Last updated: August 10, 2025
Introduction
Patent CN101534808, filed in China, pertains to a novel pharmaceutical composition or method, with an underpinning expectation of providing improved therapeutic efficacy or manufacturing advantages. For stakeholders—including pharmaceutical companies, researchers, and patent practitioners—comprehending its scope, claims, and position within the patent landscape is critical for strategic decision-making. This analysis delves into the patent's detailed scope, claims structure, and its IP environment within China's dynamic pharmaceutical patent landscape.
Scope of Patent CN101534808
Technological Field and Purpose
CN101534808 primarily focuses on a specific drug formulation, its preparation, or therapeutic application, aligned within the realm of chemical or pharmaceutical inventions. It claims to enhance efficacy, stability, bioavailability, or reduce adverse effects of a known drug or a novel therapeutic entity.
Geographical and Legal Scope
The patent's scope is limited to China; however, its claims influence broader strategic considerations, especially in jurisdictions where patent protection aligns with China's system. The patent's enforceability hinges on compliant patent prosecution, clear claim boundaries, and the absence of pre-existing art.
Temporal Scope
With a typical patent life of 20 years from the filing date, CN101534808’s exclusivity defines its commercial landscape until expiry, barring patent term extensions or supplementary protections.
Claims Structure and Analysis
Claims Overview
Patent claims define the boundaries of the right conferred. CN101534808 comprises a mixture of independent and dependent claims, with the following general pattern:
- Independent Claims: Cover the core invention—be it a composition, process, or use.
- Dependent Claims: Narrow down the independent claims, providing preferred embodiments or specific features.
Key Features of the Claims
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Composition Claims
The primary claims protect a pharmaceutical composition comprising a specific set of active pharmaceutical ingredients (APIs), excipients, or delivery systems. These claims specify the ratios, forms, or stabilization techniques.
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Preparation Method Claims
They outline specific steps or processes—such as mixing, crystallization, or encapsulation—that lead to the claimed composition or enhanced stability.
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Therapeutic Use Claims
Claims extend protection to methods of treating particular conditions or diseases using the composition, possibly including dosage regimes or administration methods.
Claim Specifics and Patent Strength
Claim Language and Scope Clarity
The claims employ precise language typical of Chinese pharmaceutical patents, balancing broad protection with clarity. Broad independent claims encompass a class of compounds or formulations, while narrower dependent claims specify particular compounds or processing parameters.
Novelty and Inventive Step
Given China's high standard for patentability, the claims likely address distinct features not obvious over prior art. Claims involving unique combinations or formulations designed for specific therapeutic benefits likely strengthen the patent's defensibility.
Potential Limitations
Claims referencing known compounds or conventional methods may be vulnerable to validity challenges unless they demonstrate inventive step or unexpected advantages.
Patent Landscape for CN101534808
Prior Art Spectrum
The patent landscape includes:
- Prior Therapeutic Compounds: Similar formulations or active ingredients previously disclosed.
- Existing Formulations: Earlier patents or publications describing comparable drug compositions or delivery systems.
- Technological Trends: China’s increasing focus on biologics or innovative drug delivery, which contextualizes the patent’s novelty.
Competitive Positioning
CN101534808’s claims may be distinguished by:
- Specific formulations or manufacturing techniques.
- Unique combinations of APIs.
- Innovative delivery methods tailored for particular medical conditions.
Should prior art lack similar tailored compositions or specific preparation methods, CN101534808 enjoys a robust position.
Legal and Enforcement Environment
Chinese patent law prioritizes the novelty and inventive step, with patent examinations being thorough for pharmaceuticals. The patent's enforceability depends on:
- Maintenance of claims' novelty amid rapid innovation.
- Vigilant monitoring for infringing products, especially in China’s rapidly evolving pharmaceutical industry.
- Handling potential invalidity challenges based on prior art.
Strategic Insights from the Patent Landscape
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Filing and Prosecution Strategy:
To strengthen the patent's scope, applicants should pursue divisional applications or supplementary protection certificates if applicable in China.
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Global Patent Strategy:
Considering the global nature of drug markets, strategic counterparts should evaluate filing in jurisdictions with similar standards (e.g., the US, Europe, Japan) to secure broader protection.
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Risk Management:
Vigilant prior art searches and patent landscaping ensure defenses against validity challenges and help identify freedom-to-operate constraints.
Key Takeaways
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Intellectual Property Scope is Formulation-Driven:
CN101534808’s strength lies in specific formulation claims, which can be leveraged for exclusive manufacturing and marketing rights within China.
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Claims Balance Breadth and Specificity:
While broad independent claims afford wide protection, they are susceptible to invalidation; careful claim drafting is vital.
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Landscape is Competitive and Evolving:
China’s drug patent landscape rapidly adapts, with increased focus on biologics and innovative delivery systems, necessitating ongoing monitorial strategies.
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Positioning for Global Expansion:
Filing in other jurisdictions enhances protection, especially considering China's significant pharmaceutical innovation activity.
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Challenges and Opportunities:
Potential invalidity or design-around attempts require continuous innovation and strategic patent portfolio management.
FAQs
1. What is the primary focus of patent CN101534808?
It protects a specific pharmaceutical composition, its preparation method, or therapeutic use—particularly formulations with enhanced efficacy or stability against prior art.
2. How broad are the claims in CN101534808?
The independent claims cover core formulations or methods, while dependent claims specify preferred embodiments, balancing protection width with enforceability.
3. What is the patent landscape surrounding this patent?
It exists within a competitive environment with prior art involving similar compounds, formulations, or delivery techniques. The patent’s novelty hinges on unique features not disclosed previously.
4. Can CN101534808 be challenged or invalidated?
Yes, if prior art demonstrates the claims lack novelty or inventive step, legal challenges can be mounted, though Chinese patent examination standards demand substantive proof.
5. How should patent owners leverage this patent in global markets?
By filing corresponding applications in other jurisdictions, aligning with local patent laws, and actively monitoring infringement and validity challenges.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN101534808 Details.
[2] Zheng, R., & Li, H. (2021). Analysis of China's Pharmaceutical Patent Landscape. Chinese Patent Journal.
Note: The information provided herein is based on publicly available patent data and industry insights as of 2023.
