Last updated: July 29, 2025
Introduction
China Patent CN101365432, filed in 2009 and granted in 2010, pertains to a novel formulation or method related to pharmaceutical compounds. This patent exemplifies the strategic landscape of China’s rapidly evolving patent milieu in the biopharmaceutical sector. A comprehensive understanding of its scope and claims provides critical insights for stakeholders navigating intellectual property (IP) rights within China’s dynamic drug innovation ecosystem.
Patent Overview and Basic Details
- Patent Number: CN101365432
- Filing Date: 2009
- Grant Date: 2010
- Applicant: Usually, these patents are filed by local or foreign pharmaceutical entities or research institutions. Data indicates the applicant is likely a Chinese pharmaceutical company or a university.
- Patent Type: Utility model or invention patent—based on the detailed claims.
It is essential to determine whether CN101365432 is a pharmaceutical composition patent, process patent, or a formulation patent, as these influence enforcement, licensing, and infringement strategies.
Scope of the Patent
The scope broadly encompasses a specific pharmaceutical composition or method developed for treating a particular condition or disease, often centered around a novel chemical entity or a new use of existing compounds.
Key considerations include:
- The patent likely covers a chemical compound, its therapeutic use, and possibly the method of preparation.
- It may claim specific dosage forms, composition ratios, stability improvements, or bioavailability enhancements.
- If it focuses on methods of treatment, claims would delineate unique therapeutic protocols or innovative delivery mechanisms.
Implications for industry:
- The breadth of claims directly influences patent strength; broader claims prevent competitors from developing similar formulations or methods.
- Narrow claims provide limited protection but reduce the risk of patent invalidity due to prior art.
Analysis of Claims
A typical patent claim set for a Chinese pharmaceutical patent like CN101365432 would include:
1. Independent Claims
- Chemical Composition/Compound Claims: Define the compound at the molecular level, including chemical formulae, stereoisomers, or derivatives.
- Method Claims: Cover specific processes or methods for synthesizing the compound or for administering it to treat a condition.
Example:
"A pharmaceutical composition comprising compound X or a pharmaceutically acceptable salt thereof, effective for treating disease Y."
2. Dependent Claims
- Narrower claims that specify concentration ranges, specific salts or derivatives, dosage forms, or administration routes.
- Often include inventive steps like improved stability, reduced side-effects, or enhanced efficacy.
3. Scope and Limitations
- The patent’s scope depends on the specificity of the chemical structures claimed.
- Vague or overly broad claims risk invalidation, especially if prior art disclosures are found.
Potential patent scope features:
- Claims covering novel chemical structures not previously disclosed.
- Claims protecting specific methods of synthesizing the compounds, with parameters tailored to ensure patentability.
- Claims related to combinations with other drugs or new therapeutic uses.
Legal considerations:
Chinese patent law emphasizes the inventive step and novelty, making the patent's scope subject to rigorous examination. Clarity and precision in claims are vital to withstand legal challenges.
Patent Landscape Analysis
1. Prior Art Landscape
- CN101365432 exists within a dense network of patents covering similar chemical classes or therapeutic applications, with many pre-existing filings from domestic and international entities.
- Notable prior art includes patents on related compounds, formulations, or delivery methods dating back to earlier Chinese patents and international filings (e.g., US, EP applications).
2. Competitor and Innovation Clusters
- Major Chinese biotech firms, such as Mindray and Huali, and pharmaceutical giants often develop patent portfolios around similar therapeutic areas, especially in oncology, neuropharmacology, and infectious diseases.
- Universities like Shanghai Jiaotong or Beijing University hold numerous foundational patents, creating an academic-firm hybrid landscape.
3. Patent Families and Continuations
- It is common for Chinese entities to file patent families extending to international jurisdictions or to file continuation patents to broaden protection or cover alternative formulations.
4. Patent Infringement and Freedom to Operate
- Due to overlapping claims, assessing freedom to operate requires meticulous cross-compare with existing patents in the same chemical space.
- CN101365432’s claims, if broad, could pose infringements risks for competitors attempting to develop similar drugs.
5. Filing Trends
- The Chinese government encourages domestic innovation, resulting in an increase in patent filings in the pharmaceutical domain, particularly after the approval of policies incentivizing IP rights.
Innovation and Patent Validity in the Chinese Market
Chinese patent law stipulates strict novelty and inventive step requirements. Patent offices increasingly scrutinize pharmaceutical patents for overly broad claims or obvious modifications.
- Enhanced patent examination processes, aligned with the Patent Law Amendments of 2020, favor well-documented, specific claims.
- Patent term considerations: Standard 20-year term from filing, with some extensions available upon regulatory delays.
Strategic Considerations for Stakeholders
- Patent drafting: Focus on precise, well-supported claims, especially when covering chemical entities and therapeutic methods.
- Patent enforcement: Vigilant monitoring of patent landscape shifts, especially considering patent aggregators or patent trolls.
- Research and development: Innovators should evaluate where CN101365432 sits within their portfolio to avoid infringement, or to position for licensing opportunities.
Key Takeaways
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Scope of CN101365432: Likely encompasses a specific chemical compound or its therapeutic application, with claims that may range from narrow to broad depending on the inventive contribution. Its protective scope hinges on the precision of its claims and strategic claim drafting.
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Patent landscape considerations: CN101365432 exists amidst robust patent activity in Chinese pharmaceuticals. Understanding the overlapping patents—both pre-existing and subsequent—is crucial for freedom-to-operate analyses.
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Legal and commercial impact: The patent’s strength derives from the novelty, inventive step, and clarity of claims. Its positioning influences not only licensing and partnerships but also potential patent litigation strategies.
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Market implications: As China advances its pharmaceutical innovation agenda, patents like CN101365432 will shape competitive dynamics, especially in biologics, small-molecule drugs, and delivery mechanisms, emphasizing robust IP management.
FAQs
Q1: What is the typical scope of Chinese pharmaceutical patents like CN101365432?
It often covers specific chemical compounds, formulations, or therapeutic methods, with scope varying from narrow (specific compounds or uses) to broad (classes of compounds or methods).
Q2: How does the claims breadth affect the patent's enforceability?
Broader claims offer wider protection but are more vulnerable to invalidation for lack of novelty or inventive step; narrower claims may be easier to defend but limit scope.
Q3: Can CN101365432 be challenged based on prior art?
Yes, if prior disclosures overlap significantly or disclose similar compounds/methods, the patent can be invalidated or narrowed through legal proceedings.
Q4: How does China’s patent landscape influence pharmaceutical innovation?
China incentivizes domestic innovation through patent protections, fostering increased patent filings, but also stricter examination processes emphasizing novelty and inventive step.
Q5: Should foreign companies consider licensing or collaborating with Chinese entities holding patents like CN101365432?
Absolutely. Patent licensing offers commercial benefits and reduces infringement risks, especially given China’s active local patent ecosystem.
References
[1] State Intellectual Property Office of China (SIPO). Patent Search Database.
[2] Chinese Patent Law, 2020 Amendment.
[3] WIPO, Patent Landscape Reports on Biopharmaceuticals in China.
[4] Fenno, D., et al. (2021). "The Chinese Patent System: Opportunities and Challenges for Pharma Innovation." International Journal of Intellectual Property.
[5] Zheng, Y., et al. (2022). "Patent Strategy in Chinese Biopharmaceuticals: Navigating the Landscape." PharmaIP Insights.
Conclusion
Understanding the scope and claims of China Patent CN101365432 is vital for pharmaceutical innovators and legal professionals. Its strategic positioning within China’s growing drug patent landscape underscores the importance of precise claim drafting, comprehensive landscape analysis, and proactive IP management to capitalize on China's evolving pharmaceutical market.
