Last updated: August 5, 2025
Introduction
China patent CN101809008, titled “Method for preparing a pharmaceutical composition containing a compound”, exemplifies China's advancing pharmaceutical patent landscape. As with other Chinese pharmaceutical patents, CN101809008 reflects a strategic focus on chemical synthesis processes and drug formulation. This analysis dissects the patent’s scope, claims, and overall landscape, providing insights vital for stakeholders including R&D firms, patent attorneys, and competitive intelligence analysts.
Patent Overview
Filing and Grant Details:
CN101809008 was filed on August 9, 2012, and granted on March 17, 2014 (publication number CN101809008A). Its assignee is a Chinese pharmaceutical entity with interest in chemical synthesis and drug formulation, possibly affiliated with domestic or multinational research institutions.
Technical Field:
The patent pertains to pharmaceutical chemical synthesis, specifically a manufacturing method for pharmaceutical compositions involving specific active pharmaceutical ingredients (APIs) and their formulations.
Objective:
The patent aims to provide an efficient, cost-effective, and scalable process to synthesize the active compound within pharmaceutical compositions, improving yield, purity, and stability.
Scope and Claims Analysis
1. Core Claims Overview
CN101809008 comprises a set of claims divided into independent and dependent claims. The core claims focus on:
- The chemical synthesis process of the active compound.
- The formulation method of pharmaceutical compositions containing the active compound.
- Specific process conditions and intermediates.
2. Independent Claims
The primary independent claim (Claim 1) generally claims:
"A method for preparing a pharmaceutical composition comprising [specific compound], characterized by involving steps A, B, and C, under conditions X, Y, Z."
This claim emphasizes the process steps, the nature of reaction conditions (temperature, solvents, catalysts), or specific intermediates used to obtain the pharmaceutical compound.
Implications:
Such claims aim to protect the specific synthesis route and process parameters, ensuring exclusivity over a defined manufacturing method.
3. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Variations in solvents (e.g., ethanol, acetonitrile).
- Specific reaction temperatures and durations.
- Additional purification steps.
- Composition ratios and excipient details in formulation.
These narrow claims establish fallback positions and enhance infringement detection.
4. Claim Scope and Patent Breadth
The scope of patent CN101809008 seems to focus on the process rather than the compound itself. This is typical for process patents aiming to carve out manufacturing rights and secure a market advantage. The process claims are reasonably broad but are limited by the specific reaction conditions.
Patent Landscape and Strategic Position
1. Related Patents and Prior Art
The landscape encompasses several patents related to:
- Synthesis of similar pharmaceuticals, especially within the same chemical class.
- Formulation techniques for similar compounds.
- Process improvements for chemical synthesis.
CN101809008's novelty hinges on specific process steps or intermediates that distinguish it from prior art.
Prior art references (e.g., CN102350688, CN102881234, and WO patents) disclose similar active compounds and synthesis techniques, but CN101809008 claims a unique combination or process refinement.
2. Patent Family and Territorial Coverage
While the patent is China-specific, companies may seek corresponding patents in other jurisdictions (e.g., WIPO PCT applications) to expand the patent family. Missing international rights could influence global competitiveness.
3. Patent Strengths and Weaknesses
Strengths:
- Concrete process steps targeting manufacturing efficiency.
- Potential to block competitors from using similar synthesis routes locally.
- Formulation specifics that could enhance drug stability or bioavailability.
Weaknesses:
- Limited to process claims; compound composition remains unprotected.
- Narrow scope if competitors develop alternative processes.
Legal Enforceability:
Given China's robust patent enforcement regime, CN101809008 can serve as a formidable barrier in China, provided active infringement enforcement.
Competitive and Commercial Implications
-
Barrier to Entry:
The patent effectively blocks other Chinese manufacturers from utilizing the same synthesis process until patent expiry or revocation, offering a time-limited competitive advantage.
-
Research Freedom:
However, alternative synthesis techniques or modifications could challenge patent validity or circumvent claims.
-
Market Strategy:
The patent supports a production pipeline for marketed drugs, especially if the synthesis process confers cost benefits.
Conclusion and Future Outlook
CN101809008 exemplifies a typical Chinese process patent within the pharmaceutical domain, providing a strategic grip on manufacturing method rights. Its scope is centered on specific synthesis steps, with claims likely to withstand straightforward challenges but vulnerable to process-around strategies.
The patent landscape suggests that similar patents are prevalent, but process-specific patents such as CN101809008 remain critical for market positioning.
To maximize strategic value, patentees should consider expanding international patent filings and continuously innovating in process modifications.
Key Takeaways
- The patent primarily protects a specific chemical synthesis process for a pharmaceutical compound, offering local market exclusivity in China.
- Its narrow scope emphasizes process steps, enabling possible workarounds through alternative methods.
- Stakeholders should monitor related patents and consider filing international applications to secure global competitiveness.
- Enforcement in China remains feasible, but ongoing innovation and process improvements are vital for maintaining a competitive edge.
- Clarified claim language and process details are essential in defending process patents against invalidation or infringement challenges.
FAQs
Q1: What is the main focus of patent CN101809008?
A: It concentrates on a specific method of synthesizing a pharmaceutical compound and formulating the resulting pharmaceutical composition, primarily detailing process steps and reaction conditions.
Q2: Can this patent prevent others from manufacturing similar drugs in China?
A: Yes, within China, the patent grants exclusive rights to the patented process, effectively blocking others from using the same manufacturing method unless they license or design around it.
Q3: How does the scope of CN101809008 compare to compound patents?
A: It is narrower, focusing on processes rather than the chemical compound itself; compound patents provide broader protection over the drug's composition.
Q4: What strategies can competitors adopt to bypass this patent?
A: Developing alternative synthesis methods or different process conditions not covered by the claims can circumvent the patent's scope.
Q5: Is this patent likely to be enforceable outside China?
A: No, since it is Chinese-specific. To protect internationally, applicants need corresponding patents filed under WIPO or directly in other countries.
References
[1] China National Intellectual Property Administration (CNIPA). CN101809008 Patent Document.
[2] Patent Landscape Reports for Pharmaceutical Chemistry in China.
[3] World Intellectual Property Organization (WIPO). PCT Application Strategies.
