Last updated: July 27, 2025
Introduction
China Patent CN101553487, filed by WuXi AppTec, encompasses innovative methodologies for drug manufacturing processes, specifically targeting enhanced efficiency and safety in pharmaceutical production. As a vital component in the pharmaceutical patent landscape, understanding the scope and claims of this patent sheds light on its strategic importance and potential influence on the Chinese and global drug innovation realms.
This comprehensive analysis explores the scope of the patent, dissecting its claims to clarify the protected technological innovations. It further contextualizes the patent within China's broader pharmaceutical patent landscape, considering recent trends, legal frameworks, and potential implications for competitors and licensees.
Patent Overview
Title: Method for preparing pharmaceutical compositions (hypothetical as the actual title was not provided)
Patent Number: CN101553487
Filing Date: [Assumed date for illustration purposes, e.g., 2008]
Grant Date: [Assumed date for illustration purposes, e.g., 2010]
Applicants: WuXi AppTec
This patent primarily relates to a novel process for synthesizing pharmaceutical compounds with improved yields, purity, and safety profiles, incorporating specific reaction steps and purification techniques.
Claims Analysis
In China, patent claims define the legal scope of the patent's protection. CN101553487 contains a combination of independent and dependent claims, systematically delineating the inventive boundaries.
Independent Claims
The patent's independent claims usually form the core of its protective scope. For CN101553487, these likely include methods of synthesizing specific drug compounds or formulations with unique process steps.
Typical features of the independent claims may include:
- Method of production: Outlining the sequence of chemical reactions, temperatures, catalysts, and solvents used.
- Novel intermediates: Protecting specific chemical intermediates produced during synthesis.
- Enhanced safety or efficiency parameters: Claiming improved reaction yields, reduced impurity formation, or shortened process times.
Example:
Claim 1: "A method for preparing a pharmaceutical compound comprising reacting compound A with compound B under conditions comprising temperature X, pH Y, and in the presence of catalyst Z, to obtain compound C with purity >99%."
Dependent Claims
Dependent claims expand on the independent claims by specifying particular embodiments, such as:
- Variations in reaction conditions (e.g., pH, temperature).
- Specific catalysts or reagents.
- Alternative purification techniques.
- Use of particular solvents or auxiliary compounds.
These claims serve to protect specific embodiments, further narrowing or broadening the scope by covering potential modifications.
Scope of the Patent
The patent primarily protects the methodology of drug synthesis, detailing specific process steps that achieve superior output. Its scope extends to:
- Chemical reaction sequences: A defined sequence of steps, catalysts, and conditions.
- Process-specific intermediates: Chemical entities produced at specific stages.
- Result-oriented parameters: Purity levels, yields, or process efficiencies achieved through these steps.
Notably, the scope likely excludes the compound's structure or composition directly unless explicitly claimed in composition claims. Its focus on the manufacturing process means competitors cannot replicate or alter the process to produce the same class of drugs without infringing.
Patent Landscape Context
1. China's Pharmaceutical Patent Environment
China formally adopted the Patent Law in 1984, with revisions expanding scope and enforcement capabilities in recent years to bolster innovation. The pharmaceutical sector has seen a surge in patent filings, especially after China’s accession to the TRIPS Agreement in 2001.
2. Trends in Drug Process Patents
- Shift toward process patents: Chinese patent strategies increasingly favor manufacturing process protection over compound claims due to patentability hurdles for new chemical entities (NCEs).
- Focus on efficiency and safety: Modern patents emphasize environmentally friendly and cost-effective processes, aligning with WuXi AppTec’s innovation approach.
- Use of multiple dependent claims: To fortify protection, patentees include numerous dependent claims covering various process embodiments, thereby reducing invalidation risks.
3. Strategic Significance of CN101553487
- Market impact: Enhances WuXi AppTec’s position in contract manufacturing and licensing.
- Legal robustness: Multiple claims create a comprehensive barrier against design-arounds.
- Innovation signaling: Demonstrates commitment to improving pharmaceutical manufacturing technologies in China.
4. Related Patent Family and Landscape
CN101553487 is part of a patent family that might include equivalents or divisional patents filed in jurisdictions like the US, Europe, or Japan, enhancing global coverage.
Competitors typically focus on similar process innovations, creating a dense landscape of process patents aimed at infiltrating China's rapidly growing pharmaceutical manufacturing market.
Legal and Commercial Implications
- Protection scope: The broad process claims enforce WuXi AppTec’s innovation rights across manufacturing steps.
- Freedom-to-operate analysis: Companies must assess whether their processes infringe or if alternative non-infringing routes exist.
- Potential for licensing: WuXi could monetize the patent through licensing agreements, especially if the process improves scalability or reduces costs.
Conclusion
CN101553487 strategically leverages China's recent legislative climate favoring process patents, covering comprehensive steps for pharmaceutical production. Its broad method claims protect WuXi AppTec’s technological innovations, reinforcing its market position.
The patent landscape in China emphasizes process innovation as a key driver for pharmaceutical growth. Protecting methods, intermediates, and parameters is thus central to maintaining competitive advantage.
Key Takeaways
- Legal scope: The patent’s protection extends to specific synthesis processes and parameters, effectively blocking competitors from employing similar manufacturing routes.
- Strategic importance: As a process patent, CN101553487 aligns with China's patent trend favoring manufacturing innovations, providing long-term competitive advantage.
- Market implications: The patent supports WuXi AppTec’s dominance in contract manufacturing, influencing licensing, R&D, and litigation strategies.
- Landscape positioning: It fits within China’s broader patent environment emphasizing process innovation, with potential for global patent family expansion.
- Defensive and offensive use: The patent can serve both to deter infringers and to position WuXi AppTec as an innovative leader in drug manufacturing.
FAQs
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What is the primary focus of patent CN101553487?
It protects an innovative pharmaceutical manufacturing process, emphasizing specific reaction steps, catalysts, and purification methods to enhance yield and safety.
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Can this patent be challenged or invalidated?
Yes, but validity is contingent on whether the claims meet China's patentability criteria, including novelty, inventive step, and sufficient disclosure. Prior art that predates the patent’s filing could form grounds for invalidation.
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How broad is the scope of the claims?
It likely covers a range of process variations within the described reaction conditions, but the exact breadth depends on the language of the claims and their dependent claims.
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What is the strategic significance of this patent in China?
It secures WuXi AppTec’s manufacturing innovations, deters competitors, and strengthens licensing opportunities within China’s burgeoning pharmaceutical industry.
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How does this patent influence global pharmaceutical patent strategies?
It exemplifies China’s emphasis on process patents, encouraging global patent holders to adopt similarly robust process protection measures in China to secure intellectual property rights.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN101553487.
[2] World Intellectual Property Organization (WIPO). China Patent Landscape Reports.
[3] Liu, S. (2020). “Emerging Trends in Chinese Pharmaceutical Patent Litigation and Strategy.” International Intellectual Property Law Review.
