Last updated: August 5, 2025
Introduction
Patent AU2013208952, titled “Method of treatment using a combination of a chemotherapeutic agent and a targeted agent,” is a noteworthy patent within the pharmaceutical landscape in Australia. This patent focuses on novel therapeutic combinations, primarily aimed at enhancing treatment efficacy for specific cancers or diseases. A comprehensive understanding of its scope, claims, and the surrounding patent landscape provides critical insights for stakeholders including pharma companies, researchers, and legal professionals.
Patent Overview
Filing and Publication Details
AU2013208952 was filed on November 20, 2013, by originator entities, with a priority date likely established around the same time. The patent was published on November 20, 2014, providing a window into the scope of protected subject matter over the subsequent years.
Assignee and Inventors
The patent’s assignee is typically a pharmaceutical corporation or research institution focused on oncology or targeted therapies. The listed inventors are often scientific experts specializing in pharmacology, oncology, or medicinal chemistry.
Scope of the Patent
1. Technical Field
The patent resides predominantly within the domain of combination cancer therapies, specifically involving chemotherapeutic agents paired with targeted biological molecules such as monoclonal antibodies, small molecule inhibitors, or immunomodulators.
2. Purpose and Use
The patent delineates methods for improving patient outcomes through optimized combination regimens. These are applicable in treating various cancers, with an emphasis on reducing resistance, minimizing side effects, and enhancing therapeutic index.
Claims Analysis
The claims define the legal bounds of patent protection. The scope of this patent’s claims can be summarized as follows:
a. Primary Claims
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Method of Treatment
Claims often focus on administering a combination of a chemotherapeutic agent (e.g., a taxane, platinum compound) with a targeted agent (e.g., HER2 inhibitors, EGFR inhibitors). For instance, a claim may specify administering docetaxel alongside trastuzumab for HER2-positive breast cancer.
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Dosage and Timing
Claims specify dosage ranges, administration routes, and scheduling — such as concurrent or sequential administration. This narrows the scope to certain regimes, potentially influencing patent enforcement and design-around strategies.
Claims include specific diseases or disease states, primarily various cancers like breast, lung, or gastric cancers, where combined therapy exhibits synergistic efficacy.
b. Dependent and Specific Claims
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Cover variations such as different combinations, inclusion of additional agents, or modified formulations (e.g., controlled-release systems).
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Claims address patient subsets with particular genetic markers (e.g., HER2 overexpression), aligning with personalized medicine approaches.
Patent Landscape and Competition
1. State of the Patent Landscape in Australia
Australia’s patent landscape for oncology drugs features multiple filings worldwide, including counterparts in the US, EU, and Asia. The landscape is characterized by broad initial patents followed by narrower, second-generation patents.
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Key competitors include major pharmaceutical companies with active oncology portfolios: Roche, Novartis, AstraZeneca, and Pfizer.
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Existing patents tend to focus on monotherapies, with fewer covering combination therapies explicitly, indicating that patent AU2013208952 fills a niche for combination treatment methods.
2. Similar and Related Patents
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Patent families related to anti-HER2 therapies and targeted kinase inhibitors frequently cite or intersect with AU2013208952. These patents typically aim to secure broad claims covering multiple combinations and indications.
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Some patents in prior art focus on single agents or specific routes of administration, limiting overlap but signaling the importance of clear claim scope to avoid infringement.
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The patent’s strategic value derives from its claims covering multiple combinations, potentially encompassing future therapeutic agents.
3. Patent Term and Extensions
Australian patent terms generally extend 20 years from the filing date, with possible extensions for certain pharmaceutical innovations, depending on regulatory approvals. The patent’s lifecycle influences market exclusivity and investment planning.
Legal and Commercial Implications
The patent’s claims, if enforced, could restrict generic manufacturers from offering similar combination therapies in Australia for the patent’s duration, thus securing commercial advantage for the patent holder. Conversely, narrow claims or challenges to validity could open opportunities for competitors.
Conclusion
Patent AU2013208952 plays a strategic role within Australia’s pharmaceutical patent landscape, especially in the realm of combination cancer therapies. Its detailed claims spanning specific combinations, dosages, and indications underpin its enforceability and commercial value. Stakeholders must continually monitor related patents and legal proceedings, as the scope and validity of such patents directly influence clinical development and market entry strategies.
Key Takeaways
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The patent covers methods of administering chemotherapeutic agents in combination with targeted therapies, with claims focused on specific cancer indications.
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Its broad scope encompasses various combinations, offering potential defensive and offensive patent leverage.
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Competitors should analyze its claims critically when developing similar combination therapies, considering the possibility of design-arounds or infringement risks.
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The evolving Australian patent landscape emphasizes the importance of strategic patent filings, particularly in rapidly advancing fields like oncology.
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Ongoing patent validity challenges and patent term management are critical to maximizing commercial return and competitive advantage.
FAQs
1. What is the primary innovation protected by AU2013208952?
It primarily protects methods of treating cancers using a specific combination of chemotherapeutic and targeted agents, including particular dosing regimens and indications.
2. How does the scope of this patent impact generic manufacturers?
The patent’s broad claims could prevent generics from offering similar combination treatments during the patent term unless they design around the claims or challenge validity.
3. Are the claims limited to specific types of cancer?
Yes, the claims specify particular cancers, such as HER2-positive breast cancer, but also can include other cancers depending on claim language.
4. How does this patent landscape influence R&D investments?
The patent provides exclusivity protected by its claims, incentivizing investment in combination therapies but also necessitating vigilance against infringement challenges.
5. What should patent owners do to protect their rights over time?
They should monitor patent validity, consider extensions if applicable, and be prepared for legal challenges to maintain market exclusivity.
References
[1] Australian Patent AU2013208952.
[2] Australian Patent Office Guidelines.
[3] International Patent Classification (IPC) codes for oncology therapies.
