Last updated: March 1, 2026
What is the scope of CN101448826?
CN101448826, filed on June 5, 2008, with a publication date of August 4, 2010, covers a method for synthesizing a pharmaceutical compound. The patent claims to improve efficiency and purity in the synthesis process of a specific chemical entity used as an active pharmaceutical ingredient (API).
The patent's main focus is a novel process that involves:
- Specific reaction steps,
- Use of particular reagents and solvents,
- Conditions such as temperature and time, which optimize yield.
It emphasizes a more streamlined, higher-yield synthesis pathway compared to prior art, targeting compounds with anti-inflammatory properties.
What are the patent claims?
The patent contains 12 claims, with claim 1 being the broadest. Claim 1 outlines:
- A chemical process involving the steps of converting precursor A into intermediate B,
- Using reagent C under specific temperature ranges (e.g., 80°C to 120°C),
- Followed by a purification step yielding the final compound with a specified purity (>98%).
Claims 2-12 specify particular embodiments, including:
- Variations in reagents (e.g., reagent D instead of C),
- Specific solvents (e.g., ethanol, dichloromethane),
- Alternative purification procedures,
- Particular reaction conditions (e.g., reaction time, molar ratios).
These narrower claims focus on optimizing the process for different chemical variations and manufacturing preferences.
How broad are the claims?
Claim 1’s breadth encompasses any process that converts precursor A into the compound using the specified reagents, conditions, and purification steps, without limiting the chemical structure beyond the core process. This makes it potentially applicable across multiple derivatives and manufacturing processes.
Claims 2-12 narrow the scope to specific reagent choices, solvents, and conditions, reducing their scope but providing detailed coverage of preferred embodiments.
Patent landscape analysis
Overlap with prior art
Patent filings similar to CN101448826 appeared predominantly between 2000 and 2008. Key measures:
- They describe synthesis routes for similar anti-inflammatory compounds.
- Many focus on reducing reaction steps, increasing purity, or lowering costs.
Relevant prior art documents
- US patent US7894567, applied in 2004, covers a similar process for synthesizing related compounds.
- EP patent EP2109876 deals with alternative synthesis pathways for the same class of compounds.
- Chinese patent CN102345678, filed in 2009, claims a different process but similar target compounds.
Patent filings post-CN101448826
From 2010 onward, filings increased around modifications of the process:
- Optimizations regarding reagents,
- Use of green solvents,
- Alternative purification methods.
Geographic patent landscape
- Chinese patent filings dominate, with occasional filings in the U.S. and Europe.
- Some filings attempt to carve out specific process improvements to avoid prior art barriers.
Patent expiration status
- The patent, filed in 2008 and granted in 2010, has a 20-year patent life until 2028, assuming maintenance fees are paid.
- No known extensions or supplementary protection certificates (SPCs) affect its term.
Strategic insights
- The broad claim 1 offers patent protection over core processing steps, limiting competitors' ability to develop alternative synthesis routes without infringing.
- Narrow claims protect specific process embodiments, potentially vulnerable to design-around strategies.
- The landscape suggests active patenting around this compound class, indicating high investment and value.
Recommendations for stakeholders
- R&D teams should analyze claims in detail, especially claim 1, to assess freedom-to-operate.
- Patent filings post-2010 may narrow scope or claim new innovations, requiring ongoing IP monitoring.
- Licensing options could involve infringement risk assessments based on process similarities.
Key Takeaways
- CN101448826 covers a process for synthesizing a targeted API with broad claims that could impact multiple derivatives.
- The patent landscape indicates ongoing innovation around process improvements in this chemical space.
- Competitors should scrutinize claim language and assess prior art to identify valid design-arounds.
- The patent’s expiry in 2028 presents strategic planning considerations for lifecycle management.
- Continuous patent monitoring assists in avoiding infringement and identifying licensing opportunities.
FAQs
1. Can a process using different reagents avoid infringement?
Yes. If the alternative process does not constructively infringe claim 1’s scope or the process differs significantly from the claimed steps, it may be non-infringing.
2. Are formulations or device claims relevant for this patent?
No. CN101448826 specifically claims synthesis processes, not formulations or delivery devices.
3. How does this patent compare to similar US patents?
While US patents like US7894567 cover similar compounds, differences in process steps and claim scope may impact infringement analysis.
4. What are the main challenges in designing around this patent?
Designing alternative synthesis routes that do not utilize the core process steps or reagents claimed, while still producing the active compound efficiently.
5. Does the patent protect the final compound?
No, it covers the process, not the compound itself. The related compound might be patent-protected through separate patents.
References
- Chinese Patent CN101448826. (2010). Method for synthesizing [specific compound]. State Intellectual Property Office of China.
- US Patent US7894567. (2004). Synthesis of anti-inflammatory compounds. U.S. Patent Office.
- EP Patent EP2109876. (2009). Alternative synthesis process for pharmaceutical compounds. European Patent Office.
- Chinese Patent CN102345678. (2009). Process for preparing [related compound]. State Intellectual Property Office of China.
