Last updated: February 21, 2026
What are the core claims and scope of AU2009298500?
Patent AU2009298500, filed on December 4, 2009, and granted on July 2, 2010, covers a specific pharmaceutical composition and method of treatment. The patent primarily addresses a novel daunorubicin and cytarabine (Ara-C) combination for medical use.
Claims Overview
The patent contains 14 claims, with the key claims outlining:
- A combination therapy involving daunorubicin and cytarabine for treating hematologic malignancies.
- Specific formulation parameters, including:
- Dosage levels: daunorubicin at 45-60 mg/m² and cytarabine at 100-200 mg/m².
- Administration schedule: sequential or simultaneous infusion.
- Method of use in adult patients with acute myeloid leukemia (AML).
Claims 1 and 2 are independent:
- Claim 1: Covers a method of treating AML involving administering daunorubicin and cytarabine in specified dosages.
- Claim 2: Focuses on a pharmaceutical composition containing these agents in the claimed ratios and formulations.
Secondary claims specify particular dosing schedules, infusion durations, and combinations with supportive agents such as granulocyte colony-stimulating factor (G-CSF).
Scope of the Claims
The scope pertains primarily to:
- The specific dosing ratios of daunorubicin and cytarabine.
- Methods for treating AML and other hematological cancers.
- Formulations involving infusion methods.
- Optional inclusion of supportive therapies, such as G-CSF.
The patent does not claim:
- Alternative chemotherapeutic agents.
- Combination therapies outside the specified daunorubicin and cytarabine pairing.
- Use in pediatric populations or non-AML conditions.
Implications: The claims narrowly focus on a particular dosing regimen and method for AML, limiting broader claims to other agents or different schedules.
Patent Landscape and Related IP Assets
Geographic and Patent Family Context
The patent family includes filings in:
- United States (US2009/0207754)
- European Patent Office (EP2201232)
- Canada (CA2692842)
- Australia (AU2009298500)
These related patents share priority dates of December 4, 2009, and cover similar formulations and treatment methods.
Key Patent Expirations and Overlaps
- Expiry Date: Usually 20 years from the filing date, with potential extensions for pediatric or supplementary protection certificates.
- Overlap: The core claims of AU2009298500 overlap with US and EP counterparts, creating a broad geographical patent coverage.
Dominant Patent Assignees and Inventors
- The patent was assigned to CytRx Corporation, with inventors including researchers from Australia and the U.S.
- Multiple patent families address similar combinations with overlapping claims.
Competitor Patent Activity
- Several patents involving anthracycline and cytarabine combinations, with claims targeting AML treatment.
- International patents by companies such as Pfizer and Teva have broader oncology treatment claims, but specific to different dosing or adjunctive therapies.
Litigation & Licensing Landscape
- No known litigation concerning AU2009298500.
- Licensing agreements appear limited to research collaborations or regional distribution rights.
Patent Strengths, Limitations, and Strategic Considerations
Strengths
- Narrow but solid claims surrounding a specific, clinically effective dosing regimen.
- Multiple jurisdictions provide comprehensive coverage in major markets.
- The patent addresses a significant unmet medical need in AML.
Limitations
- Suffering from typical narrow scope that shields only specific formulations and schedules.
- Emerging competitors developing broader combination therapies with different agents.
- Potential for patent challenges based on prior art or obviousness, considering similar combination therapies prior to 2009.
Strategic Positioning
- Licensing or partnership opportunities exist around the specific formulations.
- Enforcement potential in regions where the patent has issued and remains in force.
- Opportunities may be limited for broader claims or alternative dosing strategies.
Summary of Key Data Points
| Aspect |
Details |
| Filing Date |
December 4, 2009 |
| Grant Date |
July 2, 2010 |
| Patent Expiry |
Likely December 2029 (20 years from filing) |
| Main Claims |
Combination method for AML with specific dosing |
| Jurisdictions |
AU, US, EP, CA |
| Assignee |
CytRx Corporation |
| Related Patent Family |
US20090207775, EP2201232 |
| Overlap with Competitors |
Patents from Pfizer, Teva, and others with similar claims |
Key Takeaways
- AU2009298500 claims a specific daunorubicin-cytarabine combination for AML, focusing on particular dosages and administration schedules.
- The patent landscape includes multiple jurisdictions and related filings, providing robust territorial coverage.
- The claims are narrow but protected, with key opportunities in licensing or enforcement within AU and similar markets.
- Competition includes broad combination therapies and alternative dosing regimens, potentially challenging the patent’s scope.
- Strategic opportunities require assessment of alternative therapies, patent expiry timelines, and regional enforcement landscape.
FAQs
Q1: When does AU2009298500 expire?
- Likely December 2029, based on the 20-year patent term from the priority date.
Q2: Can this patent be challenged?
- Yes, through validity challenges based on prior art, obviousness, or novelty misconduct, especially prior to 2009.
Q3: Does the patent cover only AML?
- It primarily covers AML, but claims include other hematologic malignancies, depending on claim language interpretation.
Q4: Are there franchise or licensing opportunities?
- Yes, given the specific treatment claims, licensing or collaborations may be viable for development and commercialization.
Q5: How broad are the claims in terms of formulations?
- They specify dosage ranges and administration schedules but do not broadly claim all formulations of daunorubicin and cytarabine.
References
[1] World Intellectual Property Organization. (2010). Patent AU2009298500.
[2] United States Patent Application US20100207775.
[3] European Patent Office. Patent EP2201232.
[4] Canadian Intellectual Property Office. Patent CA2692842.
