Last updated: July 28, 2025
Introduction
China Patent CN104203266, granted in 2015, pertains to a novel pharmaceutical invention, specifically revolving around a unique formulation or application of an active pharmaceutical ingredient (API). An in-depth examination of this patent’s scope, claims, and positioning within the broader patent landscape is essential for pharmaceutical innovators, legal professionals, and strategic planners assessing patent strength, infringement risks, and market opportunities within China. This analysis synthesizes the patent’s technical content, claims architecture, and its contextual positioning within existing patents to inform business strategy and intellectual property management.
Patent Summary
CN104203266 relates to a pharmaceutical composition, possibly an innovative formulation or delivery system, designed to improve efficacy, stability, or patient compliance. The patent’s primary domain covers pharmaceutical compositions, their preparation methods, and potentially their use in treating specific conditions. While the complete technical disclosure details are proprietary, publicly available patent classifications and claim structures offer critical insights into its scope.
Patent Classification and Technical Domain
The patent predominantly falls within Chinese patent classification C07D, related to heterocyclic compounds, and A61K, designated for medical preparations. This indicates involvement with chemically active compounds, likely heterocyclic or structurally complex molecules formulated as therapeutic agents.
The focus appears centered on:
- Novel chemical entities or derivatives enhancing pharmacodynamic properties;
- Specific formulations or delivery systems improving drug stability or bioavailability;
- Methodology claims for preparing the compound or composition.
This classification positioning suggests claims are technically rooted in medicinal chemistry and formulation science, aiming to establish a competitive advantage via patent exclusivity.
Scope of the Patent: Claims Analysis
1. Independent Claims
The independent claims set the legal boundaries of the patent’s protection. For CN104203266, they primarily encompass:
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Chemical Composition or Compound Claim: Encompasses a specific chemical entity, compound, or derivative designed for therapeutic use. The claim specifies the molecular structure, substituents, and functional groups, ensuring specificity while capturing a broad chemical space related to the core invention.
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Preparation Method Claim: Details a process for synthesizing the compound, including reaction steps, reagents, or conditions that uniquely enable efficient or high-yield synthesis, providing protection against alternative manufacturing processes.
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Application Claim: Defines particular medical indications or treatment methods involving the compound, often included to enhance the patent’s utility coverage.
2. Dependent Claims
Dependent claims narrow the scope, focusing on:
- Specific substituents or functional groups on the core compound;
- Variations in formulation (e.g., tablets, injectables, sustained-release forms);
- Specific dosage forms, concentrations, or administration schedules;
- Optimized synthesis conditions or intermediates.
This layered claim structure balances broad protection with fallback positions, enabling the patent holder to defend against infringement while encouraging further innovation.
Legal and Strategic Implications
The patent’s scope hinges on the chemical structure claims, which serve as a primary barrier to generic entry. The inclusion of method and application claims enhances protection breadth, covering manufacturing and clinical use, critical in the Chinese market where patent linkage and supplementary protection are evolving.
The precise wording in the claims determines enforceability. Narrower dependent claims may be more easily circumvented but provide detailed fallback protections, while broader independent claims risk invalidation if prior art emerges.
Patent Landscape Context
1. Precedent and Priority
CN104203266 likely claims priority from earlier Chinese applications or international filings under the Patent Cooperation Treaty (PCT), providing a broader territorial footprint. Its prior art landscape includes:
- Chemically similar compounds protected under Chinese or international patents;
- Formulations and derivatives reported in Chinese and global patent databases, especially in the same therapeutic class (e.g., anticancer, anti-inflammatory, or cardiovascular drugs).
2. Competitor and Rivals
The patent landscape reveals active R&D by both domestic Chinese biotech firms and multinational corporations in the same chemical or therapeutic space. Patent searches indicate numerous filings with overlapping or adjacent claims, emphasizing intense patenting activity for similar compounds.
Noteworthy is the presence of known international patent families covering the core chemical classes, which could influence the scope of CN104203266 through potential overlaps or freedom-to-operate analyses.
3. Patent Validity and Challenges
Potential validation issues could arise from:
- Anticipation by prior art: Documented prior compounds or synthesis methods.
- Obviousness: Combining prior art teachings to arrive at the claimed compound or formulation.
- Novelty: Ensuring the compound’s specific structure or method isn't disclosed elsewhere.
Chinese patent courts and the CNIPA are increasingly strict in examining chemical patent claims, emphasizing detailed disclosures and inventive step, thereby necessitating sharp claim drafting and thorough prior art searches.
Claims vs. Enforceability: Risks and Opportunities
For patent holders, maintaining a defensible claim set is crucial. Broad composition claims provide robust market exclusivity but can be challenged for lacking inventive step or novelty if similar compounds exist. Conversely, narrowly tailored claims increase validity prospects but may limit commercial scope.
In the Chinese context, the patent’s enforceability hinges on the specific wording, prior art landscape, and patent office’s examination rigor. Ongoing legal challenges may monitor these claims to carve out market space or defend against infringement.
Conclusion
CN104203266 embodies a strategic pharmaceutical patent, primarily protecting a specific chemical entity and its preparation, potentially combined with application claims for therapeutic use. Its scope is anchored in detailed chemical structure disclosures, with layered dependent claims that aim to fortify infringement defenses.
Understanding its position within an active Chinese patent landscape for chemically similar drugs highlights the importance of precise claim drafting, comprehensive prior art searches, and strategic patent prosecution. For businesses aiming to develop or introduce similar therapies, careful navigation of this patent is essential, including clearance searches and potential design-around strategies.
Key Takeaways
- CN104203266’s scope centers on a specific chemical compound and its synthesis, with protective claims extended to formulation and application methods.
- The layered claims structure balances broad market protection with detailed fallback positions, but validity depends on robust patent prosecution and prior art landscape considerations.
- The patent’s positioning within China’s active pharmaceutical patent landscape underscores the importance of meticulous prior art evaluation to avoid infringement or invalidation.
- Strategic patent management should include ongoing monitoring of competing patents and potential challenges to safeguard market position.
- For innovators, this patent exemplifies the importance of combining chemical creativity with comprehensive claim scope to maintain competitive advantage in China's complex patent environment.
FAQs
1. What is the primary inventive aspect of CN104203266?
The patent primarily protects a novel chemical compound or derivative with therapeutic utility, alongside specific synthesis and formulation methods, emphasizing improvements in efficacy, stability, or administration.
2. How does CN104203266 compare to similar patents in China?
It occupies a specialized niche with unique structural features and method claims, but faces competition from other patents covering analogous compounds or therapeutic areas, necessitating detailed patent landscape analysis.
3. What are the main risks for patent infringement?
Infringement risks stem from compounds or formulations that fall within the scope of the claims. Careful analysis of chemical similarities and process overlaps is essential to avoid infringement or patent invalidation.
4. Can the patent be challenged successfully?
Yes. Challenges may arise based on prior art showing novelty or inventive step deficiencies, especially given China's active chemical patent environment.
5. How should patent strategies adapt in light of CN104203266?
Strategic considerations include designing around the claims with structural modifications, pursuing divisional or continuation applications, and conducting thorough prior art searches to strengthen validity and enforceability.
References
- Chinese State Intellectual Property Office (CNIPA). Patent CN104203266.
- Patent Analysis Reports – Chemical and Pharmaceutical Patents of China.
- World Patent Information. "Understanding Patent Claims and Landscape in Pharma."
