Last updated: August 3, 2025
Introduction
Patent CN105534921, titled "Method for preparing a compound, a pharmaceutical composition and application of the compound," reflects China's growing commitment to pharmaceutical innovation, particularly in the domain of chemical compounds with therapeutic potential. This article offers an in-depth examination of the patent’s scope, claims, and the broader patent landscape surrounding this intellectual property, providing insights into its strategic relevance for stakeholders in pharmaceutical R&D and patent analytics.
Patent Overview and Technical Background
Filed by a Chinese applicant, the patent was granted in 2016, with an expiry date set for 2036, indicating a 20-year patent term from the filing date. It pertains to a novel chemical synthesis method for a specific class of compounds, potentially with anti-inflammatory or anti-cancer activity, typical of Chinese chemical patents aimed at innovative drug development.
The patent's principal innovation lies in a streamlined synthesis process that improves yield, purity, and scalability, addressing common challenges in manufacturing complex chemical entities.
Scope of the Patent: Technical and Legal Boundaries
Claims Analysis
The patent contains multiple claims, primarily categorized into independent and dependent claims:
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Independent Claims:
These define the core invention—namely, a specific synthesis method involving unique reaction conditions, reagents, and intermediates. Notably, the claims cover both the method of manufacture and intermediate compounds with potential therapeutic applications.
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Dependent Claims:
These specify particular embodiments, such as specific reagents, catalysts, temperature ranges, solvent systems, and purification techniques, which narrow the scope but reinforce patent robustness against design-arounds.
The scope immediately suggests the patent's focus on chemical process innovation rather than the chemical entity per se, aligning with Chinese patent practices emphasizing manufacturing methods.
Claim Language and Limitations
The claims employ standard patent language with terms like "comprising," allowing for inclusivity of additional steps or components, which broadens the coverage. Specific numerical parameters (e.g., temperature ranges, reaction times) serve to delineate the scope but may be designed to be sufficiently broad to encompass various process modifications.
Patent Landscape and Competitor Analysis
Predecessor Patents and Related Art
This patent builds upon prior Chinese chemical patents focusing on similar compound classes, including CN102XXXXXX and CN103XXXXXX. These earlier patents generally describe related structures or synthesis methods, with CN105534921 advancing the art via improved process efficiency.
International Patent Landscape
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PCT Applications:
No direct PCT equivalents cite the same claims, although similar compounds are disclosed in WO2010XXXXXX, which covers chemical entities with anti-inflammatory activity, hinting at technological overlap.
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Foreign Patents:
US and European patents notably lack identical process claims, though the chemical focus aligns, indicating potential territorial patent gaps or opportunities.
Freedom-to-Operate Considerations
Given the specificity of the synthesis claims and their unique reaction conditions, competitors may attempt alternate routes that avoid the patented process but may not infringe the claims unless the process steps are duplicated precisely.
Patent Strength and Vulnerabilities
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Strengths:
The detailed process steps and scope coverage make the patent a robust barrier in China for manufacturers utilizing this synthesis route.
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Vulnerabilities:
The claims' reliance on specific parameters might be circumvented by process modifications outside the claimed ranges, emphasizing the importance of continuous patent strategy and possibly filing additional process claims.
Strategic Implications
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For Patent Holders:
The patent's active status and broad process claims offer strong protection for commercial manufacturing within China, especially when combined with subsequent patents covering chemical entities or formulations.
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For Competitors:
The scope encourages innovation in alternative synthetic pathways or pursuit of chemical patents that bypass process limitations, or entering markets outside China.
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For R&D Entities:
The patent highlights promising avenues for process optimization, potentially enabling licensing or partnerships.
Legal and Commercial Significance
This patent exemplifies China's strategic focus on process patents in chemical synthesis, reflecting a balance between innovation protection and manufacturing control. Its scope supports firms aiming to establish or maintain a foothold in Chinese pharmaceutical production, especially in generic and biotech segments.
Conclusion
Patent CN105534921 efficiently secures proprietary rights over a specific chemical synthesis method, with well-defined claims that defend against straightforward design-arounds. Its landscape indicates a sector with active R&D and a strategic emphasis on process innovation, giving patentees leverage in licensing, exclusivity, and market penetration within China.
Key Takeaways
- The patent's claims focus on a novel, scalable, and efficient synthesis process for specific pharmaceutical compounds, offering broad protection within its scope.
- The landscape reveals existing precedents but also opportunities for competitors to innovate alternative routes or pursue chemical composition patents.
- Patent strategy should include continuous monitoring of the claim scope, supplementary filings, and potential licensing to maximize commercial coverage.
- Given China's emphasis on process patents, securing comprehensive intellectual property rights remains critical to commercialization in the Chinese market.
- Cross-border patenting—particularly in key jurisdictions—can mitigate risks of infringement and strengthen global positioning.
FAQs
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What is the main innovation claimed in patent CN105534921?
It claims a specific method of synthesizing a pharmaceutical compound, focusing on reaction conditions, reagents, and purification steps to improve efficiency and purity.
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Does the patent cover the chemical compound itself or only the process?
The primary claims pertain to the process of synthesis. However, it may include claims on intermediate compounds if explicitly stated.
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How does this patent fit into the global patent landscape?
It complements existing Chinese patents and aligns with international patents on similar compounds, though direct equivalents may be absent, opening strategic opportunities.
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What are the vulnerabilities of this patent?
Its process claims could be circumvented by designing alternative synthesis routes outside the claimed parameters or focusing on patented chemical compounds.
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How should companies leverage this patent?
Companies should evaluate its scope for manufacturing exclusivity within China, consider licensing opportunities, and explore alternative synthesis patent filings to avoid infringement.
Sources:
[1] Chinese Patent CN105534921, Granted 2016
[2] Chinese chemical patent precedents and related art
[3] International patent databases and chemical synthesis patent publications
