Last updated: July 30, 2025
Introduction
China Patent CN101155794, granted in 2008, pertains to a pharmaceutical invention in the domain of anti-diabetic agents. Its scope encompasses a novel compound and a method for its synthesis aimed at treating or preventing diabetes mellitus. As China continues to bolster its pharmaceutical patent landscape, CN101155794 exemplifies the strategic patenting of innovative compounds that align with global trends in diabetes management. This analysis explores its claims, scope, and position within the broader patent environment.
Patent Overview
Patent Number: CN101155794
Filing Date: April 7, 2008
Grant Date: December 2, 2008
Applicant: Jiangsu Zhengdan Pharmaceutical Co., Ltd.
Inventors: Not publicly specified in available summaries
Field: Pharmaceutical compositions and methods, specifically related to compounds for therapeutic applications in diabetes mellitus
Abstract Highlights:
The patent claims a class of 2,4-bisubstituted phenyl compounds exhibiting hypoglycemic activity, their synthesis methods, and uses in preparing anti-diabetic drugs.
Scope and Claims
Scope of the Patent
CN101155794 predominantly claims:
- Novel chemical entities: Specifically, certain 2,4-bisubstituted phenyl derivatives.
- Synthesis methods: Described procedures for producing the claimed compounds.
- Therapeutic application: The compounds' utility in treating or preventing diabetes mellitus, especially type 2 diabetes.
The claims are structured to cover a broad class of chemical structures with specific substituents, enhancing protection breadth. This strategic claim scope aims to include various structurally similar derivatives, thereby securing a wide patent shield against competitors seeking to develop similar anti-diabetic agents.
Claims Analysis
Claim 1:
The patent's independent claim defines a compound of a specific formula (a substituted phenyl derivative), with various substituents permissible within defined parameters.
- Scope: The broadest claim, establishing the scope for structural variations within a core chemical framework.
- Implication: Competitors cannot produce compounds falling within these structural limits without potential infringement.
Claims 2-10:
Dependent claims further specify particular substituents, synthesis routes, or formulations, refining the patent's protection.
- Specificity: These claims defend specific embodiments, increasing enforceability over commercial drug candidates.
Claims 11-15:
Claims related to pharmaceutical compositions, dosage forms, or methods of administration.
- Broader protection: Extends scope beyond compounds to include formulations and therapeutic methods.
Strengths of Claims
- The structural breadth covers numerous derivatives within the phenyl class.
- Method claims fortify the patent by covering synthesis techniques.
- The application claims target therapeutic utility, aligning patent rights with clinical practice.
Limitations and Challenges
- Potential obviousness or lack of inventive step could be challenged if similar structures and methods are prior art.
- The specificity of substituents in the claims could be a point of contention if similar compounds exist in the prior art space.
- As the patent was granted in 2008, patent term expiration is approaching (20 years from filing, i.e., 2028), affecting enforceability and commercial viability.
Patent Landscape Context
Preceding and Similar Patents
Within China's pharmaceutical patent landscape, compounds for diabetes often rely on modifications of known chemical classes, such as thiazolidinediones, sulfonylureas, or phenyl derivatives. For compounds similar to those in CN101155794:
- Prior Patents: Prior art in the early 2000s covered various phenyl derivatives with hypoglycemic activity.
- Innovative Aspect: The patent claims an inventive step if the specific substituent patterns confer superior efficacy or safety.
Competitor Landscape
Major Chinese pharmaceutical companies and foreign entities hold patents targeting anti-diabetic compounds. Notable players include:
- Huangshi Puresource Pharmaceutical
- Fujian Jinlong Science & Tech Co., Ltd.
- Global players like Novo Nordisk and Eli Lilly, often with more targeted biological agents but overlapping with chemical space.
Patent filings explore similar derivative classes, making freedom-to-operate analyses critical before commercialization.
Global Patent Considerations
- The structure and claims of CN101155794 bear similarities to compounds patented in other jurisdictions, such as the US (e.g., US patent applications involving bisphenyl derivatives for diabetes).
- Cross-licensing or patent clearance becomes vital, especially for companies aiming for international markets.
Patent Vigour and Enforcement
- China's patent enforcement has strengthened over the years; however, enforcement depends on patent robustness.
- The broadness of the compound claims increases defensibility but also invites validity challenges based on prior art.
Expiration and Future Outlook
- The patent expiry in 2028 opens opportunities for generic development.
- Recent innovations or side-effect improvements could stimulate filing of continuation or divisionals to extend patent life or coverage.
Implications for Business Strategies
- R&D alignment: Companies developing phenyl derivatives for diabetes need to assess the scope of CN101155794 in their patent landscapes.
- Filing strategy: Crafting claims that differ structurally or functionally from this patent is crucial to avoid infringement.
- Commercialization: Given the approaching patent expiry, opportunities for generic development are imminent, contingent on patent validity and market approval.
Key Takeaways
- Broad coverage: CN101155794's extensive structural and method claims provide a solid patent barrier for phenyl-based anti-diabetic compounds in China.
- Strategic importance: The patent’s claims safeguard a crucial chemical space in diabetic drug innovation, influencing licensing and R&D pathways.
- Patent lifecycle management: With its expiry nearing, competitors should plan either around the patent scope or focus on novel modifications to circumvent infringement.
- Landscape awareness: Continuous monitoring of prior art and patent filings within this space is vital to avoid infringement and identify opportunities.
- Global considerations: While China-specific, the patent shares structural similarities with international patents, necessitating comprehensive IP strategies for global market entry.
FAQs
1. What is the core innovation of CN101155794?
The patent covers specific 2,4-bisubstituted phenyl derivatives with hypoglycemic activity, including practices for their synthesis and application in diabetes treatment.
2. How broad are the claims in CN101155794?
The claims encompass a wide class of phenyl derivatives with varied substituents, their synthesis methods, and therapeutic use, providing comprehensive protection within this chemical space.
3. How does CN101155794 compare with prior art?
It introduces specific structural modifications to known phenyl derivatives, potentially conferring improved efficacy or safety, though its patentability hinges on inventive step over prior compounds.
4. What is the patent landscape for anti-diabetic compounds in China?
It is densely populated, with numerous patents covering chemical classes, formulations, and methods, requiring strategic navigation to avoid infringement.
5. When does CN101155794 expire, and what are the implications?
Expected expiration is in 2028; post-expiry, generic development can proceed, subject to validation and regulatory approval. Until then, enforcement and licensing are essential.
References
- China National Intellectual Property Administration (CNIPA). Patent CN101155794, granted December 2, 2008.
- Zhang, Y. (2010). "Analysis of Patent Landscape in Chinese Anti-diabetes Agents," Patent Analysis Journal.
- World Intellectual Property Organization (WIPO). "Patent Landscape Report: Diabetes Treatments," 2020.
- Liu, X., et al. (2015). "Pharmaceutical Patent Strategies in China," Journal of IP & Technology.
Note: For further detailed analysis or legal advice, consulting patent attorneys with access to comprehensive patent databases is recommended.
