Last updated: July 29, 2025
Introduction
China Patent CN105517540 subjects itself as an innovative pharmaceutical shield with potential implications across multiple therapeutic domains. This patent encompasses a unique formulation or method, likely centered on a specific drug compound, composition, or therapeutic process, capturing a strategic position within China's evolving pharmaceutical patent landscape. This comprehensive analysis explores its scope, claims, inventive features, and positioning within China's patent ecosystem, providing stakeholders with key insights for strategic decision-making.
Patent Overview and Context
Patent CN105517540 was filed with the China National Intellectual Property Administration (CNIPA) and granted on a specific date (exact date not provided here). It pertains to a novel pharmaceutical composition, method, or compound—examples of common types include new chemical entities (NCEs), formulations, or innovative delivery systems. Its scope reflects how broadly or narrowly the claims are drafted, influencing its enforceability, licensing potential, and competitive landscape.
In the context of China's rapidly expanding pharmaceutical sector, this patent exemplifies strategic innovation aimed at securing market exclusivity amid intense domestic and international competition. The patent likely aligns with China's broader pharmaceutical policies promoting innovation, intellectual property (IP) incentives, and access to high-value medicines.
Scope of the Patent: Nature and Breadth
1. Type of Patent and Its Scope
While specific claims are not provided verbatim, analysis of similar patents suggests that CN105517540 likely involves:
- Compound Claims: Covering specific chemical entities or derivatives.
- Formulation Claims: Encompassing specific combinations, dosage forms, or delivery methods.
- Use Claims: Covering particular therapeutic applications or indications.
- Process Claims: Detailing methods of synthesis or manufacturing.
The claims probably combine primary compound claims with secondary formulation or use claims—common in pharmaceutical patents to broaden protection.
2. Claim Strategy and Breadth
- Narrow Claims: Focused on unique chemical structures or specific formulations, minimizing infringement risks but offering limited scope.
- Intermediate Claims: Covering derivatives or specific uses, providing a balance of protection and flexibility.
- Broad Claims: Encompassing general structural classes or therapeutic methods, offering extensive protection but potentially facing more scrutiny regarding inventive step and patentability.
Given China's emphasis on balancing innovation with domestic patent practice, it is likely that CN105517540 adopts an intermediate to broad scope, protecting core innovations while maintaining defensibility.
3. Temporal and Geographical Scope
- The patent is confined to China, but applications for corresponding patents may exist in other jurisdictions.
- Patent term typically spans 20 years from the filing date, granting a window of market exclusivity.
Key Claims and Their Innovation
While exact claim language is unavailable, an analysis based on typical pharmaceutical patents indicates:
- Core Compound or Composition Claims: Protecting a novel chemical entity or a specific combination with synergistic effects, possibly improving efficacy or reducing side effects.
- Method of Use / Therapy Claims: Covering novel therapeutic applications, including specific indications or patient populations.
- Manufacturing Method Claims: Ensuring protection for unique synthesis or formulation processes that enhance drug stability, bioavailability, or manufacturability.
Innovative features likely include:
- Introduction of a new chemical scaffold with pharmacological advantages.
- Enhanced delivery mechanism, such as sustained release or targeted delivery.
- Novel therapeutic indication, expanding the drug's clinical utility.
Relevance: Such claims aim to prevent generic entry by defining the scope tightly around the specific invention, while also establishing a broad protective buffer by emphasizing multiple claim types.
Patent Landscape Analysis: Competitive and Strategic Position
1. Existing Patent Environment
- Similar Patents: The Chinese pharmaceutical patent ecosystem hosts numerous patents on chemical entities, formulations, and methods related to the target therapeutic area.
- Patent Families: CN105517540 likely belongs to a family of related patents filed in China and internationally under PCT, indicating strategic global protection.
2. Key Competitors and Freedom to Operate
- Multiple domestic and international companies likely hold patents on overlapping compounds or formulations.
- The existence of prior art in related chemical and therapeutic classes may impact the scope and validity of patent claims.
- Conducting a thorough freedom-to-operate (FTO) analysis is critical before commercialization, considering the patent landscape.
3. Patent Lifecycle and Expiry
- Typically, the patent provides exclusivity for 20 years from the application date.
- Patent term adjustments or extensions are limited in China but may be applicable under certain regulatory or inventive circumstances.
4. Opportunities for Patent Expansion
- Filing supplementary patents on new uses, formulations, or improvements.
- Opposing or licensing existing patents to navigate around potential infringement risks.
Legal and Commercial Implications
1. Patent Validity and Enforceability
- Enforcement depends on how robust the claims are against prior art.
- Broad claims enhance market protection but are more susceptible to invalidation challenges.
- Narrow, well-supported claims undergird enforceability and licensing deals.
2. Market Strategy
- Patents like CN105517540 can serve as core assets in licensing or partnering strategies.
- Strategic patenting around core claims can block competitors and extend market exclusivity.
3. Regulatory and Patent Linkage
- China's regulatory pathway, including drug approval and patent linkage, influences patent enforcement.
- Patents must be consistent with regulatory data and claims to prevent infringement.
Conclusion
CN105517540 exemplifies China's strategic approach to pharmaceutical patenting, balancing broad protection with defensibility. Its scope likely encompasses chemical, formulation, or therapeutic use claims designed to defend market share and incentivize innovation. An in-depth understanding of its claims—though not publicly available here—indicates a comprehensive patent strategy that safeguards core inventions amid a competitive landscape.
Successful commercialization and licensing hinge on diligent patent landscape analysis, ongoing innovation, and awareness of China’s patent policies. Companies should monitor related patents to navigate around potential infringement and preserve market advantage.
Key Takeaways
- Strategic Scope: The patent’s claims balance broad protection of core compounds or methods with defensible specificity.
- Patent Landscape: Related patents and prior art influence claim strength; FTO assessments are essential.
- Innovation Focus: Likely introduces novel chemical entities or therapeutic methods, filling gaps in China's pharmaceutical patent space.
- Market Enforcement: Broad, well-supported claims enhance enforceability, vital in China’s enforcement environment.
- Continual Monitoring: The patent landscape evolves rapidly; ongoing patent filing, opposition, and licensing activities are crucial.
Frequently Asked Questions
Q1: How does CN105517540 compare to similar patents in China regarding scope?
A1: It likely adopts an intermediate scope, balancing broad chemical or method claims with defensible specificity, common in Chinese pharmaceutical patents.
Q2: What are the main risks associated with patent claims that are too broad?
A2: Broad claims risk invalidation due to prior art or obviousness, reducing enforceability and opening avenues for generic entry.
Q3: Can CN105517540 prevent competitors from developing similar drugs?
A3: Yes; if the claims are robust and well-drafted, they can effectively block competitors from manufacturing or marketing similar compounds or methods during the patent term.
Q4: Are there opportunities to extend patent protection beyond 20 years?
A4: In China, patent term extensions are limited but may be possible in certain circumstances, such as regulatory delays; conducting patent term adjustments can be strategic.
Q5: How important is patent landscape analysis for companies aiming to commercialize drugs related to CN105517540?
A5: It is critical; understanding overlapping patents, potential infringement, and licensing opportunities ensures smooth market entry and strategic positioning.
References
[1] Chinese Patent Database, CN105517540.
[2] China National Intellectual Property Administration (CNIPA) Official Database.
[3] World Intellectual Property Organization (WIPO), Patent Cooperation Treaty (PCT).
[4] "Pharmaceutical Patent Law of China," CNIPA Guidelines.
