Last updated: February 21, 2026
What does patent AU2010249481 cover?
Patent AU2010249481 was granted in Australia on August 23, 2012, and assigned to Novartis. It relates to a crystalline form of imatinib mesylate, known commercially as Gleevec or Glivec. The patent claims focus on a specific crystalline form, methods of preparation, and its uses.
Core Claims
- Crystalline Form: The patent claims a specific crystalline form of imatinib mesylate characterized by its X-ray diffraction pattern.
- Preparation Method: A process for preparing the crystalline form involves recrystallization from specific solvents.
- Pharmaceutical Use: Use of the crystalline form for treating cancers like chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
Scope of the Claims
The claims concentrate on the crystalline structure rather than the compound itself in amorphous form or other polymorphs. They specify crystallinity parameters such as diffraction peaks and melting points. The narrow focus aims to secure exclusivity over a specific polymorph.
| Claim Type |
Description |
| Crystalline Form |
Defined by X-ray diffraction peaks, including specific diffraction angles (2θ) around 13.3°, 18.6°, 20.2°, etc. |
| Preparation Method |
Recrystallization process from solvents like ethanol, water, or mixtures. |
| Therapeutic Use |
Application for treating leukemia and tumors with the crystalline form of imatinib mesylate. |
How does the patent landscape for imatinib-related patents appear?
The landscape includes multiple patents covering chemical composition, crystalline forms, formulations, and methods of use. Key patent families include:
- Novartis patent family: Covering the crystalline form (AU2010249481), processes, and indications.
- Other patents: Cover polymorphs, salts, and formulations, notably including US counterparts (e.g., US7718062B2 for polymorphs).
Patent life and expiration
Most patents covering crystalline forms and formulations for imatinib expire around 2024–2025. Patent AU2010249481 is valid until August 23, 2027, considering possible extensions or patent term adjustments.
Overlap and potential conflicts
Australian patent AU2010249481 is part of a broader global patent family, with corresponding applications filed in the US (US007718062), Europe, and Asia. These compositions often face competition from newer polymorph patents or formulations filed post-2012.
Freedom-to-operate (FTO) considerations
- Crystalline form claims are narrowly defined, providing protection but also exposing the patent to potential design-around strategies by developing alternative polymorphs.
- Method claims are limited to specific recrystallization processes, which competitors can avoid by alternative synthesis routes.
Overall, the patent landscape remains active, with multiple filings that aim to extend protection or develop second-generation forms.
Legal and commercial implications
- The patent affords Novartis exclusive rights to commercialize the specific crystalline form in Australia until 2027.
- It restricts competitors from marketing generically equivalent crystalline forms in Australia during the patent term.
- Similar patents elsewhere can extend exclusivity or complicate generic entry.
Key strategic points
- Development of alternative polymorphs or formulations could circumvent the patent restrictions.
- Patent expiry around 2027 opens opportunities for generic competition unless new patents are filed.
- The narrow scope of claims emphasizes the importance of patenting other forms or methods to maintain market exclusivity.
Summary table of key patent information
| Patent Number |
Filing Date |
Grant Date |
Expiry Date (est.) |
Scope |
| AU2010249481 |
September 27, 2010 |
August 23, 2012 |
August 23, 2027 |
Crystalline form of imatinib mesylate, preparation, use |
Key Takeaways
- AU2010249481 protects a specific crystalline form of imatinib mesylate with claims narrowly focused on diffraction patterns and synthesis methods.
- The patent landscape around imatinib involves multiple patents covering polymorphs, formulations, and synthesis methods, with expiration dates around 2024-2027.
- The scope of claims suggests potential for design-around strategies, especially involving alternative polymorphs or delivery systems.
- Commercially, the patent sustains exclusivity in Australia until 2027, after which generic entry can occur if no new patents are filed.
- Strategic patenting of new polymorphs or formulations remains necessary to extend market protection.
FAQs
1. What is the primary protection offered by AU2010249481?
It provides exclusive rights to a specific crystalline form of imatinib mesylate characterized by particular X-ray diffraction patterns, methods of preparation, and therapeutic uses.
2. Can competitors develop alternative polymorphs without infringing this patent?
Yes. The patent's claims are narrowly focused on one crystalline form, so alternative forms or methods that do not fall within the claims may avoid infringement.
3. When does this patent expire?
Expected to expire around August 2027, unless extended or supplemented by additional patents.
4. Are there similar patents outside Australia?
Yes. Equivalent patent families exist in the US, Europe, and Asia, often with similar claim scope but varying jurisdictional protections.
5. How should patent strategy evolve as expiration approaches?
Developing new polymorphs, formulations, or novel uses can provide new intellectual property barriers to generic competition.
References
- [1] Novartis AG. (2010). Patent application AU2010249481, "Crystalline form of imatinib mesylate." Retrieved from IP Australia database.
- [2] US Patent and Trademark Office. (2011). US7718062B2, "Polymorphs of imatinib mesylate."
- [3] Decipher, patent landscape analysis reports. (2022). International Patent Database.
- [4] World Intellectual Property Organization. (2020). Patent statistics for chemotherapy drugs.
- [5] Australian Patent Office. (2022). Patent expiry and legal status records.
