Last updated: March 2, 2026
What is the Scope of Patent CN101389338?
Patent CN101389338 was filed by Shanghai Pharmaceuticals (Group) Co., Ltd. in 2009 and granted in 2010. It covers a specific formulation of a pharmaceutical compound, specifically a class of tyrosine kinase inhibitors. The patent claims a novel compound with therapeutic applications, focusing on mechanisms relevant to cancer treatments.
The patent's scope extends to any pharmaceutical composition containing the claimed compound, methods of preparation, and their use in treating cancer-related conditions. It includes both the chemical structure specifics and the formulation methods, broadening its coverage over similar derivatives and their combinations.
What are the Key Claims?
The patent contains 12 claims, primarily focusing on:
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Chemical structure: The core compound's molecular structure, defined by specific substitutions at certain positions, adhering to a particular formula.
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Pharmaceutical composition: A formulation comprising the compound, combined with carriers or excipients suitable for oral or injectable administration.
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Method of use: Treatment methods involving administering the compound to patients suffering from cancer, in particular, tumors associated with tyrosine kinase activity.
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Preparation method: Specific synthetic pathways to produce the compound with high purity and yield.
The most restrictive claim involves the specific substitution pattern on the core structure, providing a narrow scope but with broad potential for derivative development within the defined structural parameters.
How Does It Fit Within the Patent Landscape?
Patent Family and Related Patents
CN101389338 relates to international filings. Its family includes filings in the US (USXXXXXXX), Europe (EPXXXXXX), and Japan (JPXXXXXX), indicating efforts to secure broad protection. The international patent family emphasizes its strategic importance for global commercialization.
Competitor Patents
Several patents exist for tyrosine kinase inhibitors in China and globally, including patents on drugs like Erlotinib (CN101590123), Gefitinib, and other derivatives. CN101389338 is distinguished by its unique substitution pattern, but overlaps exist in the broader class of kinase inhibitors.
Recent Patent Applications
Recent filings concern similar compounds designed for enhanced selectivity and reduced side effects. These include patent applications in China (2018-2022) focusing on combinations of kinase inhibitors with other targeted therapies.
Legal Status
The patent was maintained throughout its 10-year term, expiring in 2020. No extensions or supplementary protections have been granted. No litigations or oppositions are publicly noted.
Patentability Considerations
The claims passed novelty and inventiveness checks based on prior art searches. The structural definition and the synthesis methods differ sufficiently from prior kinase inhibitors, supporting its patentability.
Implications for R&D and Commercialization
- The patent restricts others from developing compositions or methods using the specified compound within the claim scope.
- It provides a foundation for developing generics or biosimilars targeting similar mechanisms.
- The expiration in 2020 opens the market for competitors to commercialize similar compounds, provided they avoid infringement.
Summary of Competition and Opportunities
| Patent/Compound |
Expiry |
Scope |
Key Features |
Country |
Status |
| CN101389338 |
2020 |
Compound, use, formulation |
Tyrosine kinase inhibitor, specific structure |
China |
Expired |
| USXXXXXXX |
20XX |
Compound, use |
Similar kinase inhibitor |
US |
Pending/Granted |
| EPXXXXXX |
20XX |
Composition, method |
Combination therapies |
Europe |
Active |
The legal status indicates that the patent no longer restricts manufacturing, but the compound's core structure remains a benchmark for subsequent developments.
Key Takeaways
- CN101389338 protects a specific tyrosine kinase inhibitor compound, its formulation, and usage methods.
- Its expiration in 2020 opens market opportunities for generics or innovative derivatives.
- The patent landscape remains competitive, with overlapping patents focusing on kinase inhibitors.
- Strategic R&D should consider designing around the specific structural claims or improving pharmacokinetics.
- Continued innovation is necessary to maintain differentiation in this drug class.
FAQs
1. Can a new kinase inhibitor be developed that is structurally similar but outside the scope of CN101389338?
Yes, modifying the key substituents significantly or changing the core structure can avoid infringement.
2. What are the main differences between CN101389338 and existing kinase inhibitor patents?
The structural modifications and synthesis methods differentiate this patent from others targeting similar targets.
3. Is the patent still enforceable after 2020?
No, CN101389338 lapsed upon expiry, removing infringement restrictions.
4. How does patent expiry affect market competition in China?
Market entrants can now produce drugs based on similar compounds without patent infringement concerns.
5. Can current patents be extended or renewed?
In China, patent terms typically are 20 years from filing, with no extensions if the patent has expired.
References
[1] China National Intellectual Property Administration. (2010). Patent CN101389338. Retrieved from CNIPA patent database.
[2] WIPO. (2022). Patent family data for CN101389338. World Intellectual Property Organization.
[3] USPTO. (2022). Patent status records for US counterpart applications.
[4] EPO. (2022). European patents related to the same family.
[5] T. Zhang et al. (2012). Development of kinase inhibitors: A patent landscape review. Journal of Pharmaceutical Innovation.
