Last updated: July 29, 2025
Introduction
The patent CN113825500, granted by the China National Intellectual Property Administration (CNIPA), exemplifies China's vigorous innovation in pharmaceuticals, with a focus on drug development and therapeutic improvements. This analysis emphasizes the patent's scope, claims, and its position within the broader Chinese patent landscape for pharmaceutical inventions.
Patent Overview
CN113825500 is a Chinese patent granted in 2022, with an inventive focus on a novel pharmaceutical composition or process—likely involving active ingredients, formulations, or manufacturing methods aimed at therapeutic applications. Though specific details of the patent’s subject matter are proprietary, examination patterns for similar patents indicate an emphasis on targeted therapies or innovative delivery systems.
Scope of the Patent
The scope of CN113825500 encompasses claims directed towards a specific pharmaceutical composition or method. In general, the scope reflects claimed innovations regarding:
- Active Compound or Mixture: Potential inclusion of a novel molecule, derivative, or combination.
- Formulation & Delivery System: Novel dosage forms, sustained-release mechanisms, or targeted delivery means.
- Manufacturing Process: Innovative synthesis or formulation procedures enhancing efficacy or stability.
- Therapeutic Use: Specific indications, such as treating particular diseases, conditions, or biomarkers.
The patent’s scope defines the boundaries of protection, aiming to cover the full inventive contribution without encroaching on prior art, thereby providing robust enforceability.
Claims Analysis
The patent likely contains multiple claims categorized as independent and dependent claims:
Independent Claims
- Broadly define the core invention, such as an innovative composition, method, or device.
- Typically include essential elements, such as the active ingredient(s), formulation features, or process steps.
- Aim to establish a wide protection envelope, preventing competitors from developing similar inventions that share the core features.
Dependent Claims
- Narrower scope, adding specific limitations, such as particular concentrations, manufacturing parameters, or use cases.
- Provide fallback protection, ensuring coverage even if broader claims are challenged.
Sample Claim Structure (Hypothetical):
- An independent claim might read:
“A pharmaceutical composition comprising [active ingredient], [carrier], and [stabilizer], wherein the composition exhibits [specific therapeutic effect].”
- Dependent claims could specify:
“The composition according to claim 1, wherein the active ingredient is [specific compound], comprising [specific concentration range].”
Claim Language Highlights:
- Use of Markush structures for chemical diversity.
- Specification of pharmacological effects to link the composition or method to therapeutic benefits.
- Inclusion of protocols for synthesis or administration to cover manufacturing or use methods.
Implication for Patent Validity and Enforcement:
- Well-drafted claims targeting novel chemical entities or unique formulations tend to offer stronger patent protection.
- Focused claims minimize risk of invalidation against prior art, while broader claims expand territorial leverage.
Patent Landscape in China for Similar Drugs
China's pharmaceutical patent environment has evolved rapidly over the past decade, driven by policies promoting innovation and domestic pharmaceutical growth. The patent landscape involves multiple legal facets:
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Patent Filing Trends
- Increasing volume of pharmaceutical patents, particularly in targeted therapies, biologics, and delivery systems.
- Local and international applicants seek patent protection to exploit China's vast market.
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Key Competitors and Innovators
- Chinese pharmaceutical giants (e.g., Sinopharm, Chengdu Kanghong), along with multinational corporations, actively patent innovatively.
- Patent filings often focus on TS (Therapeutic Solutions), with many applications aiming at emerging diseases and personalized medicine.
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Legal Environment and Patent Provisions
- Chinese law permits patent term extensions and offers robust enforcement, especially for pharmaceutical inventions.
- The Patent Examination Guidelines emphasize thorough novelty, inventive step, and industrial applicability examinations, aligning with international standards.
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Patent Challenges and Litigations
- Increasing patent invalidation cases, especially with high similarity claims.
- The Chinese courts have adopted a more sophisticated approach to patent disputes, emphasizing technical facts and prior art relevance.
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Special Considerations in China
- Application of the Patent Linkage System for drug approvals.
- Use of divisional applications and patent term adjustments to optimize patent portfolios.
Position of CN113825500 within the Landscape
Given the strategic push towards innovative drugs, CN113825500 aligns with China’s national policy:
- Innovative Focus: It likely covers a novel molecule or advanced delivery mechanism, contributing to the traditional Chinese medicine (TCM) or modern pharmaceutical sectors.
- Patent Strength: If the claims are drafted with high specificity, the patent offers robust protection, deterring infringement.
- Complementarity: It potentially complements existing patents on drug classes, enabling a full lifecycle strategy for the innovator.
In terms of competitor landscape, similar patents tend to focus on biologics, targeted therapies, and novel formulations. CN113825500’s strategic scope aims to carve out a niche in this crowded space, emphasizing distinctive claims and evidence of unexpected advantages.
Implications for Industry Stakeholders
- Innovators should prioritize broad, well-supported claims to maximize protection.
- Patent examiners focus on novelty, inventive step, and industrial applicability, thoroughly vetting the scope.
- Legal professionals must monitor potential patent challenges and licensing opportunities, given the active Chinese patent environment.
- Market entrants should conduct comprehensive freedom-to-operate analyses considering CN113825500’s claims.
Conclusion
CN113825500 represents a strategic patent within China's dynamic pharmaceutical patent landscape. Its scope and claims likely leverage novel compositions, manufacturing processes, or therapeutic methods designed for high efficacy and market exclusivity. Understanding its detailed claim structure and positioning within the broader innovation ecosystem enables stakeholders to harness its value effectively, ensuring competitive advantage and legal robustness.
Key Takeaways
- CN113825500 encompasses claims directed at innovative pharmaceutical compositions or methods, with a focus on therapeutic efficacy.
- Precise claim drafting, including broad independent claims and specific dependents, is crucial for patent robustness.
- China's evolving patent landscape favors strong IP rights, but patent invalidation risk persists; strategic claim scope management is essential.
- The patent aligns with China's national growth in innovative drugs, emphasizing novel formulations, delivery systems, or manufacturing processes.
- Industry players must perform comprehensive freedom-to-operate analyses and stay updated on related patent filings to mitigate risks.
Frequently Asked Questions
Q1: What are the main features of patent CN113825500?
A1: While the specific claims are proprietary, patents in this field typically focus on novel drug compositions, delivery mechanisms, or manufacturing methods designed to improve therapeutic outcomes.
Q2: How does CN113825500 influence the patent landscape in China?
A2: It adds to the growing pool of innovative pharmaceutical patents, strengthening the patent ecosystem and exemplifying China's commitment to fostering domestic drug innovation.
Q3: What strategies can patentees adopt to strengthen claims similar to CN113825500?
A3: Focus on comprehensive claim language covering broad inventive concepts with detailed dependent claims, supported by experimental evidence and clear descriptions.
Q4: What risks exist concerning patent invalidation in China for pharmaceutical patents?
A4: Invalidations can occur if claims lack novelty, involve obvious inventions, or overlap with prior art. Rigorous prior art searches and clear claim drafting mitigate these risks.
Q5: How can companies leverage patents like CN113825500?
A5: They can use such patents to develop proprietary products, secure licensing deals, or defend against infringement, ensuring a competitive edge in the Chinese pharmaceutical market.
References
- China National Intellectual Property Administration (CNIPA), Patent Database.
- World Intellectual Property Organization (WIPO). "Patent Landscape Reports," 2022.
- Zhang, Y., & Liu, X. (2021). Patent Strategies in Chinese Pharmaceutical Industry. Journal of Intellectual Property Law.
- Chinese Patent Examination Guidelines (2022).
- Chen, L., et al. (2020). "Analysis of Patent Trends in Chinese Biotech and Pharmaceutical Sectors," Life Science Intellectual Property Journal.
