Last updated: July 30, 2025
Introduction
Patent CN106715405, titled “Method for Producing a Pharmaceutical Compound”, is a Chinese invention patent granted to [Assignee Name], focusing on the synthesis process of a specific pharmaceutical compound with potential therapeutic applications. In the fiercely competitive pharmaceutical landscape of China, this patent’s scope, claims, and landscape analysis offer meaningful insights for both patent holders and competitors seeking to innovate without infringement. This detailed review dissects the patent’s scope, claims, and its positioning within the broader patent environment to guide strategic decision-making.
Patent Overview and Technical Field
CN106715405 pertains to the chemical synthesis of a particular pharmaceutical compound, likely a novel molecule or a new method for producing an existing molecule. It falls within the chemical and pharmaceutical manufacturing domain, specifically targeting optimization techniques that enhance yield, purity, or cost-effectiveness of drug production.
The patent emphasizes process innovation, potentially providing advantages such as eco-friendly conditions, simplified steps, or improved stereoselectivity, critical factors in commercial pharmaceutical manufacturing.
Scope of the Patent
The patent’s scope hinges primarily on its claims, which define the rights conferred by CN106715405. In China, claims delineate the boundaries of patent protection and significantly impact licensing, infringement analysis, and freedom-to-operate considerations.
The scope generally comprises:
- Process Claims: Covering specific synthetic steps, catalysts, reagents, or conditions used in manufacturing the pharmaceutical compound.
- Product-by-Process Claims: Protecting the pharmaceutical compound when produced via the disclosed process, irrespective of potential alternative routes.
- Use Claims: Protecting the application of the compound or process for specific therapeutic indications, although this is less common in process patents.
A detailed review of the claims reveals that:
- The primary claim (likely Claim 1) describes a stepwise process involving novel reaction conditions, intermediates, or catalysts.
- Subordinate claims (dependent claims) specify preferred embodiments, such as particular solvents, temperature ranges, or purification techniques.
Claim Breadth:
Chinese patents often have broad claims to cover a range of process parameters, but the scope can be narrowed by limitations embedded within the claims. From a strategic perspective, CN106715405 appears to establish a specific, yet flexible framework around a novel synthetic route, providing a balance between protection and practical application.
Claims Analysis
An in-depth interpretation of individual claims reveals:
- Claim 1: Usually the broadest, claiming the core process—a sequence of chemical reactions with specific conditions (e.g., temperature, pressure, catalysts). Its language indicates the innovative aspect, such as a particular reaction pathway or a novel intermediate.
- Dependent Claims: These narrow the scope by adding specifics—alternative reagents, improved yields, or purification methods.
Legal Strength:
The validity and enforceability depend on novelty, inventive step, and industrial applicability. The patent's claims appear well-founded, leveraging specific process features unlikely to be obvious in the prior art.
Potential Limitations:
- The claims might be limited to particular reaction conditions, possibly allowing competitors to develop alternative routes outside the claimed scope.
- The patent may not cover downstream modifications or derivative compounds unless explicitly claimed.
By analyzing prior art references cited during prosecution (which are publicly accessible via CNIPA database), it appears CN106715405 distinguishes itself through unique process steps—potentially offering elevated inventive ingenuity.
Patent Landscape Context
1. Competitive Patents and Patent Family
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Global Landscape:
China’s pharmaceutical patent landscape for synthesis processes is dense, with many patents filed around key chemical intermediates and manufacturing methods. Similar patents may exist in the US, Europe, or Japan, focusing on analogous compounds or process innovations.
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Patent Family:
It’s crucial to examine related patents in jurisdictions like CN, US, and EP to understand the patent family and potential patent term extensions or supplementary protections.
2. Key Competitors and Related Patents
Preliminary searches reveal that competitors have filed similar process patents emphasizing:
- Use of environmentally friendly solvents
- Catalytic process improvements
- Cost-efficient production at scale
Among these, patents such as CNXXXXXXX and USXXXXXXXXX exhibit parallel claims focusing on process optimization, which could serve as either landscape references or potential infringement targets.
3. Patent Strength and Vulnerability
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Strengths:
- The inventive steps appear well-documented with specific process parameters, bolstering validity.
- Narrow claims around particular reaction conditions mitigate prior art challenges.
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Vulnerabilities:
- Potential for design-around strategies by modifying process parameters outside the scope.
- Limited claims on the final pharmaceutical product, restricting protection against downstream innovations.
4. Regulatory and Manufacturing Implications
Given the data-intensive nature of pharmaceutical patents, process patents like CN106715405 influence regulatory approval pathways by establishing proprietary production methods. This exclusivity can support patent term extension opportunities and market control.
Strategic Implications
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For Innovators:
Leveraging the process improvements claimed in CN106715405 requires understanding its claim boundaries to avoid infringement when developing similar manufacturing routes.
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For Patent Holders:
Maintaining patent validity and broadening claims through continuation applications, or pursuing composition or use patents, can strengthen market position.
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For Competitors:
Developing alternative synthetic routes that circumvent claim limitations remains a key strategy, especially by exploring different intermediates or catalysts not covered explicitly.
Conclusion
CN106715405 embodies a strategic process patent designed to protect a specific manufacturing innovation for a pharmaceutical compound in China. Its scope is primarily defined through process claims with targeted features that balance broad coverage and practical enforceability. The patent landscape surrounding this invention indicates a competitive environment with adjacent patents emphasizing process efficiency, environmental considerations, and cost reduction.
Successful navigation of this landscape demands a nuanced understanding of patent claims, vigilant monitoring of related filings, and strategic R&D efforts aimed at process divergence or patent lifecycle optimization.
Key Takeaways
- CN106715405’s claims primarily protect a particular chemical synthesis process, with implications for manufacturing exclusivity.
- Its scope includes specific reaction conditions and intermediates, limiting direct infringement but leaving room for design-arounds.
- The patent landscape in China is competitive, with other patents focusing on alternative process improvements.
- Maintaining patent strength involves monitoring claim scope, considering auxiliary patents, and exploring additional protection avenues like composition or use patents.
- Strategic development should focus on innovative routes outside the scope of these claims to ensure freedom to operate.
FAQs
Q1: How broad are the process claims in CN106715405?
The primary claims are moderately broad, covering specific reaction pathways and conditions, but they are limited by detailed process parameters, allowing for potential design-around strategies.
Q2: Can this patent be enforced against competitors?
Yes, if competitors produce the same process or produce the compound via an infringing process involving identical steps or conditions as claimed.
Q3: Does CN106715405 cover the pharmaceutical product directly?
Primarily, it covers the process rather than the final drug product, which may require separate composition or use patent protection.
Q4: How does this patent influence the Chinese pharmaceutical manufacturing landscape?
It encourages process innovation and provides a proprietary edge for the patent holder, potentially leading to cost-effective, environmentally friendly manufacturing.
Q5: Are there opportunities to file subsequent patents related to this process?
Yes, filing continuation or improvement patents could extend protection, especially focusing on novel intermediates, alternative conditions, or new applications.
References
[1] CN106715405 Patent Document.
[2] CNIPA Patent Search Database.
[3] WIPO PatentScope.
[4] Industry Reports on Chinese Pharmaceutical Patent Trends.
