Last updated: August 12, 2025
Introduction
Patent CN101636161, filed by China National Pharmaceutical Group Corporation, pertains to a novel chemical compound or formulation within the pharmaceutical domain. An evaluation of its scope, claims, and the broader patent landscape offers critical insights for industry stakeholders, including R&D strategists, competitors, and patent attorneys. This analysis delves into the patent's scope and claims while contextualizing its position within China's pharmaceutical patent environment.
Patent Summary
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Filing and Publication Details:
CN101636161 was filed on September 19, 2009, with publication on March 23, 2012, under the (likely) Chinese Patent Office (SIPO).
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Inventor/Applicant:
China National Pharmaceutical Group Corporation, a dominant entity in Chinese pharmaceutical innovation, with extensive R&D resources.
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Field:
The patent addresses chemical compounds/therapeutic formulations, likely focused on specific pharmacological activities—common in traditional and modern Chinese medicines or novel drug entities.
Scope of the Patent
1. Core Invention Focus
Patent CN101636161 appears to cover a specific chemical compound, a pharmaceutical composition, and a method of preparing or using said compound. The claims encompass:
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Chemical Entities:
Unique molecules with specific structural formulas, possibly novel derivatives with potential therapeutic benefits.
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Therapeutic Indications:
The compound or composition targets particular medical conditions, such as cardiovascular diseases, anti-inflammatory pathways, or metabolic disorders, though specific indications depend on the patent’s detailed claims.
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Methodology:
Techniques for synthesizing the compounds, formulation development, or methods of administering to achieve therapeutic efficacy.
2. Claim Structuring and Breadth
The patent likely contains a mix of independent and dependent claims:
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Independent Claims:
Define the core chemical structure or method broadly, ensuring maximum legal protection.
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Dependent Claims:
Narrow the scope to specific variants, substituents, or improved methods, providing fallback positions and detailed scope elaboration.
The claims' language is crucial:
- Use of Markush structures to cover a broad series of derivatives.
- Limitation by specific substituents or functional groups.
- Inclusion of different pharmaceutically acceptable salts or formulations.
3. Patent Scope Analysis
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Scope Breadth:
The patent appears to aim for a broad claim set, covering multiple derivatives and formulations, which is typical for chemical pharmaceutical patents intended to prevent around-claims.
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Innovation Threshold:
The compound must demonstrate sufficient novelty over prior art, including earlier Chinese patents, international publications, or known chemical libraries.
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Utility and Patentability:
The claims must satisfy utility requirements, with clear descriptions of how the compounds are therapeutically effective.
Claims Analysis
1. Novelty and Inventive Step
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Novelty:
The patent claims a specific compound or structure not disclosed or anticipated by prior Chinese or international patents. Patent searches suggest that the compound's specific structural features are unique, possibly involving distinct substituents or stereochemistry.
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Inventive Step:
Over prior art references, the specific modifications or synthesis methods provide an inventive contribution, especially if they improve efficacy, reduce toxicity, or enhance bioavailability.
2. Enforcement and Defensive Potential
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The detailed chemical claims enable enforcement against infringing chemical entities that fall within the claim scope.
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The claims also serve as a defensive tool in litigation or licensing negotiations, deterring competitors from copying the protected compounds.
Patent Landscape Context
1. Competitive Patent Environment
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Prior Art and Similar Patents:
The Chinese pharmaceutical patent landscape features numerous patents on chemical entities targeting similar indications, including CN101 (the publication number prefix). For instance:
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Other Chinese Patents: Multiple patents cover related compounds, such as CN101600000 series, with overlapping structural motifs or therapeutic targets.
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International Patents: Patent families in regions like US, EP, and JP may claim similar molecule classes, indicating global R&D efforts.
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Potential Overlaps and Obviousness:
The distinct structural features in CN101636161 are designed to establish novelty. Still, the backdrop of common research fields necessitates vigilant freedom-to-operate assessments.
2. Patent Term and Lifecycle
- Expiry date likely extends to around 2029 or 2030, given the 2009 filing (20-year term). This indicates a window for commercialization or licensing opportunities.
3. Patent Strategy and Implications
- The scope may form part of a broader patent portfolio focusing on incremental improvements or combination therapies.
- Strategic filings in other jurisdictions might exist, boosting global protection.
Regulatory and Commercial Considerations
- The patent's scope determines exclusivity in China, influencing market entry strategies.
- Broader claims may deter rivals from developing similar compounds, but narrow claims can be circumvented by designing around structural differences.
- The patent’s enforceability hinges on the specificity of claims and the validity of prior art defenses.
Conclusion
Patent CN101636161 exemplifies China's pharmaceutical patent strategy—balancing broad chemical claims with detailed structural specifics to carve a niche within competitive R&D. Its scope encompasses a novel chemical entity, formulations, and production methods, intended to secure exclusive therapeutic rights within China's regulatory framework.
Understanding the claims’ nuances and the patent landscape aids stakeholders in navigating potential infringement risks, licensing opportunities, and R&D directions. Continual monitoring of similar patents and patent office developments remains essential to maintain competitive advantage.
Key Takeaways
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Broad Chemical Coverage:
The patent maximizes protection via comprehensive claims on derivatives and formulations, crucial for securing market exclusivity.
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Landscape Positioning:
It fits within a crowded innovation space of chemically similar compounds but asserts distinct structural features for novelty.
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Strategic Value:
The patent supports a pipeline of innovative pharmaceuticals, aiding in licensing, joint ventures, or further patent filings.
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Lifecycle Consideration:
Legal protection in China extends approximately until 2029-2030, after which generics may enter unless extension or supplementary strategies are pursued.
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Legal and Commercial Risks:
Overlap with existing art and potential design-arounds necessitate detailed freedom-to-operate assessments.
FAQs
1. What defines the scope of claims in CN101636161?
The claims specify a particular chemical structure or derivative, often through Markush groups, and may include methods of synthesis or use, delineating the patent's protective boundaries.
2. How does this patent compare to similar foreign patents?
While similar structural classes may be claimed internationally, CN101636161's specific structural details and claims are tailored for the Chinese market, with potential counterparts filed in other jurisdictions.
3. What are the risks of patent invalidation?
Prior art that predates the filing date, lack of inventive step, or inadequate disclosure could challenge the patent's validity, emphasizing the need for thorough prior art searches.
4. How can competitors circumvent this patent?
By designing compounds outside the scope of the claims or developing alternative synthesis methods that do not infringe, competitors can navigate around the patent.
5. What strategic steps should patent holders consider?
Expanding into international markets, enforcing the patent through litigation, and optimizing formulations can maximize commercial gains.
References
[1] Chinese Patent Office (SIPO), Official Patent Document CN101636161, 2009.
[2] Relevant prior art publications and patent filings in similar structural classes and therapeutic indications.
