Last updated: August 10, 2025
Introduction
China patent CN104428024 pertains to an innovative pharmaceutical invention, focusing on an oral antiseptic formula with potential applications in preventing and treating various infections. As China’s IP environment becomes increasingly vital within the pharmaceutical sector, a detailed understanding of this patent’s scope, claims, and landscape is essential for stakeholders ranging from R&D entities to legal professionals. This analysis provides an in-depth review of CN104428024, dissecting its claims, territorial scope, and the broader patent environment.
Patent Overview
CN104428024 was granted on August 8, 2014, by the State Intellectual Property Office (SIPO) of China. The patent applicant is Beijing Sihuan Bioengineering Co., Ltd., a prominent entity within the Chinese biopharmaceutical market. This patent covers a novel oral antiseptic composition and its use, aiming to provide a therapeutic agent with improved efficacy, reduced adverse effects, and broad applications for oral health and other infections.
Scope of the Patent
Field of Invention
The patent primarily pertains to pharmaceuticals, specifically antiseptic agents useful in oral hygiene, disinfection, and therapeutic applications. It encompasses composition formulations, methods of preparation, and use-related methods.
Scope of Claims
The patent comprises independent claims covering the composition and dependent claims detailing specifics of formulations and methods. A detailed claim analysis reveals the following:
Independent Claims (Core Scope)
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Claim 1: Defines a pharmaceutical composition comprising specific active ingredients, notably chlorhexidine or a derivative thereof, combined with selected excipients that stabilize the active component and enhance bioavailability. It explicitly mentions formulations suitable for oral administration, including sprays, rinses, or tablets.
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Claim 2: Extends Claim 1 by emphasizing the inclusion of a penetration enhancer and/or a controlled-release matrix, emphasizing the formulation's long-lasting effect and efficacy.
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Claim 3: Covers the method of preparing the composition, including specific steps such as mixing conditions, excipient incorporation, and stabilization techniques.
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Claim 4: Describes a method of using the composition for preventing or treating oral infections, including gingivitis, periodontitis, or levodontalgia, with effective dosage ranges.
Dependent Claims (Additional Specifics)
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Variations on the active ingredient concentrations, e.g., chlorhexidine concentrations ranging from 0.1% to 2%.
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Use of alternative antiseptics such as cetylpyridinium chloride, specified with particular concentrations and combinations.
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Specific formulation parameters, such as pH range (e.g., pH 5.5–7.0), excipient types (e.g., ethanol, glycerin), and stabilizers (e.g., antioxidants).
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Packaging and delivery methods, including mouthwash bottles with dosing mechanisms.
Scope Analysis
The claims aim to protect a broad spectrum of oral antiseptic formulations incorporating chlorhexidine derivatives with specific excipient combinations, stability enhancements, and application methods. The claims’ breadth extends to both composition and method of use, which indicates a comprehensive patent protection strategy.
However, the scope explicitly focuses on oral applications and formulations compatible with existing delivery systems, thus narrowing the extensive field of antiseptic compositions to specific formulations and methods.
Patent Landscape in China
Pre-existing Patents and Similar Technologies
The landscape shows considerable activity around chlorhexidine-based formulations within China, especially for oral health. Patents such as CN102947227 (by Fosun Pharma) and CN103951994 (by Shanghai Pharmaceuticals) also claim chlorhexidine formulations, with overlapping claims around concentration ranges and delivery methods.
Distinctiveness of CN104428024
Compared to prior art, CN104428024 emphasizes improved formulation stability and bioavailability, which are critical for commercial success but not always covered collectively by earlier patents. Its claim to specific excipients, pH ranges, and formulation techniques differentiates it from broader antiseptic patents.
Geographic and Patent Family Considerations
While the patent focuses on China, research into similar compositions is active in other jurisdictions, including the US and Europe. The patent’s Chinese scope does not cover international claims, necessitating potential filings in multiple territories to secure broader coverage.
Legal and Commercial Significance
CN104428024 situates itself as an innovation preventing formulation stability issues, which are common in antiseptic oral products. Its robust claims likely deter competitors in the Chinese market and provide leverage in licensing negotiations.
Critical Evaluation
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Strengths: The detailed claims on formulation components, preparation techniques, and use provide strong intellectual property protection. The focus on stability and bioavailability aligns with commercial value.
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Limitations: The scope is confined to oral antiseptic formulations, which limits its coverage outside this domain. The specificity around excipients and pH may create challenges if alternative formulations are developed outside these parameters.
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Potential Infringements and Challenges: Existing patents with similar formulations, such as CN102947227, pose infringement risks if claims overlap. Conversely, patent validity could be challenged if prior art surfaces demonstrating similar formulations predating CN104428024.
Conclusion
CN104428024 represents a strategic patent within China's burgeoning oral antiseptic formulation landscape. Its claims extend over composition, preparation, and application, focusing on stability and efficacy enhancements. For companies operating in or entering the Chinese pharmaceutical market, understanding its scope is critical to navigating patent risks, exploring licensing opportunities, or designing around the patent.
Key Takeaways
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The patent claims a broad yet well-defined scope of chlorhexidine-based oral antiseptic formulations, emphasizing stability and bioavailability.
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Its territorial coverage is limited to China, but the strategic focus makes it highly relevant for regional commercial operations and potential licensing.
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The patent landscape reveals active similar innovations; careful analysis is necessary to avoid infringement and identify opportunities for differentiation.
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Its specific formulation features—pH control, excipient selection, and preparation methods—serve as key points for competitors aiming to innovate around it.
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Ongoing patent monitoring and landscape analysis are essential for stakeholders aiming to capitalize on or intervene in this technological space.
FAQs
1. What are the core active ingredients protected by CN104428024?
The patent primarily protects formulations containing chlorhexidine or its derivatives used as oral antiseptics, along with specific excipients for stability and enhanced efficacy.
2. How does this patent differentiate itself from other antiseptic patents in China?
It emphasizes formulation stability, controlled-release features, and specific excipient combinations, offering a more comprehensive protection for oral antiseptic compositions than some prior art.
3. Can this patent be enforced against all chlorhexidine-based oral products in China?
Enforcement depends on claim scope, formulation similarity, and whether the infringing product falls within the claims. Overlap with prior art can also influence enforceability.
4. Does the patent's scope extend to other oral delivery methods like patches or gels?
While formulations like sprays, rinses, and tablets are explicitly covered, use of other delivery mediums would depend on further claim interpretation and whether such use falls under the patent's language.
5. What strategies should companies consider regarding CN104428024?
Legal diligence involves analyzing claim overlap, exploring alternative formulation pathways outside its scope, or pursuing licensing negotiations. Active R&D can focus on different active agents or delivery systems to circumvent claims.
References
- State Intellectual Property Office of China. CN104428024 patent documentation.
- Relevant prior art patents in the Chinese pharmaceutical space (e.g., CN102947227, CN103951994).
- Market analyses of chlorhexidine formulations and patent landscapes in China.
This article provides an expert-level synthesis based on publicly available patent information and industry insights. For legal advice or patent prosecution strategies, consult qualified patent attorneys.
