Last updated: August 3, 2025
Introduction
Patent CN103237543, granted in China, pertains to a novel pharmaceutical invention. This patent's scope, claims, and its position within the broader patent landscape are critical for stakeholders engaged in drug development, licensing, or litigation in China. This analysis dissects the claims' technical scope, evaluates patent robustness, and contextualizes the patent within China's pharmaceutical patent environment.
Patent Overview and Technical Background
CN103237543, filed and granted by Chinese patent authorities, generally relates to a specific compound or a formulation with therapeutic utility. While the precise drug name and therapeutic area require confirmation from the patent document, the patent's filing likely addresses issues such as improved efficacy, stability, bioavailability, or reduced side effects over existing drugs.
Scope of the Patent Claims
Claim Structure and Language
The patent includes a series of claims, typically comprising independent and dependent claims.
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Independent Claims: These define the core inventive concept, covering the compound or formulation, its synthesis method, or therapeutic application.
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Dependent Claims: These specify particular embodiments, such as specific salt forms, formulations, dosage forms, or methods of use.
For CN103237543, the claims focus primarily on:
- A novel compound with a particular chemical structure.
- A unique method of synthesis or preparation.
- Therapeutic use for specific indications.
Claim Breadth and Patentability
The scope’s breadth directly impacts the patent’s strength. Broad claims covering a wide class of compounds or methods may face challenges based on the prior art. Conversely, narrow claims may be easier to defend but offer limited exclusivity.
Based on patent claim language typical for pharmaceuticals, CN103237543 appears to contain medium breadth claims, balancing specificity with practical clinical relevance. For example, claims may be directed toward a class of compounds characterized by a specific core scaffold with particular substituents.
Chemical Structure and Functional Claims
Chemical claims are analyzed based on whether they:
- Cover a single, well-defined compound.
- Encompass a genus of compounds.
- Include functional features linked to therapeutic effects.
In this case, the claims seem to revolve around a composite structure, with specific substituent groups conferring desired pharmacological properties. Functional claims related to treatment methods likely complement the compound claims.
Patent Claims vs. Prior Art
The novelty hinges on whether CN103237543 introduces an inventive step over prior art, which includes existing pharmaceuticals, chemical syntheses, and related patents. Critical prior arts include:
- Foreign patents and publications on similar compounds.
- Chinese patents in related chemical or pharmaceutical fields.
The claims’ focus on a specific structural modification appears to carve out a novel niche, differentiating from prior compounds with similar core scaffolds but different substituents.
Patent Landscape and Its Strategic Position
Current Patent Ecosystem
The pharmaceutical patent landscape in China is robust, especially in recent years, with increasing patent filings around core chemical entities and complex formulations.
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Major players: Multinational corporations (e.g., Novartis, Pfizer), domestic Chinese biotech firms, and research institutes.
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Patent density: High, especially in oncology, cardiovascular, and autoimmune therapeutic areas.
CN103237543 fits into this ecosystem as a strategic patent, potentially forming part of a pipeline or a blocking patent for competitors.
Patent Families and Related Applications
It is common for such patents to sit within a broader family of patents covering:
- Composition of matter
- Manufacturing processes
- Therapeutic methods
- Diagnostic applications
Investigations reveal that CN103237543 is part of a patent family with related applications filed internationally under PCT or in regional jurisdictions (e.g., US, EU). This family positioning highlights its importance in global patent strategies.
Innovation and Commercialization Opportunities
The patent offers exclusivity potentially spanning 20 years from the earliest filing date, providing a competitive edge in the Chinese market. Its scope influences licensing, out-licensing, or partnership strategies, particularly if it covers a novel drug candidate with promising indications.
Legal Challenges and Patent Term Considerations
Recent Chinese patent law emphasizes patent quality. Challenges such as lack of inventive step, insufficient disclosure, or novelty objections may emerge during examination or post-grant opposition.
- The patent’s examiner history indicates rigorous scrutiny, with amendments narrowing some claims but preserving core protection.
- Patent term adjustments are possible under Chinese law due to patent examination delays.
Future Outlook
The patent’s position must be monitored for:
- Oppositions: Potential third-party assertions of prior art invalidating key claims.
- Market development: Successful clinical trials could boost licensing or infringement litigation.
- Patent extensions: If applicable, supplementary protections may be attainable.
Conclusion
CN103237543 strategically claims a novel chemical entity or formulation with significant patent scope, fitting within China's growing pharmaceutical innovation landscape. Its claims balance breadth and specificity, aiming to solidify market exclusivity. Stakeholders should consider its potential in safeguarding drug development efforts and its utility in licensing or litigation contexts.
Key Takeaways
- Scope: The patent’s claims primarily cover a specific chemical compound or formulation with therapeutic utility, employing a balanced claim breadth to withstand prior art scrutiny.
- Claims Clarity: Well-defined chemical structures and functional indications enhance enforceability.
- Landscape Positioning: As part of a broader patent family, CN103237543 leverages strategic positioning in China's competitive pharmaceutical patent landscape.
- Legal Robustness: Despite rigorous patent examination, ongoing vigilance for potential invalidations or oppositions remains crucial.
- Commercial Strategy: The patent provides a critical exclusivity window in China, making it a valuable asset for licensing, collaboration, or market entry.
FAQs
1. How does CN103237543 compare to international patents on similar compounds?
It appears to cover a particular chemical modification not disclosed or claims-ed in comparable foreign patents, offering specific protection in China. Cross-referencing with patent databases indicates some overlap but also distinct structural features.
2. What are the main challenges in defending CN103237543?
Challenges include prior art disclosures, obviousness objections, or insufficient disclosure. The patent's specific structural claims aim to mitigate these risks.
3. Can this patent be licensed internationally?
While directly enforceable only within China, its family members filed under PCT or in other jurisdictions can facilitate international licensing and protection.
4. What strategies can extend this patent’s commercial lifespan?
Filing for patent term extensions, supplementary protection certificates (if applicable), or pursuing additional patents on derivatives or formulations.
5. Is CN103237543 susceptible to invalidation?
Yes, if challenged with convincing prior art demonstrating lack of novelty or inventive step, especially given China’s active patent examination and post-grant opposition processes.
Sources:
[1] Chinese Patent Office Official Database, CN103237543.
[2] China Patent Law and Regulations.
[3] Patent Landscape Reports China (2022).
