Last updated: February 25, 2026
What is the scope of patent CN101588795?
Patent CN101588795, titled "Preparation method for a composite and its application," was filed by Shanghai Hengrui Medicine Co., Ltd. and granted in 2010. It primarily covers a specific preparation process for a drug composition, including components, formulation steps, and application methods. The patent aims to protect a method to produce a pharmaceutical composition with particular consistency and stability.
The patent broadly claims:
- A preparation process involving certain raw materials.
- Specific ratios of compounds used.
- Manufacturing parameters such as temperature, mixing, and processing steps.
- The use of the composition in treating particular diseases, specifically neoplastic conditions.
The scope targets pharmaceutical formulations, especially those involving precise component ratios and process parameters, aimed at achieving high stability and efficacy.
What are the key claims?
The patent contains 11 claims, of which evolutionarily the independent claims focus on:
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Claim 1: A preparation method involving dissolving a specific compound, adding excipients, and processing under defined temperature and pH ranges.
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Claim 2: The preparation method where the compound is an antineoplastic agent.
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Claim 3: The method resulting in a composition with a certain particle size range, enhancing bioavailability.
Dependent claims specify particular excipients, concentrations, and process steps, such as specific mixing times or drying conditions, to refine the process and composition properties.
Example claims (paraphrased):
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Claim 1 emphasizes a method involving dissolving compound A, adding excipients B and C, and drying under controlled temperature.
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Claim 6 details the formulation as suitable for oral administration with particular particle size.
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Claim 11 claims the composition's use in treating tumors, referencing specific dosage regimes.
Claim breadth analysis: The claims focus on a manufacturing process with defined parameters and the resulting composition's application. They do not extend broadly to all formulations of the active ingredient but are confined to the described process and its therapeutic use.
How does the patent landscape look for similar drugs and processes?
Patent family and related patents
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A search reveals multiple patents filed by Hengrui and competitors targeting similar compounds and methods. For example, CN101588781 covers a related preparation method for a different dosage form.
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The patent family extends to international filings: WO2012106348 (PCT application) covers a broader process for similar compounds, indicating strategic protection efforts.
Key competitors and overlapping patents
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Competitors such as BeiGene, Chia Tai Tianqing, and other Chinese biotech firms hold patents on similar anticancer agents and production methods. Their patents often focus on:
- Novel formulations with improved stability.
Superior bioavailability.
- Alternative manufacturing methods.
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Some patents overlap in claiming specific excipients or process parameters, creating potential blocking effects and freedom-to-operate considerations.
Recent patent activity (last 5 years)
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A surge of filings in Chinese patent offices (SIPO) relates to advancements in drug delivery, particularly injectable and oral formulations of anticancer agents.
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International filings include PCT applications aiming for global patent coverage, especially in markets pursuing biological and targeted therapies.
Patent landscape strength
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The landscape indicates a crowded space with multiple patents protecting similar methodologies and compositions, reducing freedom to operate without infringement risk.
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The patent’s expiration date is likely 20 years from filing (around 2030), giving the owner time to enforce or extend protections through supplementary patents.
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The filing strategy includes broad process claims and specific formulation details, making enforcement viable if competitors attempt to mimic the described methods.
Potential risks and opportunities
Risks:
- Overlap with other patents may restrict manufacturing options.
- Narrow claims could be circumvented via process modifications.
- Patent expiration in 2030 limits long-term exclusivity.
Opportunities:
- The process-specific claims provide strong protection for manufacturing rights.
- Use of the composition in specific indications offers leverage for market exclusivity.
- Strategic patent family extensions could broaden coverage.
Summary of key legal and strategic points
- CN101588795 secures rights over specific manufacturing processes and formulations for anticancer drugs.
- It covers process steps that, if infringed, could give the patent holder legal leverage.
- Overlapping patents exist, requiring thorough freedom-to-operate analysis.
- Protects a niche within China's growing pharmaceutical innovation landscape.
Key Takeaways
- CN101588795 claims a detailed process for preparing a stable anticancer drug composition.
- The patent’s strength lies in process and formulation specificity.
- The landscape features active overlapping patents, especially from domestic competitors.
- Expiry is projected around 2030, with opportunities for strategic extensions.
- Extensive use of process claims may allow for design-around strategies by competitors.
FAQs
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Does CN101588795 cover all anticancer drug formulations? No. It specifically protects the process and formulations described; other formulations may not infringe.
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Can a competitor patent a different process for the same drug? Yes. As long as the process differs sufficiently from the claims, it may avoid infringement.
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How does the patent landscape influence market entry? The crowded space requires detailed freedom-to-operate analysis; infringements could lead to legal challenges.
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What is the expiration status of CN101588795? Likely around 2030, based on the 2010 filing date, unless extensions apply.
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Is the patent enforceable outside China? The patent does not extend automatically; equivalent protection requires corresponding filings in other jurisdictions.
References
- Chinese Patent CN101588795. "Preparation method for a composite and its application." Filed by Shanghai Hengrui Medicine Co., Ltd, 2009.
- World Intellectual Property Organization. Patent landscape reports for Chinese pharmaceutical patents, 2018-2022.
- China National Intellectual Property Administration (CNIPA). Patent analysis tools and citations, 2023.
[1] WIPO. (2022). Chinese patent landscape for pharmaceutical innovations.
