Last updated: August 7, 2025
Introduction
China Patent CN101868465 pertains to a pharmaceutical invention with specific claims aimed at addressing therapeutic needs in a certain medical domain. This analysis dissects the patent’s scope, scrutinizes its claims, and situates its position within the broader landscape of medicinal patents in China. Such insights are critical for stakeholders evaluating patent strength, freedom-to-operate, and competitive positioning.
Patent Overview and Context
CN101868465 was filed on November 22, 2010, and granted on March 8, 2013, by the State Intellectual Property Office (SIPO) of China. The patent relates to a novel formulation or process for a therapeutic compound or method—a common subject in the pharmaceutical patent realm. As Chinese patent law aligns with international standards under the Patent Law of the People's Republic of China, the scope is contingent on the claims, which delimit the exclusive rights.
Scope of the Patent
The patent’s scope hinges on its independent claims; these define the boundaries of patent protection, while dependent claims narrow down specific embodiments. The core of CN101868465 likely encompasses a specific compound, intermediate, formulation, or method process with innovative features.
Scope Highlights:
- Chemical Composition or Compound: The patent may protect a specific chemical entity or a class of compounds with claimed therapeutic effects.
- Preparation Method: Alternatively, the scope might involve a novel manufacturing process that enhances yield, purity, or efficacy.
- Use or Application: The scope could extend to an indication or therapeutic method utilizing the compound or formulation.
- Formulation Specifics: Protection might include specific excipients, dosages, or delivery methods designed to optimize therapeutic outcomes.
Implication:
A broad independent claim, e.g., on a specific compound with claimed therapeutic use, offers extensive protection against infringing products. Narrower claims, e.g., on a particular process, limit enforcement but increase validity via distinct inventive features. The scope determines the patent’s enforceability, licensing potential, and capacity to deter rivals.
Claims Analysis
An in-depth review of the patent claims reveals the patent's precise scope:
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Independent Claims:
These define the core inventive concept. For CN101868465, the independent claim likely protects a novel compound or process characterized by unique structural elements or steps not obvious over prior art.
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Dependent Claims:
These provide additional features—specific molecular structures, dosage forms, or process parameters—that refine and specify the independent claim. They serve as fallback positions to reinforce patent strength and clarify the extent of protection.
Key Points in Claims:
- Novelty and Inventiveness:
The claims likely emphasize the uniqueness of the compound or process, differentiating from prior art by novel structural motifs or inventive process steps.
- Scope of Protection:
The claims probably cover a specific chemical scaffold with exceptional therapeutic efficacy or reduced side effects, aligning with common pharmaceutical patent strategies.
- Claim Language:
Precise language, including Markush structures or functional definitions, maximizes scope while maintaining clarity to withstand validity challenges.
Potential Challenges:
- Prior art references may exist for similar compounds or methods, risking claim narrowing or invalidation.
- Overly broad claims might face rejections for lack of inventive step or enablement issues during examination.
Patent Landscape in China for Similar Drugs
China’s pharmaceutical patent landscape has shown substantial growth, with a focus on chemical and formulation patents. Key points include:
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Rising Patent Filings:
The Chinese patent office reports increased filings in chemical and pharmaceutical sectors, with emphasis on innovation in biologics, chemicals, and formulations [(CNIPA Annual Reports, 2022)].
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Patent Clusters:
Several applicants, including domestic firms like Sinopharm and international companies like Novartis, hold extensive patent portfolios involving similar compounds or formulations.
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Legal and Policy Environment:
China emphasizes patent quality, with recent amendments strengthening examination procedures and enforcement mechanisms to combat patent frivolousness and infringement.
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Patent Strategies:
Companies often file multiple patents—composition, use, process—to build robust IP portfolios, facilitating licensing, collaborations, or securing market exclusivity.
Competitive Positioning:
- The patent CN101868465 sits within a crowded landscape; its strength depends on claim breadth, inventive distinctions, and prior art landscape.
- Effective patent drafting that emphasizes inventive features over known compounds enhances enforceability.
Implications for Stakeholders
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Patent Holders:
Should evaluate if their claims are sufficiently broad to prevent easy design-arounds, and whether their patent’s inventive step is defensible against existing art.
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Potential Licensees:
Need to assess patent validity and scope to avoid infringement risks when developing similar formulations or processes.
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Legal and R&D Strategists:
Can use this patent to inform freedom-to-operate analyses, R&D directions, and pipeline planning—considering its position within the broader Chinese patent environment.
Conclusion
Patent CN101868465 exemplifies a targeted Chinese pharmaceutical patent, with a scope likely centered on a novel compound or method characterized by inventive structural or process features. Its claims’ strength depends on specificity, novelty, and clarity—attributes that determine vulnerability to invalidation or design-around strategies. The patent landscape in China for similar drugs continues to evolve, emphasizing innovation, quality, and strategic patenting, critical for securing competitive advantage in this growing pharmaceutical sector.
Key Takeaways
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Scope Precision is Vital:
Broad independent claims provide extensive protection but must balance with enforceability and validity considerations.
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Claims Must Demonstrate Inventiveness:
Novel structural features or unique methods are essential for patent strength amid dense prior art environments.
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Landscape & Competition Are Intense:
Chinese pharma patent filings intensify, requiring robust patent strategies—covering composition, use, and process.
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Proactive Patent Management:
Regular patent landscaping and claim amendments safeguard market position and support licensing or collaborations.
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Legal Vigilance & Strategic Filing:
Continuous monitoring of patent validity and maintaining expansive, inventive claims are critical in China’s dynamic IP environment.
FAQs
1. What types of claims are most significant in pharmaceutical patents like CN101868465?
Independent claims that define the core compound or method are most significant, as they establish the broadest scope of protection, while dependent claims specify particular embodiments or improvements.
2. How does the Chinese patent landscape affect the protection of medicinal compounds?
With increasing filings and focus on innovation, Chinese patent law emphasizes inventive step and claims clarity, making strategic claim drafting essential for robust protection.
3. Can patents like CN101868465 be challenged or invalidated?
Yes, through invalidation procedures based on lack of novelty, inventive step, or insufficient disclosure, especially if prior art surfaces post-grant.
4. How do companies improve the strength of their pharmaceutical patents in China?
By drafting comprehensive claims, filing multiple patent families covering different aspects (composition, use, process), and regularly updating claims to align with evolving legal standards.
5. What role does patent landscaping play in the Chinese pharmaceutical industry?
It helps identify patent gaps, monitor competitors, and inform R&D and patenting strategies, ensuring alignment with market trends and legal requirements.
Sources
[1] State Intellectual Property Office of China (CNIPA). Annual Reports, 2022.
[2] Patent Law of the People's Republic of China.
[3] Chinese Patent Examination Guidelines.
[4] Industry Patent Landscape Analyses, 2021-2022.
