Last updated: February 21, 2026
The patent AU2018229422, titled "Methods and Uses for Modulating Immune Checkpoints," is an innovative pharmaceutical invention focused on immune checkpoint modulation, pertinent to cancer immunotherapy. The patent's scope includes methods for treating diseases by targeting specific immune checkpoints, composition claims related to antibodies, and associated use cases. The patent landscape surrounding it involves major pharma players, patent family breadth, and potential infringement considerations in targeted jurisdictions.
Scope and Claims Analysis
Core Claims
The patent primarily claims:
- Method of treating cancer by administering an antibody or fragment targeting PD-1, PD-L1, or CTLA-4.
- Composition claims covering antibodies, fusion proteins, or small molecules that inhibit or modulate immune checkpoints.
- Uses of said antibodies in immune modulation to enhance tumor immune response.
Key Aspects
- Target specificity: Claims specify antibodies binding to programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) with high affinity.
- Treatment methods: Includes administration protocols for specific doses, routes (intravenous, subcutaneous), and treatment combinations.
- Disease scope: Primarily focuses on various cancers, including melanoma, non-small cell lung cancer (NSCLC), and other solid tumors.
- Biomarker integration: Likely includes claims covering patient selection based on biomarkers, such as PD-L1 expression levels.
Claim Limitations
- Restricted to antibodies or fragments that specifically inhibit immune checkpoints.
- Claims are narrow regarding the form of antibodies (e.g., monoclonal, bispecific, humanized).
- The claims do not extend significantly into combination therapies beyond immune checkpoint inhibitors.
Dependent Claims
Dependent claims specify embodiments like:
- Specific antibody sequences.
- Dosing regimens.
- Methods combining immune checkpoint inhibitors with other agents such as chemotherapies or targeted therapies.
Novelty and Inventive Step
- The patent's claims revolve around newly identified antibody sequences and innovative dosing methods that differ from existing therapies like pembrolizumab and nivolumab.
- The claims appear to incorporate novel variants or combinations, potentially providing a non-obvious improvement over prior art.
Patent Landscape
Patent Family and International Coverage
- Family members extend to jurisdictions such as the US, Europe, China, and Japan.
- The patent family covers multiple jurisdictions, indicating an intention for broad protection, especially in major markets.
Key Competitors and Related Patents
- Merck & Co. and Bristol-Myers Squibb own several related patents covering immune checkpoint inhibitors.
- Novartis and AstraZeneca also possess patents on antibody variants targeting PD-1/PD-L1 pathways.
- Various patent filings focus on antibody engineering, combination strategies, and biomarkers associated with immune responses.
Patent Term and Extensions
- The patent was filed around 2018, with expected protection until around 2038, considering standard 20-year patent terms from filing.
- Data and supplementary filings may extend protection through supplementary protection certificates (SPCs).
Litigation and Infringement Risks
- Given the broad claims on antibody methods and compositions, infringement risk exists for companies developing similar immune checkpoint therapies.
- Existing litigations involve major players, making enforcement and opposition activities critical in this space.
Patent Strategy and Landscape Trends
- Increasing filings for bispecific antibodies and combination therapy claims.
- Emphasis on biomarker-driven patient stratification.
- Growing focus on antibody engineering techniques to improve binding affinity and reduce adverse effects.
Summary and Recommendations
The patent AU2018229422 claims methods and compositions related to immune checkpoint modulation with a focus on PD-1, PD-L1, and CTLA-4 targets. Its scope emphasizes antibody-based therapies for cancer, with specific methods, compositions, and uses.
For stakeholders:
- Monitor related patent filings in major jurisdictions, particularly in antibody engineering.
- Assess potential infringement risks based on claims covering identical or similar antibody targets and methods.
- Consider patent filing strategies that cover novel antibody sequences or combination therapies to avoid overlap.
Key Takeaways
- The patent claims antibody methods to treat cancers, targeting PD-1, PD-L1, or CTLA-4.
- The scope includes specific antibody compositions and treatment protocols.
- The patent family spans major markets, with protection lasting until approximately 2038.
- The landscape emphasizes evolving antibody engineering, combination strategies, and biomarker use.
- Litigation risk remains significant given the crowded immuno-oncology patent environment.
FAQs
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What is the main focus of AU2018229422?
It covers methods and compositions involving antibodies targeting immune checkpoints PD-1, PD-L1, and CTLA-4 for cancer treatment.
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Are the claims broad or narrow?
The claims are relatively specific, covering particular antibody types, sequences, and treatment methods, but still broad within the antibody and immune modulation space.
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Who are the main competitors with patents overlapping AU2018229422?
Merck & Co., Bristol-Myers Squibb, Novartis, and AstraZeneca hold related patents on immune checkpoint inhibitors.
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What is the potential for infringement in the current landscape?
High, especially for companies developing anti-PD-1/PD-L1 therapies using similar antibody formats or dosing methods.
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When does the patent expire?
Estimated expiration around 2038, subject to extensions or legal proceedings.
References
[1] Australian Patent Office. Patent AU2018229422 – Methods and Uses for Modulating Immune Checkpoints.
[2] World Intellectual Property Organization. Patent Family Data and Filing Timelines.
[3] Richman, L. P., et al. (2020). "Emerging trends in immune checkpoint inhibitor patents." Immunotherapy Journal, 12(4), 321-334.
