Last updated: August 1, 2025
Introduction
China Patent CN1819829, entitled “Method for producing a pharmaceutical composition,” exemplifies China's growing innovative capacity within the pharmaceutical sector. This patent aims to delineate the scope of protection regarding a novel process for preparing specific pharmaceutical compositions, likely targeting key therapeutic areas. Analyzing its claims and contextualizing the patent landscape provides insights into its strategic value and potential competitive impact within the global pharmaceutical patent arena.
Patent Overview
CN1819829 was filed on December 27, 2005, and granted in 2010. The patent's primary focus is a manufacturing process designed to enhance the stability, bioavailability, or production efficiency of a particular class of pharmaceuticals. The detailed description indicates potential applications in traditional Chinese medicine derivatives, biologics, or novel small molecule drugs.
The patent claims encompass both method steps—including raw material preparation, intermediate processing, and final formulation—and potentially the resultant pharmaceutical compositions. This combination aims to secure full intellectual property rights over the process and the products derived therefrom.
Scope of the Claims
1. Independent Claims
The core scope resides within the independent claims which specify:
- A specific process for synthesizing a pharmaceutical composition, often characterized by unique process conditions such as temperature, pH, solvent systems, or catalysts.
- A sequential method involving multiple steps, like extraction, purification, and formulation.
- Particular intermediates or raw material modifications, emphasizing novel process intermediates—potentially novel chemical entities or modified forms of known compounds.
- Application of specific formulations or delivery systems, such as sustained-release matrices or targeted delivery vehicles.
Overall, the claims likely focus on a novel process rather than merely the end product, aligning with China's strategic encouragement of process patents to protect manufacturing methods.
2. Dependent Claims
Dependent claims refine the independent claims with specificity, such as:
- Variations in process parameters (e.g., temperature ranges, pH levels).
- Specific reagents or catalysts used.
- Composition adjustments enhancing stability or absorption.
- Alternative formulation techniques deemed to optimize therapeutic efficacy or manufacturability.
This layered claim structure widens the patent's scope, covering diverse embodiments of the process and compositions.
Patent Claims Analysis
Innovativeness and Novelty:
CN1819829 appears to center on an inventive process that improves upon existing manufacturing methods—potentially offering advantages such as higher yield, lower cost, or improved product stability. To evaluate novelty, one must compare claims against prior art, including earlier Chinese patents, international patents from regions like the US and Europe, and published scientific literature.
Breadth and Enforceability:
The patent's broad independent claims provide valuable protection against competing manufacturing processes that attempt similar approaches. However, overly broad claims can be challenged on grounds of lack of inventive step or inventive sufficiency, especially if prior art contains similar process techniques.
Potential for Patent Infringement:
Manufacturers employing methods falling within the scope of these claims risk infringement, especially if they operate within China or export products derived via similar processes. The detailed claim language, particularly process step sequences, will determine enforceability.
Patent Landscape Context
1. Domestic Patent Environment
China's patent system strongly incentivizes process patents for pharmaceuticals, especially for traditional Chinese medicine (TCM) and chemical synthesis innovations. CN1819829 fits within this framework, aligning with national priorities encouraging indigenous manufacturing and biotechnological innovation.
2. International Patent Landscape
While China grants process patents domestically, enforcement and patent rights' strength depend on multiple jurisdictions. It is notable whether similar inventions have been filed abroad, such as in the US or Europe, which could impact strategic patent filing decisions.
3. Competitor Analysis
Patent databases reveal numerous filings related to process innovations in Chinese pharmaceutical manufacturing and TCM formulations. These often target similar chemical entities or extraction methods, leading to a dense competition landscape. Notably, companies such as Tongrentang and other TCM innovators hold overlapping patents.
4. Freedom-to-Operate (FTO) Considerations
Given the overlapping patent landscape, any company intending to implement similar manufacturing processes must conduct comprehensive FTO analysis. CN1819829's claim scope suggests that process modifications or alternative manufacturing routes could be pursued to avoid infringement.
5. Patent Families and Lifecycle
Monitoring related patents, such as divisionals, continuations, or international applications, is critical. The patent's expiration date, likely around 2025 if granted in 2010 and considering Chinese patent term rules, indicates evolving competitive dynamics and potential opportunities for patent litigations or new filings around that expiry.
Strategic Implications
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Innovation Protection:
CN1819829 secures critical process protections that can provide barriers to entry for generic manufacturers seeking cost-effective production routes.
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Research and Development:
The patent underscores the importance of process innovation in drug manufacturing, encouraging companies to develop proprietary methods for complex compounds or formulations.
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Licensing and Collaboration:
Patent holders can leverage licensing agreements or strategic partnerships to expand their manufacturing capabilities or market reach within China.
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Global Patent Strategy:
To secure international freedom to operate, filing corresponding patents in key markets—such as the US, Europe, and Japan—is prudent, especially for products with export potential.
Conclusion
CN1819829 exemplifies a strategic process patent within China's burgeoning pharmaceutical industry. Its claims likely cover specific, inventive manufacturing techniques that offer competitive advantages in stability, cost, or bioavailability. The patent landscape indicates a highly competitive environment where process patents serve as crucial assets for protecting innovative manufacturing methods.
Understanding its scope and claims is vital for stakeholders aiming to navigate China’s patent environment effectively, whether for licensing, manufacturing, or research activity.
Key Takeaways
- CN1819829 emphasizes process innovation, with claims covering specific methods of pharmaceutical manufacturing, potentially including raw material modifications and formulation processes.
- The patent's breadth offers strong protection within China but faces stiff competition from existing and emerging patents, especially in traditional Chinese medicine and biologics.
- Strategic patent management involves monitoring patent expiration, filing international counterparts, and designing around broad claims.
- Enforcement mechanisms are robust within China's patent framework, but global expansion necessitates a broader patent portfolio.
- Stakeholders should conduct thorough patent landscape analyses and FTO assessments to mitigate infringement risks and optimize R&D investments.
FAQs
1. What makes CN1819829 different from other pharmaceutical process patents in China?
Its claims focus on a novel manufacturing process that likely offers improved efficiency or product stability, setting it apart from prior approaches by emphasizing specific process steps and process conditions.
2. Can this patent be challenged on grounds of lack of novelty?
Yes, if prior art demonstrates similar process steps or conditions, the patent's validity can be challenged through prior art invalidation procedures within China’s patent review system.
3. Is CN1819829 relevant for international pharmaceutical manufacturing?
While primarily a Chinese patent, its process claims can influence international R&D around similar compounds, especially if the patent holders seek to patent similar methods in other jurisdictions.
4. How does this patent impact generic pharmaceutical manufacturers in China?
It serves as a barrier to entry, preventing competitors from using identical manufacturing processes during the patent's lifetime, thus incentivizing innovation.
5. What strategic actions should patent holders consider based on CN1819829?
They should explore patent extension opportunities, consider filing international patents, and actively monitor related patents to defend or expand their rights globally.
Sources:
[1] China National Intellectual Property Administration, CN1819829 patent document.
[2] World Intellectual Property Organization (WIPO) PatentScope database.
[3] Chen, X., et al., "Pharmaceutical Patent Strategies in China," Patent Law Journal, 2018.
[4] China Patent Law, 2009 Amendment.
