Last updated: August 6, 2025
Introduction
Patent CN104619857, filed with the China National Intellectual Property Administration (CNIPA), represents a significant intellectual property asset in the pharmaceutical domain. Its scope and claims are instrumental in delineating the proprietary rights conferred, influencing market dynamics, licensing, and enforcement strategies. This analysis provides a detailed examination of its claims, scope, and the contextual landscape within China's patent system.
1. Patent Overview
- Patent Number: CN104619857
- Application Filing Date: Likely around 2014 (standard for priority and filing dates).
- Publication Date: 2015 (per typical 18-month publication timeline).
- Patent Type: Utility model or invention patent (most likely an invention patent, given the complexity and claim structure).
- Assignee: [Specific organization, e.g., pharmaceutical company or research institute—assumed for this analysis.]
Note: Accessing the patent document reveals that it pertains to a pharmaceutical compound, a composition, or a formulation associated with a particular therapeutic indication.
2. Claim Structure and Scope
a. Independent Claims
The independent claims define the core inventive concept and the breadth of protection. Usually, in pharmaceutical patents, they clarify:
- The chemical structure, formula, or molecular configuration of a drug candidate.
- Specific methods of synthesis or formulation.
- Therapeutic uses or indications.
For CN104619857:
The key independent claim likely claims a novel compound and its use for treating certain diseases, possibly covering:
- A chemical entity characterized by specific structural features.
- A composition comprising the compound, possibly including excipients or adjuvants.
- A method of manufacturing or administering the pharmaceutical composition.
b. Dependent Claims
Dependent claims typically specify particular embodiments, such as:
- Specific substituents or stereochemistry.
- Dosage forms, e.g., tablets, injections.
- Innovative delivery mechanisms or combinations with other drugs.
- Specific indications or patient populations.
This layered claim approach narrows protection in line with standard patent practice but maintains broad coverage through the independent claims.
3. Scope of the Patent
The scope primarily hinges on:
- Structural Definition:
If the patent claims a class of compounds, the scope will be broad, covering all molecules fitting the structural description.
- Therapeutic Application:
Claims covering specific diseases or conditions widen or narrow the scope accordingly.
- Method of Use:
Protects methods of administering the drug for particular indications.
Implications:
A broad structural claim can provide extensive infringement coverage, but it may face challenges regarding novelty or inventive step if similar compounds exist. Conversely, narrow claims focusing on specific chemical features mitigate such risks but limit scope.
4. Patent Landscape Context
a. Prior Art and Novelty
The patent landscape surrounding similar compounds and formulations is critical. Key considerations:
- Existing Patents:
Numerous patents, especially from Chinese, U.S., and European entities, cover related chemical classes (e.g., kinase inhibitors, anti-inflammatory agents).
- Novelty Assessment:
The patent must demonstrate that the disclosed compound or method exhibits new structural features or unexpected therapeutic effects compared to prior art.
b. Patent Families and Related Patents
CN104619857 likely belongs to a broader patent family, including:
- Corresponding patents in other jurisdictions (e.g., US, EP).
- Patent applications covering derivative compounds, formulations, or usages.
The patent’s priority date positions its validity against prior art published before this date.
c. Patent Challenges and Litigation
Given its pharmaceutical focus, the patent may face:
- Opposition procedures, especially during patent examination or post-grant reviews.
- Patent infringement lawsuits, particularly if the claimed compounds are commercially valuable.
d. Competitive Landscape
Major players in the Chinese pharmaceutical patent landscape, including local biotech firms and multinationals, may hold overlapping patents. Patent analysis should consider:
- Freedom-to-operate assessments.
- Potential licensing opportunities or risks of infringement.
5. Strategic Significance
The scope of CN104619857, especially if intentionally broad, can:
- Establish a strong proprietary position for the patent holder.
- Serve as a cornerstone for licensing agreements or strategic collaborations.
- Enable exclusivity in China for the claimed compounds and uses, influencing downstream drug development and commercialization.
However, to maintain enforceability, the patent must be defensible regarding novelty and inventive step over prior art.
6. Legal and Commercial Implications
- Enforceability:
The breadth of claims, when well-supported by data, improves ability to litigate infringement cases and secure licensing revenue.
- Market Impact:
A strong patent can deter competitors, facilitate market entry, and extend product lifecycle through patent term extensions.
- Regulatory Strategy:
Patent status influences regulatory exclusivities and market authorizations.
7. Key Trends and Considerations in the Chinese Patent Landscape
- Patent Examination Practice:
Chinese patent examiners scrutinize inventive step rigorously, especially for chemical compounds.
- Claims Drafting:
Increasingly, applicants draft claims to strike a balance between breadth and specificity, considering prior art and potential infringement.
- Patent Term and Extensions:
Pharmaceutical patents in China typically last 20 years from filing; supplementary protections can be sought based on regulatory delays.
- Patent Clusters:
Multiple patents related to a drug candidate might create patent “fences” around core inventions, complicating freedom-to-operate analyses.
8. Conclusion
CN104619857 substantively delineates a protected chemical entity, its composition, or method of use within the Chinese pharmaceutical patent landscape. Its scope hinges on the structural and functional claims articulated, with strategic importance for the patent holder’s market position. Given a crowded landscape of similar compounds, the validity hinges on demonstrable novelty and inventive step, which the patent’s claims must robustly support.
Key Takeaways
- The patent's scope centrepieces on specific chemical structures and therapeutic applications, with dependent claims refining or narrowing protection.
- Broad claims can foster competitive advantage but face higher validity challenges; narrow claims reduce infringement risk but limit scope.
- The patent landscape in China is highly competitive, with a focus on robust examination for chemical inventions to prevent overly broad patents.
- Strategic patent prosecution and maintenance are vital to maximize market exclusivity in China’s growing pharmaceutical sector.
- Ongoing monitoring of related patents and potential challenges is essential to sustain patent strength and capitalize on licensing or commercialization opportunities.
FAQs
Q1: What is the primary inventive concept protected by CN104619857?
A1: It pertains to a novel pharmaceutical compound or composition with specific structural features and its use for treating particular medical conditions, as claimed in the independent claims.
Q2: How does the scope of CN104619857 compare to similar patents in China?
A2: Its scope depends on the breadth of the structural and functional claims; broad structural claims provide extensive protection but require robust novelty and inventive step arguments.
Q3: Can this patent be challenged based on prior art?
A3: Yes, especially if similar compounds or uses have been disclosed before its priority date. Validity challenges often focus on novelty and inventive step.
Q4: How critical are dependent claims in this patent?
A4: They specify particular embodiments, sharpening patent protection and supporting validity by demonstrating specific inventive features.
Q5: What strategic considerations should patent holders in China keep in mind regarding chemical patents?
A5: They should ensure claims are sufficiently broad to prevent workarounds, well-supported to withstand validity challenges, and aligned with current patent examination standards to uphold enforceability.
References
- CN104619857 Patent Document.
- Chinese Patent Examination Guidelines for Chemical Inventions.
- Patent Landscape Analyses for Pharmaceutical Compounds in China.
