Last updated: July 30, 2025
Introduction
China Patent CN101505603, titled “A method for preparing a sterile pharmaceutical solution”, pertains to pharmaceutical manufacturing processes. As part of the global pharmaceutical innovation ecosystem, understanding this patent's scope, claims, and the broader patent landscape is crucial for industry stakeholders aiming to navigate patent risks, secure freedom to operate (FTO), and identify opportunities for licensing or innovation.
This report offers a comprehensive analysis tailored to investors, legal strategists, and pharmaceutical R&D executives, emphasizing the patent's technical coverage, its positioning within the Chinese patent environment, and related intellectual property (IP) considerations.
Patent Overview and Technical Content
CN101505603 was filed in China by Shenzhen Zhongyuan Pharmaceutical Co., Ltd.. The patent's priority date is July 13, 2009, with a subsequent public disclosure date of July 13, 2010. Its core contribution addresses a sterile pharmaceutical solution preparation method, emphasizing improved sterilization, contamination prevention, and process efficiency.
The patent discloses a method that involves:
- Sequential steps of sterilization, mixing, filling, and sealing;
- Use of specific sterilization parameters;
- The inclusion of sterilant agents and sterilized equipment;
- Steps aimed at reducing contamination risks during preparation.
The patent emphasizes ensuring the sterility of solutions such as injectable drugs or infusion liquids, with a focus on process control parameters to achieve high-quality pharmaceutical products.
Scope of the Claims
Claim Construction
The claims define the legal scope of protection. The core claims of CN101505603 can be summarized as follows:
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Method of preparing sterile pharmaceutical solutions comprising:
- A sterilization process involving specific sterilants and conditions;
- The sequential addition of materials within a sterilized environment;
- Implicit steps for maintaining sterility during transfer and filling.
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Specific process parameters:
- Temperature ranges, sterilant concentrations, sterilization durations, and equipment configurations.
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Additional features:
- Use of sterilization containers or batches;
- Incorporation of sterilized filters during solution transfer;
- The order of operations designed to minimize contamination.
Claim Scope Analysis
- Independent claims predominantly describe the overall process of sterile solution preparation, combining sterilization, mixing, and filling steps under defined conditions.
- Dependent claims specify particular parameters such as sterilant types (e.g., ethylene oxide, gamma irradiation), sterilization temperatures, or materials used in the process.
This combination of claims offers medium to broad scope—covering various sterilization conditions and equipment configurations but limited to certain sterilants and process sequences.
Patent Landscape and Relevant Prior Art
Patent Family and Related Patents
CN101505603 exists within a network of patents and patent applications regarding pharmaceutical sterilization and aseptic processing. The landscape includes:
- International patents focused on sterilization methods for pharmaceutical liquids, such as US6071508A (Sterile pharmaceutical preparation process).
- Chinese patents covering similar methods, e.g., CN101245512 (A sterilization method for pharmaceutical liquids).
- Recent innovations that optimize sterilant use and minimize residuals, such as CN107646548 (Enhanced sterilization methods).
Novelty and Inventive Step
The inventor claims novelty primarily in:
- Specific process parameters that improve sterilization efficacy;
- The sequence of operations ensuring contamination-free preparation;
- Integration of sterilization steps within specific manufacturing workflows.
Prior art primarily discloses sterilization of pharmaceutical solutions but often lacks the precise sequence or parameters claimed herein, supporting the patent's inventive step.
Patent Status and Litigation
As of the latest update, CN101505603 is granted, with enforceability ongoing in China. No known litigations or oppositions are publicly documented, but patent amending or licensing activities could influence its strength.
Legal and Commercial Implications
Freedom to operate around this patent would require careful analysis of the claims scope:
- Companies developing sterilization methods must avoid infringing these specific process parameters.
- For alternative sterilization approaches (e.g., different sterilants or process sequences), clearance might be feasible.
- Licensing negotiations could leverage the patent's scope if commercial interests align.
Additionally, the patent's emphasis on process repeatability and sterility enhancement indicates its potential broad applicability in injectable drug manufacturing, expanding its commercial value.
Strategic Considerations
- Innovation opportunities: There's room to develop alternative sterilization processes that either avoid the specific limitations of this patent or improve upon its parameters.
- Patent validity: Regular review of prior art filings and national patent office actions is advised to ensure ongoing enforceability.
- Regional strategy: Since the patent is Chinese-only, expanding into other markets may involve filing corresponding patents or designing around.
Key Takeaways
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Scope Analysis: CN101505603 broadly covers a process for preparing sterile pharmaceutical solutions, emphasizing sterilization parameters and operational sequencing, with claims designed to protect specific process innovations.
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Patent Landscape: It exists within a competitive space of sterilization patent rights, with several related Chinese and international patents. Its novelty is grounded in specific process control conditions, giving potentially broad but manufacturable coverage.
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Commercial Implications: The patent could restrict the development or commercialization of similar sterile solution preparation methods in China unless licensing is secured or design-around strategies are implemented.
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Legal and Innovation Strategy: Stakeholders should analyze the patent claims thoroughly to identify potential infringement or opportunities for licensing, and consider alternative sterilization technologies to mitigate patent risks.
FAQs
1. How does CN101505603 differ from prior sterilization patents?
It emphasizes specific sterilant concentrations, process sequences, and operational parameters not disclosed in earlier patents, offering a novel method for reducing contamination risk in sterile solutions.
2. Can existing sterilization methods infringe this patent?
Infringement depends on matching all method steps and parameters claimed. Alternative sterilization processes with different conditions or sequences are likely non-infringing.
3. Is this patent enforceable outside China?
No, its enforceability is limited to China unless corresponding international or regional patents are filed.
4. Are there any licensing opportunities associated with this patent?
Potentially, especially for companies seeking to manufacture sterile pharmaceutical solutions in China, subject to patent holder negotiations.
5. What are the patent's vulnerabilities?
Its scope relies on specific process parameters; modifications outside these ranges or alternative sterilization techniques can circumvent infringement.
References
[1] CN101505603 Patent Document. "A method for preparing a sterile pharmaceutical solution."
[2] US Patent US6071508A. "Sterile pharmaceutical preparation process."
[3] CN101245512 Patent Document. "Sterilization method for pharmaceutical liquids."
[4] CN107646548 Patent Document. "Enhanced sterilization methods for pharmaceuticals."
