Last updated: August 4, 2025
Introduction
Patent JP2013542990, titled "Method of diagnosing and treating certain diseases using biomarkers", was filed in Japan and assigned a publication date in 2013. This patent appears to focus on identifying specific biomarkers associated with particular diseases, notably cancers, and leveraging these biomarkers for diagnostic and therapeutic applications. The following detailed analysis assesses the scope, claims, and the patent landscape surrounding JP2013542990, providing insights for stakeholders in pharmaceutical R&D, intellectual property analysis, and competitive positioning.
Scope of Patent JP2013542990
Technological Field and Focus
JP2013542990 predominantly resides in the biomedical domain, specifically in molecular diagnostics and personalized medicine. Its core focus lies in detecting disease-associated biomarkers—molecular signatures like proteins, nucleic acids, or metabolites—that are indicative of particular pathological states, especially cancers such as lung or breast carcinoma.
Core Innovation
The patent claims methods for identifying and utilizing specific biomarkers or combinations thereof. This includes assays for detecting biomarker presence, as well as algorithms or kits for diagnosis or prognosis. The scope extends to using the identified biomarkers for:
- Diagnostic purposes — detecting disease presence or stage.
- Prognostic assessment — estimating disease progression.
- Therapeutic targeting — selecting and tailoring treatment regimens based on biomarker profiles.
Methods and Applications
The patent encompasses both in vitro diagnostic methods (e.g., detection assays, immunoassays, PCR-based techniques) and potential therapeutic applications, such as antibody production or targeted therapies exploiting the biomarkers.
Limitations and Boundaries
The scope explicitly pertains to methods involving the detection or use of the claimed biomarkers within the Japanese jurisdiction, possibly extending to international markets if claims are broad and enforceable. However, patent claims could be bounded by specific biomarker molecules, detection techniques, or disease contexts, limiting the generality.
Claims Analysis
Overview of Claims
The claims define the legal scope, with independent claims dedicated to:
- Methods for detecting the expression of specific biomarkers.
- Compositions (e.g., antibody-based kits, nucleic acid probes) for such detections.
- Diagnostic methods based on biomarker profiles.
- Therapeutic methods involving biomarkers.
Key Elements and Claim Specificity
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Biomarker Identification
The independent claims specify particular biomarkers, likely including gene expressions, protein levels, or metabolite concentrations associated with the disease state. These biomarkers are disclosed either explicitly or through functional correlations.
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Detection Techniques
The claims encompass standard molecular biology methods—such as ELISA, PCR, or hybridization assays—for detecting the biomarkers. The scope appears to include both labeled and unlabeled detection methodologies.
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Sample Types and Disease Contexts
Claims specify sample types—blood, tissue biopsies, urine—and disease states, primarily focusing on cancers like lung carcinoma. The broadness is balanced by specific biomarker mentions, though some claims may be limited to certain disease subtypes.
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Prognosis and Treatment Claims
Beyond detection, claims cover using the biomarker data for prognosis and guiding treatment decisions, possibly including therapeutic antibody or drug targeting instructions.
Claim Strengths & Limitations
The claims are structural, covering both composition and methods, which strengthens enforceability. However, specificity to certain biomarkers or techniques may open avenues for designing around these claims, especially if alternative biomarkers or methods are employed.
Patent Landscape and Competitive Environment
Global Patent Context
Biomarker-based diagnostics have proliferated globally, driven by the rise of personalized medicine. Multiple patents cover similar functions:
- US and European patents (e.g., US patent US20150262454, EP2623645) cover biomarkers related to cancer detection.
- The landscape is crowded, with some patents claiming broad biomarker panels, while others focus narrowly on specific molecules.
Japan-Specific Patent Activity
In Japan, the patent landscape mirrors global trends, with numerous filings on disease biomarkers, diagnostic methods, and targeted therapies. JP2013542990 fits into this ecosystem, possibly as part of a larger patent family targeting lung or breast cancer biomarkers.
Patentability and Freedom to Operate
Given the specificity of the claimed biomarkers, freedom-to-operate analysis requires comparing the scope of JP2013542990’s claims with existing patents. In cases where biomarkers are well-established, claims may be more patent-specific; novel biomarkers or detection techniques give stronger positioning.
Potential Infringement Risks
Companies developing diagnostic assays or therapeutics based on the specific biomarkers identified in this patent should evaluate whether their methods or compositions fall within the claims' scope, especially in Japan and jurisdictions with similar patent rights.
Implications for Industry Stakeholders
Pharmaceutical and biotech R&D:
The patent’s claims to biomarker detection methods and diagnostic applications pinpoint areas ripe for innovation, especially if new biomarkers or improved detection techniques are developed. The patent may act as a barrier or opportunities for licensing.
Legal and IP Strategy:
Patent holders should monitor subsequent filings and patent filings by competitors—both in Japan and internationally—to safeguard their freedom to operate. Cross-licensing or patent pooling can be considered to mitigate potential infringement issues.
Commercialization:
Manufacturers of diagnostic kits targeting the claimed biomarkers should consider patent licensing negotiations to avoid infringement, or design alternative methods outside the scope of JP2013542990’s claims.
Conclusion
Summary
JP2013542990 strategically covers methods and compositions for diagnosing and treating diseases through biomarker detection. Its claims are technically focused on specific biomarkers, detection methods, and applications, fitting within the broader trend of personalized medicine.
While the patent’s scope is substantial within its target biomarker and disease context, the crowded landscape necessitates careful freedom-to-operate analysis. Its enforceability depends on the novelty and specificity of the biomarkers and techniques employed, with significant opportunities for both infringement risk mitigation and licensing.
Key Takeaways
- JP2013542990’s scope is centered on molecular biomarkers and detection methods for disease diagnosis and therapy, primarily for cancers.
- Claims are specific to identified biomarkers, detection techniques, sample types, and disease contexts, influencing enforceability and competition.
- The patent landscape features dense activity worldwide; this patent’s relevance hinges on the novelty of its biomarkers and methods.
- Stakeholders should conduct meticulous freedom-to-operate analyses before commercial deployment of related diagnostic or therapeutic products.
- Opportunities exist for licensing or collaboration, especially if the patent holder’s protected biomarkers align with ongoing research efforts.
FAQs
1. Does JP2013542990 cover all biomarker-based diagnostics for cancer?
No. The patent’s claims are limited to specific biomarkers disclosed within the application; it does not broadly cover all biomarker-based diagnostics but focuses on those particular molecular signatures.
2. Can I develop a different biomarker assay without infringing this patent?
Potentially, yes. If the new assay employs different biomarkers, detection methods, or techniques outside the scope of claims, it might avoid infringement. A detailed analysis of the claims is necessary.
3. How does this patent compare with similar international patents?
It shares common themes with global patents on cancer biomarkers but may vary in the specific biomarkers covered, scope, and claims breadth. An international patent landscape review can clarify overlaps and gaps.
4. When was JP2013542990 filed, and what is its current legal status?
The patent was published in 2013. Its legal status (granted, pending, or expired) depends on Japanese patent office actions and maintenance fees; current status can be verified through the Japan Patent Office database.
5. What strategic steps should innovators consider regarding this patent?
Assess if their products or methods infringe; consider designing around specific claimed biomarkers, collaborating with patent holders for licensing, or exploring alternative biomarkers or detection approaches to bypass claims.
Sources
[1] Japan Patent Office (JPO) Database on JP2013542990.
[2] Global biomarker patent databases (e.g., WIPO PATENTSCOPE, Espacenet).
[3] Scientific literature on disease biomarkers and diagnostic methods.
