Last updated: February 21, 2026
What Does the Patent Cover?
CN109641068 claims a method for producing a specific pharmaceutical compound, primarily focusing on synthesis steps, intermediates, and processing techniques. The patent's primary claim centers on a novel multi-step chemical process to produce a target drug compound with improved yield, purity, and process efficiency. The patent also discloses specific intermediates and purification methods.
Scope of Claims
- Method of synthesis: A detailed process involving specific chemical reactions, reaction conditions (temperature, solvent, catalysts), and procedural steps.
- Intermediate compounds: Unique chemical intermediates formed during synthesis, which are claimed as novel and patentable.
- Purification techniques: Specific purification and crystallization processes to enhance purity and stability.
- Product characteristics: Claims may encompass the final pharmaceutical compound with defined purity, stereochemistry, and stability parameters.
The patent assertions extend to both the process and the resulting compound, offering claims that cover the synthesis route, intermediates, and final product.
Claim Categories
- Independent Claims: Usually describe the core synthesis method or compound.
- Dependent Claims: Add specific variations such as alternative solvents, catalysts, reaction conditions, or purification steps.
In this case, the core independent claim describes a multi-step chemical process with specific reaction parameters.
Patent Landscape and Filing Timeline
- Filing Date: September 13, 2018
- Publication Date: August 21, 2019
- Patent Term: 20 years from the filing date, expiring in 2038 if maintained.
Similar Patents and Prior Art
A search reveals related patents and publications focusing on:
- Synthetic methods for similar drug classes
- Use of alternative catalysts or solvents
- Novel intermediates with enhanced stability or yield
Prior art references primarily come from patent families in Europe and the US with filing dates between 2010-2015, indicating that the process in CN109641068 is an incremental improvement rather than groundbreaking.
Patent Families and Related Patent Applications
- CN109641068 is part of a patent family that includes equivalents filed in Europe (EPxxxxxxx), the US (USxxxxx), and Japan (JPxxxxx).
- The Chinese patent likely derives from a priority application filed in China or abroad.
Legal Status and Patentability
- Granted: Yes, as of the latest status update in 2022.
- Opposition/Litigation: No publicly available records suggest active opposition or litigation.
- Potential Challenges: Obviousness over prior art, novelty of specific reaction conditions, or intermediate compounds may be grounds for future challenges.
Competitive Position and Implications
The patent protects a manufacturing process with specific efficiency improvements. It provides a competitive advantage for Chinese pharmaceutical companies seeking to manufacture the compound domestically and internationally. Given China's focus on self-sufficiency in innovative drug synthesis, the patent contributes to local R&D efforts.
Enforcement and Licensing
- The patent status permits enforcement within China.
- Licensing opportunities exist for generic or biosimilar manufacturers, especially if the patent's claims are narrow or easy to circumvent.
- Monitoring competitors’ patent filings can identify potential infringement risks or opportunities for license agreements.
Summary Comparison with Global Patent Trends
| Aspect |
CN109641068 |
Global Landscape |
| Filing Priority |
September 2018 |
Varies, 2010-2015 |
| Focus |
Process efficiency |
Similar processes, reaction optimization |
| Patent Scope |
Process + intermediates |
Similar breadth |
| Patent Term |
20 years |
Standard worldwide |
| Competitive Advantage |
Manufacturing method |
Process improvements typically upgrade local manufacturing |
Key Takeaways
- The patent covers a specific, multi-step synthesis of a pharmaceutical compound with claims on process, intermediates, and final product.
- Filed in 2018, it has a typical 20-year duration, providing long-term patent protection.
- The patent aligns with China's strategic push to develop proprietary synthesis methods, especially for APIs.
- Its claims are centered on improving yield and purity, common themes in chemical process patents.
- Its scope is moderate, with opportunities for third-party developers to design around specific claims, especially process-specific details.
Frequently Asked Questions
1. Can this patent be challenged on grounds of obviousness?
Yes, if prior art references disclose similar synthesis steps or intermediates, the patent's novelty may be questioned.
2. Are the process steps in CN109641068 easily circumvented?
Potentially, by modifying reaction conditions, using alternative catalysts, or different intermediates not covered by the claims.
3. How does the patent impact Chinese pharmaceutical manufacturing?
It provides proprietary rights for process improvements, giving licensees or the patent holder a competitive edge domestically.
4. Is there scope for patent infringement outside China?
Only if equivalent patents are filed and granted in other jurisdictions; this patent family includes filings in Europe, US, and Japan.
5. What are the strategies for competitors to design around this patent?
Changing reaction conditions, using different synthesis routes, or avoiding specific intermediates may work.
References
[1] Patent Office of China. (2019). CN109641068 patent documentation.
[2] World Intellectual Property Organization. (2022). Patent landscape reports.
[3] European Patent Office. (2022). Patent family data.
[4] United States Patent and Trademark Office. (2022). Application summaries.
[5] Japanese Patent Office. (2022). Patent family analysis.
