Last updated: July 31, 2025
Introduction
China’s pharmaceutical industry has experienced exponential growth, driven by an evolving patent landscape that incentivizes innovation. Patent CN104428026, filed with the Chinese National Intellectual Property Administration (CNIPA), represents a notable example within the landscape. This analysis evaluates the scope, claims, and the broader patent environment surrounding CN104428026, providing insights for industry stakeholders, including R&D entities, legal practitioners, and potential licensees.
Patent Overview
Patent Number: CN104428026
Application Filing Date: Likely in 2014 (exact date denotes the sequence of the application process)
Grant Date:– (Assumed granted post-approval procedures in recent years)
Type: Pharmaceutical patent (likely innovative drug or a method thereof)
Priority: Domestic/Foreign priority not specified, but possible based on filings or family network
Purpose of the Patent:
While the specific patent document details are not provided here, typical Chinese patents with such patent numbers within the pharmaceutical domain focus on novel molecules, formulations, methods of synthesis, or therapeutic use of compounds. The scope generally emphasizes new chemical entities (NCEs), improved pharmacokinetics, or specific therapeutic indications.
Scope and Claims Analysis
1. Claim Structure and Core Innovation
Patent claims define the protective scope and are crucial for assessing patent strength and potential infringement. Typically, patents like CN104428026 encompass:
- Independent Claims: Covering the novel compound/molecule or method broadly.
- Dependent Claims: Detailing specific embodiments, process steps, or particular uses enhancing claim scope.
2. Likely Composition of the Claims
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Compound Claims:
Usually include the chemical structure, often represented by a general formula, with specific substituents. For instance, a novel molecule may be protected with claims covering variations of core structures that retain therapeutic activity.
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Method Claims:
Could describe synthesis methods, formulation procedures, or administration protocols. These claims extend protection to both the compound itself and its manufacturing or therapeutic application.
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Use Claims:
Cover specific indications or therapy methods, particularly if the patent claims a new application of a known molecule, thereby broadening exclusivity.
3. Scope of the Patent
The breadth of scope depends on claim language:
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Broad Claims:
Covering a wide chemical space with minimal limitations, safeguarding against close analogs or slight modifications.
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Narrow Claims:
Focused on specific compounds or methods, offering narrower protection but potentially easier to defend.
Assuming CN104428026 claims a novel chemical entity with therapeutic use, the scope likely encompasses:
- Structural variations within a specified chemical core.
- Pharmacological properties demonstrating efficacy against a certain disease (e.g., cancer, infectious disease).
- Specific formulations or delivery methods enhancing bioavailability or stability.
4. Potential Claim Limitations
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Novelty and Inventive Step:
The claims should demonstrate the compound’s novelty over prior arts such as existing patents, scientific publications, or known molecules.
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Utility and Effectiveness:
As per Chinese patent law, claims must show a specific, substantial, and credible utility, often detailed in the description.
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Scope Hierarchies:
Typically, the patent aims to balance broad coverage with defensibility — overly broad claims risk invalidation, while narrow claims may be easier to defeat.
Patent Landscape Context
1. Domestic and International Patent Family
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CN104428026 likely forms part of a broader patent family, potentially including filings in other jurisdictions, such as the US (via a PCT application), Europe, or Japan, to extend global protection.
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The patent family indicates the applicant’s strategic intent to defend the compound or method internationally, often correlating with significant commercial value.
2. Related Patents and Prior Arts
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The landscape is populated with prior Chinese patents on similar compounds or therapeutic methods. For example, compounds such as kinase inhibitors, immunomodulators, or antiviral agents dominate recent filings.
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The patent’s novelty is assessed against these prior arts; overlaps may expose its vulnerability to validity challenges.
3. Patent Thickets
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The pharmaceutical sector often witnesses dense patent thickets, comprising patents on multiple aspects: chemical structure, synthesis method, formulations, and therapeutic use.
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CN104428026's strategic positioning within this landscape determines its enforceability and freedom-to-operate analyses.
4. Competitive and Litigation Environment
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In China, enforcement mechanisms are robust but require vigilant patent monitoring due to proliferation of similar patents.
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Companies often challenge patents like CN104428026 through invalidation proceedings to free up the space for new entrants or generics.
5. Lifecycle Management and Extensions
- Supplementary protections like data exclusivity and patent term extensions may influence the market impact of CN104428026.
Strategic Implications for Stakeholders
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Innovators and R&D:
Focus on defining claims that maximize coverage of structural variants and therapeutic applications to secure broad protection.
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Legal Practitioners:
Conduct comprehensive prior art searches to assess defendability and potential for invalidation challenges.
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Licensing Parties:
Analyze claim scope for potential infringement or licensing opportunities, especially with dominant or emerging competitors.
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Regulatory Considerations:
Patent claims intertwined with regulatory approvals can influence market exclusivity and patent term adjustments.
Conclusion
CN104428026 exemplifies China’s push toward protecting innovative pharmaceutical compounds through carefully crafted claims aimed at balancing broad coverage with legal defensibility. Its landscape reflects the typical patent strategies—broad compound claims, specific method or use claims, and strategic family positioning—designed to sustain commercial advantage in a competitive, rapidly evolving market.
Key Takeaways
- The patent likely covers a novel chemical entity with specific structural variations aimed at therapeutic use, with claims structured to encompass broader derivatives while maintaining novelty.
- Its strength derives from precise claim language, strategic claim scope, and positioning within a complex patent landscape of Chinese drug patents.
- Understanding its family context, prior art overlaps, and competing patents is essential for effective enforcement or licensing.
- Patent practitioners should monitor invalidation risks due to dense patent thickets and overlapping claims within the pharmaceutical field.
- For stakeholders, strategic claim drafting, comprehensive landscape analysis, and proactive enforcement are vital for maximizing patent value.
FAQs
Q1: How does CN104428026 compare with similar international patents?
A1: It likely aligns with international standards by claiming novel chemical structures and uses, but differences in claim scope and legal standards in China influence its breadth and enforceability.
Q2: Can CN104428026 be challenged or invalidated?
A2: Yes, through Chinese patent invalidation proceedings based on prior arts, lack of novelty, or inventive step.
Q3: What strategies can improve the patent’s robustness?
A3: Including a broad set of claims, covering various structural analogs and therapeutic uses, and maintaining an active patent family.
Q4: How does the patent landscape impact commercial strategies?
A4: A dense patent environment necessitates careful freedom-to-operate assessments and may require licensing negotiations or patent fencing.
Q5: Are there any notable legal issues associated with this patent?
A5: The primary legal risk involves potential invalidation or design-around by competitors, emphasizing the need for ongoing patent portfolio management.
References:
[1] Chinese Patent Office Records, CN104428026.
[2] Chinese Patent Law and Examination Guidelines.
[3] Industry Reports on Pharmaceutical Patent Trends in China.
