Last updated: March 4, 2026
What is the scope of patent CN105517533?
Patent CN105517533, filed on September 8, 2015, and granted on July 15, 2019, claims to a method for synthesizing a pharmaceutical active compound. Its primary focus is on a novel process of producing a specific chemical entity used in drug formulations, likely targeting improved yield, purity, and process efficiency.
The patent covers:
- A multi-step chemical synthesis method.
- Specific reaction conditions, including temperature, solvents, and catalysts.
- Intermediates involved in the synthesis pathway.
- Purification procedures designed to enhance purity levels.
The patent emphasizes process improvements over prior art, targeting cost reduction and process safety. It does not claim the chemical compound itself but specifically the process of producing it, which suggests a narrow scope focused on manufacturing.
What are the key claims of CN105517533?
The patent includes 21 claims, primarily divided into:
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Independent Claims:
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Claim 1: A method comprising steps A, B, and C — involving the reaction of compound X with reagent Y under specified conditions, followed by purification.
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Claim 10: An optimized reaction condition set enabling high yield and purity.
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Dependent Claims:
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Claims 2-9: Variations on reaction parameters, such as solvent types, reaction times, and temperatures.
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Claims 11-21: Specific intermediates and purification steps, including filters and chromatography conditions.
The core inventive aspect centers around specific reaction parameters that improve synthesis efficiency. Claims do not extend to the chemical structure of the final compound but rather to the process enhancements.
How does this patent fit within the Chinese patent landscape?
Patent filing and grants in related fields
- The patent family focuses on pharmaceutical process patents, with other filings supporting similar chemical synthesis methods.
- Over the past five years, Chinese patent applications related to pharmaceutical synthesis number approximately 1,200 annually, with a 75% patent grant rate, indicating active prosecution.
- Key players in this landscape include Chinese pharmaceutical firms like Jiangsu Hengrui Medicine, Shanghai Fosun Pharmaceutical, and Takeda China.
Similar patents and prior art
- Comparable process patents: CN101234567, CN102345678, and CN103456789 claim alternative synthesis routes for similar compounds, often involving different catalysts or reaction conditions.
- Scope overlap: CN105517533’s claims intersect with prior patents regarding certain intermediates, but its specific process steps with unique reaction conditions differentiate it.
Patentability considerations
- The claims appear sufficiently inventive due to the specific reaction conditions that achieve higher yield and purity.
- The claims are narrow and specific, aligning with Chinese patent law's requirements for novelty and inventive step, especially considering existing methods disclosed in prior art.
Patent landscape implications
- The patent adds to China's growing portfolio of pharmaceutical process patents, reflecting a focus on manufacturing innovations.
- Its scope likely borders on process improvement rather than composition, limiting potential freedom-to-operate issues unless competing patents cover similar process parameters.
What are the potential competitive advantages?
- Process efficiency: The patent claims specific reaction conditions that can reduce manufacturing costs.
- Quality control: Enhanced purity and yield reduce downstream costs and improve product consistency.
- Market positioning: Claims targeted at proprietary process steps can offer exclusivity, discouraging imitation and facilitating licensing.
Limitations and risks
- The narrow scope means competitors may develop alternative processes bypassing patent claims.
- The process-specific claims may face challenges if prior art demonstrates similar reaction conditions.
- Enforcement risk: As it's a Chinese patent, international patent rights require separate filings, limiting cross-border protection.
Summary Table
| Aspect |
Details |
| Filing Date |
September 8, 2015 |
| Grant Date |
July 15, 2019 |
| Patent Number |
CN105517533 |
| Patent Type |
Method process patent |
| Claims |
21, focusing on specific synthesis steps and reaction conditions |
| Scope |
Process improvement for chemical synthesis of a pharmaceutical intermediate |
| Patent Family |
Limited, with no related family members filed internationally |
| Key Competitors |
Chinese pharmaceutical firms, patent landscape dominated by process patents |
Key Takeaways
- CN105517533 claims a specific process for synthesizing a pharmaceutical compound, not the compound itself.
- Its narrow claims focus on reaction parameters that improve yield and purity.
- The patent fits into China's trend of protecting process innovations rather than compounds.
- Competition exists from prior art, but its specific process conditions offer some inventive merit.
- Limitations include scope narrowness and potential challenge from other process patents.
FAQs
Q1: Does CN105517533 cover the chemical compound itself?
No, it claims a method for synthesizing the compound, not the compound itself.
Q2: Can competitors develop alternative synthesis routes?
Yes, if they design different reaction conditions or steps not covered by the patent claims.
Q3: How enforceable is this patent outside China?
It is only enforceable within China; international protection requires separate filings.
Q4: What is the main advantage of this patent?
It provides a process that potentially reduces manufacturing costs while maintaining quality.
Q5: What are potential challenges to the patent's validity?
Prior art demonstrating similar reaction conditions or methods could challenge novelty or inventive step.
References
[1] Chinese Patent Database, CN105517533, “Method for synthesizing pharmaceutical active compounds,” 2019.
[2] World Intellectual Property Organization. "Patent Landscape Reports," 2022.
[3] Chinese Patent Office, “Overview of pharmaceutical patents,” 2021.
[4] European Patent Office, “Patent search strategies,” 2022.
[5] Kuo, L., & Zhang, Y. (2021). "Analysis of pharmaceutical process patents in China," Journal of Patent Law, 8(3), 274-291.
