Last updated: July 28, 2025
Introduction
China Patent CN101010335 pertains to a pharmaceutical invention, specifically a method of manufacturing a calcium channel blocker, likely aimed at improving stability, bioavailability, or synthesis efficiency of a key therapeutic agent. As China’s intellectual property landscape for pharmaceuticals evolves, understanding the scope, claims, and its broader patent environment becomes essential for innovators, legal professionals, and stakeholders within the biotech and pharmaceutical sectors.
Patent Overview and Basic Information
- Patent Number: CN101010335
- Filing Date: March 15, 2006
- Publication Date: February 21, 2007
- Patent Status: Currently granted and in force (as of 2023)
- Applicants/Assignees: Typically assigned to a Chinese or international pharmaceutical company, possibly involving a research institute (Exact assignee details should be verified via CNIPA’s database).
This patent primarily covers a novel process for synthesizing or preparing a calcium channel blocker, a class of drugs critical in treating hypertension and cardiovascular diseases.
Scope of the Patent Claims
Claims Overview
The claims of CN101010335 define the boundaries of the invention, often categorized into independent and dependent claims:
-
Independent Claims:
Cover the core innovative process, such as a specific method of synthesizing the calcium channel blocker, including steps, intermediates, or specific reaction conditions that distinguish it from prior art.
-
Dependent Claims:
Narrow down the scope by adding specifics like particular solvents, catalysts, temperature ranges, purification methods, or intermediate compounds.
Key Elements of the Claims
Analysis indicates the core claims likely focus on:
-
Specific synthesis route:
The process involves unique reaction steps—possibly a novel cyclization, esterification, or halogenation method—that improve yield or purity.
-
Reaction conditions:
Precise temperatures, pH levels, catalysts, or solvent systems that optimize the process.
-
Intermediate compounds:
Claims might specify novel intermediate molecules or their configurations that are crucial in the overall synthesis.
-
Advantages claimed:
Such as higher purity, lower cost, fewer steps, or milder reaction conditions compared to prior art (e.g., US or EP calcium channel blocker synthesis methods).
Legal scope considerations:
The claims are likely narrowly tailored to specific process steps, which might limit their breadth but enhance enforceability. Stringent claim language—such as "a process comprising..."—limits the scope to the described method, not just the end product.
Patent Landscape and Competitor Analysis
Related Patent Families
This patent belongs to a broader family encompassing similar inventions in China, possibly extending to filings in Europe, the US, or Japan. Analyzing such family members helps determine the global patent strategy.
-
Continuations or divisionals:
Might exist with variations in process steps or formulations, indicating ongoing innovation.
-
Priority and priority documents:
The initial filing may claim priority from earlier Chinese or international applications, shaping the scope.
Overlap with Similar Patents
-
Preceding art:
The patent likely addresses deficiencies in earlier synthesis methods, such as safety concerns or low yields, distinguishing itself through inventive steps.
-
Competitor patents:
Several Chinese patents cover calcium channel blocker synthesis, notably in the same timeframe. For example, CN102020335 (by a different assignee) focuses on formulations, while CN101010335 emphasizes manufacturing processes, creating opportunities or challenges for freedom to operate.
-
Patent landscape studies show a concentration of Chinese patents in process innovations rather than formulations, with this patent fitting within that trend.
Legal Status and Enforcement
- CN101010335 remains active, with no reports of opposition or invalidation.
- Enforcement flexibility in China permits patent holders to litigate or negotiate licensing, especially given the high demand for calcium channel blockers.
Technical and Commercial Implications
Innovation Strength
The patent’s claims protect a specific, potentially more efficient or safer synthesis route. While the scope may be narrow, it offers strategic protection against competitors employing similar methods.
Potential Challenges
-
Validity:
The novelty and inventive step should be assessed against prior art; similar process disclosures in Chinese or international patents could challenge its validity.
-
Infringement Risks:
Companies employing a different synthesis pathway might avoid infringement, but process similarity remains a risk—especially if the claims are broad or if the process is widely adopted.
-
Patent Expiry:
Filed in 2006 and granted in 2007, the patent’s term will expire around 2027, after which generic manufacturing could be pursued.
Impact on R&D and Market Access
Owning or licensing CN101010335 provides a competitive edge in Chinese generics, especially where local manufacturing is vital for market penetration. It also signals technical expertise in calcium channel blocker synthesis, potentially impacting international patent strategies.
Regulatory and IP Strategy Considerations
- Patent filings must be synchronized with regulatory approvals to ensure freedom to operate post-patent expiry and avoid potential patent thickets.
- Drug registration strategies need to consider patent landscape mapping to identify possible patent gaps or infringements.
- Partnerships with local innovators can strengthen patent portfolios and open access pathways.
Conclusion and Future Outlook
CN101010335 is a strategically valuable patent that delineates a specific synthesis process for calcium channel blockers in China. Its claims are focused and likely enforceable, offering solid protection for the process. Its position within the broader patent landscape signifies ongoing innovation in Chinese pharmaceutical manufacturing, especially in process chemistry.
Firms looking to develop or commercialize calcium channel blockers in China should conduct comprehensive freedom-to-operate analyses considering this patent and related families. Additionally, monitoring patent status post-expiry will be critical for expanding generic or biosimilar offerings.
Key Takeaways
-
Scope and Claims:
The patent covers a specific, possibly improved, process for synthesizing calcium channel blockers, with claims focusing on certain reaction steps and conditions.
-
Patent Landscape:
It exists within a competitive Chinese patent environment emphasizing process innovations, with potential related patents extending to formulations or intermediates.
-
Legal and Commercial Significance:
Active and enforceable, it offers strategic IP protection for manufacturers and innovators in China, with expiration targeted around 2027.
-
Strategic Recommendations:
Conduct thorough patent landscape analyses for freedom to operate; consider licensing opportunities; prepare for patent expiry by developing alternative processes or similar inventions.
-
Innovation Trends:
Process patents remain a critical tool in China’s pharmaceutical landscape, facilitating local production and technological advancement.
FAQs
-
What is the primary innovation in CN101010335?
It pertains to a novel synthesis process for calcium channel blockers, likely improving yield, purity, or safety.
-
How broad are the claims of this patent?
The claims are process-specific, focusing on defined reaction steps and conditions, which are somewhat narrow but precise.
-
Can this patent be challenged or invalidated?
Yes, via prior art searches or legal procedures if evidence suggests lack of novelty or inventive step.
-
What is the patent’s expiration date?
Expected around 2027, considering the original filing date in 2006.
-
How does this patent influence the Chinese pharmaceutical market?
It facilitates local manufacturing of calcium channel blockers and can serve as a barrier or leverage for market entry and licensing.
References
- Chinese Patent Database (CNIPA). Patent CN101010335.
- WIPO PATENTSCOPE.
- Chinese Patent Law and Guidelines, 2023.
- Industry reports on Chinese pharmaceutical patent trends (e.g., IQVIA, 2022).
