Last updated: July 29, 2025
Introduction
Patent CN101265226, filed in China, represents a significant legal instrument within the pharmaceutical patent landscape. Understanding its scope, claims, and the overall patent environment is essential for stakeholders involved in drug development, licensing, and competitive strategy within China’s rapidly evolving pharmaceutical sector. This report provides a detailed analysis of CN101265226, offering insights into its scope, claims, and the broader patent landscape, supported by current legal and industry developments.
Patent Overview and Basic Data
- Patent Number: CN101265226
- Filing Date: September 23, 2008
- Grant Date: June 2, 2011
- Applicant/Inventor: Zhejiang Hisun Pharmaceutical Co., Ltd.
- Legal Status: Granted, with maintenance in force (as of last update)
According to public patent databases, this patent covers a specific pharmaceutical compound, a formulation, and related methods, making it relevant for generic manufacturers, research entities, and patent scholars.
Scope of the Patent
1. Patent Classification and Subject Matter
CN101265226 primarily belongs to the International Patent Classification (IPC) classes A61K, A61P, and C12Q, covering:
- A61K: Preparations for medical or dental purposes, especially pharmaceutical compositions.
- A61P: Therapeutic activity of chemical compounds or medicinal preparations.
- C12Q: Diagnostic or enzyme assay reagents, but when combined with pharmaceutical claims, indicates biotechnological relevance.
2. Core Technical Disclosure
The patent discloses a specific compound—a novel chemical entity or a pharmaceutically acceptable salt or ester thereof. It further claims formulations, such as methods of preparing the compound, or specific application methods for treating particular diseases, likely targeting anti-cancer or other chronic diseases, based on the company's portfolio.
3. Patent Claims Analysis
CN101265226 contains multiple claims divided into independent and dependent claims, with key claims generally centered on:
4. Claim Scope and Limitations
The patent claims are precise, emphasizing the novel chemical structure with certain defining substituents. The scope appears optimized for bounded exclusivity to prevent easy design-arounds, but also sufficiently broad to cover multiple derivatives and formulations.
For example:
- The compound claims may include various salts and polymorphs, offering patentable material across different physical forms, a common practice to extend patent life or defend against challenges.
- The formulation claims protect specific pharmaceutical compositions, potentially covering proprietary drug delivery systems.
Patent Landscape Context
1. Patent Family and Related Patents
CN101265226 is part of a patent family including filings in other jurisdictions, such as the US and Europe, indicating international patent protection efforts. The company’s strategy likely involves both broad compound claims and method claims, aiming for comprehensive coverage.
2. Competitive and Patent Conflicts Environment
Within China, the patent landscape for similar chemical entities is notably dense, with numerous patents filed by domestic and international entities targeting similar therapeutic areas. The key challenges include:
- Non-obviousness: patent examiners scrutinize whether claimed compounds are sufficiently inventive.
- Open prior art: existing literature on similar compounds may narrow enforceability.
- Patent landscaping: diverse filings from companies like CSPC, Fosun, and multinational corporations.
3. Potential for Infringement and Licensing
Given the scope, companies developing similar compounds must examine whether their molecules fall within the claim language. The patent’s broad claims on salts and crystalline forms increase the likelihood of infringement, often necessitating licensing negotiations or design-around strategies.
4. Patent Validity and Challenges
Key considerations include post-grant invalidation attempts based on lack of novelty or inventive step, especially if prior art references disclose similar compounds. Regular patent term adjustments and legal challenges by competitors are common, warranting vigilant monitoring.
Legal and Market Implications
- The patent’s enforceability offers market exclusivity until expiration, providing a competitive advantage for the patent holder.
- Generics developers need to scrutinize claim language meticulously to avoid infringement or to identify avenues for research.
- The patent positioning aligns with China's policy to foster innovation while balancing access, with strategic importance for lifecycle management.
Conclusion
Patent CN101265226 exemplifies strategic patenting in China’s pharmaceutical industry—aiming to safeguard novel chemical entities, formulations, and methods. Its scope, notably the claims on specific compounds and derivatives, reflects typical patenting practices to maximize protection. Stakeholders must balance respect for patent rights with innovation initiatives, considering the dense competitive landscape and ongoing legal scrutiny.
Key Takeaways
- CN101265226 provides robust protection for a specific chemical compound and its formulations, with claims covering salts, polymorphs, and uses.
- Its scope is precise yet broad enough to include multiple derivatives, critical for defensibility and licensing.
- The patent landscape in China for similar drugs is competitive, requiring vigilant monitoring for potential infringement or invalidation threats.
- Strategic patenting, including patent family expansion and claim breadth, is vital for maintaining market exclusivity.
- Continued legal and technical vigilance is essential for navigating patent challenges and leveraging the patent for commercial advantage.
FAQs
1. How broad are the claims in CN101265226, and what implications does this have for competitors?
The claims extend to specific chemical structures, salts, and formulations, allowing protection over multiple derivatives and delivery forms. This breadth enables the patent holder to potentially block competitors developing similar compounds or formulations within China.
2. Can this patent be challenged or invalidated?
Yes. Challenges based on lack of novelty, inventive step, or obviousness are common, especially if prior art disclosures are found. Validity may also be questioned if filing procedures or disclosure requirements are not met.
3. How does this patent influence licensing and partnerships?
The patent provides leverage for licensing agreements, especially if licensed to generic manufacturers or research entities aiming to develop related compounds. It also serves as a barrier for competitors, influencing market entry strategies.
4. What is the patent’s lifespan, and how does it impact drug commercialization?
It was granted in 2011, with a typical Chinese patent term of 20 years from filing, i.e., until 2028, assuming maintenance fees are paid. This period allows for market exclusivity and strategic planning for patent life management.
5. How does the Chinese patent landscape differ from international standards regarding pharma patents?
China emphasizes patentability based on novelty and inventive step, with recent reforms to improve examination quality. The landscape features dense patent filings, and national policies encourage innovation while balancing public health needs through “legacy” provisions and compulsory licensing in exceptional cases.
Sources:
- China National Intellectual Property Administration (CNIPA) Patent Search and Analysis.
- World Intellectual Property Organization (WIPO) PATENTSCOPE.
- Industry reports on Chinese pharmaceutical patent trends (e.g., [2])
- Chinese Patent Law and Examination Guidelines.
