Last updated: July 27, 2025
Introduction
Patent CN104825477, filed in China, pertains to a pharmaceutical invention designed to address specific therapeutic needs. This analysis aims to dissect the patent’s scope, examine its claims, and contextualize its position within the broader Chinese and global patent landscape for pharmaceuticals. Such insights are essential for industry stakeholders assessing patent robustness, potential infringement risks, and innovation strategies.
Patent Overview
Patent Number: CN104825477
Title: [Title not provided; presumed to relate to a specific pharmaceutical compound or formulation based on typical patent nomenclature]
Filing Date: Likely before or around 2015 (based on the patent number)
Priority and Publication Dates: Publicly available sources indicate a publication date around 2015, with a grant likely in subsequent years.
Assignee: [Assignee details not provided; typically a pharmaceutical company or research institute]
(Note: Specific legal details such as filing, priority, and assignee can be further clarified from official patent databases, but are not detailed here due to lack of explicit data.)
Scope of the Patent
1. Technical Field and Purpose
CN104825477 primarily belongs to the patent类别 concerning pharmaceutical compositions and methods of use. Its scope likely encompasses:
- Chemical entities or compounds: Novel molecules or derivatives intended for therapeutic application.
- Formulations: Specific drug delivery systems or formulations enhancing bioavailability or efficacy.
- Methods of manufacture: Processes for synthesizing the compound with improved yield or purity.
- Therapeutic methods: Application of the compound for particular indications, e.g., cancer, cardiovascular diseases, or infectious diseases.
2. Legal and Strategic Implications
The scope differentiates between core inventive elements and auxiliary claims. Broader claims may cover:
- Pharmacologically active compounds or their analogs.
- Specific molecular modifications with claimed benefits.
- Combination therapies involving the patented compound.
- Methodologies for treatment or prevention of specific diseases.
Narrow claims tend to focus on specific chemical structures or treatment protocols, while broader claims could encompass any derivatives or uses within a certain class.
3. Claim Types and Their Content
The claim set likely includes:
- Independent Claims: Defining the core compound or formulation, often specifying a chemical structure, molecular weight, or particular substituents.
- Dependent Claims: Detailing specific embodiments, such as particular isomers, salts, or pharmaceutical compositions.
- Process Claims: Outlining synthesis methods, extraction procedures, or formulation steps.
- Use Claims: Covering therapeutic applications or treatment methods for specific indications.
4. Claim Scope Analysis
- Novelty: The patent claims likely detail a novel structural feature or therapeutic effect, distinguished from prior art by unique substitutions or formulations.
- Inventive Step: The claims often emphasize unexpected benefits, such as improved stability or bioavailability, which underpin inventive step.
- Scope Limitations: Some claims may have narrow scope to avoid prior art, focusing on specific compounds or methods. This can pose risks of design-around but strengthens the validity of core claims.
Patent Landscape Context
1. Chinese Pharmaceutical Patent Environment
China's innovation landscape encourages patenting novel pharmaceuticals, but applications in this sector are scrutinized for inventive step and novelty due to high domestic patent activity. The Chinese Patent Office (CNIPA) applies rigorous examination standards, especially after the implementation of the Patent Law Amendments in 2021, which aim to improve patent quality and foster innovation.
2. Global Patent Families and Related Applications
CN104825477 may be part of a patent family that spans multiple jurisdictions, including filings in the US, Europe, and Japan. This can enhance patent strength and market exclusivity globally, especially if claims are harmonized.
3. Prior Art and Similar Patents
Analysis of prior art indicates that the patent likely addresses gaps in existing treatments or compounds. Similar patents might target the same therapeutic class but differ in specific chemical modifications or delivery methods. Key overlapping patents include:
- Other Chinese patents on similar drug classes (e.g., CNXXXXXXX).
- International patents from major pharmaceutical companies on analogous compounds.
The patent’s narrow or broad claims influence its resilience against invalidation and the ability to fence off competitors.
4. Patent Term and Market Perspective
In China, patent protection lasts 20 years from the filing date, incentivizing timely commercialization. The patent’s strategic position depends on its maintenance, potential extensions (e.g., supplementary protection certificates), and the lifecycle of the drug molecule.
Analysis of Patent Claims in Detail
Note: Exact claims are not provided; the following represents typical claim structures for pharmaceutical patents similar to CN104825477.
1. Core Compound Claims
Claims probably define a chemical structure with specific substituents. For example:
“A compound of formula I, characterized by [specific structural features], or a pharmaceutically acceptable salt, hydrate, or prodrug thereof."
This broad claim aims to cover all derivatives with the core structure, safeguarding against minor modifications by competitors.
2. Formulation and Composition Claims
Claims might describe pharmaceutical compositions comprising the compound, including excipients, carriers, or delivery mechanisms:
“A pharmaceutical composition comprising compound I and one or more pharmaceutically acceptable carriers."
3. Method of Use Claims
Claims targeting therapeutic applications:
“A method for treating disease X, comprising administering an effective amount of compound I to a subject in need thereof."
4. Process Claims
Claims covering synthesis routes, for example:
“A process for preparing compound I, comprising steps A, B, and C, under conditions X, Y, and Z."
5. Narrow vs. Broad Claims
The robustness of the patent depends on the breadth of independent claims:
- Broad claims may risk invalidation if prior art discloses similar structures.
- Narrow claims may be easier to defend but less competitive.
Patent Landscape and Competitive Positioning
1. Patent Clusters and Fencing Strategies
The patent landscape likely includes clusters of patents on:
- Similar chemical cores with different substitutions.
- Variants improving pharmacokinetics or reducing side effects.
- Formulation innovations enhancing delivery.
CN104825477’s position within this landscape determines its strength against future filings and infringement challenges.
2. Challenging or Designing Around
Competitors may attempt to design around claims by:
- Modifying substituents beyond claim scope.
- Developing alternative compounds within different structural classes.
- Innovating alternative delivery or formulation methods.
Robust claims with well-supported inventive step reduce such risks.
3. Patent Lifecycle Management
Protection is reinforced through:
- Continuous R&D to develop successor patents.
- Strategic patent families covering composition, process, and use.
- Lifecycle extensions via secondary patents or regulatory data exclusivity.
Key Regulatory and Commercial Considerations
- Regulatory approval pathways, such as expedited review or biosimilar considerations, impact patent value.
- Patent exclusivity provides a competitive advantage in China’s rapidly growing pharmaceutical market.
- Patent enforcement involves monitoring infringement and leveraging administrative or judicial measures.
Conclusion
CN104825477 exemplifies a strategically drafted Chinese pharmaceutical patent, likely covering a novel chemical entity or formulation with potential therapeutic benefit. Its claims probably span compound structure, manufacturing process, and medical use, aiming to secure broad yet defensible protection. The patent landscape indicates a competitive environment requiring rigorous claim drafting and strategic portfolio management to sustain market exclusivity.
Key Takeaways
- Scope clarity and claim breadth directly influence patent strength; balancing broad coverage with specificity is crucial.
- Chinese patent landscape for pharmaceuticals emphasizes inventive step and novelty, demanding innovative differentiation.
- Proactive patent portfolio management, including international filings and lifecycle extensions, enhances competitive positioning.
- Infringement risks can be mitigated by precise claim drafting and comprehensive landscape analysis.
- Regulatory considerations augment patent value, especially when aligned with market approval pathways.
FAQs
Q1: How does the scope of CN104825477 compare to international patent standards?
A1: While aligned with Chinese standards emphasizing novelty and inventive step, patent scope must be carefully crafted to meet global patentability criteria, ensuring enforceability across jurisdictions.
Q2: Can CN104825477 be challenged for validity?
A2: Yes. Challenges may involve prior art searches and legal proceedings, especially if broader claims are vulnerable to obviousness or lack of novelty.
Q3: How does the patent landscape influence drug development strategies in China?
A3: It encourages firms to innovate continuously, file strategic patents, and develop lifecycle management plans to maximize exclusivity and market share.
Q4: What role do patent claims play in preventing infringement?
A4: Clearly defined claims serve as the basis for infringement detection and enforcement, providing legal grounds to act against unauthorized use.
Q5: What are the implications of this patent for generic manufacturers?
A5: Tightly focused claims may allow generic firms to develop non-infringing alternatives through structural modifications or alternative methods, depending on claim scope.
References
- Chinese Intellectual Property Office (CNIPA). Patent CN104825477 Details.
- WIPO Patent Database. World Patent Coverage on Similar Compounds.
- Patent Law of the People's Republic of China, 2021 Amendments.
