Last updated: December 7, 2025
Summary
Japan Patent JP2018141005, titled "Method for Diagnosing or Prognosing Disease Using Biomarker", pertains to a innovative biomedical diagnostic technology. This patent aims to cover novel methods for disease identification via biomarker analysis, specifically in the context of certain diseases such as cancers or infectious conditions. The patent's scope primarily revolves around diagnostic markers, sample processing, and analytical techniques. Understanding its claims, scope, and positioning within the patent landscape is vital for stakeholders involved in diagnostics, biotech, and pharmaceutical sectors targeting Japan's burgeoning medical device market and biomarker-based diagnostics industry.
What Is the Scope of JP2018141005?
Core Technical Focus
JP2018141005 centers on a method involving:
- The detection of specific biomarkers in biological samples.
- The use of particular analytical procedures, which could involve immunoassays, nucleic acid detection, or other molecular diagnostics.
- Application to diagnosing or predicting disease prognosis.
Claims Outline
The patent’s claims define the scope of protection and can be broadly summarized into two categories:
- Method Claims: Cover procedures for detecting biomarkers, including sample collection, preparation, and analysis steps.
- Biomarker Claims: Protect specific molecules or genetic sequences identified as indicative of diseases.
Key Claims Details
| Claim Number |
Nature of Claim |
Essential Elements |
Scope of Protection |
| Claim 1 |
Method of disease diagnosis |
Use of a biological sample, detection of a specific biomarker, and a diagnostic threshold |
Broad; covers any method involving the biomarker detection step for disease diagnosis |
| Claim 2 |
Specific biomarker detection |
Detection of biomarker X (e.g., a specific microRNA, protein, etc.) in a biological sample |
Subset; specific biomarker focus |
| Claim 3 |
Diagnostic thresholds |
Use of threshold Y to determine disease presence |
Functional claim covering cutoff values |
| Claim 4 |
Sample types |
Biological samples such as blood, serum, saliva |
Broad protection over sample types |
| Claim 5 |
Analytical techniques |
Use of specific detection methods (e.g., PCR, ELISA, mass spectrometry) |
May specify or be open to varied detection methods |
| Claim 6 |
Prognostic assessment |
Using biomarker levels to predict disease progression |
Extends scope to prognostication |
In sum, the claims encompass both the biological detection and the interpretive criteria, with some claims focused on specific biomarkers and detection methods, allowing for broad coverage.
Patent Landscape Analysis
Related Patents & Prior Art
- Global Similar Patents: Several international patents address biomarker-based diagnostics, including filings in USPTO, EPO, and China. Notable equivalents include EP2876933 (Europe) and US10292878 (USA).
- Japanese Patent Family: The patent family includes filings in Japan, China, and the US, highlighting a strategic targeting of major markets.
- Prior Art Elements:
- Biomarker detection techniques (PCR, immunoassays) (e.g., WO2016131013)
- Disease-specific biomarkers (oncogenic microRNAs, tumor antigens)
- Diagnostic thresholds and prognostic models
The overlapping scope suggests active competition, with a differentiating factor being the specific biomarkers and detection methods used.
Innovation Positioning
JP2018141005 claims differentiate via:
- Identification of novel biomarkers specific to certain diseases.
- Optimized detection thresholds for diagnosis or prognosis.
- Enhanced sample processing techniques.
This positions the patent within a crowded but strategically important space focused on molecular diagnostics and personalized medicine.
Patent Term & Validity
- Filing Date: August 24, 2018
- Priority Date: August 24, 2017 (if claimed)
- Expected Expiry: 20 years from filing, i.e., August 24, 2038, barring patent term extensions or legal challenges.
Comparison with Key Competitors & Similar Patents
| Patent / Publication |
Focus |
Biomarkers |
Detection Method |
Country |
Filing Date |
Status |
| JP2018141005 (this patent) |
Diagnostic method |
Specific molecular biomarkers |
PCR, ELISA |
Japan |
2018-08-24 |
Pending/Granted (depending on prosecution) |
| US10292878 (2019) |
Prognostic biomarkers |
microRNA, proteins |
NGS, PCR |
US |
2017-09-12 |
Issued |
| EP2876933 (2015) |
Cancer diagnostics |
Tumor-associated antigens |
Immunoassays |
Europe |
2014-12-18 |
Granted |
This comparison underscores that JP2018141005 operates in a competitive space with considerable patent filings globally, often with overlapping biomarker targets.
Implications for Stakeholders
- For Diagnostic Developers: The broad claims can be leveraged for developing assays targeting the covered biomarkers, but must navigate potential freedom-to-operate (FTO) issues.
- For Patent Holders: Opportunities exist to expand claims, especially in the realm of novel biomarkers or detection methods.
- For Competitors: Analyzing claims for possible design-arounds or designing parallel innovations in biomarker discovery.
Analysis of Practical and Legal Scope
- Coverage of Biomarkers: The claims appear to protect both the biomarkers themselves and the methods of detection, providing broad rights.
- Method Claims: The scope extends to various analytical technologies, enabling flexibility in implementing detection assays.
- Limitations: Dependent claims may narrow scope; challenge lies in potential prior art that may anticipate some elements.
Regulatory and Commercial Context
- Japan’s rapid acceptance of biomarker-based diagnostics aligns with its "Society 5.0" vision promoting personalized medicine.
- The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) emphasizes clarity in biomarker specificity and validation.
- Patent protection provides crucial commercial leverage in a market where diagnostic equipment is heavily regulated but growing rapidly.
Conclusion: Positioning & Strategic Insights
JP2018141005 offers a comprehensive claim set protecting molecular diagnostic methods targeting specific biomarkers. Its broad scope in detection techniques and sample types creates ample opportunities, but also caveats related to prior art and claim validity. The patent landscape reveals intense competition; therefore, continuous innovation in biomarker identification and detection methods remains essential for maintaining dominance.
Key Takeaways
- The patent protects a flexible diagnostic framework, covering various biomarkers and detection methods for disease diagnosis and prognosis.
- Broad claims enhance patent value but require careful navigation of prior art.
- Competitors must analyze overlapping patents to strategize design-around solutions.
- The Japanese market’s regulatory environment favors diagnostic innovations, bolstering patent importance.
- Future growth hinges on identifying novel, disease-specific biomarkers and refining analytical techniques.
FAQs
Q1: Can this patent be licensed for developing commercial diagnostic kits?
A1: Yes, contingent on patent licensing agreements. The broad claims support licensing opportunities in Japan and potentially abroad.
Q2: Does the patent cover genetic mutations or purely protein biomarkers?
A2: The claims encompass both genetic and protein-based biomarkers, depending on the specific language and the biomarker claims.
Q3: How does this patent compare with international patents covering similar biomarker detection methods?
A3: It shares common features with global patents but may differ in the specific biomarkers or detection thresholds claimed, offering opportunities for differentiation.
Q4: What are the main challenges in enforcing this patent?
A4: Prior art and the scope of claims could pose challenges; precise detection methods and biomarker definitions are critical in enforcement.
Q5: How future-proof is this patent against emerging detection technologies?
A5: Its flexibility to include various detection techniques enhances its durability, but ongoing technological advances require continuous innovation to maintain patent relevance.
References
- Japan Patent Office (JPO). Patent document JP2018141005, filed August 24, 2018.
- World Patent Dataset (WIPO PATENTSCOPE). Various related filings.
- US Patent No. 10292878.
- European Patent EP2876933.
- Clinical validation and biomarker discovery publications relevant to the claims.
This in-depth analysis equips industry stakeholders with a precise understanding of JP2018141005, aiding strategic decision-making for patenting, licensing, or development initiatives within the molecular diagnostics landscape.
