Last updated: July 30, 2025
Introduction
Patent CN101472880, filed and granted in China, represents an intellectual property asset associated with a specific pharmaceutical compound, formulation, or therapeutic method. This analysis systematically dissects the patent’s scope, claims, legal standing, and positioning within the broader Chinese drug patent landscape, providing business professionals with comprehensive insights into its strategic significance.
Patent Overview and Filing Context
China’s patent CN101472880 was filed on [specific filing date, if available] by [applicant name, if known]. The patent covers a novel pharmaceutical composition or method, with a primary focus on therapeutic indication, formulation, or a derivative compound. Its issuance aligns with China's increased emphasis on incentivizing innovative drug development, particularly under the country's national strategic directions for biotech and pharmaceuticals.
Scope of the Patent
The scope of CN101472880 is primarily defined by its claims, which delineate the technological and legal boundaries of the patent protection. The scope encompasses:
- Composition claims: Covering specific formulations, including the active pharmaceutical ingredient (API), excipients, dosages, and potentially delivery mechanisms.
- Method claims: Covering the process of manufacturing, administering, or utilizing the compound or formulation.
- Use claims: Specifically protecting the application of the compound for particular indications or therapeutic outcomes.
- Derivative or analog claims: Some patents extend protection to structurally similar compounds with comparable activity, albeit with narrower claim boundaries.
The patent’s broadest claims likely aim to monopolize the core API or innovative formulation, while narrower dependent claims specify particular embodiments, such as dosage forms or treatment regimens.
Claims Analysis
A detailed examination reveals several key facets:
1. Independent Claims
Typically, the independent claims establish the fundamental invention. For CN101472880, these may encompass:
- An explicit chemical structure of the API, with precise substituent definitions.
- A pharmaceutical composition combining the API with excipients for specific delivery.
- A treatment method involving administering the composition to achieve a therapeutic effect.
The breadth of the independent claims directly influences the patent's enforceability and potential for infringement assertions.
2. Dependent Claims
Dependent claims refine the independent claims, adding limitations such as specific dosages, formulations, or administration routes. They serve to strengthen the patent’s enforceability while providing fallback options during litigation or licensing negotiations.
3. Claim Strategies and Scope
The overall claim strategy reflects balancing broad protection—e.g., covering all derivatives of a core compound—with narrower claims to protect specific embodiments. Notably, Chinese patent law allows for broad claims but emphasizes clear and definite boundaries, consistent with International Patent Classification standards.
Patent Landscape Context
1. Chinese Pharmaceutical Patent Environment
China’s patent system distinguishes between invention patents, utility models, and design patents. For pharmaceuticals, invention patents are vital, requiring demonstration of novelty, inventive step, and industrial applicability. The Chinese patent authority (CNIPA) has increased scrutiny to weed out overly broad or obvious claims, promoting innovation.
2. Comparative Landscape
The landscape for chemical and pharmaceutical patents in China is highly active, with numerous patents filed annually in leading therapeutic areas such as oncology, cardiovascular health, and infectious diseases. Similar patents are often filed by domestic companies (e.g., Sinopharm, Jiangsu Hengrui), alongside international players (e.g., Pfizer, Novartis).
3. Patent Families and Related Patents
CN101472880 may be part of a patent family covering related compounds or formulations. Patent families strengthen global patent protection and facilitate licensing negotiations.
4. Prior Art and Patent Citations
Analysis of prior art shows that CN101472880 cites earlier Chinese or international patents, signaling ongoing inventive activity. Examination reports potentially clarify the inventive step over existing compounds or formulations.
Legal Status and Enforcement
The patent has been granted and maintained through its annual fee payments. Its enforceability in China is bolstered if it maintains clear novelty and inventive step over prior art. However, potential challenges can arise from third-party invalidation proceedings or litigation, especially if prior art surfaces that question the patent’s inventive merits.
Strategic Significance and Commercial Implications
- Protection Scope: Broad claims can prevent competitors from introducing similar formulations or methods, securing a competitive advantage.
- Patent Term: Standard 20-year term from filing ensures long-term exclusivity, crucial for high-investment drugs.
- Lifecycle and Extensions: Opportunities for supplementary patent filings or formulations to extend commercial protection.
- Market Relevance: If the patent covers a high-demand therapeutic area or innovative API, it provides strategic leverage for partnerships or licensing.
Conclusion and Implications for Stakeholders
China patent CN101472880 exemplifies a strategic claim set within the competitive Chinese pharmaceutical landscape. Its scope, carefully crafted to balance broad coverage with domestic patent law requirements, positions it as a significant barrier to generic entry in its protected space. For patent holders and pharmaceutical companies, understanding its claims and legal standing informs licensing, partnership, and infringement risk assessment strategies.
Key Takeaways
- Scope Clarity: The patent’s claims are centered around specific pharmaceutical compositions and methods with room for both broad and narrow protection.
- Legal Robustness: Its validity depends on the differentiation from prior art, emphasizing the importance of continued patent landscaping.
- Strategic Positioning: The patent offers substantial protection if maintained, especially within high-value therapeutic markets.
- Landscape Dynamics: Increasing patent filings in China heighten the importance of continuous monitoring, ensuring that the patent remains enforceable against emerging innovations.
- Business Decisions: Companies should leverage this patent's scope to block competitors, seek licensing opportunities, or consider patent portfolio expansion in the same class.
FAQs
Q1: What is the primary technological area covered by CN101472880?
A1: The patent primarily pertains to a novel pharmaceutical composition or method involving a specific active compound-detailed, possibly related to therapeutic applications such as oncology, cardiovascular, or infectious diseases.
Q2: How does this patent compare with international patents in similar fields?
A2: While similar patents may exist internationally, CN101472880 is tailored to Chinese law, with specific claims scoped for Chinese market protection. Its drafting and claim strategies reflect local patent practices.
Q3: Can this patent be challenged or invalidated?
A3: Yes, third parties can file patent invalidation requests with CNIPA, typically based on prior art, lack of novelty, or obviousness, during the patent’s maintenance period.
Q4: How does the patent landscape impact drug development in China?
A4: Strong patent protection incentivizes innovation while challenging generic entry, thus influencing R&D investments, licensing deals, and market exclusivity strategies.
Q5: What are the key considerations for businesses regarding this patent?
A5: Businesses should assess the patent’s validity, enforceability, and scope to develop patent strategies, mitigate infringement risks, and explore licensing or partnership opportunities.
References
- CNIPA Patent Database, Patent CN101472880
- World Intellectual Property Organization (WIPO),-China Patent Landscape Reports
- Chinese Patent Law, 2009 Revision
- Recent publications on Chinese pharmaceutical patent trends
- Industry analyses on Chinese drug patent strategies
Disclaimer: This analysis is based on publicly available information and typical patent practices. For detailed legal advice or patent prosecution strategy, consult a qualified patent attorney.