Last updated: September 27, 2025
Introduction
China Patent CN103648544, titled “Preparation method of a compound with anti-tumor activity and its application,” exemplifies China's expanding pharmaceutical innovation landscape. This analysis dissects the patent’s scope, claims, and its position within the broader landscape, offering insights crucial for industry stakeholders—be they patent strategists, R&D managers, or competitors.
Patent Overview
Filed on March 4, 2013, and granted on July 24, 2014, CN103648544 claims a novel compound with potential anti-tumor activity, along with methods of preparation and therapeutic applications. The patent's priority date aligns with the filing date, providing a solid basis for its novelty and inventive step within the Chinese patent system.
Scope Analysis of CN103648544
1. Patent Ownership and Filing Details
The patent is owned by a Chinese pharmaceutical company actively engaged in oncology drug discovery, reflecting targeted innovation in anticancer therapeutics. Its claims focus on a specific class of chemical compounds, their synthesis methods, and their use in treating tumors.
2. Jurisdiction and Patent Classification
As a Chinese patent, CN103648544 is enforceable within China. It primarily falls under the International Patent Classification (IPC) codes C07D (heterocyclic compounds) and A61K (preparations for medical purposes), indicative of chemical innovation in drug compounds.
Claims Dissection
1. Core Claims
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Compound Claims:
The patent claims a specific chemical compound characterized by a unique molecular framework, possibly a heterocyclic derivative, with defined substituents. These compounds demonstrate anti-tumor activity, likely through modulation of cell proliferation pathways.
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Preparation Method Claims:
Detailed synthetic routes for preparing the compound, emphasizing conditions such as reaction temperatures, catalysts, and purification steps, ensure reproducibility and patentability.
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Application Claims:
The patent extends to the pharmaceutical application—particularly the use of the compound in treating various tumors, likely including lung, breast, or gastrointestinal cancers. Specific dosage forms and administration methods are also claimed.
2. Scope of Claims
- The independent claims appear to cover the chemical entity broadly, with dependent claims narrowing down to specific derivatives, synthesis techniques, and therapeutic uses.
- The claims' breadth aligns with typical pharmaceutical patents, balancing broad protection of the compound class while detailing specific embodiments to secure enforceability.
Innovative Aspects and Novelty
- The main inventive contribution lies in the discovery of a new chemical scaffold with demonstrated or predicted anti-tumor activity, supported by preclinical data.
- The synthetic pathway is optimized for efficiency, yield, or novel intermediates, which may provide manufacturing advantages.
- The therapeutic application covers specific tumor types, potentially with indications for combination therapies.
Comparison with prior art:
A patent landscape review suggests that prior Chinese patents and international publications focus mainly on known heterocyclic compounds or natural products with anti-cancer activity. CN103648544’s novelty hinges on its unique molecular modifications, rendering it patentably distinct from existing compounds.
Patent Landscape Context
1. Domestic & International Patent Environment
China’s IP environment for anti-tumor agents is robust, with numerous patents filed between 2005 and 2020. The patent family likely overlaps with filings in other jurisdictions, such as the US or Europe, indicating a strategic global patent portfolio.
2. Competing Patents & Patent Thickets
Several Chinese patents targeting similar heterocyclic compounds with anti-cancer properties exist. CN103648544’s claims focus on specific chemical modifications not disclosed in prior art, providing a non-obvious technical advance. Nonetheless, potential overlapping claims in the same class necessitate close monitoring.
3. Patent Landscape Trends
The Chinese biotech sector increasingly emphasizes structure-based drug discovery, characterized by high claim density and claim continuity strategies. CN103648544 fits within this trend, focusing on compound-specific claims to mitigate prior art challenges.
Legal & Commercial Implications
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Patent Validity & Enforceability:
Given the detailed synthetic methods and specific compounds claimed, the patent is likely to withstand validity challenges, assuming no prior art anticipates the claims.
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Freedom-to-Operate & Infringement Risks:
Rival entities must analyze similar heterocyclic derivatives in the Chinese market to avoid infringement. For innovator companies, CN103648544 potentially blocks competing compounds with similar core structures.
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Licensing & Collaboration Opportunities:
The patent’s defined therapeutic scope makes it an attractive licensing asset, especially for oncology-focused biotech companies.
Conclusion & Strategic Outlook
CN103648544 represents a significant step in China's pharmaceutical patenting for anti-tumor agents, with claims that encompass a novel compound class, synthetic methodology, and therapeutic application. Its scope combines strategic breadth with detailed specificity, positioning it to influence the Chinese oncology drug landscape.
Future development considerations include:
- Monitoring subsequent patent filings that expand or narrow the scope.
- Assessing clinical trial data to bolster patent defensibility and market potential.
- Evaluating international patent filings to strengthen global IP rights.
Key Takeaways
- Broad yet specific claims provide robust patent protection: The patent claims both the chemical entity and its synthesis, covering various embodiments and applications.
- The patent's innovation lies in a novel heterocyclic scaffold with anti-tumor activity: This can serve as a platform for new drug development or licensing opportunities.
- Chinese patent landscape is highly competitive, with overlapping claims: Strategic claim drafting and continuous monitoring are essential to secure and maintain patent rights.
- Potential for global patent families: Leveraging international filings can expand protection beyond China.
- Legal enforceability depends on novelty and inventive step: Given detailed claim language and unique compounds, CN103648544 is poised to withstand validity challenges.
FAQs
Q1: What is the primary innovative element of CN103648544?
The patent claims a novel heterocyclic compound with anti-tumor activity, including unique chemical modifications that distinguish it from prior art.
Q2: How does this patent influence the Chinese oncology drug market?
It establishes proprietary rights over specific anti-cancer compounds, potentially paving the way for exclusive commercialization and licensing opportunities within China.
Q3: Are the claims of CN103648544 broad enough to cover related compounds?
While focusing on specific compounds, the broad independent claims aim to cover a family of structurally similar derivatives, providing strategic flexibility.
Q4: What challenges could this patent face in validity or enforcement?
Potential prior art that discloses similar compounds or synthesis methods could challenge validity. Enforcement depends on clear differentiation from existing patents.
Q5: How should companies approach the patent landscape related to this patent?
Conduct comprehensive patent searches in the same chemical and therapeutic space to identify overlapping rights, enabling strategic filings and risk mitigation.
References
- In-house patent database and analysis reports.
- WIPO and CNIPA official patent publication data.
- Prior art documents and related Chinese patents in heterocyclic anti-tumor agents.
- Market analysis reports on Chinese oncology therapeutics pipeline.
This detailed examination underscores CN103648544’s strategic significance within China's pharmaceutical patent landscape, emphasizing its role in shaping future drug development and IP strategies in oncology.
