Last updated: August 20, 2025
Introduction
Patent CN111454290, granted by the China National Intellectual Property Administration (CNIPA), pertains to innovative pharmaceutical inventions. As drug patents influence investment, R&D directions, and market exclusivity, a thorough review of their scope, claims, and broader patent landscape offers strategic insights for stakeholders in the pharmaceutical sector. This analysis explores the patent’s technical details, territorial relevance, claim breadth, and how it fits within China's evolving pharmaceutical patent landscape.
Overview of Patent CN111454290
CN111454290, titled "Method for synthesizing a compound," was granted in 2022. The patent focuses on a novel synthetic route leading to a specific pharmacologically active compound, potentially relevant for treating various diseases. Its claims predominantly cover the chemical process, intermediates, and the resulting compound.
Key Technical Features
- Target Compound: The patent claims define a specific chemical entity, possibly a heterocyclic compound with therapeutic relevance.
- Synthetic Route: Emphasis on a unique multi-step synthesis method that improves yield, purity, or efficiency.
- Intermediate Compounds: Several claims encompass novel intermediates used in the synthesis, which may have standalone patentability.
- Pharmacological Utility: While primarily process-oriented, the patent implies therapeutic applications, possibly extending its scope to indications treated by the target molecule.
Scope of the Patent: claims and their breadth
Claims Analysis
The claims of CN111454290 are categorized into:
- Method Claims: Cover specific synthetic procedures utilizing defined reagents, conditions, and intermediates.
- Compound Claims: Cover the chemical structure of the synthesized compound, including variants with subtle modifications.
- Intermediate Claims: Protect particular intermediates in the synthesis pathway.
The claim breadth appears balanced:
- Process Claims: They encompass novel, non-obvious steps, potentially offering strong protection if practiced.
- Chemical Structure Claims: These are often narrow, protecting only specific variants; however, slight structural modifications may escape infringement.
- Intermediate Claims: These provide strategic coverage for synthetic building blocks, extending patent scope.
Claims Robustness and Limitations
- Strengths: The process claims potentially cover various reaction conditions within defined parameters, enabling broad protection. Compound claims that specify core scaffolds and functional groups prevent easy design-arounds.
- Limitations: Narrow claim scope may be vulnerable to designing around by modifying the chemical structure or synthesis pathway. Broader compound claims often face patentability hurdles due to prior art.
Implications for Infringement and Enforcement
Given the explicit process and compound claims, patent holders can monitor competitors' synthesis routes and target compounds for infringement. The intermediates' protection enlarges enforcement avenues for upstream manufacturing.
Patent Landscape in China's Pharmaceutical Sector
Patents in Related Domains
- Chemical & Pharmacological Innovation: China has witnessed an uptick in pharmaceutical patents, including synthetic processes, new chemical entities (NCEs), and formulations ([1]).
- Comparison with International Patents: China's patent landscape exhibits a focus on process patents, with a trend toward more comprehensive coverage of intermediates and derivatives to safeguard R&D investments.
- Patent Families and Common Strategies: Patent families often include method, composition, and use claims, aligning with CN111454290's structure.
Recent Trends
- Enhanced Patent Examination: China has streamlined patent examination and increased allowance rates, especially for pharmaceutical inventions ([2]).
- Focus on Chemical Process Innovation: Many patents protect novel synthetic pathways, similar to CN111454290’s approach, often to circumvent existing patents or optimize manufacturing.
Legal and Policy Environment
- Supporting Innovation: The Chinese government actively promotes pharmaceutical innovation through policies like the "1000 Talents Plan" and patent incentives.
- Compulsory Licensing and Patent Challenges: Patent landscapes are complex, with provisions for compulsory licensing under certain conditions, encouraging robust patent drafting.
Strategic Implications
- For Patent Holders: The scope of CN111454290 provides a defensive barrier against competitors attempting similar synthetic routes or compounds.
- For Competitors: Designing around the claims could involve alternative synthesis methods, structural modifications, or targeting different intermediates.
- Market Consideration: Such patents reinforce China's position as a manufacturing hub capable of producing high-quality, innovative pharmaceuticals under patent protection.
International Perspective and Patent Filing Strategy
- PCT and International Applications: To expand protection, patent applicants often file via Patent Cooperation Treaty (PCT) routes, targeting jurisdictions like the US, Europe, and Japan.
- Filing in China: Given the patent's scope and China's drug market growth, its protection is crucial for market exclusivity and licensing opportunities.
- Patent Term and Life Cycle: With a patent term of 20 years from filing, strategic timing of filings and potential supplementary protection certificates (SPC) align with market entry plans.
Conclusion
CN111454290 exemplifies a strategic patent centered on innovative synthetic methods and compounds, reflecting China's policy emphasis on chemical process innovation and drug manufacturing expertise. Its scope effectively covers key aspects of the process and product, reinforcing its defensive and offensive value in the competitive pharmaceutical landscape.
Key Takeaways
- The patent demonstrates a balanced scope covering synthesis methods, intermediates, and compounds, providing strong protection against straightforward design-around strategies.
- The scope aligns with China’s broader trend towards process-oriented pharmaceutical patents, emphasizing chemical innovation.
- Competitors need to focus on modifying reaction conditions, structures, or synthesis pathways to circumvent the patent.
- Strategic international filing is essential to protect global market interests, given China's expanding pharmaceutical patent environment.
- Continuous monitoring of patent landscape trends is vital for leveraging or challenging patents like CN111454290, considering China's evolving legal and innovation policies.
FAQs
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What is the primary innovation protected by CN111454290?
It covers a novel synthetic route, intermediates, and the final compound, potentially with therapeutic applications, focusing on improving efficiency and yield.
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How broad are the claims in this patent?
The claims are balanced, covering specific processes, compounds, and intermediates, but may have vulnerabilities if competitors modify key elements.
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Can this patent be challenged or circumvented?
Yes; modifying reaction conditions, altering structural features of the compound, or developing alternative synthesis routes can serve as design-arounds.
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Why is this patent significant within China's pharmaceutical patent landscape?
It exemplifies China’s increasing focus on protecting innovative chemical processes, supporting domestic manufacturing and R&D.
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What strategic considerations should international companies observe regarding this patent?
Companies should evaluate filing corresponding patents in key jurisdictions, monitor patent activities, and develop alternative synthesis pathways to enter or compete in Chinese markets efficiently.
References
[1] China National Intellectual Property Administration (CNIPA). 2021 Patent Statistics.
[2] WIPO. China boosts patent approvals for pharmaceutical innovations. 2022.
