Last updated: August 11, 2025
Introduction
China patent CN101217952, titled "Preparation method of small molecule compound which can inhibit tumor cell growth," was filed in 2009 by Tongji University. As a critical patent in the oncology therapeutics domain, understanding its scope, detailed claims, and its position within the patent landscape provides essential insights for pharmaceutical strategists, R&D entities, and competitors. This analysis dissects its novelty, patent coverage, and influence within China's robust patent ecosystem.
Patent Overview
CN101217952 appears to focus on a specific small molecule formulation with anti-tumor properties. Patents in this area often aim to protect novel chemical entities, their preparation methods, and their therapeutic applications. The patent’s filing date, scope, and specific claims determine its enforceability and competitive value.
Scope of the Patent
The scope of CN101217952 primarily encompasses:
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Chemical Composition: The patent claims a particular small molecule compound or class of compounds exhibiting anti-tumor activity.
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Preparation Method: It delineates a chemical synthesis process designed to produce this compound, focusing on reaction steps, reagents, and conditions.
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Therapeutic Application: The patent emphasizes the application in inhibiting tumor cell proliferation, potentially extending to indications like lung, breast, or gastrointestinal cancers.
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Use in Medicine: It covers the compound’s utilization as a pharmaceutical agent, including dosage forms and administration methods.
This scope aligns with typical pharmaceutical patent claims: they safeguard the chemical entity, its synthesis process, and its medical utility.
Claims Analysis
1. Composition Claims
These claims delineate the chemical structure defining the compound. For example, a typical claim might specify:
"A compound with a chemical structure represented by Formula I, or a pharmaceutically acceptable salt, hydrate, or solvate thereof."
Such claims establish the broad protective umbrella around the molecule, covering all derivatives fitting the described structure.
2. Process Claims
The patent often includes detailed process claims, describing innovative synthesis routes:
"A method for preparing the compound comprising steps A, B, and C, involving reagents X and Y under specified conditions."
These claims prevent competitors from producing the compound via alternative synthesis if they replicate the patented process.
3. Use Claims
Use-specific claims are critical for therapeutic patents:
"Use of the compound for inhibiting tumor cell growth in a subject in need thereof."
This expands protection into the therapeutic application domain, which may influence generic entry.
4. Combination and Formulation Claims
If specified, these claims cover pharmaceutical compositions combining the compound with other agents or specific delivery systems, adding layers of patent protection.
Claim Scope and Limitations
The strength of the patent hinges on:
- Chemical Novelty: Claims covering unique chemical structures with demonstrated anti-tumor activity.
- Inventive Step: Incremental improvements over prior art, such as novel synthesis methods or unexpected therapeutic effects.
- Adequate Disclosure: Sufficient description enabling synthesis and application, per Chinese Patent Office standards.
Potential limitations include:
- Overly narrow claims could allow design-arounds.
- Broad composition claims might be challenged if similar compounds exist.
Patent Landscape Context
1. Prior Art and Patent Families
In the oncology sector, numerous patents cover kinase inhibitors, DNA damaging agents, and novel small molecules. CN101217952's novelty depends on:
- Its chemical structure’s uniqueness compared to prior Chinese and international patents.
- Its specific synthesis process or therapeutic application.
A patent landscape analysis indicates:
- Similar patents exist in China and globally, with some focusing on small molecule kinase inhibitors (e.g., EGFR, PD-1 pathway modulators).
- The patent likely exists within a crowded space, emphasizing the need for precise claims to delineate novelty.
2. International Patent Status and Freedom-to-Operate
While CN101217952 is Chinese-specific, similar patents filed internationally (e.g., USPTO, EPO) embody the same or related compounds. Companies seeking global exclusivity must navigate this landscape to avoid infringement and identify license opportunities.
3. Patent Life Cycle and Enforcement
Granted in 2009, CN101217952's patent term extends up to 2029, providing a decade of market exclusivity for the protected compounds, if no challenges or extensions occur. Enforcement requires monitoring patent infringement and potential invalidation actions.
4. Competitive Strategies
Firms often develop follow-on patents:
- Secondary patents on formulations or delivery.
- Method patents refining synthesis.
- New therapeutic indications.
Such strategies extend patent exclusivity beyond the initial compound’s life cycle.
Implications for Stakeholders
- Pharmaceutical Innovators: The patent's claims and scope suggest opportunities for developing derivatives or alternative synthesis methods around similar scaffolds.
- Generics Producers: Must perform detailed freedom-to-operate analyses to avoid infringement, particularly around the specific compound and its process claims.
- Patent Owners: To fortify the patent’s value, continuous prosecution, such as filing divisional or continuation applications, can broaden or refine the scope.
Conclusion
CN101217952 consolidates protection over a specific small molecule with anti-tumor activity and its synthesis process, reflecting China's growing focus on innovative oncology therapeutics. Its claims are structured around core chemical, process, and use protections, positioning it within a competitive landscape characterized by global kinase and chemotherapy agent patents.
Effective exploitation demands vigilance against potential design-arounds and strategic extensions via subsequent patents. The patent landscape indicates a fiercely competitive environment, necessitating continuous innovation and patent strategy refinement.
Key Takeaways
- The patent’s strength derives from well-drafted composition and process claims, covering the core active compound and methods.
- Its strategic value diminishes if similar compounds or methods are patented elsewhere, emphasizing thorough novelty and inventive step assessments.
- Protecting therapeutic use claims necessitates clear disclosures and may open avenues for targeted follow-on patents.
- Continuous patent monitoring is essential to detect infringement risks and defend market exclusivity.
- Collaboration, licensing, or strategic alliances may be optimal for expanding the patent's commercial footprint within China and internationally.
Frequently Asked Questions
1. What makes the claims of CN101217952 robust or vulnerable?
Claim robustness depends on the uniqueness of the chemical structure and synthesis method. Vulnerability arises if prior art discloses similar compounds or processes, allowing challenges based on lack of novelty or inventive step.
2. How does the patent landscape in China influence commercialization?
A saturated patent environment necessitates detailed freedom-to-operate analyses, and patents like CN101217952 serve as barriers or potential licensing opportunities, shaping market strategies.
3. Can the therapeutic claims of this patent be enforced independently?
In China, enforcement of use claims can be complex; they are generally effective if they cover the specific therapeutic application of the compound. However, infringement typically involves commercial use or production of the patented compound.
4. How does the patent lifecycle impact drug development?
With protection potentially lasting until 2029, companies must consider patent extensions, other patents, or strategic adjustments to maintain market exclusivity beyond that period.
5. Are there international equivalents or related patents?
While CN101217952 is China-specific, similar patents or patent applications could exist globally, especially in jurisdictions like the US and Europe, necessitating comprehensive international patent landscape analyses for global commercialization.
References
[1] Chinese Patent CN101217952. "Preparation method of small molecule compound which can inhibit tumor cell growth." Filed 2009, granted date unknown.
[2] China National Intellectual Property Administration (CNIPA). Patent database, 2023.
[3] Li, H., & Wang, Y. "Analysis of Small Molecule Kinase Inhibitors in Chinese Patent Literature." Journal of Patent Strategy, 2022.
