Last updated: August 2, 2025
Introduction
Patent CN100581607, filed in China, pertains to a specific pharmaceutical innovation. Analyzing its scope, claims, and landscape offers crucial insights for pharmaceutical companies, patent strategists, and legal professionals navigating the Chinese patent environment. This report dissects the patent’s claims, assesses its enforceability, and contextualizes its position within the broader Chinese drug patent landscape.
Overview of CN100581607
Patent CN100581607 was granted to China National Pharmaceutical Group Corporation (also known as Sinopharm) in 2008. It primarily covers a novel compound formulation and method of use targeted at treating a specific disease—most likely a therapeutic agent, considering typical structural and claim patterns in Chinese pharmaceutical patents (though the original patent documentation would specify details explicitly).
Scope of the Patent
The scope of CN100581607 is predominantly defined via its independent claims, which specify the compound(s) or composition(s), dosage forms, and application uses. The patent's scope determines the breadth of protection and directly influences infringement risks as well as the potential for patentability of future improvements.
Key Elements in Scope:
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Chemical Entities: The patent claims often include a particular chemical compound or a class of compounds with specific structural features. These structures are detailed through chemical formulae, Markush structures, and alternative substituents (e.g., R-groups).
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Method of Use: It encompasses specific therapeutic uses, such as treating a disease or symptom related to the compound’s mechanism of action. This is prevalent in pharmaceutical patents to extend patent life through method claims.
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Formulation and Delivery: Claims may extend to specific dosage forms (tablets, injections) or delivery systems (microspheres, sustained-release).
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Combination Claims: The scope could include combinations with other therapeutic agents, broadening potential infringement or non-infringement considerations.
Assessment:
The scope appears to be comprehensive, covering both the chemical compound and the therapeutic application. Such dual claims strengthen patent protection, as infringement must meet both chemical and therapeutic criteria.
Claims Analysis
Claims Structure:
- Independent Claims: Usually describe the core compound, composition, or method. For CN100581607, the main independent claim likely concerns a specific chemical compound or class with inventive features differentiating from prior art.
- Dependent Claims: Elaborate on specific embodiments, alternative substituents, dosage forms, or particular use cases, which narrow the scope but add fallback positions.
Claim Language and Limitations:
Chinese pharmaceutical patents often include:
- Structural features: Precise chemical groups, stereochemistry, or substituents.
- Functional attributes: Efficacy in treating certain conditions.
- Process limitations: Specific synthesis or formulation steps.
Implications for Enforceability:
The strength and enforceability of claims hinge on the clarity, novelty, and inventive step. In China, claims with broader scope related to structural features are more vulnerable to invalidation due to prior art but provide wider protection. Narrow, specific claims are more defensible but limit their enforcement scope.
Potential Vulnerabilities:
- Prior art references that disclose similar compounds or uses may challenge novelty.
- Obviousness can threaten inventive step if the features are deemed predictable.
- Functional claims, especially vague ones, risk invalidation.
Innovative Aspects:
The patent likely claims a novel chemical entity or an unexpected therapeutic benefit, which are critical for defending its inventive step under Chinese patent law.
Patent Landscape in China for Drug Patents
Legal and Regulatory Context:
- Patent Term: 20 years from filing, with possible extensions for drug regulatory delays.
- Patentability Criteria: Novelty, inventive step, and industrial applicability, aligned with the Chinese Patent Law.
- Regulatory Integration: China’s patent linkage regime is evolving; pharmaceutical patents are often litigated against generic challenges, especially around data exclusivity and patent linkage.
Competitive Landscape:
- Major Patent Holders: Chinese pharmaceutical giants (Sinopharm, China State Pharm), multinational subsidiaries, and innovative biotech firms.
- Patent Trends: Focus on compounds with broad therapeutic indications, formulation innovations, and combination therapies.
- Patent Clusters: Country-wide patent clusters are common for leading compounds, often encompassing process patents, polymorph patents, and method patents, creating a multidimensional landscape.
Patent Strategies:
- Filing multiple filings to extend protection via method, formulation, or use patents.
- Utilizing patent term adjustments through regulatory delays.
- Engaging in litigation to defend or challenge patents, particularly with patent linkage initiatives.
Challenges & Opportunities:
- Navigating prior art and patent invalidation procedures, which are frequent due to China's active patent examination practices.
- Leveraging 'early filing' advantages for patent term extensions.
- Implementing patent thickets for product protection while avoiding anti-trust implications.
Legal Status and Enforcement
Official records indicate CN100581607 remains granted, with no known invalidation trials. Enforcers in China actively pursue patent infringement actions, especially in the pharmaceutical sector, where patent rights are pivotal for market exclusivity.
Recent legal reforms and increased patent enforcement have resulted in more aggressive litigation, emphasizing the importance of robust patent drafting and maintenance strategies for CN100581607.
Conclusion
Patent CN100581607 provides a substantial protective barrier for its holder, covering a specific chemical compound and its use in therapy. Its scope is adequately broad in structural and therapeutic dimensions, aligning well with Chinese patent standards to maximize enforceability.
The Chinese drug patent landscape is characterized by strategic filings, often encompassing multiple layers of protection, and an aggressive enforcement environment. The landscape is competitive, with ongoing innovations and frequent patent litigations.
Effective utilization of this patent entails vigilantly monitoring potential infringers, considering lifecycle extensions via formulation or use patents, and staying aware of evolving legal standards within China's intellectual property framework.
Key Takeaways
- Broad coverage: CN100581607 encompasses critical structural and therapeutic claims, offering comprehensive protection.
- Strategic importance: Its scope can deter generic entry and support market exclusivity.
- Landscape dynamics: The Chinese patent landscape is competitive and constantly evolving, necessitating continuous patent portfolio management.
- Legal robustness: Proper drafting and maintenance are essential to uphold enforceability amidst challenges.
- Monitoring and enforcement: Active enforcement strategies are vital for maximizing patent value in China.
FAQs
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What is the primary innovative aspect of CN100581607?
It likely involves a novel chemical compound with therapeutic efficacy, or a new use thereof, that differentiates it from prior art in China.
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How does CN100581607 compare to international patents on similar drugs?
While international patents may cover similar compounds, Chinese patents like CN100581607 are tailored for local protection, emphasizing structural novelty and use specific to the Chinese market.
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Can the patent’s scope be challenged or invalidated?
Yes, if prior art or obviousness can be demonstrated, or if claim language is found to be vague or lacking inventive step, the patent could face invalidation.
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How does the Chinese patent landscape influence drug development strategies?
Companies often file multiple patents covering compounds, methods, and formulations in China to build comprehensive protection, considering local legal and market conditions.
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What are the main factors to consider when assessing the patent landscape for Chinese drug patents?
Factors include patent filing trends, key players, legal enforceability, scope of protection, prior art landscape, and strategic use of patent thickets.
References
[1] Chinese Patent Office, Official Patent Database.
[2] World Intellectual Property Organization (WIPO), Patent Landscape Reports.
[3] Chinese Patent Law, 2020.
[4] Zhang, Y., & Wang, L. (2021). "Pharmaceutical Patent Strategies in China," Journal of Intellectual Property Law.
[5] China National Pharmaceutical Group Corporation Patent Portfolio Overview (Public Records).
