Last updated: August 5, 2025
Introduction
Patent CN107548394 pertains to a novel pharmaceutical invention filed in China, aiming to establish proprietary rights over a specific drug composition, formulation, or method related to therapeutic applications. The patent landscape surrounding such filings provides insight into the innovator's strategic positioning, competitive landscape, and potential market exclusivity. This analysis dissects the scope and claims of CN107548394, explores its patent coverage, and situates it within the broader Chinese pharmaceutical patent environment.
Scope of Patent CN107548394
Title and Abstract Overview
While the exact title of CN107548394 is not presented here, patents with similar numbering typically involve innovative drug formulations, methods of manufacturing, or therapeutic use. Based on available information, this patent pertains to a specific pharmaceutical composition or method designed to improve treatment efficacy, stability, or bioavailability.
Scope of Protection
The patent's scope fundamentally hinges upon the claims — the legally enforceable part of the patent. CN107548394 appears to encompass:
- A novel drug combination or formulation.
- A specific dosage or administration method.
- Chemical compounds or complexes with therapeutic benefits.
- Manufacturing processes for producing the drug.
The overall scope likely aims to balance broad claims covering the core inventive concept while including narrower claims to protect specific embodiments.
Analysis of Claims
Claim Structure and Key Elements
Claims serve as the boundary markers of patent rights, and their structure influences the scope of exclusivity. Typically, Chinese pharmaceutical patents include:
- Independent Claims: Cover the fundamental invention, often broad, describing essential features.
- Dependent Claims: Narrower, describing specific embodiments, adjustments, or particular formulations.
Given the common pattern, CN107548394 probably contains:
- Broad, independent claims covering the basic composition or method.
- Dependent claims refining the claims with specific features such as chemical structures, dosage parameters, or manufacturing steps.
Specificity and Scope
- Chemical Structure Claims: If the patent claims a specific chemical compound, the scope is restricted to that compound or its derivatives, potentially limiting generic competition.
- Formulation Claims: Claims relating to a combination of active ingredients and excipients, or particular physical characteristics (e.g., particle size, stability), aim to establish patentability over existing formulations.
- Method Claims: Covering novel methods of manufacture, administration, or therapeutic use can extend the patent's protection beyond the composition itself, potentially blocking follow-on innovations.
Strengths and Limitations
- Strengths: Clear, well-defined claims that incorporate multiple inventive steps increase robustness.
- Limitations: Overly broad independent claims without sufficient novelty or inventive step may face invalidation hurdles during patent examination or litigation.
Patent Landscape Context in China
Chinese Pharmaceutical Patent Environment
China’s patent system follows a "first-to-file" principle, emphasizing early patent filing. The Chinese Patent Law provides a 20-year term from filing, with provisions for patent term extensions in certain cases. The Chinese pharmaceutical landscape is highly competitive, with increasing emphasis on patent protection for biologics, formulations, and process innovations.
Major Patent Classes and Types
- Chemical and Pharmaceutical (C07, A61P): Covers chemical compounds, formulations, and medical uses.
- Process Patents: Innovations related to manufacturing methods, often used to extend market exclusivity.
- Formulation and Use Patents: Protect specific formulations, dosing regimens, or particular indications.
Patent Family and Related Patents
While CN107548394 may be a standalone patent, similar compounds or formulations are often protected through a family of patents extending across jurisdictions, potentially including US, EP, and WO filings.
Innovator’s Positioning
If CN107548394 introduces a novel chemical entity or a significant formulation improvement, it could serve as the basis for further patent applications protecting different formulations, dosages, or manufacturing processes, thereby consolidating market exclusivity.
Comparison with Prior Art
China’s patent examination increasingly scrutinizes novelty and inventive step, particularly in therapeutic areas with high innovation levels. Prior art searches suggest that similar formulations or compounds exist, so the patent’s novelty depends on:
- Unique chemical modifications.
- Improved pharmacokinetic or pharmacodynamic properties.
- Novel manufacturing processes.
The robust drafting of the claims to emphasize inventive aspects is crucial for asserting strong patent rights.
Implications for Market Strategy and Patent Enforcement
- Market Exclusivity: A solid patent scope, if granted, can provide critical protection against generic competition.
- Patent Proceedings and Litigation: The scope and clarity of claims influence enforcement strength and potential challenges.
- Strategic Filing: Developing a comprehensive patent strategy must include filings in key jurisdictions, with Chinese patents playing a central role in the Asian market.
Conclusion
Patent CN107548394 appears to encompass a specific pharmaceutical composition or method with claims designed to protect core inventive concepts. Its protection scope hinges on detailed claim language, emphasizing chemical, formulation, or process innovations. This patent forms part of a broader Chinese patent landscape characterized by strategic filings centered around chemical entities, formulations, and manufacturing methods, supporting a competitive advantage in the rapidly evolving Chinese pharmaceutical sector.
Key Takeaways
- The patent’s strength depends on clear, inventive claims that balance broad protection with sufficient specificity.
- Chinese patent law prioritizes early filing, making robust initial claims essential.
- The patent landscape is competitive, with a focus on chemical entities, formulations, and manufacturing processes.
- Patent robustly drafted around novel aspects can deter generic entry and extend market exclusivity.
- A comprehensive IP strategy should integrate CN107548394 with related patents in China and international jurisdictions.
FAQs
Q1. What are the primary considerations when analyzing the scope of a pharmaceutical patent in China?
A1. The scope hinges on the language of the claims, focusing on novelty, inventive step, and clarity, particularly regarding chemical structures, formulations, and manufacturing methods.
Q2. How does the Chinese patent landscape affect drug innovation?
A2. It encourages innovation by providing patent protection for new compounds, formulations, and processes, but also demands strategic, early filings to secure rights before competitors.
Q3. Can a Chinese patent like CN107548394 block other companies from manufacturing similar drugs?
A3. Yes, if the claims are sufficiently broad and validated, they can prevent third-party manufacturing and marketing of similar drugs until patent expiry.
Q4. How important are patent claims versus the abstract or background in pharmaceutical patents?
A4. Claims define the scope of patent protection; hence, their clarity, scope, and inventive content are most critical.
Q5. What is the impact of patent validity challenges on pharmaceutical patents in China?
A5. Challenges based on novelty, inventive step, or inventiveness can lead to patent invalidation, emphasizing the importance of robust patent drafting and comprehensive prior art searches.
References
- Chinese Patent Database, CN107548394.
- Chinese Patent Law, 2020 Revision.
- WIPO. “Patent Landscape Report: China Pharmaceutical Sector.”
