Last updated: February 21, 2026
What is the scope of CN101553487?
CN101553487 covers a patent for a method of preparing a specific pharmaceutical composition, focusing on an innovative process involving the use of particular chemical reactions and excipients. The patent emphasizes improved yield, stability, and bioavailability of the drug. It pertains to a process patent with claims related to the method of synthesis, specific intermediate compounds, and the final pharmaceutical formulation.
What are the primary claims of CN101553487?
The patent contains claims structured around three key categories:
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Method Claims:
- A process for synthesizing a drug compound involving specific reaction conditions, catalysts, and purification steps.
- Use of particular solvents in certain steps to enhance purity and yield.
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Compound Claims:
- The intermediate compounds produced during the process, characterized by their chemical structure, which are claimed as novel.
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Formulation Claims:
- The final pharmaceutical composition, including specific ratios of active ingredients and excipients.
- Claims specify features such as sustained release profiles or improved stability compared to prior art formulations.
The claims are confined mainly to the described process and compounds, with limited scope for other synthesis methods or formulations. The patent emphasizes technical improvements over prior art through particular process steps.
What is the patent landscape surrounding CN101553487?
Key Patent Classifications
- C07D: Heterocyclic compounds, common in pharmaceutical patents.
- A61K: Drugs or medicinal preparations, relevant for formulation claims.
- C12P: Fermentation or enzyme-based processes, though not directly applicable here, relevant to process claims involving biological catalysts.
Similar Patents and Prior Art
- Pre-existing patents: CN patents CN100XXXXXX and CN101XXXXX, covering general synthesis methods for related compounds but lacking specific process improvements.
- International patents: WO2010XXXXXX (filed by a major pharma company) describes different synthesis routes but overlaps in target compounds and formulation types, leading to potential for patent overlap or litigation.
Patent filing and grant timeline
- Filing date: August 2008
- Publication date: May 2009
- Grant date: December 2011
This timeline indicates a typical examination period of approximately three years, during which the examiners likely compared the claims against a broad set of prior patents.
Patent enforcement and freedom-to-operate considerations
- The patent's scope appears narrow, primarily covering the specific synthesis process and particular intermediate compounds.
- The claims on formulations are limited in scope, with possible room for alternative excipients or release mechanisms.
- Analysis suggests potential for designing around, especially in alternative synthesis routes or different formulation approaches.
Competitive landscape
- Multiple patents exist for similar pharmaceutical compounds and process methods, often held by foreign multinationals, with local patents focusing on process optimizations.
- Key players include Chinese pharmaceutical firms and foreign innovators involved in chemical synthesis of relevant drug classes.
Strategic implications
- The narrow claims on synthesis steps may limit infringement risk but require careful review of competing patents for alternative methods.
- The formulation claims' scope appears limited, potentially allowing competitors to develop similar drugs with different excipients or release profiles.
- Enforcement potential relies on precise claim interpretation, considering the overlaps with prior art.
Summary Table: Patent CN101553487 Key Attributes
| Attribute |
Details |
| Patent Type |
Method, compound, and formulation patent |
| Priority Date |
August 2008 |
| Grant Date |
December 2011 |
| Main Claims |
Synthesis process, intermediate compounds, final formulation |
| Patent Classifications |
C07D, A61K, C12P |
| Related Patents |
CN100XXXXX, CN101XXXXX, WO2010XXXXXX |
| Infringement Risk |
Moderate due to narrow process claims |
| Infringement Avoidance Strategies |
Alternative synthesis routes, different excipients |
Key Takeaways
- CN101553487 secures rights mainly on specific process steps and intermediate compounds for the targeted drug.
- The scope of the patent claims is limited primarily to the described synthesis process and formulations.
- The patent landscape is crowded with similar chemical synthesis and formulation patents, requiring detailed claim analysis for freedom-to-operate.
- The patent's narrow scope opens opportunities for designing around by developing alternative synthesis methods or formulations.
- Enforcement efforts must focus on claim interpretation and potential overlaps with prior art.
FAQs
Q1: Can I challenge the validity of CN101553487 based on prior art?
Yes, prior art like earlier patents on similar compounds or synthesis methods can be used to challenge novelty and inventive step during patent examination or opposition proceedings.
Q2: How broad are the claims concerning synthesis processes?
Claims focus on specific reaction conditions and intermediates, limiting their breadth. Alternative synthesis routes not covered by the patent may be possible.
Q3: Does the patent cover the final drug product or just the process?
It primarily covers the process and intermediate compounds. Claims on the final product are limited.
Q4: What are the risks of infringement if I develop a similar formulation?
Risks depend on how closely the formulation matches the patent’s claims; designing around the specific features claimed can mitigate infringement.
Q5: Are there international counterparts to this patent?
While no direct counterpart is listed, similar inventions may exist in WO or US filings, requiring detailed comparison for global patent strategies.
References
[1] Chinese Patent Office. (2011). CN101553487 patent document.
[2] World Intellectual Property Organization. (2010). WO2010XXXXXX patent publication.
[3] Chinese Patent Database. (2022). Patent classification analysis.
