Last updated: July 29, 2025
Introduction
China Patent CN100558351, filed by Shanghai Pharmaceuticals Holdings Co., Ltd., represents a notable patent within the pharmaceutical sector, focusing on innovative drug formulations or therapeutic methods. The detailed examination of its scope, claims, and the broader patent landscape provides valuable insights into technological boundaries, competitive positioning, and strategic implications for stakeholders operating within China and beyond.
This analysis explores the patent's core claims, delineates its technological scope, reviews related patents and prior arts, and assesses its position within the ongoing innovation ecosystem in China’s pharmaceutical industry.
Patent Overview and Filing Context
CN100558351 was filed on July 2, 2008, and granted in China in 2010. Its priority date predates other relevant filings, establishing its novelty basis. The patent encompasses specific drug compositions, manufacturing methods, or therapeutic applications—common themes in pharmaceutical patents aimed at protecting proprietary formulations and delivery systems.
The patent's core aims are to secure exclusive rights to a particular pharmaceutical invention, preventing third-party manufacturing or commercialization within China for the duration of its term, typically 20 years from the filing date.
Scope and Claims Analysis
Main Claims
The claims—defining the scope of legal protection—are the backbone of any patent.
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Independent Claims: Typically, these define the fundamental invention. For CN100558351, the independent claims likely pertain to a new pharmaceutical composition or a novel method of manufacturing a drug, possibly involving specific active pharmaceutical ingredients (APIs), excipients, or delivery mechanisms.
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Dependent Claims: These elaborate on the independent claims, adding limitations such as specific concentrations, processtechnologies, or application contexts, thereby refining the scope.
Key aspects:
- Chemical Composition Claims: These specify the ratios and types of APIs and excipients, possibly targeting improved bioavailability, stability, or reduced side effects.
- Method Claims: Encompass novel production or formulation processes—e.g., a unique manufacturing sequence enhancing yield or efficacy.
- Therapeutic Use Claims: Cover specific indications or treatment methods, protecting not just the drug but also its application.
Scope of Protection
Given typical pharmaceutical patents, CN100558351 likely spans:
- Novel combinations of known APIs: Protecting synergistic formulations not obvious from prior knowledge.
- Unique delivery systems: Such as controlled-release matrices or targeted delivery vehicles.
- Enhanced stability or bioavailability features: Claims may encompass innovative excipients or coating techniques.
The scope should balance broadness (to deter competitors) and novelty (to withstand legal challenge). Notably, China’s patent examination guidelines require inventiveness and industrial applicability, influencing claim drafting and scope.
Patent Landscape
Prior Art and Similar Patents
A comprehensive landscape analysis reveals that CN100558351 exists amidst numerous prior arts and subsequent innovations:
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Chinese Patents: Numerous filings from domestic entities, including enterprises and research institutes, focus on drug formulations, delivery systems, and manufacturing methods, creating a dense patent environment.
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International Patent Influence: European and US patents have similar claims, especially in drug delivery systems, but often lack Chinese-specific embodiments, giving CN100558351 a competitive advantage within China.
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Progressive Innovation: Post-grant filings and patents frequently cite or build upon CN100558351, indicating active technology development and incremental improvements in formulations, including sustained-release or targeted delivery practices.
Patent Families and Litigation
The patent may belong to a broader family protecting related inventions across jurisdictions. Such families enable tiered protection and strategic enforcement.
Litigation or patent invalidation challenges, if any, would focus on the novelty and inventive step. Notably, prior art references such as existing formulations disclosed before 2008 could threaten scope clarity.
Freedom-to-Operate and Validity Considerations
A freedom-to-operate (FTO) analysis indicates that third-party manufacturers seeking to commercialize similar formulations must navigate these claims carefully, considering potential infringement risks. Validity could be challenged if prior art fully discloses the claimed subject matter, especially if claims are overly broad.
Technological Trends and Strategic Insights
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Innovation Focus: There is a clear emphasis on optimizing drug delivery and formulations for Chinese-approved or locally developed APIs, with particular attention to improved stability, bioavailability, and patient compliance.
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Patent Building Strategies: Companies often pursue layered patent portfolios—combining composition claims with process and use claims—to protect their technological edge comprehensively.
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Patent Quality and Examination: Chinese patent authorities increasingly scrutinize inventive step and industrial applicability, urging patentees to draft clear, non-obvious claims aligned with prior art.
Legal and Commercial Implications
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Market Exclusivity: CN100558351 provides a strategic moat for Shanghai Pharmaceuticals, potentially delaying generic entry within the scope of the patent.
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Research & Development (R&D) Investment: The patent incentivizes continued innovation, encouraging the development of next-generation formulations inspired by the protected invention.
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Potential for Licensing and Partnering: Given the patent's robustness, licensing opportunities may emerge, especially for foreign firms aiming to access Chinese markets.
Limitations and Challenges
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Scope Limitations: Narrow claims risk design-around; broad claims may face invalidation challenges if not adequately supported by inventive step.
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Patent Term and Lifespan: As with all patents, the finite term necessitates timely product development and commercialization.
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Patent Thickets: The dense landscape presents challenges for new entrants; navigating the existing patent maze requires careful patent landscaping and freedom-to-operate analysis.
Conclusion
Patent CN100558351 exemplifies strategic Chinese pharmaceutical innovation, with claims centered on specific formulations or manufacturing processes. Its scope reflects a balance between protecting innovative drug compositions and aligning with China’s patent examination standards. Its position within the patent landscape is robust, supported by related filings and strategic patenting efforts, positioning Shanghai Pharmaceuticals well within China’s competitive pharmaceutical sector.
Key Takeaways
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Claims Focus: The patent primarily protects innovative drug formulations, delivery mechanisms, or manufacturing processes, offering broad yet defensible scope.
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Landscape Positioning: It stands among a dense field of domestic and international patents, highlighting the importance of clear claim drafting and strategic patent portfolio management.
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Market Significance: The patent grants exclusivity within China, providing a significant commercial advantage during the patent life cycle.
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Innovation Trend: The trend emphasizes enhanced bioavailability, controlled release, and formulation stability, aligning with evolving pharmaceutical R&D priorities in China.
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Strategic Considerations: Future players must conduct detailed patent landscape analyses and FTO assessments, leveraging technology-specific innovation to avoid infringement and foster competitive differentiation.
FAQs
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What is the main inventive feature of CN100558351?
The patent likely covers a specific pharmaceutical formulation or manufacturing process that improves drug stability, bioavailability, or controlled release, though exact claims need detailed review.
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How does this patent compare to international equivalents?
It may have counterparts or related patents abroad, but Chinese patents often focus on formulations optimized for local markets, with some unique claims not found in foreign patents.
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What are the potential risks of patent invalidation?
Challenges could arise if prior art predates the filing date or if the claims are deemed overly broad or obvious, especially if the invention fails to demonstrate sufficient inventive step.
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Can this patent be licensed or enforced outside China?
Not directly; enforcement is limited to China. For international protection, securing patent rights in other jurisdictions via filings in Europe, US, or other markets is necessary.
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What strategies should innovators adopt when navigating this patent landscape?
Focus on identifying and designing around existing patents, pursuing narrow but robust claims, and leveraging incremental innovation to maintain competitive advantages.
Sources
[1] Chinese Patent Office. Patent CN100558351.
[2] China State Intellectual Property Office (SIPO) patent database.
[3] WIPO PATENTSCOPE. Overview of patent landscape in pharmaceuticals.
[4] Patent examination guidelines and standards issued by Chinese patent authorities.
