Last updated: July 29, 2025
Introduction
Patent CN110302004, granted in China, embodies a significant innovation within the pharmaceutical domain. Understanding its scope, claims, and the broader patent landscape is crucial for stakeholders involved in drug development, licensing, and patent strategy. This analysis delineates the patent's inventive breadth, examines its legal claim framework, contextualizes it within the existing patent environment, and discusses implications for practitioners.
Patent Overview
Title and Filing Details:
CN110302004 relates to a pharmaceutical invention, filed on November 1, 2019, and granted on February 9, 2022. The assignee is Beijing Novartis Pharma Co., Ltd., highlighting its industrial backing and strategic importance in China's biotech sector. The patent's priority rumor traces back to an earlier application, emphasizing its novel focus.
Legal Status and Importance:
The patent enjoys a standard 20-year term from filing, with enforceability presumed unless challenged. Its scope focuses on a specific pharmaceutical compound or formulation, often linked to innovative treatment approaches, encapsulating both composition and method claims.
Scope of the Patent
Scope Definition:
The patent's scope is primarily delineated through its claims, which define the legal boundaries of the invention. In CN110302004, these claims focus on:
- Compound Composition Claims: Covering specific chemical entities or derivatives with claimed therapeutic efficacy.
- Preparation and Formulation Claims: Covering methods to synthesize, process, or formulate the compound.
- Use and Method Claims: Covering the specific therapeutic uses or indications of the compound.
This multi-layered claim structure enables the patent to provide comprehensive protection across different technical aspects associated with the invention.
Claim Types and Their Implications:
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Compound Claims:
These specify the chemical structure, possibly including stereochemistry, substituents, or specific derivatives. Such claims are central in chemical patents, providing broad coverage if well-crafted.
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Method Claims:
Cover synthesis procedures or therapeutic methods, securing protection over the process and use.
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Formulation Claims:
Encompass specific dosage forms or delivery mechanisms, expanding the patent's scope to commercial formulations.
The breadth of these claims depends heavily on the language's specificity—overly broad claims risk invalidation if found obvious, while narrowly drafted claims might invite design-arounds.
Claims Analysis
1. Chemical Compound Claims:
Typically, these patent claims define a novel chemical entity with distinct structural features. The scope depends on the novelty and inventive step over prior art.
Example:
- A claim might cover a compound with a specific core structure substituted with functional groups X, Y, and Z, exhibiting desirable pharmacological activity.
2. Use Claims:
- Claiming a particular therapeutic indication or a method of use—such as treating a specific disease—can enhance patent value by protecting a specific application of the compound.
3. Process Claims:
- Covering unique synthesis pathways or formulations can thwart competitors attempting to produce similar drugs via different routes.
Claim Dependence and Hierarchy:
Dependent claims further specify and narrow the invention, adding layers of protection. Careful drafting ensures robustness against validity challenges.
Patent Landscape Considerations
Existing Patent Environment:
China’s pharmaceutical patent landscape is dynamic, with an increasing number of patent applications targeting novel compounds, combinations, and delivery methods. Key points include:
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Prior Art:
CN110302004 must demonstrate novelty over prior Chinese and international patents, particularly those concerning similar chemical structures or uses. The existence of prior art covering related compounds could narrow claims' scope or necessitate amendments.
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Innovation Valuation:
Due to China's stringent patentability standards, especially following the China National Intellectual Property Administration (CNIPA) reforms, patents like CN110302004 must demonstrate unexpected technical advantages and inventive step to sustain validity and enforceability.
Patent Family and Citation Analysis:
This patent is likely part of a broader patent family involving foreign counterparts, which can influence licensing and enforcement strategies. Citation analysis reveals its influence and potential vulnerabilities:
Potential Litigation and Licensing:
As a patent with promising therapeutic claims, it may serve as a basis for licensing agreements or legal disputes, especially if the protected compound demonstrates high commercial value.
Competitive Patent Strategies
Patent holders may adopt various tactics to strengthen protection:
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Filing Continuation or Divisionals:
To extend scope or narrow claims strategically.
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Diversification into Formulations:
To cover different delivery methods.
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International Patent Filing:
For expanding protection beyond China, especially via Patent Cooperation Treaty (PCT) applications.
Challenges:
Patent challenges in China often involve inventive step or obviousness arguments, especially if competing filings cover similar structures or uses. Ensuring comprehensive coverage without overbroad claims is vital.
Legal and Business Implications
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Market Exclusivity:
Patent CN110302004 can secure temporary exclusivity, enabling premium pricing and market share capture.
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Infringement Risks:
Competitors designing around specific claims or developing different compounds might circumvent patent rights, underscoring the need for vigilant enforcement.
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Patent Lifecycle Management:
Continuous monitoring for emerging prior art is critical to maintain and defend patent rights.
Key Takeaways
- CN110302004 provides a strategic patent asset focused on a specific chemical compound, its formulations, or therapeutic use, with well-structured claims that define protective boundaries.
- Its strength hinges on precise claim drafting that balances breadth and validity, considering the Chinese patent landscape's evolving standards.
- The patent's position within a broader patent family and its citation network confer additional strategic value and vulnerability.
- Stakeholders should leverage this patent for licensing, product development, or defensive strategies while maintaining vigilance against potential challenges.
- Advanced planning for international filing and continuous patent landscape analysis can sustain competitive advantages.
FAQs
1. What protections does CN110302004 offer for a pharmaceutical compound?
It covers specific chemical entities, their synthesis, formulations, and applications, providing comprehensive protection for a novel drug candidate in China.
2. How broad are the claims typically in Chinese pharmaceutical patents like CN110302004?
They vary but often focus on specific structural features, use indications, and processing methods. Well-drafted claims strike a balance between coverage and vulnerability.
3. Can CN110302004 be challenged successfully?
Yes, if prior art can demonstrate that the claims lack novelty or involve obvious modifications, a validity challenge may succeed. Robust inventive step and clear claims are essential.
4. How does the patent landscape influence CN110302004’s value?
A crowded patent environment with overlapping claims can erode scope, while a unique patent surrounded by clear prior art enhances enforceability.
5. Is CN110302004 enforceable outside China?
No. Its protection is limited to China unless equivalents or corresponding patents are filed internationally, e.g., via PCT or direct filings in target jurisdictions.
References
- China National Intellectual Property Administration (CNIPA). Official patent database and publications.
- Wu, J., et al. “Patent strategy in China’s pharmaceutical industry,” Intellectual Property & Technology Law Journal, 2021.
- Li, H., “Analysis of patent litigation trends in Chinese biotech sector,” Patent Strategy Review, 2022.
