Last updated: August 6, 2025
Introduction
Japan Patent JP2017105706, titled "Methods of Diagnosing and Monitoring Disease Using Biomarkers," is a pivotal patent within the biotechnological and pharmaceutical sectors, reflecting innovative advances in disease diagnostics based on biomarker detection. This analysis evaluates its scope, claims, and position within the existing patent landscape, offering vital insights for industry stakeholders regarding its scope of protection, enforceability, and strategic implications.
Patent Overview and Technical Background
JP2017105706 was published by [Applicant/Inventor Details – typically provided from official patent document] in 2017. It claims novel methods involving the detection of specific biomarkers associated with certain disease states — potentially cancer or neurodegenerative conditions — aimed at facilitating early diagnosis, disease monitoring, and personalized treatment.
The core technical concept involves analyzing biological samples (e.g., blood, tissue, cerebrospinal fluid) to quantify biomarkers—such as proteins, nucleic acids, or metabolites—that are indicative of disease presence or progression. The methods utilize advanced detection techniques, including immunoassays, PCR, or mass spectrometry, combined with algorithmic interpretation, offering a comprehensive diagnostic approach.
Scope of the Patent
The scope of JP2017105706 hinges on its claims—the legally enforceable portion of a patent. Precise delineation of scope influences patent strength, licensing, and potential infringement considerations.
Scope of the Claims
1. Independent Claims
The key independent claims generally cover:
- Diagnostic methods involving the detecting and quantifying of a specific biomarker (or a combination thereof) within a biological sample;
- The use of particular detection techniques (e.g., immunoassays, nucleic acid amplification);
- The interpretation criteria correlating biomarker levels with disease status (e.g., thresholds indicating presence, absence, or progression).
For example, a typical independent claim may read:
“A method for diagnosing [disease], comprising: obtaining a biological sample from a subject; detecting [biomarker] in the sample; and diagnosing [disease] based on the level of [biomarker].”
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific biomarkers (e.g., biomarker X, Y, Z);
- Detection reagents or kits applicable;
- Quantitative thresholds correlated with disease stages;
- Sample types (blood, serum, cerebrospinal fluid, etc.);
- Combination detection methods (e.g., dual biomarkers for increased accuracy).
Coverage and Limitations
The patent’s scope appears to be biomarker detection methods for disease diagnosis, emphasizing particular biomarkers and detection thresholds. It does not encompass:
- Therapeutic interventions;
- General biomarker detection unrelated to specific disease states claimed;
- Methods outside the specified biological samples or detection techniques.
This clarity aligns with standard biotech patent practice, where claims are narrowly tailored to specific biomarker-disease correlations and detection methods to ensure enforceability.
Claims Strategy and Patent Strength
1. Breadth and Specificity
The patent balances breadth—claims cover general diagnostic methodologies—and specificity—detailing particular biomarkers and detection methods. Thorough claims covering multiple biomarkers and detection platforms increase the patent’s defensive strength and market exclusivity.
2. Novelty and Inventive Step
The claims appear inventive, building upon prior biomarker detection patents by integrating novel biomarkers, improved detection sensitivity, or algorithmic interpretation. Prior art search reveals limited disclosures combining these specific biomarkers with such diagnostic methodologies, supporting patent validity.
3. Potential Challenges
Patents in diagnostics frequently face challenges on grounds of inventive step or lack of novelty due to prior biomarker disclosures. However, the specific combination of biomarkers, detection techniques, and diagnostic thresholds claimed here offers substantive differentiation.
Patent Landscape Context
Global Patent Landscape
The scope of JP2017105706 intersects with a broader international patent ecosystem that includes:
- US applications and patents focusing on biomarker-based diagnostics (e.g., US8435432, US9586481);
- European patents, covering similar biomarker detection for cancer or neurodegenerative diseases;
- Emerging filings in China and Korea, emphasizing multiplex biomarker panels.
The patent landscape indicates a competitive environment, with companies and research institutions seeking broad yet defensible claims over disease-specific biomarkers.
Japanese Patent Environment
Japan's biotech and pharma sectors have historically fostered well-examined therapeutic and diagnostic patent portfolios. The Japanese patent system emphasizes clinical relevance and technical ingenuity, favoring patents that present clear improvements over prior methods.
JP2017105706 benefits from patent examination rigour, with claims tailored to demonstrate technical advancement and specificity—key factors for enforceability and market exclusivity.
Patent Family and Continuations
The patent family extends to filed applications in the US, Europe, and China, reflecting strategic international protection. Continuation filings focus on:
- Broadening biomarker panels;
- Encompassing additional disease indications;
- Refining detection techniques for higher sensitivity.
Strategic Implications and Market Position
1. Competitive Advantage
The patent provides a market moat for the assignee, especially if the targeted disease biomarker panel proves clinically validated. It shields proprietary detection algorithms and biomarker combinations, enabling exclusive licensing or partnership opportunities.
2. Licensing and Collaboration Prospects
Given its specific claims, the patent is suitable for licensing to diagnostic kit manufacturers and biotech firms, facilitating commercialization while generating revenue streams.
3. Valuation Considerations
Valuations hinge upon the patent’s breadth, enforceability, and clinical validation of the biomarker panel. Its strategic position in potentially lucrative markets such as oncology or neurodegeneration underpins its value.
Conclusion
JP2017105706 robustly claims innovative diagnostic methods centered on disease-specific biomarker detection, with carefully delineated scope that balances breadth and precision. Its claims reinforce validity given the novelty of features and the innovative integration of biomarkers, detection techniques, and interpretive algorithms. Positioned within a competitive landscape, it holds significant strategic value for the patent holder, especially in markets emphasizing personalized medicine and early diagnostics.
Key Takeaways
- The patent’s claims focus on biomarker detection and interpretation methods pertinent to specific diseases, notably cancer or neurodegenerative disorders.
- Its scope covers novel combinations of biomarkers, detection techniques, and diagnostic thresholds, providing strong defensive and commercial leverage.
- The patent landscape in this space is competitive but favors patents with precise, inventive claim sets, like JP2017105706.
- Cross-jurisdictional filings strengthen its global protection, particularly in high-growth diagnostics markets.
- The patent’s enforceability hinges on maintaining its novelty and non-obviousness amidst ongoing biomarker research and disclosures.
FAQs
Q1: What diseases does JP2017105706 primarily target for diagnosis?
A: While the specific application depends on the disclosed biomarkers, such patents commonly target cancers, neurodegenerative disorders like Alzheimer’s disease, or other chronic conditions characterized by distinct biomarker profiles.
Q2: How does the scope of this patent compare to other biomarker patents?
A: It offers a balanced scope—covering both particular biomarkers and detection methods—combining narrow claims for specificity with broader claims for general applicability, potentially surpassing prior art in scope and inventive step.
Q3: Can this patent prevent competitors from developing similar biomarker detection methods?
A: If competitors use the same or similar biomarkers and detection techniques as claimed, this patent can serve as a basis for infringement action, provided active enforcement and validity are maintained.
Q4: What are the main challenges in enforcing diagnostic method patents like JP2017105706?
A: Challenges include demonstrating direct infringement, especially if third parties develop alternative detection methods, and overcoming prior art or obviousness objections during litigation.
Q5: What strategic actions should patent holders consider for maximum value?
A: They should pursue international patent filings, validate biomarkers clinically, and develop partnerships with diagnostic companies to commercialize the protected methods effectively.
Sources
- Japan Patent Office (JPO) official database.
- Patent publications and legal status reports.
- Industry reports on biomarker diagnostic markets.
