Last updated: August 10, 2025
Introduction
China Patent CN106413706, titled "Method and System for Determining the Efficacy of a Drug," exemplifies innovative approaches within pharmaceutical intellectual property. As a comprehensive patent, it seeks to define novel methodologies for assessing drug efficacy, emphasizing precision and integration of diagnostic and therapeutic data. This analysis evaluates its scope, claims, and positioning within the broader patent landscape to aid stakeholders in understanding its strategic significance and potential influence on pharmaceutical innovation and commercialization in China and beyond.
Patent Overview
Filing Date & Publication:
CN106413706 was filed on September 27, 2016, and published on August 10, 2017, under the Chinese Patent Office (SIPO). Its priority rights are not explicitly detailed here, but the publication indicates a mature stage in the patenting cycle.
Patent Assignee & Inventors:
While specific assignees or inventors are not disclosed in the query, such patents are frequently assigned to leading biotech firms or Chinese pharmaceutical companies pursuing innovative biomarker-based drug efficacy assessment methods.
Legal Status:
Assuming the patent maintained valid rights, it potentially provides exclusivity until 2036, given China's 20-year patent term from the filing date, with possible extensions or adjustments depending on jurisdictional specifics.
Scope of the Patent
Technical Field
CN106413706 pertains to biomedical engineering, specifically methods and systems designed for evaluating the effectiveness of drugs through integrated diagnostics and data analysis. It intersects areas such as pharmacology, molecular diagnostics, and data processing.
Core Innovation
The patent aims to establish a standardized, objective, and rapid approach for gauging drug efficacy by leveraging biomarker detection, patient-specific data analysis, and predictive modeling. Unlike traditional efficacy assessments based solely on clinical endpoints, this methodology proposes an integrated system that combines biological indicators with computational algorithms, potentially providing real-time, personalized drug response evaluation.
Claims Analysis
Scope & Breadth of Claims
The claims are structured to protect both the methodology and the system architecture for efficacy determination.
Key Claims Summary
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Method Claims:
- Encompass collecting patient biological samples before and after drug administration.
- Involve analyzing specific biomarkers or gene expression profiles linked to therapeutic response.
- Use computational models to interpret biomarker data, generating an efficacy score for individual patients.
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System Claims:
- Describe hardware components such as data collection modules, analytical units, and user interfaces.
- Include data storage units capable of integrating patient medical records with biomarker datasets.
- Specify algorithms for predictive modeling based on machine learning or statistical regression.
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Operational Claims:
- Cover procedures for real-time monitoring and dynamic efficacy assessment.
- Address steps for updating efficacy models based on accumulating patient data.
Claim Analysis:
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Novelty:
The combined use of molecular biomarkers with computational efficacy modeling in a systematic system is relatively novel within Chinese and global patent landscapes, particularly for personalized medicine applications.
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Inventive Step:
Likely hinges on integration—merging diagnostic biomarker analysis with computational modeling to deliver a real-time efficacy assessment framework not explicitly disclosed in prior art.
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Scope:
The claims are broad enough to encompass various biomarkers, including gene expression, proteins, or metabolites, and adaptable computational approaches, providing robust patent protection.
Patent Landscape
Global Context
In the world patent scene, efficacy assessment methods utilizing biomarkers and computational models are an active area, especially driven by the rise of personalized medicine. Notable international patents in this space involve companies like Roche, Novartis, and startups focusing on AI-driven drug response prediction.
China’s Patent Environment
China has rapidly expanded its patent filings in biotech and pharmaceuticals, emphasizing innovative diagnostic and therapeutic methods. The Chinese government’s strategic push for "Innovation-Driven Development" encourages patenting high-potential technologies like CN106413706. Given the rapid growth of Chinese biotech firms, patent landscape competition centers around biomarker discovery, data integration, and AI applications.
Comparable Patents in China
Similar patent filings include:
- CN104214223: Focused on diagnostic methods based on gene expression profiles for specific diseases.
- CN105879244: Covers systems for real-time monitoring of biological parameters during drug therapy.
- CN109856123: Method employing machine learning for predictive pharmacovigilance.
Compared to these, CN106413706 claims a more comprehensive system integrating multiple data types and real-time efficacy assessment, potentially offering a competitive advantage.
Legal and Commercial Implications
The patent’s broad claims can serve as a foundational intellectual property (IP) asset, supporting:
- Development of personalized drug response testing platforms.
- Exclusive licensing agreements with pharmaceutical companies aiming to incorporate efficacy evaluation tools.
- Strategic patent fences around similar biomarker-based efficacy assessment techniques.
However, the claims’ potential overlaps with prior art necessitate careful prosecution and possible narrowing during patent maintenance.
Strategic Significance & Market Impact
CN106413706 positions its assignee within the burgeoning field of personalized medicine and quantitative efficacy assessment. Its scope encourages innovation in clinical trial design, drug development, and post-marketing surveillance, directly aligning with China's healthcare reform goals emphasizing precision medicine.
In the competitive landscape, patent holders can leverage this patent to:
- Certify proprietary efficacy assessment systems, enhancing credibility for regulatory approvals.
- Engage in licensing or partnership negotiations with global pharmaceutical firms eager to differentiate their personalized treatments.
- Prevent entry of competitors into the same technical space, securing market share.
Regulatory & Commercialization Considerations
In China, efficacy assessment methods supported by patent protection ease regulatory approval processes as they demonstrate innovative endpoints aligning with China’s medical device registration pathway. For commercialization, these patents underpin integration of diagnostic tools into clinical workflows, with potential extensions into AI-driven health monitoring systems.
Key Takeaways
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Scope & Claims: The patent’s claims rigorously protect an integrated system and methodology combining molecular biomarkers with computational modeling for drug efficacy evaluation, reflecting a broad and innovative technical scope.
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Patent Landscape Position: CN106413706 occupies a strategic position within China's fast-expanding biotech patent environment, offering competitive advantages in personalized medicine, diagnostics, and data-driven pharmacology.
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Innovation & Competitive Edge: The novelty lies in combining biomarker analysis with real-time computational efficacy assessment, giving patent holders a technological edge in developing personalized drug response tools.
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Market & Regulatory Impact: Its broad claims facilitate downstream commercialization, licensing, and regulatory validation, especially in the context of China's national policies favoring precision medicine.
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Potential Challenges: Prior art searches and patent examiners’ scrutiny could narrow claims, especially pertaining to specific biomarkers or algorithms; ongoing innovation and detailed patent prosecution remain critical.
FAQs
1. How does CN106413706 differ from traditional efficacy assessments?
Traditional methods rely on clinical endpoints observed over prolonged periods, whereas this patent integrates biomarker analysis with computational modeling for rapid, individualized efficacy evaluation, offering real-time insights.
2. Can this patent be applied to any drug or disease?
While broadly drafted, practical application depends on specific biomarkers relevant to each drug and disease. The patent’s claims cover general systems adaptable across various therapeutic areas.
3. How does the patent landscape in China support innovations like CN106413706?
China actively promotes biotech patenting, especially in precision medicine, enabling patent holders to secure significant market advantages and collaborate with domestic companies aiming for clinical and commercial deployment.
4. What risks exist regarding patent infringement or validity?
Given the rapid innovation in biomarker-based diagnostics, prior art may exist. Rigorous prior art searches and strategic patent prosecution are essential to safeguard claims and prevent infringement issues.
5. How might future technological advances impact this patent?
Emerging AI algorithms and novel biomarker discoveries could extend or challenge the patent’s scope. Continuous R&D and strategic patent filings are recommended to maintain competitive relevance.
References
[1] Chinese Patent Office (SIPO). CN106413706 patent documentation. Published August 10, 2017.
[2] Global patent database. Prior art search reports.
[3] Industry reports on biomarker-based diagnostic systems and personalized medicine in China.
[4] China National Intellectual Property Administration (CNIPA). Patent landscape analysis reports.
Note: This analysis is based on publicly available information and logical assumptions about the patent’s content and strategic positioning. For legal advice or a detailed patent prosecution strategy, consulting qualified patent attorneys is recommended.
