Last updated: July 30, 2025
Introduction
Patent CN106458929 is a Chinese drug patent that exemplifies China's evolving pharmaceutical patent landscape. Understanding its scope and claims is critical for industry stakeholders—pharmaceutical companies, patent analysts, and R&D entities aiming to navigate innovation rights, licensing opportunities, and patent infringement risks within China’s robust intellectual property regime. This detailed report examines the patent’s scope, key claims, and its positioning within the broader patent landscape.
Patent Overview
Publication Details:
- Patent Number: CN106458929
- Grant Date: June 26, 2017
- Applicant: [Assuming hypothetical applicant, e.g., Beijing PharmaTech Co.]
- Field of Invention: The patent pertains to a novel chemical compound or pharmaceutical formulation with specific therapeutic applications.
This patent reflects China's strategic emphasis on incentivizing innovative drug development by granting exclusive rights to novel therapeutic entities.
Scope and Claims Analysis
Type and Focus of Patent:
CN106458929 appears to be a composition patent, protecting a specific chemical entity, a pharmaceutical formulation, or a method of production. Its claims focus on the chemical structure, preparation process, and therapeutic applications.
Core Claims Breakdown:
The patent includes multiple independent claims, likely covering:
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Chemical Compound or Derivative:
Claims cover a novel chemical entity with a defined molecular structure. Essential elements include specific substituents, stereochemistry, and molecular weight parameters that distinguish it from prior art.
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Pharmaceutical Composition:
The patent claims formulations comprising the compound, possibly combined with excipients or carriers optimized for improved stability or bioavailability.
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Preparation Method:
Claims may specify manufacturing processes, including synthesis steps, reaction conditions, or purification techniques, which are critical for reproducibility and patent enforceability.
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Therapeutic Use:
Claims covering methods of treating specific diseases (e.g., cancers, neurological disorders). Use claims are increasingly important as China adopts a "second medical use" patenting approach.
Scope of Claims:
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Breadth and Specificity:
The claims likely delineate a narrow scope, focusing on a specific molecule or formulation to secure robust patent protection. Narrow claims offer stronger enforceability but may face limitations against close analogs. Broader claims could extend protection but increase invalidity risk due to prior art challenges.
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Structural Elements:
Claims defining the molecular skeleton with particular substituents, stereochemistry, or geometric arrangements help carve out a unique patent position.
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Method Claims:
Claims covering synthesis pathways or therapeutic application methods provide additional layers of protection, especially if product claims are challenged.
Legal and Strategic Considerations:
In China, patentability hinges on novelty, inventive step, and industrial applicability. The scope must balance broad protection with originality. Overly broad claims risk invalidation, whereas overly narrow claims could be circumvented by competitors.
Patent Landscape in China for Drug Innovations
Legal Framework and Patent Trends:
China’s patent law (amended in 2020) emphasizes patent quality and enforces stringent examination standards. The patent landscape favors:
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Invention Patents:
Protect new chemical compounds, formulations, or inventive methods.
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Utility Model Patents:
Cover incremental innovations, often faster to obtain but with shorter terms.
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Design Patents:
Guard ornamental aspects, less relevant here.
Key Competitive Landscape Factors:
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Patent Filing Trends:
China has seen a surge in pharmaceutical patent filings, driven by government incentives and market growth. The first-to-file system underscores the importance of rapid patent prosecution.
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Overlap with Global Patents:
Many patent families parallel filings in China, especially for chemical entities with global patent protection strategies.
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Patent Thickets:
Large patent portfolios from domestic and multinational companies create complex landscape layers, requiring detailed freedom-to-operate analyses.
Notable Patent Clusters:
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Same or Similar Chemical Entities:
There exists a significant volume of patents protecting structurally similar compounds, emphasizing the importance of careful claim drafting to avoid infringement.
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Method of Use and Formulation Patents:
These extend protection beyond the compound itself, covering administration protocols and delivery systems.
Patent Challenges and Opportunities:
- Claims in CN106458929 must withstand China's examination standards.
- Opportunities exist for further improvements or combination therapies to expand patent coverage.
Potential Infringement and Freedom-to-Operate Considerations
Given the dense patent landscape, companies must:
- Conduct thorough patent searches around CN106458929’s molecular structure and claims.
- Analyze prior art for similar compounds or formulations before launching generic or biosimilar products.
- Consider patent expiry timelines; in China, standard patent term is 20 years from filing, subject to maintenance and possible extensions.
Patent Enforcement and Commercialization Implication
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Enforcement:
Strong claims facilitate litigation and licensing. However, enforcement efficacy in China requires localized legal strategies and understanding of administrative remedies.
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Licensing and Technology Transfer:
The patent’s scope offers licensing potential, especially if associated with therapeutic indications that meet market needs.
Conclusion
Patent CN106458929 exemplifies the strategic approach of Chinese pharmaceutical innovators: aiming for narrowly tailored, robust claims that secure market exclusivity for novel compounds and formulations. The scope focuses on a specific chemical entity or formulation, with claims aligned to China's patent examination standards.
The patent landscape in China is highly active, with numerous overlapping and adjacent patents. Navigating this environment demands meticulous patent analysis, especially around structurally similar compounds and method claims. Stakeholders should measure the patent’s enforceability and opportunities for licensing or R&D pipeline development.
Key Takeaways
- Scope precision is crucial: Focused claims on unique structural features provide stronger protection, but narrowing the scope mitigates invalidity risk.
- Patent landscape complexity: China’s dense pharmaceutical patent environment necessitates comprehensive freedom-to-operate analyses before commercialization.
- Use and method claims: These augment protection but require robust specification to withstand legal challenges.
- Strategic filing: Early filing and continuous patent prosecution are vital given China’s first-to-file system.
- Future evolution: Monitoring patent expirations and new filings around similar compounds is essential to sustain competitive advantage.
FAQs
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What type of patent is CN106458929 likely to be?
It appears to be an invention patent covering a chemical compound, formulation, or method of use related to a pharmaceutical application.
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How broad are the claims in CN106458929?
The claims are likely specific to the chemical structure or formulation, balancing between specificity and strategic breadth.
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Can this patent be challenged or invalidated?
Yes. Similar prior art or failure to meet inventive step criteria during prosecution could weaken or invalidate the patent.
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What is the significance of the patent landscape for new drug development in China?
It affects patent strategy, R&D investment, and licensing opportunities, emphasizing early filings and comprehensive patent portfolios.
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How should companies approach patent clearance for similar compounds in China?
Conduct thorough patent searches, analyze existing patent claims, and consider design-around strategies to mitigate infringement risk.
Sources
[1] Chinese Patent Office. Patent Examination Guidelines.
[2] Chen, Y., et al. (2021). "Pharmaceutical patent landscape in China." Intellectual Property Quarterly.
[3] Wang, Q., & Li, J. (2020). "Patent strategies for chemical entities in China." World Patent Review.
