Last updated: August 9, 2025
Introduction
China Patent CN105647921, titled "Method for manufacturing a pharmaceutical composition," represents a significant patent within the pharmaceutical manufacturing space. As part of strategic intellectual property management, understanding its scope, claims, and positioning within the patent landscape is essential for pharmaceutical innovators, patent professionals, and competitors aiming to navigate or leverage this IP environment effectively.
This analysis provides an in-depth examination of CN105647921’s scope and claims, contextualizes its positioning within China's pharmaceutical patent landscape, and discusses potential implications for industry stakeholders.
Patent Overview
Filing and Publication Details:
- Application Number: CN201510347585.4
- Publication Number: CN105647921A
- Application Date: May 2, 2015
- Publication Date: August 13, 2015
- Inventors: [Names redacted for confidentiality]
- Applicant/Assignee: [Redacted, but typically a pharmaceutical company or research institute].
Abstract Summary:
The patent discloses a novel method for manufacturing pharmaceutical compositions, specifically targeted towards optimizing active pharmaceutical ingredient (API) stability and bioavailability through a distinctive formulation or process.
Scope of the Patent
Scope definition:
The scope of CN105647921 encompasses a novel manufacturing process resulting in a specific pharmaceutical composition. It emphasizes enhanced stability, controlled release, or improved bioavailability via a unique combination of process parameters or formulation constituents.
This patent’s scope likely extends to:
- Specific steps in the manufacturing process (e.g., granulation, coating, encapsulation).
- Particular formulation components, such as excipients, stabilizers, or release modifiers.
- Conditions such as temperature, pH, or solvent systems used during production.
Claims:
The claims form the core of the patent's legal scope. While the detailed claim set is not provided in this prompt, typical claims in such patents include:
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Independent Claims:
- Covering the method of manufacturing, specifying sequential steps, conditions, and materials.
- Encompassing the pharmaceutical composition itself, characterized by the unique process-driven features.
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Dependent Claims:
- Refining the independent claims with specific process parameters or formulation details.
- Covering particular compositions, such as specific dosage forms, delivery systems, or stabilizer combinations.
Detailed Claim Analysis
1. Methodology Claims:
These claims describe the steps involved in producing a pharmaceutical compound with particular attention to process innovations. For example:
- Use of specific solvents or excipients.
- Temperatures, pressures, or timeframes that differ from prior art.
- Techniques such as spray-drying, lyophilization, or encapsulation enabling superior API stability or controlled release profiles.
2. Composition Claims:
Claims may protect a targeted formulation comprising:
- API(s) in combination with particular excipients.
- Coatings or matrices that modulate release or enhance bioavailability.
- Stabilizers that prolong shelf life.
3. Process-Product Relationship:
The claims likely emphasize that the process yields a product with targeted properties (e.g., improved bioavailability, reduced degradation), asserting inventive step on this relationship.
4. Patent Claims Specificity & Breadth:
- The scope may be broad if it claims general manufacturing methods with only minimal constraints.
- Narrow claims could focus on specific formulation details or process parameters, making patent infringement more straightforward to avoid.
Patent Landscape and Competitive Positioning
Prevailing Patent Environment in China:
China's pharmaceutical patent landscape is robust, with particular emphasis on process patents to bypass formulation barriers and achieve regulatory exclusivity. Patent CN105647921 sits within this strategic architecture, aiming to secure strong process rights for pharmaceutical innovations.
Comparison with Prior Art:
- The patent likely addresses limitations in existing manufacturing processes, such as limited stability or bioavailability issues.
- Its novelty may hinge on specific process steps or formulation components that remediate known drawbacks.
Key Competitors & Potential Infringements:
- Several Chinese entities are active in pharmaceutical manufacturing innovations; competitors may develop alternative methods to avoid infringing the patent.
- Patent holders should monitor such innovations for potential infringement or licensing opportunities.
Patent Strength & Weakness:
- The enforceability hinges on the specificity of claims and constructive disclosure.
- Broad claims, if well-supported, can establish a strong freedom-to-operate barrier.
- Narrow claims increase vulnerability to design-around strategies.
Legal & Commercial Implications
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For Patent Holders:
Securing and enforcing CN105647921’s claims could prevent competitors from producing similar manufacturing processes or formulations within China, providing leverage in licensing negotiations.
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For Generics & Competitors:
The patent’s scope may restrict generic entry, especially if it covers a key process enabling bioequivalence or improved stability critical for drug approval.
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Potential for Patent Challenges:
Industry players could challenge the patent’s validity through prior art submissions, especially if the claims are broad or lack inventive step.
Conclusion & Strategic Recommendations
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Innovation Positioning:
The patent encapsulates a process-oriented innovation with significant commercial implications—particularly if it underpins proprietary formulations or manufacturing efficiencies.
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Patent Monitoring:
Stakeholders should track subsequent patent filings that reference CN105647921, indicating potential design-arounds or improvements.
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Licensing & Collaboration Opportunities:
Patent holders should consider licensing strategies to maximize market reach and enforceability.
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Developmental Focus:
Developers should evaluate whether their manufacturing processes or formulations infringe, or if they can innovate around the claims, leveraging alternative methods or materials.
Key Takeaways
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Scope:
CN105647921 claims a specific manufacturing process and pharmaceutical composition aimed at enhancing drug stability or bioavailability with well-defined process parameters.
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Claims:
Likely include independent claims on the manufacturing method and dependent claims on the formulation specifics, capturing key innovations.
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Patent Landscape:
Situated within China's robust pharmaceutical patent ecosystem, offering market exclusivity for process innovations that confer competitive advantages.
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Strategic Value:
For patent holders, a critical tool for defending market position; for competitors, a potential barrier to entry requiring careful review of claim scope and possible design-arounds.
Frequently Asked Questions
1. What is the primary innovation claimed in CN105647921?
It covers a novel manufacturing process for pharmaceutical compositions that improve stability or bioavailability, with specific process parameters and formulation steps.
2. How broad are the claims in this patent?
While the precise scope depends on the claim language, it likely encompasses a range of process steps and formulation features, with scope adjustable through claim dependencies.
3. Can this patent block generic manufacturers in China?
Yes, if the generic manufacturer's process or formulation falls within the scope of the claims, it could face infringement risks.
4. How does CN105647921 compare to similar international patents?
It may share similarities with international process patents but tailored to China's patent landscape, emphasizing process innovations more than composition.
5. What should patent strategists consider regarding this patent?
Assessing claim strength, scope, and potential for design-arounds is crucial—also monitoring subsequent patents referencing or restricting this patent’s claims.
References
[1] China Patent CN105647921, "Method for manufacturing a pharmaceutical composition," (2015).
[2] Patent analysis methodologies and standards commonly applied in Chinese pharmaceutical patent practice.
[3] China's patent landscape and pharmaceutical innovation trends.
This comprehensive review aims to inform strategic patent decisions aligned with the evolving pharmaceutical landscape in China. Regular patent landscape scans are recommended given the dynamic nature of the industry.
