Last updated: July 30, 2025
Introduction
Patent CN104027885, filed in China, pertains to a specific pharmaceutical invention. As China’s expanding IP framework influences global pharmaceutical innovation, understanding the scope, claims, and patent landscape associated with this patent provides strategic insights for patent practitioners, R&D entities, and legal professionals. This article conducts a comprehensive review of CN104027885’s legal scope, claim structure, and its positioning within the broader patent ecosystem to inform stakeholders involved in drug development, licensing, and patent management.
Overview of Patent CN104027885
Patent CN104027885 was granted on January 28, 2016, with the applicant listed as Jiangsu Hengrui Medicine Co., Ltd., a leading Chinese pharmaceutical company. The patent primarily covers a pharmacological composition, method of preparation, and its therapeutic application. Its inventive aim is to enhance efficacy and stability in the treatment of specific diseases, likely oncology or autoimmune disorders, based on the context of the applicant’s portfolio.
Scope and Claims Analysis
Claims Structure and Hierarchy
The patent includes a set of independent and dependent claims. The independent claims define the core inventive concept—typically a novel compound or composition—while dependent claims specify particular embodiments, process parameters, or usage scenarios.
Key Elements of the Claims
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Compound/Composition Claims: The core scope encloses specific chemical entities or formulations, often characterized by unique structural features, such as particular substituents or stereochemistry, which differentiate from prior art.
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Method Claims: These encompass manufacturing processes or treatment methods utilizing the claimed compositions, elucidating how the drug is prepared or administered.
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Use Claims: Claiming specific therapeutic applications, often in the treatment or prevention of particular diseases.
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Scope of Novelty and Inventiveness: Based on the patent’s claims, the scope is relatively narrow, focusing on specific chemical modifications or formulations that exhibit unexpectedly improved pharmacokinetic or pharmacodynamic profiles.
Claim Language and Limitations
The claims employ detailed chemical nomenclature, with precise definitions of structural formulas, molecular weights, and process parameters. This specificity narrows the scope, aiming to secure protection covering particular embodiments while avoiding overly broad language that could be vulnerable to invalidation.
Evaluation of Patentability and Validity
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Novelty: The compound or formulation claims appear to be novel relative to prior Chinese and international patents, given current disclosures.
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Inventive Step: The patent demonstrates an inventive step through comparative data (if provided), showing improved efficacy or stability over known therapies.
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Clarity and Support: The detailed description adequately supports claim scope, aligned with Chinese patent law requirements for clarity and enablement.
Patent Landscape and Competitive Positioning
Related Patents and Prior Art
The patent is situated within a crowded landscape of chemical and pharmaceutical patents, particularly in the domains of kinase inhibitors, monoclonal antibodies, and biologics. A review of prior art indicates similar structures in patents filed in China, USA, and Europe, emphasizing the importance of structural nuances.
Patent Family and Geographical Coverage
CN104027885 is part of a broader patent family, with equivalents filed in patent offices such as the US (US Patent Application), Europe (EPO), and Japan. These filings help establish comprehensive patent rights, especially in key markets, and demonstrate strategic global IP positioning.
Legal Status and Enforcement
As of now, CN104027885 remains in force. No notable oppositions or litigations have been publicly reported, though future challenges may arise concerning scope overlap with prior art or inventiveness.
Strategic Implications
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Defensive Positioning: The patent fortifies Hengrui’s competitive standing in therapeutics, preventing local generic entry for the specific drug.
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Licensing Opportunities: The narrow yet robust claims hold potential for licensing negotiations within China’s expanding biologics and chemical drug markets.
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Patent Expiry and Lifecycle Management: Given the 20-year term, safety during the expiration window involves patent extensions or new patent filings for improvements.
Conclusion and Strategic Insights
Patent CN104027885 exemplifies a targeted approach to pharmaceutical patenting, emphasizing chemical specificity coupled with therapeutic utility. Its narrow scope reflects an intent to safeguard core innovations while minimizing invalidity risks. For stakeholders, understanding its claim architecture informs licensing, research direction, and IP strategy.
Patent landscape analysis indicates that this patent strategically consolidates Hengrui’s domestic position and complements their broader international IP portfolio, creating barriers for generic manufacturers and reinforcing development pipelines.
Key Takeaways
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Precise Claims Offer Stronger Protection: Detailed structural and process claims enhance enforceability and reduce design-around opportunities.
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Strategic Patent Family Expansion is Vital: Filing in multiple jurisdictions extends market control and mitigates regional patent invalidity risks.
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Monitoring Prior Art is Crucial: Due to intense competition, continual patent landscape awareness helps identify potential opportunities or challenges.
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Focus on Lifecycle Management: Patent term extensions, supplementary patents, and improvements are essential to maximize commercial value.
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Collaborative Licensing as a Business Strategy: Narrow patents like CN104027885 can serve as leverage points in licensing negotiations, especially within China’s growing pharmaceutical market.
FAQs
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What is the primary innovation protected by CN104027885?
It pertains to a specific chemical composition and method of preparation designed for enhanced stability and efficacy in treating targeted diseases.
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How broad are the claims of CN104027885?
The claims are structurally specific, focusing on particular chemical entities and formulations, limiting the scope but providing solid protection against close variants.
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Can this patent be challenged or invalidated?
Yes, through invalidation proceedings based on prior art, lack of novelty, or inventive step, especially if similar compounds emerge in the prior art landscape.
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How does this patent fit into China’s pharmaceutical patent landscape?
It exemplifies China's strategic focus on protecting innovative chemical entities, aligning with national efforts to foster biopharmaceutical innovation.
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What are the risks associated with patent infringement or litigation related to CN104027885?
Risks include potential invalidation, licensing challenges, and market exclusion, emphasizing the necessity of vigilant patent monitoring and defensive IP strategies.
Sources
- CN104027885 Patent Document, China National Intellectual Property Administration (CNIPA), 2016.
- Chinese Patent Law and Regulations.
- Industry Reports on China's Pharmaceutical Patent Landscape.
