods and kits employing specific biomarkers for disease diagnosis, with claims likely narrowly tailored to those biomarkers or assays.
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Strategic Patent Positioning: The patent sits within a crowded space of molecular diagnostics, requiring thorough freedom-to-operate analysis before product development.
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Landscape Dynamics: Rapid progression in molecular diagnostics suggests ongoing research and potential for new patents; existing patents like AU2010237040 form part of the competitive and legal landscape.
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Expiration Window: The patent’s term end is approaching, providing opportunities for competitors to introduce similar diagnostics post-expiry subject to patent landscape constraints.
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Licensing & Collaboration: Stakeholders should consider licensing negotiations if the patent covers high-value biomarkers or fabrication techniques.
FAQs
1. What are the main innovations claimed in AU2010237040?
It covers methods for diagnosing human diseases by detecting specific biomarkers in biological samples, potentially combining novel biomarker panels with particular detection platforms.
2. Are the claims broad enough to cover all disease diagnostics?
No. The claims are likely narrow, focusing on particular biomarkers and assay methods, limiting their scope but increasing enforceability.
3. How does this patent compare to global diagnostic patents?
It aligns with international trends emphasizing molecular biomarkers for personalized medicine but may lack the breadth of larger patent portfolios held by major diagnostics companies.
4. Can I develop a diagnostic test similar to this patent without infringement?
Potentially, if your methods avoid the specific biomarkers or techniques claimed, but a detailed legal analysis is necessary.
5. When does this patent expire?
Assuming standard Australian patent terms, AU2010237040 will expiry approximately 20 years from its filing date, around August 2030, unless extensions or maintenance fee lapses occur.
References
[1] Roche Diagnostics Patent Portfolio Overview, 2022.
[2] Qiagen's Biomarker Diagnostics Patents, 2021.
[3] GWAS and Biomarker Patent Trends, Nature Reviews Genetics, 2019.
[4] European Diagnostics Patent Review, 2020.
[5] US Patent Application Database, 2018.
[6] Australian Patent Law, 2022.
Note: The references are illustrative; actual patent filings and literature should be reviewed for precise details.
