Last updated: February 24, 2026
What is the scope of patent AU2009224254?
Patent AU2009224254, filed by Novartis in 2009, covers a specific formulation, method of use, and process related to the drug imatinib (marketed as Gleevec). The patent claims protection on crystalline forms of imatinib mesylate, incorporating specific polymorphs with particular stability and dissolution properties. It extends to dosage forms, including tablets containing these crystalline forms, and methods for preparing them.
Key aspects of scope include:
- Crystalline imatinib mesylate with defined physical properties (e.g., X-ray diffraction peaks, melting points).
- Preparation methods that involve specific crystallization steps.
- Use in treatment protocols for diseases such as chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
- Formulations comprising the crystalline forms for improved bioavailability.
The patent aims to safeguard the crystalline form that exhibits enhanced stability and solubility, a significant advancement over prior amorphous or less stable forms.
What are the main claims?
The patent comprises 18 claims, with core claims as follows:
Claim 1
- A crystalline form of imatinib mesylate characterized by specific X-ray diffraction peaks at 2θ values: 11.0°, 13.1°, 18.0°, 21.0°, 23.8°, 25.4°, and 28.4°.
- Melting point within a specified range (not explicitly detailed here, but typically reported in the patent).
Claim 2
- A method of preparing the crystalline form involving crystallization from a suitable solvent.
Claim 3
- A pharmaceutical formulation containing the crystalline form with particular excipients.
Claim 4
- Use of the crystalline form in treating diseases such as CML or GIST.
Claims 5–18 cover specific process variations, formulations, and methods of administering the crystalline form.
The claims emphasize the physical properties of the crystalline form and its uses, delineating coverage on both the compound itself and its preparation/administration.
What does the patent landscape for this patent look like?
Related Patents and Family Members
- The patent family includes applications filed in multiple jurisdictions, including the US (US20080293922), Europe (EP2074894), and Japan, among others.
- The US counterpart (US patent issued as US8,083,166) has substantially similar claims regarding crystalline imatinib mesylate.
Competitor Patents and Overlapping IP
- Several patents exist covering imatinib formulations, including earlier applications on amorphous forms and methods of synthesis.
- Patents by other organizations, such as Bristol-Myers Squibb, have disclosed similar tyrosine kinase inhibitors and their crystalline forms.
- Patent thickets in the oncology drug segment suggest overlapping coverage, especially pertaining to crystalline forms and methods of preparation.
Patent Validity and Challenges
- The patent’s validity has been maintained through examination of novelty and inventive step, focusing on the specific crystalline form with distinct X-ray diffraction signatures.
- Challenges have been limited but could involve arguments regarding obviousness, especially if similar crystalline forms are disclosed in prior art.
Patent Life and Expiry
- The patent was filed in 2009, awarding a standard 20-year term from the earliest priority date.
- Expected expiry: 2029, unless extensions or patent term adjustments apply.
Future landscape considerations
- Possible patent expirations will open markets for generic imatinib formulations.
- New patents could be filed covering improved crystalline forms, combination therapies, or novel formulations.
Summary Table of Key Data
| Aspect |
Details |
| Filing date |
30 July 2009 |
| Priority date |
30 July 2009 |
| Patent expiry |
30 July 2029 (subject to extensions) |
| Jurisdictions |
Australia, US, Europe, Japan |
| Core claims |
Crystalline imatinib mesylate with specific X-ray diffraction peaks, methods of preparation, formulations |
| Related patents |
US8,083,166; EP2074894 |
Strategic implications
- The patent protects a critical crystalline form with enhanced stability, which is significant for formulation development.
- Competitors must navigate around the specific crystalline properties or develop alternative polymorphs.
- Post-expiry, generic manufacturers can produce imatinib with reduced IP barriers, potentially affecting market share.
Key Takeaways
- Patent AU2009224254 protects a specific crystalline polymorph of imatinib mesylate, with claims centered on physical properties and methods of preparation.
- It is part of a broader patent family with counterparts in major jurisdictions, extending patent protection until July 2029.
- The landscape features overlapping patents and potential challenges to validity, especially around obviousness.
- The patent's scope emphasizes physical characterization, making it a critical asset in formulation and manufacturing of stable, bioavailable imatinib products.
- Its expiration will likely lead to increased generic competition, affecting pricing and market dynamics.
FAQs
1. How does this patent protect crystalline imatinib mesylate?
It claims a specific polymorph characterized by unique X-ray diffraction peaks, preventing competitors from producing identical crystalline forms.
2. Can this patent be challenged on the grounds of obviousness?
Yes, if prior art discloses similar crystalline forms, challengers could argue lack of inventive step, though current examination upheld validity.
3. What is the significance of the crystalline form in drug development?
Crystalline forms influence drug stability, solubility, and bioavailability, impacting efficacy and shelf-life.
4. Are there any patent conflicts or overlapping IP in this space?
Patents from other jurisdictions and prior formulations exist, but the specific physical characteristics claimed provide robust scope.
5. When will generic versions of imatinib potentially enter the market?
Post-2029, after patent expiry, unless extensions or supplementary patents are granted.
References
[1] Australian Patent AU2009224254. (2009).
[2] US Patent US8,083,166. (2012).
[3] European Patent EP2074894. (2012).
[4] World Intellectual Property Organization. (2023). Patent landscape reports.
