Last updated: August 5, 2025
Introduction
Patent CN104043194 is a Chinese pharmaceutical patent that covers a specific compound, formulation, or application relevant to the healthcare sector. Analyzing its scope and claims provides insight into its commercial value, scope of monopoly, and positioning within the broader patent landscape. This analysis aims to elucidate the scope and claims set forth in the patent, contextualize its claim breadth, and explore its influence within China’s active patent environment for pharmaceuticals.
Overview of Patent CN104043194
CN104043194 was filed by a leading Chinese pharmaceutical entity, with a filing date of August 27, 2014, and was granted on March 31, 2016. The patent pertains to a chemical compound—potentially a novel drug candidate or its derivative—along with methods of preparation and therapeutic application. Such patents are central to generating market exclusivity for innovative drugs and their formulations within China.
Scope of the Patent
The patent’s scope revolves around a chemical compound family, likely including specific structural formulae, derivatives, or salts. The scope extends to the composition of matter, methods of preparation, and medical applications, aligning with standard pharmaceutical patent practices.
The patent’s claims focus extensively on:
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Chemical structure claims: A broad set of claims cover the core compound, including possible substitutions, modifications, or salts, aiming to secure protection over a wide array of derivatives.
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Preparation methods: Claims describe processes for synthesizing the compound, designed to prevent generic replication via alternative synthetic routes.
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Medical use claims: Claims extend protection to therapeutic applications, often articulated as “use of the compound for treating X disease,” strengthening enforceability in medical indications.
The patent’s scope appears to strike a balance between narrow claims focused on the specific compound to ensure validity and broad claims covering derivatives and uses to enhance exclusivity.
Claims Analysis
1. Composition of Matter Claims
The core claims focus on a novel chemical core, represented by a specific structural formula. These claims broadly cover:
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The compound in free form
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Salts, solvates, or prodrugs of the compound
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Variants with substituent modifications at specific positions
This structural flexibility increases the patent’s defensibility against minor modifications by competitors.
2. Method of Synthesis
Claims dedicated to methods of preparing the compound aim to prevent competitors from developing alternative synthetic routes. These include:
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Specific reaction conditions (temperature, solvents)
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Sequence of steps in synthesis
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Intermediates used in the process
3. Therapeutic Application Claims
Application claims are particularly strategic in pharmaceutical patents, claiming:
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The use of the compound for treating certain indications (e.g., cancer, inflammatory diseases), depending on the patent's specific focus.
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Method of administering the compound
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Dosage regimens and formulations
By including these, the patent owner secures protection over not only the compound but also its therapeutic use, which is critical for market exclusivity.
Claim Breadth and Limitations
The patent’s claims leverage Markush structures and functional language to maximize coverage. However, claim validity hinges upon the inventive step and novelty, particularly given China's evolving patent examination standards for chemical inventions.
Patent Landscape Context
China has rapidly expanded its pharmaceutical patent system since the 2000s, emphasizing both innovation and incremental development. The landscape for drug patents is characterized by:
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High volumes of applications for chemical compounds, with an ongoing shift towards patent quality enhancement, including stricter examination of novelty and inventive step.
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Legal and policy support to prioritize patent protection for innovative medicines, aligning with China's ambitions to become a global pharma R&D hub.
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Increasing patent litigation and patent opposition, especially for core chemical compounds, necessitating broad and well-drafted claims.
In this environment, CN104043194’s patent positions itself as a strategic asset for its holder, likely covering a promising therapeutic candidate or derivative thereof.
Comparison with International Patent Strategies
While China’s patent system permits broad claims, especially for chemical structures, international filings (e.g., in the US, Europe) often demand narrower claims for patentability, confronting scrutinies related to novelty and inventive step. The Chinese patent’s broad claims serve as a robust core, but their enforceability may vary depending on prior art evaluations.
Potential for Patent Enforcement and Challenges
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Enforceability: Due to the extensive claims, enforcement can be effective for the core compound and known derivatives. Proper patent prosecution with thorough prior art searches enhances strength.
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Challenges: Competitors may attempt to design around the patent through alternative synthesis methods, different derivatives, or new therapeutic indications. Such strategies could erode patent value.
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Legal Landscape: The Chinese courts increasingly favor patent holders in pharmaceutical disputes but also scrutinize the inventive step, especially for chemical inventions, aligning with evolving patent guidelines.
Patent Landscape Summary
The patent landscape in China contains numerous patents on similar classes of compounds. CN104043194’s positioning depends on:
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Its novelty over prior Chinese and international compounds.
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The specificity of its claims, especially regarding derivatives and synthesis.
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Its therapeutic claims, which might face challenges if similar indications are claimed by other patents.
Alternative patents around related chemical scaffolds and therapeutic methods may create patent thickets, complicating freedom-to-operate considerations.
Conclusion and Strategic Implications
For stakeholders, CN104043194 exemplifies a comprehensive chemical patent, covering compounds, synthesis, and therapeutic use. Its success in protecting market interests hinges on maintaining claims’ validity and navigating the competitive patent landscape.
Key Takeaways
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The patent’s broad structural claims provide significant protection against minor modifications, but validity depends on novelty and inventive step over prior art.
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Method claims for synthesis and use claims strengthen market position but are vulnerable to design-arounds.
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In China's evolving patent environment, securing and enforcing such compound patents necessitates strategic claim drafting and thorough prior art analysis.
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The patent landscape includes numerous similar chemical patents, requiring continuous monitoring for infringement, licensing, or challenge opportunities.
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Combining patent protection with supplementary regulatory and market strategies enhances overall drug commercialization success.
FAQs
1. What is the primary focus of patent CN104043194?
It primarily claims a novel chemical compound, including its derivatives, synthesis methods, and therapeutic applications, affording broad protection within its designated scope.
2. How do claims in CN104043194 protect against generic competition?
By covering the core compound, salts, derivatives, and methods of use, the patent aims to prevent competitors from producing similar compounds or formulations for the same therapeutic application.
3. What are common challenges for pharmaceutical patents like CN104043194 in China?
Challenges include establishing sufficient novelty and inventive step over prior art, as well as defending against potential design-arounds by competitors altering derivatives or synthesis routes.
4. How does the patent landscape in China influence the value of CN104043194?
A crowded patent space with overlapping claims necessitates precise claim drafting and vigilant patent management to ensure market exclusivity and prevent infringement.
5. What strategic actions should patent holders consider?
They should conduct comprehensive patent landscaping, strengthen claims through continuous research, monitor competitor patents, and consider international patent filings for broader protection.
References
[1] China National Intellectual Property Administration. (2016). Patent CN104043194 documentation and patent prosecution information.
[2] World Intellectual Property Organization. (2022). Patent Landscape Reports for Pharmaceuticals in China.
[3] Chinese Patent Examination Guidelines (2020). Guidelines for chemical and pharmaceutical patent examination.
[4] Liu, Y., & Zhang, H. (2019). “Patent strategies in China's pharmaceutical industry,” Journal of Intellectual Property Law.
[5] China Food and Drug Administration. (2021). Regulatory framework for pharmaceutical patents and market approval.
