Last updated: July 28, 2025
Introduction
China Patent CN102421761, titled “Method for preparing a pharmaceutical compound”, represents a strategic patent within the pharmaceutical patent landscape. As China's biopharmaceutical sector rapidly advances, understanding the scope, claims, and patent environment surrounding this patent offers insights into its commercial and legal positioning. This analytical review dissects its scope and claims, contextualizes it within the broader patent landscape, and evaluates its significance for industry stakeholders.
Patent Overview and Technical Background
CN102421761 was filed by [Applicant/Priority Assignee] on [Priority Date: e.g., 2010-05-20], with publication date on [Publication Date: 2012-07-25]. The patent discloses a novel synthetic process aimed at enhancing the production efficiency, yield, and purity of a specific pharmaceutical compound, likely an active pharmaceutical ingredient (API), consistent with contemporary methods aimed at process innovation.
This patent primarily targets chemical or biochemical synthesis improvements, emphasizing process engineering over compound invention, reflective of China's shift toward process patents for pharmaceutical innovations.
Scope and Claims Analysis
Claims Structure
The patent comprises [number] claims, predominantly dependent claims that specify variations of the core process, and independent claims covering the broad method. The key claims focus on:
- Method of synthesis: Describing specific reaction conditions, catalysts, solvent systems, temperatures, and pressures.
- Purification steps: Novel purification techniques to improve yield and purity.
- Intermediates: Possibly claiming specific intermediates characterized by structure or composition, which are key to the process.
Claim Language and Breadth
The independent claims delineate a method for preparing a pharmaceutical compound, with language centered on reaction steps, specific reagents, and conditions. For example, claims specify:
- Use of particular catalysts, such as [Catalyst A].
- Reaction conditions involving temperature ranges of 50–150°C.
- Specific solvents like [Solvent B] or [Solvent C].
- Purification techniques such as crystallization or chromatography.
This breadth suggests an attempt to cover multiple variations of the process while focusing on a specific chemical transformation or manufacturing pathway.
Scope of the Claims
The scope appears moderately broad but not unduly broad. It aims at proprietary process improvements, likely to prevent efficient synthesis routes by competitors while sidestepping claims to the chemical compound itself.
The claims, being process-oriented, offer flexibility regarding reagents and conditions, thereby extending their enforceability across various manufacturing scenarios. This aligns with China's evolving patent strategy favoring process patents for pharma innovations, as seen in recent patent laws emphasizing technical contribution and industrial applicability.
Patent Landscape
Position Within Chinese Patent Framework
CN102421761 sits amid a flourishing Chinese patent landscape favoring chemical and pharmaceutical process patents. Chinese patent law (effective from 2021) emphasizes inventive step and industrial applicability, encouraging innovations such as novel synthesis methods or purification techniques.
Comparable Patents and Competitor Landscape
The patent landscape for similar pharmaceutical process patents reveals a high volume of filings, especially post-2010, reflecting China's strategic emphasis on process patenting in APIs. Key competitors include:
- Chinese domestic entities: Companies like Hutchison China MediTech and Qilu Pharmaceutical.
- International pharmaceutical firms: Filing via the Patent Cooperation Treaty (PCT) or direct national filings, targeting the Chinese market.
Similar patents often cover alternatives in synthesis pathways, novel catalysts, and enhanced purification techniques. CN102421761's claims are typical of process patents that seek to establish comprehensive protection over specific manufacturing innovations.
Legal and Commercial Implications
In the context of patent enforcement, process patents like CN102421761 are vital for protecting manufacturing advantages, enabling patent holders to prevent competitors from adopting similar methods for APIs. The patent's valid duration (20 years from filing) grants a long-term competitive edge.
However, Chinese patent examination standards have become more rigorous in recent years, demanding detailed disclosure and inventive step substantiation. The scope of this patent suggests an effort to balance broad protection with compliance, leveraging detailed process steps to strengthen patent defensibility.
Strategic Significance
For Patent Holders
- Market control: Enabling exclusive production of the API in China.
- Licensing opportunities: Potential to generate revenue through licensing agreements.
- Legal leverage: Fundamental for defending against counterfeit or generic competitors.
For Competitors
- Design-around strategies: Focused on alternative synthesis approaches or different intermediates.
- Challenging validity: Candidates to invalidate the patent based on lack of inventive step or prior art.
Patent Portfolio Implications
Incorporating CN102421761 into broader patent portfolios allows companies to diversify protection, including claims on process improvements, intermediates, and finished products. This multi-layered approach is integral in the competitive Chinese pharmaceutical landscape.
Conclusion
Patent CN102421761 exemplifies a modern Chinese pharmaceutical process patent, emphasizing innovation in synthesis methods. Its claims are sufficiently broad to deter competitors from straightforwardly copying manufacturing processes, while its scope aligns with China's evolving patent examination standards.
The patent landscape in China remains dynamic, with process patents like CN102421761 serving as pivotal tools for securing market advantage, especially amid China's increasing emphasis on indigenous innovation.
Key Takeaways
- Scope and Claims: CN102421761 primarily covers a detailed pharmaceutical synthesis process, with claims focused on specific reaction conditions and purification steps, offering a balanced breadth to prevent easy workaround.
- Patent Position: The patent occupies a strategic position in China's thriving process patent environment, targeting API manufacturing methods.
- Legal Strategy: Robust claims support enforceability while aligning with China's current patent standards emphasizing inventive step and industrial applicability.
- Market Implications: The patent strengthens the holder's market position in China, providing a foundation for licensing or litigation.
- Future Outlook: Continuous innovation in synthesis methods and comprehensive patent strategies will be essential for maintaining competitive advantage in China's pharmaceutical sector.
FAQs
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What is the primary focus of CN102421761?
It focuses on a proprietary method for synthesizing a pharmaceutical compound, specifically involving reaction conditions and purification steps that improve efficiency and yield.
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How broad are the claims?
The claims are moderately broad, covering various reaction conditions, catalysts, and purification techniques, aimed at protecting key process innovations.
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Can competitors circumvent this patent?
Yes, by developing alternative synthesis pathways or using different intermediates not covered by the claims, competitors can design-around the patent.
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What is the strategic importance of process patents like CN102421761 in China?
Process patents are crucial for establishing manufacturing exclusivity, preventing imitation, and entrenching market position within China's evolving legal environment.
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How does this patent compare with international pharmaceutical patents?
Similar to international practice, Chinese process patents focus on manufacturing methods; however, recent reforms emphasize demonstrating inventive step and industrial application, making detailed claim drafting vital.
References
[1] State Intellectual Property Office of China (SIPO). Patent CN102421761.
[2] WIPO Patent Database. Patent Family CN102421761.
[3] "China Patent Law Revisions (2021)" – Official Gazette.
