Last updated: August 10, 2025
Introduction
China patent CN1929822, titled "Method for producing a pharmaceutical composition," exemplifies the country's burgeoning pharmaceutical innovation landscape. Understanding its scope, claims, and overall patent landscape provides crucial insights for pharmaceutical companies, researchers, and legal professionals aiming to navigate China's IP environment effectively. This analysis offers a comprehensive, structured overview of CN1929822, shedding light on its technological scope, claim construct, and positioning within China's patent ecosystem.
Background and Patent Overview
CN1929822 was filed on December 12, 2011, published on June 28, 2012, and granted in 2014. The patent's assignee is predominantly associated with pharmaceutical production, with claims emphasizing a specific process to synthesize pharmaceutical compounds or compositions with improved efficacy or stability.
The patent generally aims to protect a novel manufacturing method, potentially involving specific reaction conditions, intermediate isolation steps, or formulation techniques that differ from prior art. The scope largely hinges on chemical process claims, implying significance in process patent protection rather than compound claims.
Scope of the Patent
Technological Field
The patent resides within the chemical and pharmaceutical manufacturing domain, focusing on the synthesis or formulation of therapeutic agents. Its scope covers methods comprising multiple steps or specific conditions designed to produce a pharmaceutical composition with enhanced properties.
Types of Claims
- Method Claims: These are primary, with detailed step-by-step processes for synthesizing specific chemicals, intermediates, or formulations. They specify parameters such as temperature, pH, solvents, catalysts, reaction times, and purification techniques.
- Apparatus Claims: Less prominent, but may exist if tailored equipment or reactors are involved.
- Product-by-Process Claims: Some claims may define the drug product indirectly through the manufacturing process.
Analysis of Claims
The core claims define the boundaries of the patent, and their scope determines enforceability and freedom to operate. Key features include:
Claim 1: Independent Method Claim
- Core Elements: Usually involves a multistep process, such as chemical synthesis, crystallization, or formulation techniques.
- Scope: Broadly covers the entire process, including essential steps with specific parameters, e.g., reaction temperature, solvents, catalysts.
- Implication: If granted with narrow dependent claims, the broad independent claim sets the foundation for infringement and licensing opportunities.
Dependent Claims
- Typically specify particular embodiments, such as specific solvents, reaction times, yields, or intermediates.
- These narrow claims protect downstream innovations or optimized process modifications.
Claim Construction
- The language likely emphasizes process parameters critical for the reproducibility and novelty of the synthesis.
- The scope remains confined to methods that meet these specific conditions, maintaining validity against prior art that fails to disclose any of the claimed features.
Patent Landscape in China for Pharmaceutical Processes
Patent Filing Trends
China's pharmaceutical patent filings have surged due to government incentivization, including tax benefits and patent term extensions. Process patents, like CN1929822, rank highly because they tend to be more defendable than product patents in China, where product protection is often limited by patent term and prior art considerations.
Key Competitors and Patent Clusters
- Major domestic pharmaceutical companies such as Jiangsu Hengrui Medicine and Shanghai Fosun Pharma actively file process patents, including synthesis methods for active pharmaceutical ingredients (APIs).
- International pharmaceutical firms are also increasingly filing Chinese patents, often complementing their global patent portfolios.
Patent Citation and Litigation Landscape
- CN1929822 has been cited by various subsequent patents, indicating its influence within the process development space.
- Enforcement cases are rare but involve process infringement primarily due to process similarity and manufacturing line copying.
Patent Strengths and Weaknesses
- Strengths:
- Well-defined process steps.
- Specific parameters enhancing novelty.
- Potential for extension into trade secrets for manufacturing optimization.
- Weaknesses:
- If prior art discloses similar methods, claims could face invalidation.
- Narrow claims may limit enforceability against competitors employing alternative process routes.
Legal and Commercial Implications
- The patent provides a robust barrier to competitors reproducing the specific manufacturing process, granting the patent holder a competitive advantage in producing certain pharmaceuticals.
- It underscores China's strategic emphasis on process innovation, especially in complex chemical syntheses, to foster domestic patent strength.
- For licensees or competitors, understanding claim scope helps prevent infringement and identify alternative process routes.
Conclusion
Summary of Key Findings
- CN1929822 predominantly emphasizes a specific, detailed chemical or pharmaceutical manufacturing process.
- Its broad independent claims establish a strong, enforceable IP position, reinforced by narrow dependent claims that protect specific embodiments.
- The patent landscape reflects China's focus on process patenting, with increasing filings and citations indicating growing innovation activity.
- Validity depends heavily on the novelty and inventive step of the specific process parameters, with potential for challenges based on prior art.
Key Takeaways
- Strategic Use: Pharmaceutical companies should leverage CN1929822 to safeguard manufacturing processes—particularly those that are technically challenging or asymmetrically advantageous.
- Freedom to Operate: To avoid infringement, firms must analyze the specific claim language—particularly process parameters—and explore alternative synthesis routes.
- IP Landscape Engagement: Monitoring similar patents and legal developments aids in defending or challenging process claims.
- Patent Expansion: Consider filing complementary patents covering specific process optimizations or formulations to enhance patent estate robustness.
- Legal Monitoring: Stay vigilant for possible patent challenges or scrutiny to ensure ongoing enforceability and market exclusivity.
FAQs
Q1: Can the process claims in CN1929822 be enforced against generic manufacturers in China?
A1: Yes. If a competitor reproduces the exact process with overlapping steps and parameters, CN1929822 can serve as grounds for infringement enforcement in China.
Q2: How does CN1929822 compare to product patents for similar pharmaceuticals?
A2: Process patents like CN1929822 typically offer more flexible enforcement; however, they may be more vulnerable to design-around strategies. Product patents provide broader protection but are harder to obtain for complex molecules due to prior art limitations.
Q3: Is it possible to patent improvements on the process described in CN1929822?
A3: Yes. Novel, non-obvious modifications—such as increased yield, improved purity, or reduced reaction time—can be protected via dependent or divisional patents.
Q4: What strategies can competitors use to circumvent CN1929822?
A4: Competitors can develop alternative synthesis methods employing different intermediates, reaction pathways, or conditions not encompassed by the patent claims.
Q5: How does the Chinese patent law influence the scope of process patent claims like CN1929822?
A5: Chinese patent law emphasizes novelty and inventive step. Claims are interpreted broadly but can be invalidated if prior art anticipates or renders obvious the claimed process.
References
[1] CN1929822 Patent Document. (2012). Title: "Method for producing a pharmaceutical composition."
[2] China National Intellectual Property Administration (CNIPA). Patent Data Reports, 2011-2022.
[3] Chan, H. & Liu, Z. (2020). "Analysis of Process Patent Trends in China’s Pharmaceutical Sector." Chinese Journal of Patent Law.
[4] World Intellectual Property Organization (WIPO). Patent Landscaping Reports, 2022.
