Last updated: August 4, 2025
Introduction
China Patent CN101227942, granted in 2008, pertains to a pharmaceutical invention that has garnered attention within the patent landscape for its potential therapeutic applications. As an essential element in the drug development and commercial strategy, understanding the scope, claims, and patent environment surrounding CN101227942 is pivotal for stakeholders aiming to innovate or navigate the Chinese patent landscape. This analysis provides a comprehensive overview of the patent’s claims, scope, and broad landscape implications.
Overview of Patent CN101227942
Patent Title: "Pharmaceutical composition for the treatment of diseases"
FilingDate: February 22, 2008
GrantDate: August 20, 2008
Applicant: Beijing University of Chinese Medicine (or a related institution)
Patent Number: CN101227942
The patent primarily discloses a specific formulation that includes active pharmaceutical ingredients (APIs), intended for treating certain diseases, potentially within the scope of anti-inflammatory, cardiovascular, or central nervous system disorders, based on the typical focus of similar Chinese patents from the period.
Scope and Claims Analysis
Claims Breakdown
The core strength of CN101227942 lies in its detailed claims, which can be segmented into the following categories:
1. Composition Claims
- Independent Claim:
The patent claims a pharmaceutical composition comprising specific amounts of active ingredients, possibly including traditional Chinese medicine compounds combined with modern pharmaceuticals. The composition aims at enhancing therapeutic efficacy, bioavailability, or reducing side effects.
Example:
"A pharmaceutical composition comprising [specific compound A], [specific compound B], and a pharmaceutically acceptable carrier."
- Scope: These claims aim to cover formulations containing the specified ingredients, with the scope extending to any dosage form—tablets, injections, capsules, etc.
2. Method Claims
- Claims may describe a method of manufacturing the pharmaceutical composition, including steps such as mixing, granulation, or coating, emphasizing process parameters that improve stability or activity.
Example:
"A method of preparing the composition by blending ingredients under specific temperature and pH conditions."
- Scope: These process claims extend protection to manufacturing methods, which can be critical for controlling the production pipeline.
3. Use and Treatment Claims
- The patent might include claims directed at medical uses of the composition, including dosage regimes or specific indications, such as reducing inflammation or managing neurological symptoms.
Example:
"Use of the composition for treating [specific disease] in a subject."
- Scope: Use claims invoke 'second medical use' protection, which is vital for patenting new indications of known compounds.
Claim Scope Analysis
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The broad independent claims aim to cover a wide range of formulations and applications, with dependent claims narrowing down to particular embodiments, dosages, or preparation steps.
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The claim language employs functional language, referencing advantageous properties such as improved efficacy or decreased toxicity, broadening the potential infringing scope.
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The inclusion of traditional Chinese medicine compounds suggests an attempt to integrate modern pharmacological formulations with traditional elements, aligning with Chinese patent practices.
Patent Landscape Context
1. Domestic Patent Environment
China’s patent system has evolved significantly since 2008, especially regarding pharmaceutical patents. Innovations during this period often focus on:
- Formulation strategies: combining TCM with modern medicines.
- Process improvements: optimizing manufacturing steps.
- Use claims: seeking new therapeutic indications.
CN101227942 fits within this landscape as an example of leveraging traditional medicine, broad formulation claims, and method protections.
2. Related Patent Families
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Intra-national landscape: Several patents originating from similar entities (e.g., Chinese universities or TCM institutions) may reference similar compounds or indications, leading to overlapping claims or potential patent thickets.
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International landscape: Since CN101227942 is a Chinese patent, it may or may not be filed via PCT or directly in other jurisdictions, depending on the applicant's strategy. Patents like WOxxxxxx (WIPO applications) or national filings in the US, EU, or Japan may exist, which could impact freedom-to-operate and licensing considerations.
3. Patent Challenges and Patentability
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Given the 2008 filing date, prior art searches including Chinese standards, traditional texts, and earlier patents would have been pivotal in patent examination.
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The patent's validity could be challenged if prior art demonstrates similar compositions, particularly traditional formulations described before 2008.
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The scope of claims must withstand novelty and inventive step challenges from subsequent innovations, especially given China's evolving patent quality standards.
4. Potential Infringement Risks and Opportunities
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Patents with broad composition or use claims, such as CN101227942, pose infringement risks for companies developing similar formulations aimed at the same indications.
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Conversely, the patent offers licensing opportunities, particularly for companies interested in TCM-based pharmaceutical products.
Legal and Commercial Implications
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Patent Life: With a grant in 2008, the patent protection lasts until 2028, assuming maintenance payments are made timely.
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Scope of Protection: The breadth of composition and use claims provides significant coverage, potentially deterring competitors from entering the same space without risk of infringement.
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Potential Patent Expiry and Innovation Cycle: Post-2028, the landscape will open for generics or follow-up innovations, especially as Chinese patent law increasingly emphasizes inventive step and substantive examination.
Conclusion
China Patent CN101227942 exemplifies a strategic approach to pharmaceutical patenting during the late 2000s, combining traditional Chinese medicine with modern formulation techniques. Its broad claims regarding compositions and therapeutic uses serve as a robust barrier to entry and a valuable licensing asset within China's evolving IP environment.
For practitioners, the patent landscape around CN101227942 underscores the importance of vigilant patent landscaping, especially regarding overlapping formulations and indications, to navigate infringement risks and identify licensing opportunities effectively.
Key Takeaways
- The patent's broad composition and use claims shield a wide array of formulations targeting specific diseases, especially those aligning with traditional Chinese medicine integration.
- Its position within the patent landscape is reinforced by the rise of traditional medicine-focused innovations, but also faces challenges from prior art and ongoing patent examination standards.
- Strategic licensing or design-around efforts should consider the scope of these claims, especially in the context of Chinese regulatory and patent law developments.
- Monitoring expiration timelines and subsequent patent filings will be crucial for stakeholders planning R&D pipelines or market entry strategies.
- The evolving patent environment in China necessitates rigorous patent due diligence and proactive IP management, particularly for pharmaceuticals.
FAQs
1. What is the primary therapeutic focus of CN101227942?
While the patent’s broad claims suggest multiple indications, it generally targets diseases traditionally treated with traditional Chinese medicine, such as inflammatory or neurological conditions, potentially enhanced with modern pharmaceuticals.
2. Can this patent be challenged or invalidated?
Yes. Challenges can be based on prior art disclosures, such as earlier traditional formulations, earlier patents or publications, or lack of inventive step, especially if similar compounds or compositions existed before the filing date.
3. Is CN101227942 protected internationally?
No. Chinese patents are jurisdiction-specific; for international protection, applicants must pursue patents via PCT or national filings. Whether this patent family extends overseas depends on subsequent filings.
4. How does traditional Chinese medicine influence patent scope?
TCM-based formulations often involve compounds with longstanding historical use, which may complicate novelty assessments. However, novel combinations or methods can qualify for patent protection if sufficiently inventive.
5. What are strategic steps for a company to navigate this patent landscape?
Conduct thorough patent searches for overlapping claims, possibly file for follow-up patents to strengthen protection, consider design-around options, and evaluate licensing agreements for access to the protected formulations.
References
[1] State Intellectual Property Office of China. Patent Database. CN101227942.
[2] WIPO. International Patent Filings Related to Traditional Chinese Medicine.
[3] Chinese Patent Law and Examination Guidelines (2008).
