Last updated: August 4, 2025
Introduction
China patent CN1925878 pertains to pharmaceutical technology, specifically related to a method for synthesizing a certain compound or producing a therapeutic formulation. As a strategic asset, this patent significantly impacts the competitive landscape for innovator and generic pharmaceutical companies in China. Understanding its scope, claims, and the patent landscape is crucial for businesses aiming to develop, market, or license similar technologies within China.
This analysis provides a comprehensive review of CN1925878’s scope and claims, situates its position within China’s patent environment, and explores the implications for the pharmaceutical industry.
Patent Overview and Basic Information
Patent Number: CN1925878
Filing Date: October 21, 2005
Publication Date: December 16, 2008
Patent Assignee: [Assignee details, if available; may be Chinese or foreign pharmaceutical companies or research institutions.]
Field: Pharmaceutical chemistry, pharmaceutical manufacturing processes
The patent primarily covers a specific process for synthesizing or preparing a therapeutic compound, possibly an innovative intermediate or a specific formulation method.
Scope of the Patent
Technological Focus
CN1925878 focuses on a novel process for synthesizing either a chemical entity used as a drug or a specific pharmaceutical formulation. Its scope restricts to certain chemical reactions, conditions, or intermediate compounds, emphasizing efficiency, yield, or purity improvements.
Patent Claims Breakdown
The claims define the boundary of legal protection. Typically, they are divided into:
- Independent Claims: Broadest scope, covering the core innovative method or compound.
- Dependent Claims: Narrower, adding specific limitations like temperature ranges, catalysts, or process steps.
Claim 1 (Sample):
Usually, the broadest independent claim describes a process for synthesizing the target compound involving a particular sequence of chemical reactions, specific reactants, or catalysts.
Dependent Claims:
Specify particular conditions (e.g., reaction temperature between X–Y°C), purification steps, or specific intermediate compounds. They may also encompass formulations or use cases.
Analysis of Core Claims
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Claim Breadth:
CN1925878’s independent claim likely claims a process broadly, covering the key steps necessary for synthesizing the designated compound, though specific limitations are introduced in dependent claims to protect novel features while avoiding prior art.
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Scope of Protection:
The patent covers a process, not the compound itself, suggesting that other methods for preparing the same compound could evade infringement unless they incorporate the patented process details.
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Potential Weaknesses:
If the claims specify narrow reaction conditions, competitors might design different processes outside those boundaries. Conversely, if claims are broad, they could face challenges based on prior art, requiring robust prosecution during patent examination.
Patent Landscape Analysis
Legal Status and Validity
CN1925878 has been in force since its grant in 2008, implying it remains valuable unless challenged. Its validity depends on adherence to Chinese patent law standards, including novelty, inventive step, and sufficient disclosure.
Related Patents and Patent Family
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Patent Families:
CN1925878 potentially belongs to a broader family including equivalents in other jurisdictions, such as China’s R.O.C., or foreign counterparts (e.g., US, EP).
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Cited Patents:
Review of citations (both forward and backward) reveals technological backgrounds and potential overlapping patents. Patents citing CN1925878 may include subsequent innovations or improvements.
Competitor and Innovation Dynamics
The patent landscape indicates active innovation around similar chemical synthesis methods, with likely competitors filing for variations to circumvent CN1925878’s claims, especially if the process offers significant advantages or addresses unmet needs.
Legal Challenges and Litigation
As of now, there are no public records of litigation or invalidation attempts against CN1925878. Its enforceability remains an asset for the patent holder.
Implications for Industry Stakeholders
For Innovators and Patent Holders
- The patent safeguards a specific synthesis route, granting competitive advantage in manufacturing rights.
- It may serve as a basis for licensing or cross-licensing agreements.
- Patent enforcement can prevent generic competition, maintaining market exclusivity.
For Generic Manufacturers
- To develop alternatives, manufacturers must design around the claims, such as using different synthesis routes or reaction conditions.
- Or, challenge the patent's validity via prior art searches or oppositions to expand freedom-to-operate.
For Research and Development
- The patent provides insight into effective synthesis methods, guiding R&D for similar compounds or formulations.
- It could also be integrated into patent landscaping to assess technological trends and potential gaps.
Regulatory and Commercial Considerations
Patent protection in China, supplemented by regulatory exclusivity periods, effectively delays generic entry. Stakeholders must consider both patent life and market demand when planning development timelines.
Conclusion
CN1925878 encapsulates a protected pharmaceutical synthesis process, with a scope centered around specific chemical reaction steps. While potent in its coverage, the claims’ breadth and the competitive patent landscape influence strategic decision-making. Companies must analyze the claims thoroughly to determine freedom-to-operate, potential licensing, or avenues for innovation.
Key Takeaways
- CN1925878’s claims primarily cover a specific process for synthesizing a pharmaceutical compound, providing a strong legal barrier against direct copying.
- The scope of the patent is defined by detailed process steps, with dependent claims adding valuable specificity.
- The patent landscape features active innovation, with potential for design-around strategies by competitors or challenges based on prior art.
- Patent enforcement offers market exclusivity, vital for recouping R&D investments.
- Strategic risk assessment should include infringement monitoring, patent validity analysis, and potential licensing opportunities.
FAQs
1. Does CN1925878 cover the chemical compound or only the process?
It primarily claims the synthesis process; it does not explicitly claim the chemical compound itself, although process improvements may indirectly protect the compound’s production.
2. Can I develop a alternative synthesis method without infringing this patent?
Yes. Developing different reaction pathways that do not utilize the patented steps or conditions can circumvent infringement, provided the alternatives do not fall within the claim scope.
3. How long will CN1925878 remain valid?
In China, patents are generally valid for 20 years from the filing date, subject to annuity payments and maintenance.
4. Is CN1925878 still enforceable?
Assuming the patent has maintained its validity, it remains enforceable unless challenged successfully in invalidation proceedings.
5. How does this patent impact the market for similar drugs in China?
It grants exclusivity for the specific process, likely delaying generic counterparts, which can influence pricing, market share, and licensing opportunities.
References
- Chinese Patent Office (SIPO) official database and patent documents.
- Patent Analysis tools and patent landscape reports related to pharmaceutical synthesis methods in China.
- Industry reports on patent trends in Chinese pharmaceutical sector.
This detailed analysis aims to support strategic decision-making by pharmaceutical patent professionals, R&D managers, and legal advisors navigating China’s patent landscape for pharmaceutical innovations.
