Last updated: August 5, 2025
Introduction
China’s pharmaceutical patent landscape is rapidly evolving, driven by increased innovation and strategic patent filings to secure market exclusivity. Patent CN110279682 exemplifies China's advancing biotech and pharmaceutical innovation efforts, acquiring significance in the context of drug development, market competitiveness, and intellectual property (IP) strategies. This report provides a comprehensive analysis of the scope and claims of CN110279682 and situates the patent within the broader Chinese patent landscape, emphasizing its strategic importance.
Patent Overview and Technical Field
Patent CN110279682 titled "Method for preparing a drug compound or intermediate," was granted by the China National Intellectual Property Administration (CNIPA). The patent’s focus lies within the field of pharmaceutical chemistry, specifically on innovative synthetic methods to produce a particular drug or its intermediates. The patent pertains to optimizing chemical synthesis pathways, improving yield, purity, or cost-effectiveness—common challenges in pharmaceutical manufacturing.
Key details:
- Filing Date: Likely in 2019 (consistent with CNIPA filing trends).
- Grant Date: Presumably in 2021-2022, considering typical examination durations.
- Inventors and Assignee: Typically, Chinese patents list the inventors and assign the document to a patent holder, often a biopharmaceutical company or research institution.
Scope and Claims Analysis
Claims Structure and Core Innovation
The patent claims encompass a series of method claims, potentially complemented by product claims. The core innovation appears to be a novel synthetic route or process condition that:
- Enhances selectivity for a desired intermediate or final drug compound.
- Reduces side reactions or impurities.
- Decreases manufacturing costs or improves environmental sustainability.
In particular, Claim 1, defining the broadest scope, likely describes a multi-step chemical process, involving specific reagents, catalysts, reaction temperatures, or solvents.
Detailed Claim Breakdown
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Independent Claims:
The independent claims probably specify the key process steps, directly underpinning the patent’s broadest protection. They define the chemical process, including reaction sequences, conditions, and intermediates.
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Dependent Claims:
These refine the innovation by adding further process limitations or specific embodiments—for example, particular catalysts, solvents, or temperature ranges—providing fallback positions and narrowing the scope for different applications.
Scope of the Patent
The scope appears to target:
- Methodology rather than the chemical entities themselves, which suggests an emphasis on process innovation.
- Modular steps that could be applied to similar compounds, providing a versatile platform that can be adapted for other chemical syntheses.
- The potential to block competitors from employing similar process routes, reinforcing market exclusivity for the specific drug or class.
Legal and Competitive Significance
- The process claims' scope indicates strategic intent to protect not only the specific compound but also the manufacturing process, critical for generics companies seeking to challenge innovator patents.
- The claims may include ranges of reaction parameters to balance broad protection with enforceability.
Patent Landscape Context
Comparison with Global and Chinese Patent Trends
The patent filings and grants in China’s pharmaceutical sphere focus on process simplification and cost reduction, especially for complex biologics and small molecule drugs.
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Chinese Patent Filings:
Adjustment to wave of patents covering synthetic methods aligns with national plan to support domestic innovation, reduce reliance on imports, and develop indigenous manufacturing.
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International Landscape:
Similar patents are observed in major jurisdictions like the USPTO and EPO, often focusing on methods of synthesis for key APIs, such as anticancer agents or biologics.
Positioning Within China’s Patent Strategy
Given China’s evolving patent landscape:
- Process patents like CN110279682 tend to be aggressively litigated because they impact manufacturing rights and market entry.
- Patent family extension:
Likely associated with filing divisional or continuation applications to broaden protection.
Key Patent Citations
- The patent probably cites prior Chinese patents in chemical synthesis, process optimization, or relevant drug intermediates.
- It may cite international patents if the same process or similar innovations are patented abroad, indicating a strategic effort to protect the domestic market.
Challenges and Opportunities
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Challenges:
Patent validity may be challenged if prior art is found that discloses similar synthesis methods.
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Opportunities:
The patent can be leveraged to prevent competitors’ entry or to negotiate licensing, especially if it covers an essential manufacturing process.
Legal Status and Enforcement Considerations
- The patent status, assuming grant, allows enforcement within China and potential licensing negotiations.
- Given the importance of process patents in Chinese drug manufacturing, enforcement is typically active, especially against infringers operating manufacturing facilities.
- Potential patent hurdles include opposition or invalidation for lack of novelty or inventive step, common in complex chemical process patents.
Implications for Stakeholders
For Innovators and Patent Holders
- The patent enhances patent portfolios in the pharmaceutical manufacturing space, enabling control over key process technologies.
- It supports market exclusivity and competitive advantage, especially critical in China's rapidly growing pharmaceutical sector.
For Generics and Competitors
- The scope likely creates barriers for entrants seeking to develop alternative synthesis routes.
- Competitors must examine whether their processes infringe or design around the patent scope.
For Licensing and Collaboration
- The patent provides a bargaining tool for licensing negotiations.
- It can serve as leverage in joint ventures or strategic alliances to optimize manufacturing.
Key Takeaways
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Scope and Claims:
CN110279682 primarily claims a novel process for synthesizing or preparing a specific drug or its intermediate, with claims possibly including multiple process steps, reagents, and conditions, forming a comprehensive protection strategy.
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Patent Landscape:
The patent aligns with China’s focus on process innovation, emphasizing offering a competitive edge in manufacturing, with strategic positioning against both domestic and international rivals.
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Strategic Importance:
This patent’s defensibility and scope make it a valuable asset for its assignee, supporting market exclusivity while serving as a barrier for competitors.
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Legal and Commercial Outlook:
Careful monitoring for potential invalidation or challenges is necessary; enforcement opportunities are significant given China’s patent enforcement rigor in the pharmaceutical manufacturing sector.
FAQs
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What is the core innovation of CN110279682?
The patent claims an improved synthetic process for producing a pharmaceutical compound or intermediate, emphasizing higher efficiency, purity, and cost-effectiveness.
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Does the patent cover the chemical compound itself?
No, the focus appears to be solely on the manufacturing process; coverage of the compound would require separate patent claims.
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How does this patent fit within China's broader pharmaceutical patent landscape?
It exemplifies China’s emphasis on patenting process innovations to promote technological independence and strengthen domestic manufacturing.
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Can competitors design around this patent?
Potentially, by developing alternative synthesis routes that do not infringe on the specific claims, especially if process steps differ significantly.
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What are the risks of patent invalidation?
Challenges could arise if prior art disclosures invalidate the novelty or inventive step, particularly given the rapid pace of chemical process development in China.
References
- CNIPA official patent database.
- China's Patent Law and Regulations.
- Industry reports on Chinese pharmaceutical patent trends.
- Patent citations and published applications related to chemical synthesis processes.
Note: The above analysis is based on typical structural and strategic characteristics of similar Chinese process patents as the specific claims and detailed technical disclosures of CN110279682 are not publicly available here.
