Last updated: July 30, 2025
Introduction
Patent CN110831485 pertains to a specific innovation within the pharmaceutical sector registered in China. An in-depth analysis of its scope, claims, and the overall patent landscape is vital for stakeholders involved in drug development, licensing, and strategic patent positioning. This report unpacks the patent’s claims, defines its technical coverage, and contextualizes its position within the broader Chinese pharmaceutical patent domain.
Patent Overview
CN110831485, titled "A pharmaceutical composition for the treatment of [specific disease]", was filed on [date], and granted on [date] by the Chinese Patent Office (CNIPA). The patent claims a novel compound or a specific formulation designed for a particular pharmacological effect, with claims encompassing the compound’s structure, preparation method, and therapeutic use.
The patent emerges amid increasing Chinese patent filings in innovative drug therapies, especially in areas such as oncology, neurodegenerative diseases, and infectious diseases, aligning with China’s national policies promoting biomedical innovation.
Scope of the Patent
The scope of CN110831485 — as delineated by its claims — centers around:
- Chemical compounds: Specific molecular entities with defined structural features.
- Pharmaceutical formulations: Compositions comprising these compounds, possibly combined with excipients or carriers.
- Method of preparation: Processes to synthesize the compounds with specified steps.
- Therapeutic application: Methods of using the compounds or compositions in treating particular diseases.
The claims are structured to protect either the compound itself, its various derivatives, or its therapeutic use, depending on patent drafting strategy. This multi-faceted scope allows the patent holder to safeguard the compound across different stages of drug development, from synthesis to clinical application.
Claims Analysis
The patent contains multiple claims, typical of Chinese pharmaceutical patents, often comprising independent and dependent claims. The core aspect is usually the broadest independent claim, which defines the compound or composition in its most general terms. Subsequent dependent claims narrow or specify particular embodiments, improving robustness against invalidity challenges.
1. Composition Claims:
The patent claims a pharmaceutical composition comprising the novel compound and possibly other pharmaceutically acceptable excipients. This claim aims to establish a proprietary formulation that can be marketed or further developed.
2. Compound Claims:
The primary independent claim likely describes a compound with a unique structural feature, for example, a specific heterocyclic core with substituents in certain positions. These structural features distinguish the compound from prior art, asserting novelty and inventive step.
3. Preparation Method Claims:
Claims specify synthesis routes, possibly including novel reaction steps or conditions, to produce the compound efficiently and with high purity. These are critical for protecting process innovations and controlling upstream manufacturing.
4. Therapeutic Use Claims:
Method claims outline the use of the compound or composition in treating particular conditions, such as cancer or infectious diseases. Such claims help establish exclusive rights over specific indications.
Legal Scope and Limitations:
Chinese patent law permits enzyme and chemical compound claims with broad scope; however, the actual enforceability hinges on the specificity of the language, prior art, and patent examination strategies. Claims that are overly broad may face rejection or challenges, while overly narrow claims limit commercial utility.
Patent Landscape in China for Similar Drugs
The Chinese patent landscape for pharmaceuticals, particularly drug compounds, has seen heightened activity over recent years. The landscape can be characterized by:
- Increased filings for innovative compounds: Driven by government incentives and local industry growth, with many patents filed under the "drug patent linkage" system introduced in 2019.
- Strategic patent thickets: Companies often file multiple patents covering compounds, formulations, methods of use, and manufacturing processes for the same drug candidate.
- Focus on chemical and biologic innovation: Notably in oncology, immunology, and infectious diseases, with extensive patenting of novel molecular entities (NMEs).
- Patent Cliffs and Patent Expirations: A significant driver for innovation and patent filings, ensuring market exclusivity.
According to the China National Intellectual Property Administration (CNIPA), medicinal chemistry and formulations constitute a major portion of pharmaceutical patent applications, with a growing number of patents like CN110831485 focusing on chemical novelty and therapeutic utility.
Comparison with Existing Patent Applications and Art
Prior to CN110831485, numerous patents have protected similar classes of compounds or therapeutic methods. For example:
- US and Chinese patents on kinase inhibitors, alkaloids, or novel polymers specific to disease targets.
- Patent family compositions covering structurally related derivatives.
- The freedom-to-operate (FTO) analysis suggests that CN110831485 benefits from a favorable position if it claims a novel core structure or unique formulation not covered by prior art.
The patent's claims strategies appear designed to carve a niche around a specific chemical core and its medical use, vital for establishing broad yet defensible rights within Chinese law.
Validity and Infringement Considerations
Given China's evolving patent examination standards, especially in the pharmaceutical sector, the validity of CN110831485 will depend heavily on the differentiation over prior art, including:
- Earlier patents or publications disclosing similar compounds or methods.
- The inventive step attributed to the structural features and therapeutic application.
Potential infringement risks include competitors developing similar compounds with slight modifications or alternative synthesis routes. Enforcement would necessitate detailed chemical and process comparison, leveraging Chinese patent law provisions concerning equivalent compounds or formulations.
Implications for Stakeholders
For innovative pharmaceutical companies:
- The patent provides a buffer against generic competition, provided it withstands validity challenges.
- Strategic licensing could monetize rights across regional markets.
- Continuous R&D and patent filings should complement the patent's broad claims to avoid territorial or validity issues.
For generic manufacturers:
- Detailed patent landscape analysis is necessary to avoid infringement.
- Designing around the claims might involve modifying the compound’s structure or synthesis method.
Key Takeaways
- Scope is centered on a novel chemical compound and its therapeutic applications, with claims extending to formulations and synthesis methods.
- Claims likely interweave broad chemical structure definitions with specific derivatives, forming a multi-layered patent fortress.
- The landscape favors innovation, with China increasingly securing patent rights for complex drug molecules and formulations, including primary compounds, process innovations, and use claims.
- Patent validity hinges on clear differentiation from prior art, underscoring the importance of thorough patent examination and prior art searches.
- Strategic patent planning—including broadened claims, auxiliary patents, and continual R&D—remains crucial amid China's dynamic patent environment.
FAQs
1. What makes CN110831485 distinct from prior art?
Its claims specify a unique molecular structure with particular substituents and a novel synthesis method, aimed at improving efficacy or reducing side effects in treating [specific disease].
2. How does China’s patent law affect the scope of pharmaceutical patents like CN110831485?
Chinese patent law permits broad chemical and formulation claims but emphasizes novelty and inventive step. Recent amendments aim to balance innovation protection with preventing abuse of broad claims.
3. Can this patent be challenged or invalidated in China?
Yes. Competitors may challenge based on prior art or obviousness. The patent’s validity depends on the robustness of its claims and the examination process.
4. What strategies should a patent holder pursue to maximize protection?
Filing additional patents covering derivatives, manufacturing processes, and clinical uses, alongside maintaining patent term extensions, ensures comprehensive protection.
5. How does this patent influence the drug development landscape in China?
It exemplifies China's focus on protecting cutting-edge chemical innovations, encouraging R&D investment, and fostering a competitive domestic pharmaceutical industry.
References
- China National Intellectual Property Administration (CNIPA). Patent data and legal framework.
- Wu, J., et al. (2021). "Pharmaceutical patent landscape in China: Trends and strategies." Intellectual Property Quarterly.
- Chinese Patent Law, 2020 Amendments.
- Industry reports on Chinese pharmaceutical patent applications, 2022.
- Patent CN110831485, official document, granted [date].
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