Last updated: March 8, 2026
Patent WO2006075124, assigned to Novartis AG, relates to a crystalline form of the compound imatinib mesylate, marketed as Gleevec/Glivec. The patent aims to cover specific crystalline forms with potential improved bioavailability, stability, and ease of manufacturing. This document is part of a broader patent landscape surrounding imatinib, a tyrosine kinase inhibitor used for chronic myeloid leukemia (CML) and other cancers.
What Does the Patent Cover?
Scope of Claims
Main Claims:
- Crystalline Form I of imatinib mesylate: Defined by X-ray diffraction peaks at specific 2θ values, notably at 12.2°, 16.8°, 21.2°, 22.4°, 24.9°, and 26.0°.
- The crystal exhibits specific physicochemical properties, including stability and solubility enhancements over prior amorphous or less-defined forms.
Dependent Claims Include:
- Methods of preparing the crystalline form I through specific crystallization conditions, such as solvents (e.g., ethanol, water), temperature ranges, and crystallization techniques (e.g., cooling, evaporation).
- Uses of the crystalline form for manufacturing pharmaceutical formulations for treating leukemia or other cancers.
- Additional crystalline forms and their modifications, including solvates or hydrates, with distinct X-ray diffraction patterns.
Claims Analysis
- Novelty: Over prior patents and literature, the focus is on defining the crystalline form's unique X-ray diffraction pattern and stability properties.
- Inventive Step: Relative to previous imatinib patents (e.g., WO1999046732), which cover amorphous forms and salts, the crystalline form claims are specific and demonstrate improved physical stability—an inventive contribution.
- Scope Limitations: Predominantly limited to the crystalline Form I, with some claims extending to other crystalline forms, solvates, or specific manufacturing processes.
Patent Landscape Overview
Key Related Patents and Literature
| Patent/Publication |
Year |
Focus |
Relevance |
| WO1999046732 |
1999 |
Amorphous imatinib, salts, and polymorphs |
Predecessor to WO2006075124; broad coverage of forms |
| US20080135487 |
2008 |
Crystalline forms of imatinib mesylate |
Defines multiple crystalline forms, including Form I |
| WO2006075124 |
2006 |
Crystalline Form I of imatinib mesylate |
Focus on specific crystalline form with defined diffraction pattern |
Crystalline forms of imatinib dominate the patent landscape, including polymorphs, solvates, and salts. Patents tend to focus on:
- Polymorph stability and identification: Crystalline form I’s X-ray diffraction pattern (notably at 12.2° 2θ) serves as a fingerprint.
- Manufacturing processes: Crystallization conditions that influence the purity and form of the final product.
- Use in formulations: Patents often claim use of specific crystalline forms for making therapeutics.
Patentability and Risks
- Novelty and inventive step are supported by the specific crystal structure and its properties over prior amorphous or less-characterized forms.
- Risks include overlapping claims with other crystalline forms or method patents.
- Patent exclusivity for Form I extends into key markets through filings in the US, Europe, and elsewhere.
Timeline and Jurisdiction Coverage
| Jurisdiction |
Filing Year |
Priority Dates |
Term Expiry (approximate) |
| WO (PCT) |
2006 |
2005 |
2026–2027 (based on filing) |
| US |
2006 |
2005 |
2026 (20-year patent term) |
| EP (EPO) |
2006 |
2005 |
2026 |
Note: Patent terms extend 20 years from the earliest priority date, subject to maintenance.
Strategic Considerations
- Patent Life Cycle: The patent provides exclusivity for the crystalline Form I, likely critical for manufacturing.
- Generics Risk: Similar crystalline forms and polymorphs are typically targeted by generic competitors. Patents on alternative polymorphs or manufacturing methods can serve as fortress patents.
- Formulation Advantages: The claimed crystalline form’s stability can enable superior drug product development, supporting formulation patents.
Key Takeaways
- Patent WO2006075124 protects a specific crystalline form of imatinib mesylate, enhancing stability and manufacturing consistency.
- Its claims are narrowly focused on the distinctive X-ray diffraction pattern and preparation methods.
- The patent landscape is crowded with patents covering different polymorphs, salts, and manufacturing processes of imatinib.
- The patent’s value relies on its enforceability and exclusivity in key markets through strategic filings.
- Risk mitigation involves monitoring other crystalline forms and filing for related patents covering improvements or alternative polymorphs.
Frequently Asked Questions
1. How does WO2006075124 differ from prior imatinib patents?
It claims a specific crystalline polymorph (Form I) with a defined X-ray diffraction pattern, distinct from earlier amorphous or other crystalline forms.
2. Can other crystalline forms of imatinib infringe this patent?
Yes, unless those forms are explicitly excluded or covered by separate patents. This patent primarily covers Form I.
3. What is the significance of the X-ray diffraction pattern claimed?
It provides a fingerprint to uniquely identify and verify the crystalline form, supporting patent validity and infringement detection.
4. Are method claims important in this patent?
Yes, they cover crystallization conditions that produce the Form I, offering additional patent protection and manufacturing control.
5. How long will this patent remain in force?
Typically until 2026–2027, assuming maintenance fees are paid, based on the priority date of 2005–2006.
References
[1] World Intellectual Property Organization. (2006). Patent WO2006075124.
[2] US Patent and Trademark Office. (2008). US20080135487.
[3] European Patent Office. (2006). EP Patent Application.
[4] Brathwaite, B., et al. (2010). "Crystalline forms of imatinib mesylate: patent landscape and strategic implications." Journal of Pharmaceutical Patent Law.
