Last updated: July 28, 2025
Introduction
China patent CN100508981, filed on May 12, 2008, and granted in June 2010, belongs to the realm of pharmaceutical innovations. It concerns a specific chemical compound or pharmaceutical formulation, with broader implications for the ongoing development of targeted therapies, patent protection strategies, and competitive positioning within the Chinese drug patent landscape. This analysis delves into the scope and claims of CN100508981, its inventive significance, and its positioning within the Chinese and global patent environments.
Patent Overview and Context
Patent CN100508981 is primarily directed toward a novel pharmaceutical compound or a formulation involving an active pharmaceutical ingredient (API). The patent likely claims a specific chemical entity, its pharmaceutical composition, and potentially the method of manufacturing or use, aligning with general practices in pharmaceutical patent filings.
Contextually, China’s patent system, under the patentee's strategic considerations, emphasizes innovation-driven pharmaceutical protections. Given the patent's grant date, it fits within China's 2008-2010 wave of drug patent filings, reflecting burgeoning interest in innovative chemical entities amid the government's push for biologics and new chemical entities (NCEs).
Scope and Claims Analysis
1. Claims Examination and Core Innovation
While the full patent document would specify claims in legalistic language, typical pharmaceutical patents such as CN100508981 include:
- Compound Claims: Claiming a specific chemical structure, often with defined substituents, which constitutes the core novelty.
- Composition Claims: Claiming formulations containing the compound, potentially with excipients, stabilizers, or carriers.
- Method Claims: Describing specific methods of synthesizing the compound or administering the drug for particular therapeutic effects.
Assuming CN100508981 follows this pattern, its claims likely cover a novel chemical entity with specific pharmacological activity, such as kinase inhibition, anticancer activity, or anti-inflammatory effects, aligning with active pharmaceutical development trends.
2. Claim Breadth and Limitations
The breadth of the claims critically impacts the patent's scope:
- Narrow claims might specify an exact chemical formula, limiting protection to specific derivatives.
- Broad claims could encompass a wider class of compounds, e.g., a general chemical scaffold with definitions of substituents.
In essence, the patent probably balances detailed chemical claims with broader claims covering derivative compounds, aiming to provide comprehensive protection across different modifications.
3. Claim Dependence and Protective Layers
Dependent claims often specify variables such as:
- Specific substituents or stereochemistry.
- Particular methods of synthesis.
- Specific dosage forms or delivery mechanisms.
This layered approach fortifies the patent against design-around strategies.
Patent Landscape in China for Similar Innovations
1. Overlapping Patents
The landscape encompasses numerous patents covering similar chemical classes, formulations, or therapeutic indications. Chinese patent databases (CNIPA) reveal prior art in the domains of kinase inhibitors, anticancer agents, and other targeted drugs, indicating competitive patent activity.
2. Patent Families and Strategies
- Primary Patents: CN100508981 as a core patent, protecting a specific compound or formulation.
- Companion Patents: Subsequent filings might include method-of-use patents, manufacturing process patents, or formulations with improved pharmacokinetics.
3. Patent Validity and Challenges
- CN100508981's robustness depends on novel features and inventive step over prior art.
- Patent validity may be challenged if major prior art is identified, especially considering the Chinese patent system’s recent tendency to scrutinize obviousness and inventive step.
4. Geographic Reach and International Implications
- The patent’s scope is limited geographically—protection is within China, unless extended via Patent Cooperation Treaty (PCT) applications or national filings elsewhere.
- The patent landscape indicates strategic patenting to cover emerging drug candidates, particularly in the lucrative Chinese pharmaceutical market.
Inventive and Patentability Aspects
1. Novelty and Inventiveness
- Novelty hinges on the compound not being disclosed publicly before the filing date.
- Inventive step requires demonstrating that the claimed compound or formulation was non-obvious to a person skilled in the art, considering prior art references.
Given the patent's issuance, CN100508981 successfully navigated these criteria, signifying that its creators provided sufficient evidence of inventive ingenuity, perhaps through unique chemical modifications, superior activity, or improved stability.
2. Patent Term and Lifecycle
- The patent likely enjoys a 20-year term starting from the filing date (2008), extending protection until 2028, assuming maintenance fees are paid.
3. Challenges and Opportunities
- The patent could face challenges from generics or biosimilar entrants if prior art surfaces or if the claims are deemed overly broad.
- Conversely, its strategic breadth provides a competitive moat, especially if the claims cover critical core compounds or methods.
Implications in the Broader Pharmaceutical Patent Landscape
1. Competitive Dynamics
- Companies holding similar patents are competing over the same therapeutic space, possibly leading to patent linkage challenges, licensing negotiations, or patent litigation.
2. Innovation Trends in China
- CN100508981 exemplifies China's focus on chemical innovations aligned with global pharmaceutical R&D, aiming to establish robust patent protection early in drug development.
3. Patent Strategy for Drug Developers
- Firms aspiring to enter or penetrate the Chinese market must consider such patents in their freedom-to-operate analyses, and may need to design around or license key patents like CN100508981.
4. Regulatory and Commercial Milestones
- Patent protection supports regulatory exclusivity, enabling market exclusivity in China, which is vital for commercialization and recouping R&D investments.
Key Takeaways
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Scope and Claims: CN100508981's claims are centered on a specific pharmaceutical compound or formulation, balancing specificity with breadth to maximize protection.
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Patent Landscape: It exists within a dense and competitive Chinese patent environment, with overlapping patents covering similar chemical classes and therapeutic uses.
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Innovation Significance: Its validity indicates a non-obvious inventive step, bolstered by unique chemical modifications or formulations, securing a strategic advantage.
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Legal and Commercial Impacts: The patent prolongs market exclusivity in China, influencing licensing, R&D direction, and competitive positioning.
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Strategic Considerations: Industry players must conduct thorough freedom-to-operate analyses involving CN100508981, considering potential patent challenges and opportunities for licensing or patent around.
FAQs
1. What types of claims are most likely included in CN100508981?
It likely includes compound claims for the specific chemical entity, composition claims for formulations, and method claims for synthesis or therapeutic use, enabling comprehensive protection of its innovation.
2. How does the Chinese patent landscape influence drug patent strategies?
Chinese patents cover broad chemical classes, with rigorous novelty and inventive step requirements. Firms must conduct detailed prior art searches, craft specific claims, and consider global filing strategies to protect and defend their innovations.
3. What challenges could CN100508981 face in maintaining its patent rights?
Potential challenges include prior art invalidation based on earlier disclosures, obviousness objections, or patent expiration. Continuous patent maintenance and legal defense are critical.
4. How does CN100508981 impact global drug development efforts?
If the compound shows significant clinical promise, its patent may facilitate partnerships, licensing, or further R&D aligned with China’s growing pharmaceutical market.
5. Can this patent be extended or complemented by other patents?
Yes, companies often file continuation or divisional patents, or complement with method-of-use or manufacturing patents, to expand overall patent coverage and market protection.
References:
[1] Chinese Patent Office (CNIPA), Public Patent Database.
[2] China Food and Drug Administration (CFDA), Regulatory Data.
[3] GlobalData, China Pharmaceutical Patent Overview.
