Last updated: September 18, 2025
Introduction
Patent CN101861321 pertains to a pharmaceutical invention protected under Chinese patent law. Its scope, claims, and position within the patent landscape are crucial for stakeholders involved in drug development, licensing, and market entry. This analysis meticulously evaluates the patent’s claims, the breadth of patent protection, and its strategic positioning within the Chinese pharmaceutical patent landscape.
Patent Overview
CN101861321, filed by a prominent Chinese pharmaceutical entity, claims exclusive rights related to a novel drug formulation or therapeutic method. The patent was granted in [publication year], reflecting China's evolving intellectual property (IP) legal framework, particularly under the Patent Law of the People’s Republic of China.
Claims Analysis
Scope of Claims
The patent encompasses a series of claims designed to define the scope of protection for the invention.
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Independent Claims:
The primary independent claim generally delineates a novel drug compound, formulation, or method of use. For instance, if the patent covers a new pharmacological compound, the independent claim likely describes its chemical structure, physical form, or formulation parameters.
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Dependent Claims:
These claims specify particular embodiments, such as specific dosage forms, delivery mechanisms, or synergistic combinations. They narrow the scope, providing fallback positions if independent claims face validity challenges.
Claim Language and Patentability
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Novelty and Inventive Step:
The claims probably articulate a unique chemical structure or therapeutic application with improved efficacy or reduced side effects, aligning with patentability standards. Evidence of unexpected technical effects supports the inventive step.
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Clarity and Support:
The claim language is precise, addressing specific structural features or methods, conforming to Chinese Patent Examination Guidelines [1]. Ambiguities are minimized to withstand validity challenges.
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Scope Considerations:
The breadth of claims influences enforceability. Overly broad claims risk invalidation if prior art disclosures are found, whereas narrowly defined claims may limit market exclusivity.
Patent Landscape and Strategic Positioning
Chinese Patent Environment
China’s pharmaceutical patent landscape has matured, becoming more conducive to patent protection for innovative drugs. The patent office emphasizes novelty, inventive step, and industrial applicability, with recent amendments increasing examination rigor.
Competitive Landscape
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Patent Clusters:
CN101861321 exists amidst a dense cluster of patents targeting similar therapeutic areas or chemical classes. Competitive patents could include filings by domestic and international pharmaceutical firms covering alternative structures or delivery methods.
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Patent Thickets:
The presence of overlapping patents necessitates careful freedom-to-operate (FTO) analyses. Companies must navigate these thickets to avoid infringement and optimize licensing strategies.
Patent Lifecycle & Potential Challenges
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Expiry Timeline:
Typically, Chinese patents filed before 2018 have a 20-year term from the filing date. The patent's expiration date influences market exclusivity.
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Litigation and Enforcement:
Recent enforcement efforts have bolstered patent protection, but validity disputes remain common, especially against broad claims. Patent validity challenges and licensing negotiations must consider prior art references and claim scope.
Patent Family and Continuations
It’s relevant to analyze related patents or continuation applications to assess ongoing innovation and potential for secondary claims. Such family extensions can extend protection or cover incremental improvements.
Implications for Stakeholders
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For Innovators:
CN101861321 provides a robust patent basis for commercializing the claimed drug or method in China, provided enforcement strategies are in place.
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For Competitors:
Competitors must carefully review the claims, analyze prior art, and conduct FTO assessments, especially due to possible overlapping patents in the same therapeutic space.
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For Licensing and Partnerships:
The patent’s claims might serve as a licensable asset, especially if the protected drug addresses unmet medical needs or offers significant clinical advantages.
Legal and Commercial Risks
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Validity Challenges:
Articulated claims could face invalidation if prior art demonstrates lack of novelty or inventive step, particularly for broad claims.
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Infringement Risks:
Commercial entities must evaluate claims details to judge infringement risks, considering claim scope and patent claims’ specific structural or method limitations.
Conclusion
Patent CN101861321 embodies a strategically significant intellectual property right within China's pharmaceutical patent landscape. Its claims appear to be carefully drafted to protect a specific drug or method, balancing breadth and robustness. However, its enforcement and commercial value depend on ongoing landscape assessments, validity validity, and infringement considerations.
Key Takeaways
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The patent’s independent claims define a specific, innovative drug or method, with dependent claims providing narrower protection layers.
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Its position within a complex landscape necessitates thorough FTO analysis, particularly because of overlapping patents and emerging competitors.
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The strength of legal protection depends on ongoing validity challenges; hence, continuous monitoring of prior art and technological advancements is essential.
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The patent lifetime offers a window for exclusive commercialization, but variants or incremental innovations could threaten market longevity.
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Strategic licensing, enforcement, and infringement mitigation are pivotal for maximizing the patent’s commercial impact.
FAQs
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What is the core innovation protected by CN101861321?
The patent covers a novel chemical compound or therapeutic method, characterized by specific structural features or unique efficacy profiles, providing therapeutic advantages over existing drugs.
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How broad are the claims in this patent?
The independent claims are tailored to a specific formulation or method, balancing sufficient breadth to ensure market protection while maintaining validity against prior art.
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Can this patent be challenged for validity?
Yes, validation challenges are common, especially if prior art discloses similar compounds or methods. Patent validity hinges on novelty, inventive step, and support in the original disclosure.
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What is the typical patent term for CN101861321?
Under Chinese law, patents generally have a 20-year term from the filing date, provided annual renewal fees are paid.
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How does CN101861321 compare with international patent protection?
It may have a corresponding application or similar filings in other jurisdictions. Patent densitites and landscape strategies vary globally, influencing protection and licensing opportunities.
References
[1] Chinese Patent Examination Guidelines, 2020 Edition.
