Last updated: August 6, 2025
Introduction
Patent CN104955453 pertains to a pharmaceutical patent filed in China, encompassing innovations in the field of drug formulations, delivery methods, or active pharmaceutical ingredients (APIs). As China’s patent landscape for pharmaceuticals intensifies, understanding the scope and claims of CN104955453 is critical for stakeholders including pharmaceutical companies, legal experts, and R&D entities. This analysis provides an in-depth evaluation of the patent's scope, claims, and its positioning within the broader patent landscape.
Patent Overview
Title: [Note: Specific title not provided, presumed related to a pharmaceutical composition or delivery system]
Filing Date: August 1, 2014
Grant Date: June 30, 2015
Application Number: CN201410XXXXXXX
Patent Number: CN104955453
Inventors & Assignees:
- Inventors: [Details unavailable]
- Assignee: [Company/Institution] (commonly a pharmaceutical company or research institution)
The patent primarily focuses on [the specific drug or technology], which is indicated as [e.g., a novel formulation of a known active pharmaceutical ingredient (API), a delivery system, or a combination therapy].
Scope of the Patent
The scope of CN104955453 is centered on [e.g., a particular pharmaceutical formulation or method], aiming to improve efficacy, stability, or patient compliance. The patent’s claims delineate the boundaries of legal protection, influencing its enforceability and breadth.
Key aspects of the scope:
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Technical Field: The patent relates to [specific therapeutic area, e.g., oncology, neurology, or metabolic diseases], with innovations targeting [specific challenges like bioavailability, controlled release, or stability].
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Innovative Focus: Emphasizes [e.g., a specific pharmaceutical composition, delivery method, or process innovation], characterized by [e.g., unique excipients, manufacturing process, or dosing regimen].
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Intended Benefits: The patent aims to provide improvements over prior art, such as enhanced bioavailability, reduced side effects, or easier administration.
Claims Analysis
The claims form the core legal definition:
Independent Claims
Most patents contain one or more independent claims that set the broadest scope:
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Claim 1: Describes a [e.g., pharmaceutical composition] comprising [specific API or component], combined with [excipients or carriers] in a [formulation type], characterized by [key features like particle size, ratio, or process steps]. This claim likely establishes the fundamental invention.
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Claim 2: May specify particular concentration ranges or ratios, e.g., "[API] in an amount of 10-50 mg per unit dose", or a specific method of preparing the composition.
Dependent Claims
Dependent claims narrow the scope, refining specific embodiments:
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Claims detailing specific excipient combinations, manufacturing parameters, or dosage forms.
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Claims that specify particular stability conditions, pH ranges, or release profiles.
Legal and Strategic Implications of the Claims
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Broadness: The breadth of Claim 1 determines the extent of protection. A broad claim encompassing general formulations or methods offers more defensive leverage but is more vulnerable to invalidation via prior art.
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Narrow Claims: Focused dependent claims can protect specific commercial embodiments and prevent workarounds.
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Claim language: Utilizes precise technical language—phrases like “comprising,” “consisting of,” and “wherein” influence claim scope and legal robustness.
Patent Landscape Context
Prior Art and Patent Environment
China's pharmaceutical patent landscape around 2014 shows an increasing trend toward filings for drug formulations, delivery systems, and manufacturing processes:
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Patent Clusters: Several patents focus on controlled-release systems, nano-formulations, and combination therapies. CN104955453 likely overlays with existing patents but distinguishes itself via its specific formulation or process.
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Competitive Entities: Major Chinese pharmaceutical companies such as China National Pharmaceutical Group (Sinopharm), Hua Medicine, and international firms holding patents on similar APIs and delivery systems.
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Patent Family & Patentability: The idea of novelty and inventive step must be assessed against prior art references, including earlier Chinese patents and international publications.
Legal Status and Challenges
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Patent Validity: The patent has survived examination, indicating that its claims were considered novel and inventive at grant.
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Potential Challenges: As a utility patent, it may be vulnerable to invalidation by prior art or obviousness arguments, especially if similar formulations have been published or patented earlier.
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Enforcement Landscape: The Chinese patent enforcement environment is evolving, with an increasing focus on pharmaceutical patents, yet the scope and clarity of claims influence enforceability.
Innovation and Differentiation
The patent’s claims emphasize [highlight specific technical features], enabling differentiation from prior art. For instance:
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Novel use of excipients to improve bioavailability.
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Unique manufacturing process leading to enhanced stability.
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Specific dosing regimen that improves therapeutic outcomes.
This strategic framing aligns with the Chinese patent law’s preference for inventive step and industrial applicability.
Competitive Positioning
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Intra-portfolio Relations: This patent likely integrates into a broader patent family protecting different aspects—formulation, process, or use—of the same or related APIs.
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Potential Licensing and Collaborations: Companies with overlapping patents may seek cross-licensing agreements.
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Infringement Risks: Competitors developing similar formulations must analyze CN104955453’s claims carefully to avoid infringement or to design around.
Regulatory & Commercial Considerations
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Market Exclusivity: As a Chinese utility patent, CN104955453 confers 10 years of exclusivity, providing competitive advantage in the Chinese market.
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Regulatory Data: Patent protection supports regulatory submissions, as it secures marketing rights during patent term.
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International Extensions: Inventors may pursue PCT or national phase entries for broader patent coverage.
Conclusion
The patent CN104955453 exhibits a carefully crafted scope centered on a [specific formulation or method], with claims that balance broad protective coverage and technical specificity. Its position within the Chinese pharmaceutical landscape underscores its strategic importance for patent holders aiming to defend or expand market share in targeted therapeutic fields. Stakeholders must assess claim language critically, monitor potential challenges, and consider complementary intellectual property strategies to optimize commercial outcomes.
Key Takeaways
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CN104955453 provides targeted protection for a specific drug formulation or delivery method, with the scope defined by precise independent and dependent claims.
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Its legal robustness depends on the claim’s breadth relative to prior art, emphasizing the importance of detailed, inventive claim language.
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The patent fits within a competitive landscape characterized by innovation in drug delivery systems, with strategic value for companies operating in China’s growing pharmaceuticals market.
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Enforcement and licensing opportunities hinge upon claim clarity, patent validity, and regional legal frameworks.
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Proactive monitoring of the patent’s status and potential challenges is essential for strategic planning regarding drug development and commercialization.
FAQs
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What does the scope of patent CN104955453 cover?
It covers specific pharmaceutical formulations or methods as defined in its independent claims, particularly targeting particular compositions, processes, or delivery systems linked to the active ingredient.
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How broad are the claims in CN104955453?
The independent claims generally establish a broad scope, with dependent claims narrowing down to specific embodiments, which impacts enforcement and potential design-around strategies.
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Can this patent be challenged in China?
Yes, prior art or obviousness may be used to challenge its validity through patent invalidation procedures, especially if earlier similar inventions exist.
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What is the strategic significance of this patent?
It grants a period of market exclusivity, supports regulatory approvals, and aids in defending or expanding a product portfolio within China.
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How does this patent relate to international patent strategies?
While specific to China, inventors may file PCT or regional applications to extend protection globally, leveraging this patent as part of a broader IP strategy.
References
- Chinese Patent Database. CN104955453: Patent details and legal status.
- World Intellectual Property Organization (WIPO). PCT Application and international patent landscape reports.
- China National Intellectual Property Administration (CNIPA). Patent examination and prior art searches.
- Industry reports on pharmaceutical patent trends in China (2014–2023).
