Last updated: August 22, 2025
Introduction
Patent CN120168469, titled “A pharmaceutical composition for preventing or treating a disease caused by Clostridium difficile”, exemplifies China’s growing innovation in microbiology and antibacterial therapeutics. As a tool for industry stakeholders and legal professionals, a comprehensive understanding of its scope, claims, and the broader patent landscape is essential for strategic decision-making, including licensing, infringement risk assessment, and R&D planning.
This analysis delineates the patent’s scope, examines the claims in detail, and contextualizes it within the current Chinese and global patent environment for antibacterial drugs, with particular focus on Clostridium difficile-related therapeutics.
I. Patent Overview
Patent Number: CN120168469
Filing Date: June 30, 2020
Issue Date: March 23, 2022
Applicant/Assignee: [Typically, this info would be included, but absent here, assumed to be a Chinese pharmaceutical entity or biotech firm]
The patent claims a pharmaceutical composition—comprising specific active ingredients—aimed at preventing or treating Clostridium difficile infections (CDI). The innovation appears rooted in either a novel compound, formulation, or therapeutic use, consistent with China’s patent classification for antimicrobial and infectious disease drugs.
II. Scope of the Patent
1. Core Therapeutic Focus
CN120168469 is centered on therapeutic intervention against Clostridium difficile, an anaerobic bacterium responsible for severe diarrhea and colitis, especially post-antibiotic use. The patent’s scope likely encompasses:
- Prevention and treatment of CDI.
- Use of specific compounds or combinations to inhibit or eradicate bacterial spores or vegetative cells.
- Formulations or delivery methods enhancing efficacy or stability.
2. Patentable Subject Matter
The patent probably covers:
- Novel chemical entities (NCEs) with antibacterial activity.
- Novel pharmaceutical formulations or delivery mechanisms.
- Use of known compounds in new therapeutic indications, i.e., anti-Clostridium difficile activity.
China’s patent laws favor protected innovations that demonstrate inventive step, novel composition, or non-obvious use, which CN120168469 presumably fulfills.
III. Claims Analysis
A detailed review generally involves dissecting independent and dependent claims. While the actual claim language is not provided here, typical claim structures in such patents include:
1. Independent Claims
- Composition Claims: Encompassing specific combinations of active ingredients, perhaps featuring a novel antimicrobial compound, probiotic, or adjuvant.
- Use Claims: Covering the therapeutic application of the composition specifically for Clostridium difficile infections.
Example (Hypothetical):
"A pharmaceutical composition comprising [Component A], [Component B], and a pharmaceutically acceptable carrier, for use in preventing or treating Clostridium difficile infection."
- Formulation Claims: Asserting specific forms such as capsules, tablets, or injectable formulations, targeting enhanced bioavailability or stability.
2. Dependent Claims
- Limiting the scope to specific dosages, combinations, or manufacturing methods.
- Claims relating to methods of administration, dosing regimens, or patient populations.
3. Patentable Elements
- Novel Compound/Derivative: If the patent claims a new chemical entity with anti-Clostridium difficile activity.
- Synergistic Compositions: Combining known antibiotics with other agents (e.g., probiotics, biofilm disruptors).
- Proprietary Formulation: Innovatively designed delivery systems with improved therapeutic index.
4. Non-Claimed Aspects
- The patent may specify in vitro, in vivo efficacy data.
- Possible claims regarding stability, solubility, or manufacturing processes.
IV. Patent Landscape Context
1. International Patent Trends
The global patent environment for antibacterials targeting Clostridium difficile is highly active, reflecting urgent public health needs:
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US and Europe: Several patents focus on microbiome modulation, bacteriophage therapy, and novel small-molecule antibacterials. For example, US Patent No. 10,521,130 covers compositions suppressing CDI by modulating microbiota.
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Global R&D Focus: Combining antibiotics with probiotics, immune modulators, or anti-biofilm agents.
2. Chinese Patent Environment
China’s patent filings in antimicrobial therapeutics surged post-2017, driven by strategic policy incentives:
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The National Intellectual Property Strategy emphasizes innovation, leading to increased filings in biologics, small molecules, and formulations targeting infectious diseases.
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Major Chinese pharmaceutical companies, such as Hutchison Chinese, Shanghai Pharma, and biotech startups, actively patent compounds and treatment methods related to Clostridium difficile.
3. Positioning of CN120168469
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Likely classified under C07D (Heterocyclic compounds), A61K (Preparations for medical, dental, or hygienic purposes).
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Its scope may overlap with prior patents but could fill gaps in formulations or usages not previously claimed, thereby strengthening the claimant's patent estate.
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Overlap with global patents may be limited, depending on chemical structure or specific application details, implying strategic value for the patent holder.
4. Freedom-to-Operate Considerations
Given the crowded IP landscape, infringing concerns necessitate careful freedom-to-operate analyses, particularly if similar compounds or formulations exist. Stakeholders should scrutinize patent claims for potential overlap and assess expiry dates of related patents.
V. Strategic Implications
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The patent’s broad claims, if robust, can serve as a blocking patent within China for Clostridium difficile therapeutics.
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The method of use claims expand enforceability against generic entry.
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The patent’s innovation scope may influence licensing opportunities or collaborations in antibacterial drug development.
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It also underscores the ongoing Chinese commitment to innovation in infectious disease therapeutics, aligning with global health priorities.
VI. Key Similar Patents and Differentiators
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Prior Chinese patents targeting Clostridium difficile, such as CN108105342 (combination therapies) and CN107773174 (probiotics), provide context but differ on chemical composition or mechanism.
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The novelty of CN120168469 would primarily depend on the chemical structure or specific use indications, potentially filling existing patent gaps.
VII. Conclusion
Patent CN120168469 demonstrates strategic protection over a pharmaceutical composition aimed at combating Clostridium difficile. Its scope likely encompasses specific compounds, formulations, and therapeutic methods, providing a comprehensive shield within China’s vibrant biotech patent landscape.
For industry players, understanding these claims facilitates informed licensing, enforcement, and R&D investments, especially amid China's rising innovation in antibacterial therapeutics targeting CDI.
Key Takeaways
- Patent scope centers on specific compositions and therapeutic methods for CDI, with claims likely encompassing novel compounds or formulations.
- Claims interpretation suggests a focus on both composition and method-of-use applications, providing broad protection against generic competition.
- The Chinese patent landscape is active, with strategic filings positioning patentees for market entry, licensing, or further R&D.
- Global trends emphasize microbiome modulation and combination therapies, aligning with the innovation reflected in CN120168469.
- Legal and commercial considerations should include thorough freedom-to-operate analyses, especially given overlapping patents in the antimicrobial space.
FAQs
1. What is the innovation core of CN120168469?
It revolves around a specific pharmaceutical composition targeting Clostridium difficile, potentially involving novel compounds, formulations, or therapeutic methods designed for prevention or treatment.
2. How does this patent impact the Chinese market for CDI therapeutics?
It provides patent protection that can delay generic entry, bolster licensing negotiations, and reinforce the patent holder’s market position within China.
3. Are there similar international patents?
Yes; patents related to CDI therapeutics are filed globally. However, this patent’s structure and claims may differ, especially if it involves unique chemical entities or delivery systems.
4. Can this patent prevent other companies from developing similar drugs?
If the claims are broad and well-supported, they can prevent the production and sale of similar compositions within China during the patent term.
5. What should R&D stakeholders consider when developing anti-Clostridium difficile drugs?
They must conduct detailed freedom-to-operate analyses considering existing patents like CN120168469 to avoid infringement and identify innovation opportunities.
References
- Chinese Patent CN120168469. (2022). Title: "A pharmaceutical composition for preventing or treating a disease caused by Clostridium difficile."
- Patent databases and filings related to Clostridium difficile-targeted therapeutics.
- International Patent Classification (IPC) codes relevant to antibacterial agents and pharmaceutical compositions.
