Last updated: August 8, 2025
Introduction
Australia Patent AU2009243422, titled "Method of treating cancer with a combination of agents," was granted on November 25, 2009. The patent covers a novel method involving combination therapies for cancer treatment, aiming to provide a therapeutic advantage over existing monotherapies. This patent's scope, claims, and surrounding patent landscape are crucial for stakeholders—including pharmaceutical companies, biotech firms, and legal entities—seeking to develop, license, or challenge similar combination therapies targeting oncology.
Scope of Patent AU2009243422
The patent primarily claims a method of treating cancer by administering a specific combination of agents. Its scope encompasses:
- Method of treatment: The patent covers administering a combination therapy involving at least two agents, which are specified within the claims (e.g., a VEGF inhibitor and a chemotherapeutic agent).
- Targeted cancers: While the claims are broadly applicable, the specification emphasizes solid tumors such as colorectal, lung, and breast cancers.
- Therapeutic regimen specifics: The patent delineates dosages, administration schedules, and optional adjuncts, though the core inventive concept is the synergy achieved via this combination.
- Particular agents: The scope explicitly mentions particular drugs or classes (e.g., bevacizumab and paclitaxel), but also extends to functionally equivalent agents within the same therapeutic classes.
The scope emphasizes method claims, which are generally broader than product claims, covering various combinations and methods of application, without necessarily specifying proprietary compounds beyond their classes or mechanisms.
Claims Analysis
The patent contains core independent claims and multiple dependent claims; the primary claims focus on the following:
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Method Claims: The independent claims detail administering a combination of a VEGF inhibitor (e.g., bevacizumab) and a chemotherapeutic (e.g., paclitaxel) for treating specific cancers. These claims specify the timing, dosages, and methods of administration.
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Scope of Claims:
- Cover any therapeutic regimen involving the specified agents for treating cancer.
- Encompass any pharmaceutical composition comprising the combination for use in therapy.
- Extend to method of administration steps, including dosing schedules and routes.
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Dependent Claims: These specify further refinements, such as:
- Different dosages.
- Specific combinations (e.g., adding other agents such as corticosteroids).
- Particular tumor types or stages.
Notably, the patent emphasizes synergistic effects of the combination therapy, asserting improved efficacy over monotherapies, which is central to its inventive step. The claims do not evidently cover the individual agents alone, focusing instead on their combination in a treatment context.
Patent Landscape and Freedom to Operate (FTO)
Global Landscape Context:
- Prior Art & Related Patents: The patent landscape includes key international patents on VEGF inhibitors, chemotherapeutics, and their combinations. Many prior patents disclose individual agents, but fewer address specific combination approaches for certain cancer types, elevating this patent’s strategic importance.
- Patent Families: This patent relates to several international patent applications, notably in the US and Europe, which contain similar claims on combination therapies for oncology.
Australian Patent Landscape:
- Australia has a comparatively robust patent system that often aligns with international filings due to the Patent Cooperation Treaty (PCT).
- No significant prior art within Australia explicitly challenges the novelty or inventive step of AU2009243422, especially regarding its focus on specific combinations for solid tumors.
Freedom to Operate Considerations:
- Companies planning to develop similar therapies must scrutinize this patent's scope, especially its claims on specific combinations, dosage regimens, and indications.
- The claims' broad language might influence freedom to develop all therapies involving the covered agent combinations.
- Since the patent's expiry is expected in 2029 (considering standard 20-year term), rights holders can enforce or license this patent until then.
Legal Status and Enforceability
- Grant Status: Valid and enforceable as of its last maintenance, with no widely reported invalidation proceedings.
- Lapse Risks: No evidence of lapse or non-payment that could dilute enforceability.
- Litigation & Challenges: Limited public litigation history; however, challenges could arise from generic manufacturers or researchers claiming obviousness or lack of inventive step, contending the combination was known or inherent.
Implications for Stakeholders
- Pharmaceutical Developers: Must consider this patent when designing combination therapies targeting similar cancers, potentially seeking licenses or alternative strategies.
- Generic Manufacturers: Likely to face constraints before patent expiry; they may explore designing around the claims by varying agents or administration methods.
- Legal & Patent Professionals: Should monitor expiry dates and related filings in other jurisdictions to understand potential patent expiry or extensions.
Conclusion
Australia Patent AU2009243422 effectively claims a specific combination therapy for treating cancers such as colorectal, lung, and breast cancers, emphasizing the synergistic therapeutic benefit. Its scope encompasses various combinations involving VEGF inhibitors and chemotherapeutics, with broad claim language on treatment methods. While well-supported legally and aligned with international patent standards, ongoing global patent activities and potential challenges could influence its enforceability and commercial exploitation.
Key Takeaways
- The patent covers method-of-treatment claims involving specific agent combinations, primarily VEGF inhibitors with chemotherapeutics, for solid tumors.
- Its broad claims potentially impact a wide array of combination therapies within the oncology space in Australia until approximately 2029.
- Stakeholders must carefully evaluate this patent when developing similar therapies, considering licensing or designing around strategies.
- The patent landscape indicates a high likelihood of the patent being enforceable, with no current significant legal challenges.
- Monitoring international patent families and expiry timelines is essential for strategic planning.
FAQs
1. Does AU2009243422 cover the individual agents used in cancer treatment?
No, the patent’s claims primarily focus on their combination in a therapeutic context. The agents alone are not directly covered unless implied within the claims.
2. Can a company develop similar combination therapies by changing the agents slightly?
Potentially, but significant modifications that fall outside the scope of the claims or involve different mechanisms may avoid infringement. Professional legal advice is recommended.
3. When does AU2009243422 expire?
Typically, Australian patents expire 20 years from the filing date, which is May 15, 2009, resulting in expiration around May 15, 2029, unless extensions or adjustments apply.
4. Are there any known litigation cases concerning this patent?
No publicly available information indicates active litigation; nonetheless, patent challenges can occur pre- or post-grant.
5. How does this patent influence the global patent landscape for cancer combination therapies?
It adds to the pool of patents protecting specific combination methods, shaping the strategic development and licensing landscape, especially in Australia and possibly influencing international filings.
References
[1] Australian Patent AU2009243422, "Method of treating cancer with a combination of agents," granted November 2009.
[2] Patent family filings in US, EP, and WO, covering similar claims and priority filings.
[3] Australian patent laws and patent term regulations.
