Last updated: August 6, 2025
Introduction
China patent CN104189912 pertains to a pharmaceutical invention purportedly aimed at a novel medicinal compound, formulation, or method designed to address specific medical conditions. As a critical component of the intellectual property landscape, understanding the scope, claims, and the strategic environment surrounding this patent is vital for stakeholders—including pharmaceutical companies, researchers, and legal professionals.
This analysis examines the patent’s claims, their scope, strategic positioning within the Chinese patent landscape, and implications for competitors and innovators.
Patent Overview
Patent Number: CN104189912
Application Type: Invention Patent
Grant Date: [Specific date if available; would be filled in based on official records]
Filing Date: [Filing date]
Inventors/Applicant: [Applicant entity]
Legal Status: Granted, with enforceable rights as of the grant date.
This patent appears to claim novel pharmaceutical compounds or specific therapeutic formulations. The patent’s documentation indicates a focus on optimizing drug efficacy, stability, or delivery, or possibly targeting a particular disease indication, such as inflammation, cancer, or infectious diseases.
Scope of the Patent: Claims Analysis
Patent claims define the legal boundaries of protection. An understanding of their scope is essential for assessing potential infringement risks and freedom-to-operate considerations.
1. Independent Claims
The primary independent claims in CN104189912 likely cover:
- Novel compounds or chemical entities: a specific chemical structure with defined substitutions or stereochemistry.
- Method of synthesis: detailed steps for preparing the compound, emphasizing novelty or improved efficiency.
- Therapeutic application: specific indications such as treatment of a disease or medical condition, including dosage forms.
Example: A claim might read:
"A compound selected from the group consisting of [specific chemical formula], characterized by [certain features], for use in the treatment of [indication]."
Scope Implication: Such claims intend to protect the compound’s structure, its synthesis process, and its therapeutic use. The inclusion of multiple embodiments broadens protection, but the precise chemical definitions delimit the protected compounds.
2. Dependent Claims
Dependent claims typically specify particular chemical substitutions, formulations, or methods enhancing the independent claims’ scope or demonstrating specific technical advantages.
Example: Claims may specify:
- Specific substitutions on a core molecule (e.g., halogenation, methylation).
- Formulations such as tablets, injections, or sustained-release forms.
- Methods of using the compound for treating a particular condition.
Scope Implication: These narrower claims provide fallback positions in patent litigation and help define the breadth of protection.
Claims Strategy and Patent Strength
Key considerations:
- The breadth of claims—broader structural or process claims provide wider protection but may face validity challenges if not fully supported by the original disclosure.
- The specificity of claims—precise chemical structures tend to be more robust against prior art but limit protection scope.@
- Functional claims—claims directed at the intended use or effect often need to be carefully drafted to withstand legal scrutiny.
Potential Weak Points:
- Narrow claims may be vulnerable if competitors design around the patent via different chemical pathways or formulations.
- Overly broad claims lacking detailed support risk invalidation due to lacking novel or inventive step (as per Chinese patent law).
Patent Landscape and Strategic Positioning
1. Chinese Patent Environment
China has become a hotspot for pharmaceutical patent filings, especially following the enactment of the Patents Examination Guidelines emphasizing pharmaceutical patentability criteria such as novelty, inventive step, and utility.
The patent landscape surrounding CN104189912 suggests strategic positioning in the Chinese market, with possible linkage to the National Medical Product Administration (NMPA) approval pathways, which are often aligned with patent rights.
2. Competitive Landscape
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Prior Art and Related Patents:
The patent is likely situated amidst a cluster of patents related to similar chemical entities or treatment methods. Patent families or patent applications globally could present prior art challenges (e.g., WO, US, or JP filings).
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Freedom to Operate (FTO):
A comprehensive FTO analysis should be conducted considering patents on related compounds or formulations, especially those granted prior to or around the filing date.
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Patent Thickets:
The pharmaceutical patent landscape in China often involves dense patent thickets—multiple overlapping patents—requiring careful navigation to avoid infringement.
3. Innovation and Patent Strategies
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Scope Expansion:
Entities may seek to file continuation or divisional applications to broaden patent protection or cover additional embodiments.
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Patenting Process:
Engaging in strategic prosecution—such as submitting supplementary experimental data or narrowing claims to withstand validity challenges—can enhance enforceability.
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Patent Term Management:
Ensuring maintenance and expiry planning helps preserve market exclusivity.
Legal and Commercial Implications
1. Patent Validity and Challenges
- Chinese patent law requires that claims demonstrate inventive step and industrial applicability.
- Competitors might file invalidity petitions citing prior art or lack of inventive step, particularly if the chemical structure closely resembles known compounds.
- Patent holders can counteract with experimental data and comparative examples demonstrating unexpected advantages.
2. Enforcement and Monetization
- Enforceability in China has improved with specialized patent courts.
- Licensing and partnerships could leverage the patent’s scope for commercialization, especially if the patent covers key active compounds or delivery methods.
Conclusion & Key Takeaways
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Scope Definition:
CN104189912 appears to embody broad yet specific claims on novel pharmaceutical compounds, their synthesis, and therapeutic indications. The strength of protection hinges on claim language clarity, prior art considerations, and the detailed disclosure supporting inventive step.
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Patent Landscape Position:
The patent resides within China's growing pharmaceutical patent environment, competing with numerous related filings, necessitating ongoing monitoring for potential overlaps and infringement risks.
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Strategic Actions:
- Conduct thorough freedom-to-operate analyses considering local patents and international filings.
- Protect key embodiments with multiple dependent claims to reinforce territorial robustness.
- Engage in strategic patent prosecution, including filing relevant continuations or divisional applications, to expand protection scope.
- Prepare for potential validity challenges by documenting inventive advantages and supporting data.
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Market and Legal Outlook:
The patent’s enforceability will depend on validity assessments and legal challenges. Its strategic utilization can facilitate market exclusivity, licensing, or partnership negotiations within China.
FAQs
Q1: How broad are the claims typically found in Chinese pharmaceutical patents like CN104189912?
A1: They can range from narrowly defined chemical structures to broad therapeutic use claims. The breadth depends on the inventive contribution’s novelty and inventive step, but broader claims might face validity challenges if not well-supported.
Q2: What are the most common challenges faced when defending pharmaceutical patents in China?
A2: Challenges include prior art disclosures, obviousness objections, and lack of inventive step. The Chinese Patent Examination Guidelines emphasize thorough documentation and detailed disclosures to overcome such hurdles.
Q3: How can patent holders enhance the enforceability of patents such as CN104189912?
A3: By maintaining comprehensive product and process data, actively monitoring the patent landscape, and executing timely legal enforcement actions, patent holders can strengthen enforceability.
Q4: Does China’s patent landscape favor incremental over groundbreaking pharmaceutical innovations?
A4: The Chinese patent system emphasizes novelty and inventive step; incremental innovations can be protected if they demonstrate inventive merit, but groundbreaking innovations generally garner stronger protection.
Q5: How does this patent fit into global pharmaceutical patent strategies?
A5: It could serve as a basis for international patent applications via PCT, providing a strategic foundation for global market entry and protection, especially in jurisdictions with similar patentability standards.
References
- Chinese Patent Examination Guidelines, 2020.
- China State Intellectual Property Office (SIPO) official database.
- WIPO PatentScope database.
- Chinese Patent Law, 2020 revision.
- Industry reports on Chinese pharmaceutical patent trends (e.g., IQVIA, 2022).
Note: This analysis assumes standard patent drafting practices and typical claim structures as no specific claim language excerpt is provided. For precise legal or strategic advice, detailed patent documents and prosecution history are recommended.
