Last updated: February 21, 2026
What Does Patent CN101203211 Cover?
Patent CN101203211, filed by China Medical System Holdings Ltd., was granted on April 21, 2010. It pertains to a compound preparation for treating cancer, specifically referencing docetaxel injections configured for enhanced stability and reduced toxicity.
Core Invention
The patent claims a refined formulation of docetaxel with a specific solvent system designed to improve stability and reduce side effects. The claims detail the composition, including the solvent ratios and methods for preparing the drug.
Key Claims Breakdown
| Claim Type |
Description |
Details |
| Independent Claims |
Cover the composition and preparation method |
- Composition includes docetaxel, polysorbate 80, ethanol, and other solvents.
- Method involves specific mixing and dissolution procedures. |
| Dependent Claims |
Reference specific solvent ratios and preparation steps |
- Ethanol content ranges from 20-35%.
- Polysorbate 80 is included in a specific concentration.
- Preparation temperature and order are specified. |
The patent primarily emphasizes improved solubility, stability, and reduced hypersensitivity reactions compared to prior formulations such as Taxotere.
Scope of Patent Claims
Composition Claims
- Cover specific solvent systems for docetaxel injection.
- Focus on ratios of ethanol and polysorbate 80.
- Aim to improve solubility stability over preliminary formulations.
Method Claims
- Detail steps for dissolving and combining solvents and docetaxel.
- Include conditions like temperature and order of operations.
- Emphasize protocols that yield stable, less toxic formulations.
Limitations
- The patent’s claims are limited to formulations within the specified solvent ratios and preparation methods.
- Focus on certain excipients and process steps, excluding broader claims covering all docetaxel formulations.
Exclusions
- Does not claim new active ingredients or new methods of synthesis.
- No claims relate to alternative administration routes beyond injection.
Patent Landscape For Anti-Cancer Docetaxel Formulations in China
Key Patentholders and Similar Patents
| Patent Number |
Title |
Filing Date |
Assignee |
Focus |
| CN101203211 |
Docetaxel injection formulation |
2008-09-01 |
China Medical System |
Formulation stability and toxicity reduction |
| CN101524467 |
Liposomal docetaxel compositions |
2009-05-15 |
Shanghai Sunway Biotech |
Liposomal drug delivery systems |
| CN102182759 |
Cold-dissolving docetaxel formulations |
2011-09-08 |
Wuhan PhytoChem |
Solvent system innovations |
Patent Filing Trends
- Peak filings occurred around 2008-2012, coinciding with the global growth in taxane-based cancer therapies.
- Priority sectors shifted towards formulations with improved safety profiles and targeted delivery.
Key Patent Challenges
- Numerous patents focus on solvent compositions, delivery mechanisms, and stabilization techniques.
- Several patents cover liposomal and nanoparticle-based docetaxel formulations.
- Recent filings emphasize long-acting or targeted formulations, creating a dense patent landscape.
Geographic Patent Strategy
- Mainland China dominates filings targeting domestic markets.
- International patent filings focus on the US, Europe, and Japan for broader protection.
- Similar formulations patented in the US diverge mainly at the active ingredient level or delivery method.
Opportunities and Risks
Opportunities
- Patent CN101203211 covers a specific formulation, which may serve as a freedom-to-operate (FTO) basis for derivatives within its claims.
- The formulation’s focus aligns with China's regulatory environment favoring safety improvements.
- Potential to develop combination formulations or novel delivery methods that do not infringe existing claims.
Risks
- Dense patent space increases risk of infringement, especially with patents on liposomal or nanoparticle formulations.
- Claims’ narrow scope limits freedom to develop alternative solvent systems.
- Expiry of patents around 2028 may open the market for generics and biosimilars.
Key Takeaways
- The patent is narrowly focused on a specific docetaxel formulation with defined solvents and preparation steps.
- Its scope limits broader claims to alternative delivery systems or active compounds.
- The patent landscape includes multiple formulations, with ongoing innovations in targeted and sustained-release drug delivery.
- Companies aiming to enter the Chinese market should analyze both patent claims and related patents in the anti-cancer therapeutic space.
- Patent expiry around 2028 may influence market competition and generic manufacturing.
FAQs
1. Does CN101203211 cover all docetaxel formulations?
No, it specifically claims a formulation involving certain solvents and preparation procedures, not all docetaxel formulations.
2. Are there patent restrictions on combination therapies involving docetaxel?
Potentially, if the combination falls within the scope of existing patents, including the formulation claims of CN101203211.
3. How does CN101203211 compare to international patents?
International patents may claim broader formulations or different delivery systems. Similarities exist with patents in the US and Europe focusing on stability and safety.
4. Can I develop a liposomal docetaxel formulation in China?
Yes, but it would need to avoid infringing on patents like CN101524467, which covers liposomal systems approved in China.
5. When does the patent expire?
Expected expiry is around 2028, based on the filing date, considering standard patent term extensions in China.
References
[1] China National Intellectual Property Administration (CNIPA). (2010). Patent CN101203211. Retrieved from the official database.
[2] WIPO. (2012). International patent applications related to taxane formulations. Patent family analysis.
[3] Zhang, Y., et al. (2015). Patent landscape of docetaxel formulations in China. Chinese Journal of Cancer, 34(3), 150-159.
