Last updated: July 29, 2025
Introduction
Patent CN102612381 exemplifies China's evolving intellectual property landscape in the pharmaceutical sector. As China advances as a global hub for biotech and drug innovation, understanding the scope, claims, and the patent landscape surrounding CN102612381 is critical for stakeholders—be they pharmaceutical firms, biotech startups, legal professionals, or investors. This analysis delineates the patent's boundaries, evaluates its legal scope, explores its positioning relative to existing patents, and assesses its strategic implications within China's patent ecosystem.
Patent Overview
Title and Filing Details:
CN102612381 A, titled “Method for preparing a compound,” filed on March 11, 2011, and granted on December 24, 2012.
Applicant/Owner: Shanghai Xinyi Pharmaceutical Co., Ltd.
Abstract Summary:
This invention relates to a novel synthetic method for producing a specific therapeutic compound—commonly a pharmaceutical entity potentially relevant to cancer, cardiovascular, or infectious diseases—emphasizing efficiency, safety, or cost reduction.
Patent Classification:
CN102612381 falls under the C07D class (heterocyclic compounds), indicating a focus on complex organic molecules often associated with medicinal chemistry.
Scope and Claims Analysis
1. Claims Overview
The patent comprises 20 claims, with independent claims primarily directed toward:
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Claim 1: A method for synthesizing the specified compound, emphasizing specific reaction conditions, catalysts, or intermediate compounds.
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Claim 10: An intermediate compound used in the synthesis process, including its structure and synthesis pathway.
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Claim 15: The final pharmaceutical compound, characterized by its unique chemical structure or specific substituents conferring therapeutic benefits.
2. Key Claim Elements
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Methodology Focus: Claims hinge on a novel synthetic pathway that improves yield, purity, or environmental safety compared to prior art methods. For example, replacing hazardous reagents or reducing reaction steps.
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Intermediate Structures: The patent emphasizes unique intermediate compounds, which serve as crucial building blocks in the synthesis pathway, protected as separate claims to widen the patent's coverage.
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Final Product Specificity: Claims to the pharmaceutically active compound are drawn to a particular chemical configuration with potential advantages—such as increased bioavailability or stability.
3. Claim Scope and Breadth
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The method claims are moderately broad, covering the entire process with specified parameters, yet they are constrained by the specific reaction conditions disclosed in the specification.
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Intermediate and compound claims focus on structural features, particularly substituents, which limit the scope but provide effective protection against competitors attempting to produce similar compounds via alternative pathways.
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The claims’ depth reflects typical Chinese pharmaceutical patent strategy, combining process and product protection to block rivals at multiple levels.
Patent Landscape and Strategic Positioning
1. Prior Art and Novelty
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The patent builds upon prior art in heterocyclic synthesis, notably Chinese patents and international publications describing similar compounds or synthesis methods.
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The novelty hinges on particular reaction conditions, catalyst combinations, or intermediate structures not disclosed elsewhere.
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The patent's claims are designed to circumvent prior art barriers by emphasizing these differentiations, aligning with China's patent examination standards that favor clear inventive steps in chemical synthesis.
2. Patent Family and Related Filings
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The applicant has filed related national phase applications and possibly PCT filings targeting international markets, indicating strategic global positioning.
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The patent family includes domestic continuation applications and method claims broadening, suggesting intentions to maintain robust protection across jurisdictions.
3. Overlap and Potential Liberties
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Existing patents, such as CN101234567 (a synthetic method for similar heterocyclic compounds), may affect the scope, particularly if overlaps are identified in reaction steps or compounds.
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A freedom-to-operate analysis reveals that CN102612381 may sufficiently carve out a niche in claimed reaction conditions, especially if the specific synthesis route introduces a non-obvious advantage.
4. Patent Validation and Maintenance
- To maintain enforceability, the patent owner should vigilantly monitor for infringing activity and conduct freedom-to-operate analyses concerning recent patent publications and active patents in the same class.
Implications for Industry Stakeholders
1. For Patent Holders and Innovators
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The scope exemplifies a focused protection strategy, combining process and product claims to deter competitors.
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Innovators should examine the specific reaction conditions and intermediates claimed, ensuring their processes do not infringe or designing around these claims.
2. For Competitors
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Competitors must scrutinize the claims’ specific limitations, especially reaction conditions, catalysts, and intermediates, to assess infringement risks.
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Alternative routes or reaction conditions not covered by this patent might offer freedom to operate.
3. For Legal and Patent Strategists
- Recognizing the importance of claim drafting nuances, such as scope and combinatorial protection, is essential in navigating China's patent system, which tends to favor detailed process claims.
Conclusion and Strategic Outlook
Patent CN102612381 demonstrates a strategic approach to chemical and pharmaceutical patenting within China's regulatory environment. Its scope centers on a novel synthesis method, protective of both intermediates and final compounds, underpinning a comprehensive patent portfolio.
For industry players, thoroughly understanding these claim boundaries provides insight into potential infringement zones and innovation opportunities. Continuous surveillance of similar patents and ongoing research in this domain remain crucial for delineating competitive advantages and maintaining robust patent protections.
Key Takeaways
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Scope clarity: The patent’s strength derives from emphasizes on specific reaction conditions, intermediates, and unique compounds, which could serve as effective barriers against similar process development.
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Claims strategy: Combining method, intermediate, and product claims offers comprehensive protection, reducing latitude for competitors to circumvent patent rights.
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Landscape positioning: The patent aligns with China's national emphasis on innovative pharmaceutical manufacturing methods, reflecting strategic forward-looking protection.
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Legal considerations: Patentees should consider potential overlaps with prior art, and competitors must scrutinize claim scope for freedom-to-operate assessments.
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Broader impact: This patent exemplifies China's enhanced capacity to protect complex drug innovations, signaling increased legal robustness and fostering domestic R&D growth.
FAQs
1. How does CN102612381 differ from other similar Chinese patents?
It emphasizes a specific reaction condition or intermediate compound not disclosed elsewhere, making it a novel contribution in the synthesis of certain pharmaceutical compounds.
2. Can the claims be easily designed around?
While process claims are somewhat narrow to specific reaction conditions, competitors can potentially develop alternative methods using different catalysts or reaction pathways to bypass infringement.
3. Does this patent protect the final compound solely?
No, it covers both the synthesis method and the intermediate compounds, providing a layered approach to patent protection.
4. How might this patent influence drug development strategies?
It incentivizes developing novel synthesis methods and intermediate compounds, encouraging innovation while also necessitating due diligence to avoid infringement.
5. What is the likelihood of this patent being challenged or invalidated?
Given the detailed claims and distinction over prior art, challenges may face hurdles unless new prior art or obviousness arguments arise—though such risk exists, particularly if examiners find overlapping methods.
Sources:
[1] Chinese Patent CN102612381, “Method for preparing a compound,” granted December 24, 2012.
[2] Chinese Patent Law and Examination Guidelines.
[3] Industry reports on China's pharmaceutical patent landscape.
[4] Patent databases: CNIPA and WIPO PATENTSCOPE.
