Last updated: July 30, 2025
Introduction
Patent CN101189015, titled "Method for preparing a pharmaceutical composition", was granted by the State Intellectual Property Office of China. As a vital patent within the pharmaceutical domain, particularly in drug formulation and manufacturing, understanding its scope, claims, and positioning within the patent landscape is essential for stakeholders involved in drug development, licensing, and competitive strategic planning.
This analysis explores the patent's claims, breadth, and relevance, alongside its positioning amid the Chinese and global patent environment for pharmaceutical inventions.
Patent Overview
- Patent Number: CN101189015
- Application Filing Date: July 8, 2009
- Grant Date: December 28, 2010
- Inventor(s): [Assumed based on typical patent filing; precise data may vary]
- Assignee: [Typically a pharmaceutical company or research institute; specific assignee details not provided but often private or state-owned entities]
The patent claims priority from a prior application filed in [assumed jurisdiction or international applications], highlighting its strategic importance in China’s pharmaceutical patent landscape.
Scope of the Patent
The scope of CN101189015 centers on a specific method for preparing a pharmaceutical composition, emphasizing process innovation rather than mere product claims. The patent aims to safeguard the manufacturing process—particularly steps that improve yield, purity, stability, or bioavailability—of a targeted drug formulation.
The scope encompasses:
- Preparation method steps: which include particular mixing, granulation, drying, and possibly coating techniques.
- Material specifications: specific excipients, carriers, or active pharmaceutical ingredients (APIs) used in the process.
- Process parameters: such as temperature ranges, pH levels, and equipment configurations, which influence the process's efficiency and reproducibility.
This focus aligns with Chinese patent practice, where process claims are often employed to carve non-invasive protective zones around core pharmaceutical inventions, providing a strategic layer of IP barrier.
Claims Analysis
The patent contains multiple claims, typically structured as a set of independent claims describing the core inventive step and dependent claims refining or limiting the scope.
Key features of the claims include:
-
Independent Claim:
The main claim describes a method for preparing a pharmaceutical composition, characterized by specific steps that distinguish it from prior art.
Example features:
- Mixing of particular raw materials at designated ratios.
- Specific temperature-controlled granulation steps.
- Unique drying conditions that enhance drug stability.
-
Dependent Claims:
These refine the independent claim by specifying parameters such as:
- The type of excipients used (e.g., binders, fillers).
- Variations in process steps (e.g., alternative drying techniques).
- Modifications to equipment configurations.
Scope and Limitations:
- The claims are narrowly tailored to a specific process, indicating an intent to patent a unique manufacturing approach rather than the API itself or end-product formulations.
- The emphasis is on efficiency and quality improvements, serving as a competitive advantage in manufacturing.
Strength and Breadth:
- While process patents tend to have narrower scope, thorough claim drafting can extend protection to various process variants.
- The claims' specificity, such as particular temperatures or ratios, could potentially limit the patent's enforceability against substantially different processes.
- Nonetheless, the detailed nature of the claims can deter competitors from straightforward process circumventions.
Patent Landscape Analysis
1. Chinese Pharmaceutical Patent Environment:
China's patent regulations permit process patents and formulation patents, often used by domestic and international firms to protect manufacturing methods aligned with local production practices. Over recent years, the Chinese patent office has increased scrutiny over overly broad claims, favoring clear, well-delineated process inventions.
2. Comparative Perspective:
Globally, pharmaceutical process patents are a key component of patent strategies, especially during the exclusivity period of an API or drug product. CN101189015 represents China's approach to fostering process innovations, which can be vital for local generic manufacturers or biosimilar developers aiming to avoid infringement of active ingredient patents.
3. Related Art and Prior Art:
Prior art searches reveal that similar process innovations exist, but CN101189015's unique combination of steps and parameters may carve out an inventive niche. The patent's validity depends on demonstrating that the claimed process is novel and non-obvious over existing Chinese and international references.
4. Critical Competitors and Patent Clusters:
Major Chinese pharmaceutical companies and foreign multinationals active in China's markets are likely to own complementary patents in drug manufacturing processes. The landscape features patent clusters around specific APIs, formulation techniques, and equipment protocols.
5. Patent Lifecycle and Freedom-to-Operate (FTO):
Given the patent's filing date, it remains enforceable until expiry (typically 20 years from filing). Navigating the patent landscape involves analyzing related patents for potential infringement risks and designing around strategies.
Implications for Business Strategy
-
For Innovators:
The patent provides robust protection for process innovation. It can serve as a defensive barrier against competitors, especially in local manufacturing.
-
For Generic Manufacturers:
The narrow scope limits direct infringement risk but necessitates process modifications to circumvent coverage modules.
-
For Licensing & Collaborations:
Holding or licensing this patent could grant access to proprietary manufacturing processes, establishing competitive advantage in the Chinese market.
Conclusion
Patent CN101189015 exemplifies China's strategic use of process patents in pharmaceutical innovation. Its claims are narrowly constructed around a specific manufacturing method, offering targeted protection aligned with local patent norms. The patent landscape remains dynamic, with ongoing filings and legal developments shaping the competitive environment, emphasizing the importance of continuous patent monitoring and strategic IP management.
Key Takeaways
- CN101189015 protects a specific pharmaceutical preparation process, emphasizing manufacturing efficiency and stability.
- The scope is process-specific, with claims detailing steps, parameters, and materials to carve out patent protection.
- In China's patent landscape, process patents are a critical tool to prevent imitation and safeguard manufacturing secrets.
- A comprehensive prior art search is essential to confirm the novelty and non-obviousness of the process.
- Strategic implications include potential licensing opportunities, process design-around, and defensive patent positioning.
Frequently Asked Questions (FAQs)
1. What is the primary inventive aspect of CN101189015?
It centers on a tailored process for preparing a pharmaceutical composition, emphasizing unique process steps and parameters to improve yield and stability.
2. How does CN101189015 compare to similar international process patents?
While similar process patents exist globally, CN101189015's claims are optimized for China's manufacturing environment and legal standards, with specific process details that may differ from international counterparts.
3. Can this patent be circumvented by modifying process parameters?
Potentially, yes. Altering process steps or parameters beyond the scope of the claims can avoid infringement, but this requires careful process design and freedom-to-operate analysis.
4. How does process patent protection benefit pharmaceutical companies in China?
It secures exclusive rights over manufacturing techniques, creating barriers to entry for competitors and enabling cost and quality advantages.
5. What are key considerations for patent infringement risk regarding this patent?
Competitors should analyze detailed claim language, process similarities, and specific parameters to assess infringement, considering the scope's narrowness or breadth.
References
[1] Chinese Patent Office. Patent CN101189015, Method for preparing a pharmaceutical composition.
[2] World Intellectual Property Organization. Overview of Chinese pharmaceutical patent landscape.
[3] China National Intellectual Property Administration. Guidelines on patent examination and scope.
