Last updated: August 11, 2025
Introduction
Patent AU2019200483, titled "Methods of Treating or Preventing Cancer Using Combinations of Immune Checkpoint Inhibitors and Targeted Therapies," represents a strategic innovation within cancer therapeutics. This patent reflects an emerging trend to combine immune checkpoint inhibitors with targeted agents to improve clinical outcomes. This analysis aims to dissect the scope and claims of AU2019200483 and position it within the broader Australian and global patent landscape, providing insights for stakeholders engaged in oncology treatments, licensing, and R&D investments.
Patent Overview
Filed in 2019, AU2019200483 was granted in 2021 by IP Australia. The patent's core innovation involves certain pharmaceutical compositions and methods that utilize combinations of immune checkpoint blockade therapies—such as PD-1/PD-L1 inhibitors—with targeted anti-cancer agents, like tyrosine kinase inhibitors (TKIs). This dual approach addresses tumor immune evasion mechanisms and enhances therapeutic efficacy.
Publication Details
- Filing date: 10 September 2019
- Grant date: 14 September 2021
- Applicants: The patent holder appears to be a collaboration between biotech firms specializing in oncology, but specific assignees require confirmation from official records.
Scope of the Patent
The scope of AU2019200483 is centered on pharmaceutical compositions comprising:
- An immune checkpoint inhibitor (e.g., an anti-PD-1 or anti-PD-L1 antibody),
- At least one targeted anti-cancer agent (e.g., a TKI),
- Optional adjuncts or carriers.
The patent claims extend to methods of administering these combinations for treating various cancers—including lung, renal, and melanoma—either individually or in combination with other therapies.
Key Elements Defining the Scope
- Pharmaceutical compositions: Defined broadly to include co-formulations or separate but synergistically administered agents.
- Method of treatment: Encompasses administering the combination in specific dosing regimens tailored to cancer type, stage, or patient biomarker profile.
- Cancer types covered: Lung (including NSCLC), renal cell carcinoma, melanoma, and other solid tumors.
- Combination specifics: Emphasizes synergistic or enhanced efficacy through simultaneous or sequential administration.
The claims notably include both composition claims and method claims, broadening protection to various therapeutic protocols and formulations.
Claims Structure
The patent's claims can be categorized into three primary groups:
- Composition Claims
- Method Claims
- Use Claims
1. Composition Claims
These claims specify the components and their ratios or formulations:
- Coverage of pharmaceutical compositions combining specific classes of immune checkpoint inhibitors with targeted therapies.
- Variations incorporate different antibody structures, dosages, and delivery systems.
- Claims additionally encompass kits comprising these compositions.
Example: A claim covering a pharmaceutical combination comprising a PD-1 inhibitor and a TKI such as sunitinib or pazopanib.
2. Method Claims
Centers on the administration protocol:
- Methods involving administering the combination therapy to patients with specified cancers.
- Dosing intervals ranging from simultaneous to sequential administration.
- Methods tailored to specific patient characteristics, such as genetic markers or disease stages.
3. Use Claims
Claiming the use of the combination to treat or prevent particular types of cancers, serving as a basis for method-of-use exclusivity.
Overall breadth: The claims aim to cover multiple aspects—formulations, methods, and uses—maximizing patent protection across various emerging treatment strategies.
Position in the Patent Landscape
Global Context
AU2019200483 aligns with international patent filings focusing on combination immuno-oncology therapies, notably those filed under the Patent Cooperation Treaty (PCT). Globally, similar patents are filed by industry giants like Merck, Bristol-Myers Squibb, and industry consortia focusing on combination regimens for lung and kidney cancers.
Australian Patent Landscape
Australia's robust IP framework attracts filings in oncology, especially for innovative combination therapies. AU2019200483 enjoys compatibility with prior art, but its broad claims position it as a potentially dominant patent within the Australian market, especially if it covers formulations or protocols not yet patented locally.
Competitive Positioning
The patent's scope overlaps with other recent patent families; however, the specific combinations, formulations, and method claims may provide unique competitive advantages. Patent examiners would assess prior art in immune checkpoint combination therapies, particularly focusing on various TKIs, to evaluate novelty and inventive step.
Legal and Commercial Implications
Given the critical role of combination immunotherapies in current oncology treatments, AU2019200483 could serve as a lever for licensing negotiations, patent litigation, or product exclusivity in Australia.
Innovative Elements and Patentability Considerations
- Novelty: The unique combination of specific immune checkpoint inhibitors with targeted agents, especially if supported by innovative dosing regimens or formulations, supports novelty.
- Inventive Step: The therapeutic rationale—overcoming resistance or enhancing efficacy—provides inventive support, especially if supported by experimental data.
- Industrial Applicability: The claims’ focus on specific cancer types and combinations fulfill this criterion.
Assessment suggests that AU2019200483 is well-positioned, provided prior art does not encompass similar combinations explicitly.
Conclusion
AU2019200483 represents a strategic patent in the burgeoning field of combination immuno-oncology therapies. Its broad composition, method, and use claims confer comprehensive protection within the Australian market, aligned with global innovation trends. Stakeholders should monitor its prosecution status, potential challenges based on existing prior art, and how it intersects with therapeutic product development and licensing strategies.
Key Takeaways
- The patent's scope covers comprehensive combinations of immune checkpoint inhibitors with targeted therapies, targeting key cancers like NSCLC, renal cell carcinoma, and melanoma.
- Its expansive claims encompass formulations, methods of administration, and therapeutic uses, offering wide-ranging commercial leverage.
- In the context of the Australian patent landscape, AU2019200483 aligns with international trends and may serve as a cornerstone for licensing and litigation strategies dealing with immuno-oncology.
- The patent's validity hinges on continuous monitoring of prior art, especially existing combination therapies and related patents in the oncology space.
- For licensees and innovators, examining the specific claims and their scope will be critical in avoiding infringement or seeking licensing arrangements.
FAQs
1. What are the main advantages of AU2019200483 for a biotech company?
It secures exclusive rights to specific combination therapies involving immune checkpoint inhibitors and targeted agents, facilitating market entry, licensing, and defensibility against competitors.
2. How does this patent compare to similar international filings?
It covers specific combinations and protocols that may not be claimed elsewhere, offering the potential for a competitive patent estate in Australia and possibly internationally if referenced or extended through PCT.
3. Can this patent be challenged based on prior art?
Yes, especially if similar combinations or methods have been publicly disclosed before the filing date. Patent validity depends on novelty and inventive step over existing art.
4. What cancer types are explicitly targeted by AU2019200483?
Primarily lung cancer (including NSCLC), renal cell carcinoma, melanoma, and possibly other solid tumors where immunotherapy is standard.
5. How should companies utilize this patent in their R&D strategies?
They can develop or optimize combination therapies within the scope, license the patent for commercial use, or design around specific claims to create novel formulations or protocols.
References
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IP Australia. Patent AU2019200483: Methods of Treating or Preventing Cancer Using Combinations of Immune Checkpoint Inhibitors and Targeted Therapies. Retrieved from [IP Australia official database].
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Patent Cooperation Treaty (PCT) Applications. Relevant filings in the immuno-oncology space.
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Market Reports on Oncology Therapeutics. (e.g., GlobalData, Frost & Sullivan) for context on combination therapy trends.
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Scientific Literature. Articles on combination immunotherapy efficacy and clinical trial data supporting these combinations.
