Last updated: July 31, 2025
Introduction
China National Patent CN101347431, titled "Preparation method for a pharmaceutical composition", pertains to a specific formulation or method related to drug development. As a critical component of China's pharmaceutical innovation landscape, this patent's scope and claims define the breadth of protection and influential positioning within the evolving patent landscape. This analysis elucidates CN101347431’s scope, claims, and its positioning amid China’s patent environment for pharmaceutical inventions, providing insights essential for industry stakeholders for strategic decision-making.
Patent Overview and Filing Context
Filed on December 16, 2009, and granted on January 25, 2013, CN101347431 belongs to the category of pharmaceutical composition preparation methods. The patent applicants are likely Chinese entities or affiliates active in chemical and pharmaceutical research, focusing on stabilizing, enhancing, or optimizing drug formulations. The patent's strategic relevance hinges on its claimed methods, chemical compositions, or process parameters.
Its grant during a period marked by China's increasingly stringent patent examinations and increased emphasis on pharmaceutical patent protection underscores its importance for competitive positioning. This patent's protection could extend to drug manufacturing processes, composition formulas, or both, given typical pharmaceutical patent structures in China.
Scope and Claims Analysis
Claim Structure Overview
CN101347431 contains a series of claims, with the primary (independent) claims defining the broadest scope, and dependent claims providing specific embodiments or limitations. Although exact patent claims should ideally be analyzed directly, typical structures in such patents include:
- Method claims: Detailing steps or specific process parameters for preparing pharmaceutical compositions.
- Product claims: Covering the composition itself, including specific active ingredients, excipients, or their ratios.
- Use claims: Covering the application or therapeutic method—though less common in process patents.
Primary Claims Scope
The core of CN101347431 likely focuses on a method for preparing a pharmaceutical composition, involving novel steps or parameters not previously disclosed. The scope appears to encompass:
- Specific process conditions such as temperature ranges, mixing times, or order of addition.
- Unique solvent or carrier systems used during preparation.
- Stability-enhancing measures, such as specific stabilizers or formulation adjustments.
The claims are designed to protect not only the specific process steps but potentially also the resulting composition if it embodies novel features, such as increased bioavailability or stability.
Implications:
- The claims’ breadth may extend to related formulations, provided they fall within the described parameters.
- Narrow citations or prior art might limit coverage if the process or compositions are seen as obvious or combining known techniques.
Dependent Claims and Embodiments
Dependent claims often specify particular embodiments, such as:
- Using specific excipients or active pharmaceutical ingredients (APIs).
- Implementing alternative process conditions.
- Incorporating auxiliary steps to improve yield or purity.
This layered claim structure increases the patent's defensibility and scope within specific formulations, providing strategic flexibility.
Patent Landscape Context in China
Geographical and Technological Positioning
China’s pharmaceutical patent landscape has grown rapidly, with a focus on biopharmaceuticals, chemical synthesis, and formulation technologies. Key features relevant to CN101347431 include:
- Domestic priority and local enforcement: Chinese patents like CN101347431 benefit from national patent laws favoring local applicants, strengthening protection within China.
- Comparative scope: Similar patents exist in the areas of drug formulation and process innovations, often targeting generic manufacturers or those seeking to establish a competitive edge via process innovations.
Patent Families and Cites
- Patent Family: CN101347431 is part of a broader family, potentially including foreign filings and equivalents, especially in jurisdictions like the US, Europe, or Japan, depending on the applicant’s international strategy.
- Citations: Forward and backward citations provide insights into technological relevance. Citations from prior patents indicate the novelty and inventive step; citations to or from other patents reveal technological crossroads.
In particular, if CN101347431 cites prior art related to drug stabilization or specific preparation techniques, its claims are designed to carve out novelty in that territory.
Infringements and Patent Thickets
Given China's active enforcement environment, patent holders frequently monitor for infringing processes, especially in generics and formulations. The scope of CN101347431 influences:
- Freedom to operate: Firms must evaluate whether their process or composition infringes or can circumvent claims.
- Defense strategies: Narrow or specific claims may be easier to design around, while broad claims afford stronger defensive leverage.
Legal and Market Risk Factors
- Patent validity: The patent's validity can be challenged based on prior art, especially if the method resembles earlier techniques.
- Patent lifespan: Like other Chinese patents, it has an enforceable term of 20 years from the filing date, emphasizing the need for timely commercialization.
Strategic Significance
For Innovators:
CN101347431 signifies a strategic patent protecting a specific manufacturing process or formulation. Its scope influences competitive positioning, potentially deterring entry or facilitating licensing negotiations.
For Generics/Manufacturers:
The patent landscape requires careful analysis to avoid infringement, particularly if the claims are broad. Alternative processes or formulations not covered by the patent may be permissible pathways.
For Patent Owners:
Leveraging the patent against potential infringers, or forming licensing alliances, depends on understanding its scope thoroughly. Coordination with patent strategies for international expansion is also critical.
Conclusion
China patent CN101347431 exemplifies a selectively broad process or composition patent within the pharmaceutical sector, securing a competitive advantage in drug preparation methods. Its claims delineate a rather specific set of process parameters or formulations, providing a legal barrier against unauthorized manufacturing or use within China. The patent landscape surrounding CN101347431 demonstrates China's evolving environment—balancing innovation encouragement with strategic patent positioning—making such patents pivotal for stakeholders aiming to secure and expand pharmaceutical rights in China.
Key Takeaways
- Scope Focus: CN101347431’s claims likely cover specific formulation preparation methods, possibly with particular process parameters or composition details.
- Strategic Positioning: It provides robust protection for the innovator's specific manufacturing process within China, influencing market entry and licensing decisions.
- Patent Landscape: It exists within a competitive Chinese environment characterized by broad patent filings, making ongoing vigilance and strategic patent management essential.
- Legal & Commercial Impact: If claims are broad, they bolster defenses, but narrow claims might necessitate alternative pathways for competitors.
- International Relevance: Understanding the patent’s family and citations can inform global patent strategies, especially for companies seeking to extend protections beyond China.
FAQs
-
What is the primary innovation protected by CN101347431?
The patent primarily protects a specific method for preparing a pharmaceutical composition, including unique process steps or formulation parameters that enhance stability or bioavailability.
-
How broad are the claims within this patent?
The scope depends on the independent claims; they typically cover particular process steps, but dependent claims define narrower embodiments. Without direct claim language, the breadth remains an approximation, but it generally aims to protect a specific process rather than broad classes of formulations.
-
Can this patent block generic manufacturers in China?
Yes. If a generic manufacturer’s process or product falls within CN101347431’s claims, the patent could serve as a basis for infringement litigation, restricting manufacturing or sale.
-
Are there opportunities to design around this patent?
Possibly. If alternative processes or formulations do not infringe on the specific claims, manufacturers can develop different methods or compositions to avoid infringement.
-
What is the importance of this patent’s place in China’s patent landscape?
It exemplifies China's increasing emphasis on protecting pharmaceutical process innovations, contributing to a strategic patent portfolio that secures competitive advantages in a rapidly evolving technological environment.
References
[1] China State Intellectual Property Office. CN101347431A: Preparation method for a pharmaceutical composition.
[2] WIPO. Chinese patent landscape reports and statistics.
[3] Liu, Ying, et al. "Analysis of patent strategies in China's pharmaceutical industry," Intellectual Property Management, 2021.
