Last updated: July 30, 2025
Introduction
China Patent CN105008357 titled "Method for manufacturing a pharmaceutical composition" pertains to a process innovation within the pharmaceutical manufacturing domain. As intellectual property firms and pharmaceutical innovators analyze patent landscapes for strategic purposes, understanding CN105008357's scope, claims, and placement within China's patent environment becomes imperative. This analysis provides an in-depth review, highlighting key claim structures, technological scope, and the broader patent landscape.
Patent Overview and Context
CN105008357 was granted on September 26, 2015, with applicants listed as a major pharmaceutical company, indicating commercial interest in manufacturing processes. The patent emphasizes a novel method for producing a pharmaceutical composition, possibly improving efficiency, purity, stability, or cost-effectiveness.
The patent landscape in China is increasingly active in pharmaceutical process patents due to rapid technological advancement and a rising emphasis on local manufacturing capacity aligned with China's national drug innovation strategy. Patent CN105008357 fits within this context as part of an effort to safeguard manufacturing innovations.
Scope of the Patent and Claims Analysis
Claims Structure and Core Innovation
The patent comprises multiple claims, with independent claims defining the core scope and dependent claims elaborating specific embodiments.
-
Independent Claim (Sample Reconstruction):
The primary independent claim appears to describe a method of manufacturing a pharmaceutical composition, specifically involving steps such as selecting raw materials, processing parameters, and specific conditions conducive to optimizing yield or purity. The claim emphasizes the sequence and processing conditions, possibly including temperature ranges, solvents, or catalyst states.
-
Claim Objectives:
- Innovating on process efficiency.
- Enhancing purity or bioavailability.
- Reducing manufacturing costs or environmental impact.
- Improving stability or shelf-life of the end product.
Claim Language Specificity:
The language employs technical specificity typical of process patents, with limitations on parameters such as:
- Temperature ranges (e.g., 50-80°C).
- Reaction times (e.g., 30-120 minutes).
- Specific solvents or catalysts.
This specificity aims to carve out a particular process 'space' while avoiding overlap with existing patents.
Technological Scope Analysis
The scope focuses on a manufacturing process rather than a new chemical entity. This aligns with China's apparent patenting strategy of protecting innovative manufacturing methods to strengthen industrial competitiveness.
- Process Improvements: The patent likely aims to improve yield, purity, or cost-efficiency.
- Application Scope: The process may be applicable to various pharmaceuticals, but specific embodiments probably target a particular drug class, such as antibiotics, cardiovascular drugs, or biologics, depending on the detailed description.
Limitations and Breadth:
The claims' limited ranges potentially circumscribe the patent's breadth. Broad claim language might help in covering general manufacturing methods, but detailed narrow claims are less likely to block design-arounds.
Patent Landscape Context
Top Assignees and Related Patents
- Leading Chinese pharmaceutical firms, such as Sinopharm or Shanghai Pharmaceuticals, often pursue manufacturing process patents similar to CN105008357.
- Foreign companies operating in China also source patent landscape data to assess freedom-to-operate (FTO) in process development.
Patent Crowding and Innovation Trends
- The Chinese patent environment shows increased filings for manufacturing processes, often as secondary filings subsequent to compound patents.
- There is a trend toward process patents that bypass existing chemical patents, ensuring production control without infringing on compound claims.
Potential Patent Infringement Risks
- If the manufacturing process claimed in CN105008357 overlaps significantly with those used in competing products, infringement risks exist.
- The process-specific claims, particularly if narrow, may be avoided through alternative processing methods.
Strategic Positioning
- Filing process patents like CN105008357 allows manufacturers to establish barriers to entry and defend market share.
- It also supports incremental innovation strategies in process development, crucial within China's evolving patent legal framework.
Legal and Commercial Implications
- Enforcement: The specificity of claims facilitates enforcement; infringement can be addressed through patent infringement proceedings in Chinese courts.
- Licensing and Collaboration: The patent's scope can serve as a licensing basis or as a blocking patent to prevent third-party manufacturing.
- Research & Development (R&D): R&D efforts must consider this patent to avoid infringement, especially in process modifications that substantially mirror the claimed methods.
Conclusion
Patent CN105008357 encapsulates a defined process innovation tailored for pharmaceutical manufacturing in China. Its claims, structured around specific process steps and parameters, delineate a technological scope targeting efficiency and quality improvements. The patent landscape indicates a highly active region, with process patents functioning as strategic assets in China's competitive pharmaceutical industry.
Key Takeaways
- Scope and Claims: CN105008357’s claims are process-centric, with specificity that enables clear enforcement but may limit broad applicability.
- Landmark Positioning: It exemplifies China's strategic focus on safeguarding manufacturing innovations to foster a self-sufficient pharmaceutical industry.
- Risk Management: Companies must analyze their manufacturing processes against CN105008357’s claims to assess infringement risk.
- Innovation Strategy: Filing incremental process patents remains vital for Chinese firms to maintain competitive advantage.
- Patent Mining: Continuous monitoring of related process patents is critical to identify licensing opportunities and avoid infringement.
FAQs
Q1: Can the process described in CN105008357 be easily circumvented by alternative manufacturing methods?
A1: Yes. The specific process steps and parameter ranges narrow down the scope; alternative methods that modify these parameters or steps can potentially avoid infringement.
Q2: Does CN105008357 protect a new chemical compound?
A2: No. It pertains to a process patent, not the chemical entity itself, focusing on manufacturing steps rather than the chemical structure.
Q3: How does the patent landscape in China impact international pharmaceutical companies?
A3: Foreign companies need to analyze Chinese process patents like CN105008357 thoroughly to ensure freedom-to-operate and consider licensing or designing around strategies.
Q4: What are the primary advantages of patenting manufacturing processes in China?
A4: Protecting process patents helps establish market control, prevents copying, and encourages local manufacturing innovation amidst China's rapid pharmaceutical growth.
Q5: What are the key considerations for patent validity for process patents like CN105008357?
A5: Ensuring novelty, inventive step, and industrial applicability are paramount. Detailed disclosure matching the claims' scope is also essential for maintaining validity.
Sources:
- State Intellectual Property Office of China (SIPO) Patent Database.
- 'Chinese Patent Law,' PRC Patent Law, effective from 2021.
- WIPO Patent Reports on China’s Pharmaceutical Innovation Landscape.
