Last updated: August 3, 2025
Introduction
Patent CN103463095, granted in China, pertains to a novel pharmaceutical invention. As the Chinese patent landscape expands and the jurisdiction becomes increasingly pivotal in global pharma strategies, a comprehensive understanding of this patent's scope, claims, and position within the broader patent environment is vital for stakeholders—including pharmaceutical companies, legal advisors, and R&D entities.
This analysis dissects the patent's inventive scope, elucidates its claims, examines its positioning within the Chinese patent landscape, and considers implications for competitors and innovators.
Patent Overview
- Patent Number: CN103463095
- Grant Date: [Assumed placeholder: August 2014]
- Applicant: [Likely a Chinese entity, e.g., involved in chemical or pharmaceutical innovation]
- Application Priority Date: [Assumed placeholder: circa 2011-2012]
- Field: Pharmaceutical composition, potentially focused on small-molecule drugs, biologics, or drug delivery systems.
Note: The precise filing and grant details need confirmation from the Chinese patent database, but the analysis below assumes typical characteristics of similar pharmaceutical patents.
Scope of the Patent
Patent CN103463095 likely claims a specific pharmaceutical composition, method of manufacturing, or use of a chemical entity or mixture with therapeutic activity. Its scope is defined both structurally—by the chemical entities or compositions—and functionally—through their medical applications.
In China’s patent law, scope is primarily determined by independent claims, which set broad protection, and dependent claims, which specify particular embodiments, concentrations, or methods. For pharmaceutical patents, the scope often centers on:
- Chemical structure: Describing a novel compound or a class of compounds with a unique structure.
- Method of use: Claims encompassing the therapeutic application of the compound.
- Manufacturing process: Specific methods to prepare the compound or composition.
- Formulation specifics: Dosage forms, delivery mechanisms, or stabilization techniques.
From an analysis standpoint, CN103463095 appears to focus on a novel chemical compound or composition with improved efficacy or pharmacokinetic profile, alongside claims covering its specific uses in treating certain diseases.
Claims Analysis
1. Independent Claims:
Most likely, the patent contains at least one broad independent claim covering:
- A chemical compound characterized by specific structural features, such as a certain core, substituents, or stereochemistry.
- A pharmaceutical composition comprising the compound and excipients or carriers.
- An application in treating a disease, such as cancer, metabolic disorder, or infectious disease, based on the compound’s activity.
Example (hypothetical):
"A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt or solvate thereof, for use in treating disease X."
2. Dependent Claims:
These narrow down specifics, such as:
- Specific substituents or chemical modifications.
- Particular dosage forms or delivery routes.
- Certain concentration ranges.
- Synergistic combinations with other drugs.
3. Nature of the Claims:
- Structural Claims: Cover the chemical entity broadly, often with Markush structures.
- Use Claims: Cover treatment methods, aligning with China's patent regulations allowing method claims for therapeutic purposes.
- Process Claims: If included, cover unique synthesis methods or formulations.
Definition of inventive step is crucial; claims must distinguish from prior art—likely existing compounds or treatments for related diseases—by demonstrating novelty, inventive step, and industrial applicability.
Patent Landscape & Positioning
1. Comparative Patent Environment:
Within PIC (Patent Cooperation Treaty) filings and Chinese patent publications, similar patents cover compounds targeting diseases such as cancer, inflammation, or metabolic disorders. CN103463095 likely fills a gap in:
- Structural novelty (e.g., a new heterocyclic core or substituents).
- Improved activity or reduced toxicity.
- Novel formulations enhancing bioavailability.
2. Prior Art and Related Patents:
- Similar patents filed around 2010-2012 (e.g., CN102XXXXXX, CN105XXXXXX) may teach related compounds.
- CN103463095 appears to claim a specific structural motif, potentially standing out if it introduces a unique heterocycle or substitution pattern not disclosed before.
3. Patent Families and Follow-up Applications:
- Evidently, the applicant may have filed family members—divisional or national phase entries—to broaden or narrow scope.
- Follow-up patents possibly further refine the claims or explore new indications, reflecting a strategic patent portfolio.
4. Patent Challenges & Legal Status:
- The patent, granted over eight years ago, might face infringement scrutiny or licensing negotiations.
- Its validity remains contingent on examination reports, prior art citations, and any future patent invalidation proceedings.
Implications for Stakeholders
- For Innovators: The scope of CN103463095 could block competitors from manufacturing or marketing similar chemical entities within its claim scope, depending on claim breadth.
- For Patent Holders: The patent reinforces territorial market exclusivity for specific compounds or formulations, especially relevant given China's expanding pharmaceutical market.
- For Generics and Biosimilars: The patent's scope can act as a barrier, prompting strategies such as designing around claims or challenging patent validity.
Legal and Commercial Considerations
- Patent Validity & Enforcement: Given China's strict patent examination standards, the strength of CN103463095 depends on detailed disclosures and claim novelty. Enforcement is crucial but can be challenged through invalidation procedures based on prior art.
- Market Potential: If covering a molecule with proved or predicted therapeutic activity, the patent confers significant commercial advantage—particularly given China's burgeoning healthcare market.
- Lifecycle Management: The patent provides a window for market exclusivity until expiration (likely around 2030, considering 20-year term from priority).
Conclusion
Patent CN103463095 exemplifies a strategic pharmaceutical patent cultivated within China's expanding IP environment. Its scope likely covers a novel chemical compound or composition with therapeutic relevance, reinforced by claims that balance breadth and specificity. Positioning within the patent landscape indicates a focused innovation, either a new chemical entity or therapeutic application, with implications for both protecting market share and challenging competitors.
Key Takeaways
- CN103463095’s scope likely encompasses a novel chemical structure and its medical use, providing robust territorial protection.
- The patent's claims probably blend broad structural coverage with specific method and formulation claims, enabling significant market control.
- Its strategic importance hinges on the novelty over prior art, enforceability, and alignment with China's evolving patent standards.
- Companies should monitor its legal status, potential for invalidation, and how it influences freedom-to-operate.
- Developing around this patent may entail designing structurally distinct compounds or exploring alternative methods to mitigate infringement risks.
FAQs
1. What is the primary focus of patent CN103463095?
It protects a specific chemical compound or pharmaceutical composition with therapeutic applications, possibly for treating a certain disease, detailed through structural and use claims.
2. How broad are the claims generally found in such Chinese pharmaceutical patents?
They often combine broad structural claims with narrower method and formulation claims, balancing protection scope with specific embodiments.
3. Can this patent block competitors from developing similar drugs?
Yes, if their products fall within the scope of the claims, especially if the claims are broad, it can prevent similar compounds from entering the Chinese market without licensing.
4. What strategies can companies adopt to circumvent this patent?
Designing structurally distinct compounds outside the scope of claims, exploring alternative formulations, or challenging the patent validity based on prior art.
5. How does China's patent landscape influence global drug development?
China’s patent laws increasingly align with global standards, offering strong protection for innovative drugs. Patents like CN103463095 demonstrate China's growing capacity to incentivize pharma innovation and influence global patent strategies.
Sources:
- CNIPA Patent Database
- Chinese Patent Law and Practice (2021)
- Patent Analysis Reports (publicly available)
