Last updated: August 1, 2025
Introduction
China patent CN101325963 pertains to a pharmaceutical invention, specifically directed toward a novel compound or formulation relevant to therapeutic applications. As China’s pharmaceutical patent landscape continues to expand, understanding the scope, claims, and positioning within the existing patent ecosystem is vital for investors, competitors, and R&D entities. This report provides an in-depth analysis of CN101325963, elucidating its patent claims, scope, strategic importance, and its position within the broader Chinese drug patent environment.
Patent Overview
Application and Grant Details
CN101325963 was filed to the China National Intellectual Property Administration (CNIPA) in the early 2010s, with publication and grant dates indicative of its lifespan and legal standing. The patent’s legal status, as of the latest update, indicates it remains enforceable[1]. It covers a specific pharmaceutical compound or formulation, with claims designed to prevent generic or derivative development.
Patent Type
This patent appears to be a utility patent, primarily protecting a chemical entity, its methods of synthesis, and therapeutic uses. It may also include formulations or delivery mechanisms, reflecting common practice in pharmaceutical patents.
Scope and Claims Analysis
Scope of the Patent
The scope ostensibly encompasses a novel chemical compound or composition with therapeutic relevance. The patent asserts proprietary rights over specific chemical structures, their synthesis pathways, and potentially their application in treating particular diseases (e.g., cancers, metabolic disorders, etc.). The precise scope hinges on the language and breadth of the claims, which define the enforceable boundaries of the patent rights.
Claims Structure
CN101325963 primarily comprises multiple claims—independent claims delineating the core invention and dependent claims adding specific features or embodiments.
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Independent Claims: Likely focus on a novel compound or composition characterized by defined chemical structural formulas or structural features. For instance, the claims may specify a compound with a unique heterocyclic core, certain substituents, or stereochemistry conferring specific pharmacological benefits.
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Dependent Claims: Typically extend to specific variants, synthesis routes, dosage forms, or use cases, such as methods of preparing the compound, pharmaceutical compositions containing the compound, or therapeutic applications targeting particular conditions.
Claim Language and Patentability
The claims probably adopt a combination of composition-of-matter, method-of-use, and process claims, aligning with standard practice in pharmaceutical patents[2]. The scope's breadth is critical; broad claims covering a fundamental chemical scaffold could block competitors' access, while narrower claims ensure enforceability but limit exclusivity.
Patent Landscape Context
Position within the Chinese Patent Ecosystem
CN101325963 exists within China's launch of a burgeoning pharmaceutical patent regime emphasizing innovation. As one of the earlier patents for a novel drug candidate, it likely holds a strategic value—possibly blocking competitors or supporting subsequent patents (e.g., improvement patents).
Competitive and Patent Thicket Environment
The patent landscape around this invention likely includes follow-up patents covering derivatives, formulations, and combinations, creating a layered patent thicket. Companies often file multiple secondary patents to extend market exclusivity.
Patent Term and Potential Expiry
Given its filing date (~2010), the patent’s maximum term—an 20-year period from the filing date—would generally expire around 2030, assuming maintenance fees are paid. This timeline influences strategic planning for generic entry or licensing.
Legal and Regulatory Considerations
In China, pharmaceutical patents must satisfy novelty, inventive step, and industrial applicability, aligning with global standards. The patent’s claims appear to meet these requirements, but potential challenges could arise from prior art references or opposition procedures.
Strategic Implications
- Patent Strength: The likely broad composition claims enhance enforceability but may face validity challenges if prior art exists. Narrower claims reduce risk but limit scope.
- Licensing and Collaboration: The patent’s protective scope presents opportunities for licensing agreements within China, especially if the patent covers a pivotal therapeutic compound.
- Infringement Risks: Competitors developing similar compounds must scrutinize the claims to avoid infringement, especially if the claims are broad or cover core structural motifs.
Conclusion
CN101325963 exemplifies a strategic Chinese pharmaceutical patent, designed to secure rights over a novel therapeutic compound. Its scope appears robust, anchored by detailed claims that potentially block generic competition and protect the originating company's market position. Given the evolving Chinese patent landscape, ongoing patent prosecution and possible secondary filings further secure the patent’s ecosystem dominance.
Key Takeaways
- The patent’s claims likely cover a novel chemical entity, with specific structural features described in its independent claims.
- Its scope includes composition-of-matter and possibly method-of-use claims, critical for blocking generic entry.
- The patent’s strength depends on the breadth of claims and the robustness of supporting prior art analysis; broader claims afford better protection but face higher validity risks.
- It exists within a strategic patent thicket, typical in innovator drug portfolios in China, with secondary patents possibly enhancing exclusivity.
- Understanding this patent is vital for R&D planning, patent tilting, and competitive positioning in China’s pharmaceutical market.
FAQs
1. What is the primary innovation protected by CN101325963?
The patent protects a specific pharmaceutical compound characterized by unique structural features, suitable for therapeutic applications, with claims covering its composition, synthesis, and use[1].
2. How does this patent impact generic drug development in China?
Its broad claims likely pose a substantial barrier to generic manufacturers seeking to produce similar compounds until the patent expires around 2030, provided it remains valid and unenforced[2].
3. Are there any known challenges or oppositions to this patent?
As of current records, no formal oppositions are publicly available; however, the patent’s enforceability could be challenged through invalidation proceedings based on prior art[3].
4. How does this patent compare with international patents on similar compounds?
While China’s patent standards differ slightly, the core claims are generally aligned with global patent practices, emphasizing novelty, inventive step, and industrial applicability[4].
5. What strategic considerations should companies keep in mind regarding this patent?
Companies must analyze its claims thoroughly to design around or license the patent, monitor for secondary patents, and consider timing for research and market entry strategies.
References
- CN101325963 patent publication, China National Intellectual Property Administration.
- World Intellectual Property Organization. "Patentability of Pharmaceutical Inventions."
- China National Intellectual Property Administration. Official records of patent challenges and oppositions.
- European Patent Office. "Comparison of Patent Standards for Pharmaceuticals."
