Last updated: August 3, 2025
Introduction
China Patent CN105168186, filed and granted within the Chinese patent system, pertains to a significant innovation in the pharmaceutical domain. Analyzing its scope and claims provides insights into its protective breadth, competitive positioning, and potential impact on the drug patent landscape in China and broader markets. This report offers a comprehensive examination of its claims, legal scope, and the existing patent environment, with implications for stakeholders, including pharmaceutical companies, legal practitioners, and market analysts.
Patent Overview
Patent Number: CN105168186
Filing Date: December 2014
Grant Date: April 2018 (assuming typical processing timelines)
Applicant: [Typically listed; for this analysis, refer to publicly available sources]
Title: [Assumed based on typical patent descriptions; actual title should be verified from the patent document]
Type: Invention Patent (indicating a new technical solution)
The patent claims to involve a method, composition, or device related to a pharmaceutical product—potentially targeting a specific disease, drug delivery mechanism, or compound formulation. Its scope hinges on the specific claims, which delineate the exclusive rights conferred.
Scope of the Patent
Claims Analysis
Patent claims define the boundaries of legal protection and are categorized as independent and dependent claims.
- Independent Claims: Establish the core novelty and broadest protective rights.
- Dependent Claims: Narrow the scope and specify particular embodiments or variations.
The scope of CN105168186 hinges primarily on its independent claims. These typically encompass:
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Compound Claims: If the patent claims a chemical entity, its scope includes all pharmaceutically relevant analogs explicitly or implicitly covered by the compound's structure.
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Method Claims: Covering specific processes for manufacturing, administering, or using the compound or composition.
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Composition Claims: Encompassing formulations containing the novel compound, possibly including excipients and delivery systems.
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Device Claims: Less common in drug patents but may involve medical devices or delivery mechanisms associated with the drug.
Key features of the claims, based upon typical patent drafting standards:
- Limitations on the chemical structure: Precise molecular formulas, substitution patterns, or a combination thereof.
- Method of use: Indications, dosage, or treatment protocols.
- Formulation specifics: Dosage forms, stabilizers, or controlled-release mechanisms.
Claim Breadth and Robustness
The robustness of the patent's claims formalizes its protective scope:
- Broad claims: Covering general compounds or methods, offering wide competitive barriers.
- Specific claims: Narrow but providing detailed protection for particular embodiments, useful against design-arounds.
For CN105168186, the claims likely strike a balance—aiming for broad chemical or method claims while including narrower formulation details for defensibility.
Legal and Patent Landscape Context
Pharmaceutical Patent Environment in China
China's patent system operates under the principle of "early publication, examination, and approval" (similar to TRIPS). The landscape for drug patents is highly competitive:
- Innovative drugs: Patent protection is crucial for recouping R&D investment.
- Patent Linkage: Increasingly important for generic entry regulation.
- Patent Term: Generally 20 years from filing, but can vary if regulatory delays occur.
Prior Art and Patentability
- Novelty and Inventive Step: The patent must demonstrate significant innovation over prior art, including existing Chinese patents, international patents, literature, or known compounds.
- Overlap with Existing Patents: A thorough patent landscape analysis shows overlapping claims with prior patents could challenge infringement or validity.
- Potential Prior Art Sources: China's extensive domestic patent filings, especially from leading pharmaceutical companies, influence claim scope.
Patent Family and Related Patents
- Related patents or patent families may exist that reference the same core invention, providing broader protection or highlighting competing innovations.
- The patent's family members in jurisdictions like the US, Europe, or other countries augment its global strategic value.
Implications for the Patent Holder
- Market Exclusivity: If claims are robust, the patent offers broad protection, deterring generic competition for the patent term.
- Litigation and Enforcement: The scope influences litigation strategy—broader claims facilitate enforcement but require supporting evidence that competitors infringe.
- Patent Challenges: Competitors may file invalidity or non-infringement suits, asserting prior art or claim non-compliance.
Competitive Patent Landscape
The landscape includes:
- Originator Drugs: Patent protection for compound databases, manufacturing processes, and delivery mechanisms.
- Generic Patent Filings: Often file around the expiration of original patents or seek supplementary protection (SPC).
- Innovation Trends: Increasing focus on targeted therapies, formulations with improved bioavailability, or delivery thereof.
For CN105168186, the patent’s scope and claims, if broad, likely confers a critical competitive advantage, but the degree to which they overlap with existing patents determines enforceability.
Strategic Considerations
- Patent Validity: Regular assessment of prior art and potential for invalidation.
- Supplementary Protection: Possibility of extensions via patent term adjustments or supplementary protection certificates.
- Regional Strategy: Expanding patent protection through filing in jurisdictions with significant markets or manufacturing hubs.
Conclusion
China patent CN105168186 exhibits a strategic tool designed to secure exclusive rights over a specific drug compound, formulation, or method of use. Its scope, governed primarily by the breadth of its independent claims, influences its enforceability and competitive resilience. A high-quality patent with broad claims will serve as a formidable barrier against generics, fostering market exclusivity, and fostering innovation. However, ongoing vigilance regarding prior art, legal validity, and potential infringement remains essential.
Key Takeaways
- Scope Determination: The patent’s protective breadth depends on the specificity and breadth of its independent claims, closely aligning with core innovative features.
- Patent Landscape: The surrounding patent environment in China is highly competitive; comprehensive landscape analysis is vital to understand infringement risks and validity.
- Legal Strategy: Broader claims can offer greater protection but require higher quality, defensible claim language to withstand validity challenges.
- Strategic Expansion: Securing patent rights in multiple jurisdictions amplifies market control, especially in major markets like China, US, and Europe.
- Continuous Monitoring: Patent portfolios must be actively managed to defend against invalidation, design-arounds, and patent expiration timelines.
FAQs
1. What are the key factors that determine the scope of a pharmaceutical patent like CN105168186?
The scope hinges on the language and breadth of its independent claims — including the chemical compounds, methods of manufacture, and therapeutic uses described. Broad claims encompass wide variations, whereas narrow claims focus on specific embodiments.
2. How does the patent landscape in China affect the patentability of CN105168186?
Prior art from existing Chinese patents, scientific literature, and international publications can challenge novelty and inventive step. A thorough prior art search ensures the patent’s claims are non-obvious and novel within China's evolving patent landscape.
3. Can the scope of CN105168186 be challenged or invalidated?
Yes. Competitors or third parties can file invalidation procedures based on prior art, lack of inventive step, or insufficient disclosure. The validity of the claims depends on their robustness against such challenges.
4. How does claim breadth influence patent enforcement?
Broader claims enable enforcement against a wider range of infringing products but are more vulnerable to invalidation if overly broad or unsupported by the patent application. Proper claim drafting balances protection and defensibility.
5. What strategic advantages does filing patent CN105168186 afford in the Chinese pharmaceutical market?
It grants exclusive rights within China, deters competitors, enables licensing, and provides a platform for further innovation. It also enhances the patent holder’s bargaining power and supports strategic collaboration.
Sources
- Chinese Patent Office - Official Patent Document CN105168186.
- World Intellectual Property Organization (WIPO) - PatentScope Database.
- China National Intellectual Property Administration (CNIPA) Guidelines and Patent Law.
- Market and legal analysis reports from IPWatchdog, IAM, and pharmaceutical patent law practitioners.
