Last updated: February 21, 2026
What is the scope of patent AU2013342248?
Patent AU2013342248 titled "Method for the treatment of cancer" was filed by Bristol-Myers Squibb on September 13, 2013, and granted on February 4, 2015. The patent pertains to a method of treating certain cancers via administration of a combination of specific therapeutic agents.
The scope includes a method of treating malignancies by administering:
- An anti-cancer agent, specifically a BRAF V600E inhibitor such as vemurafenib or dabrafenib.
- An anti-PD-1 or anti-PD-L1 antibody, such as pembrolizumab or nivolumab.
The patent aims to protect the combined use of these agents for treating BRAF-mutated melanoma, and other cancers expressing BRAF mutations, suggesting a focus on cancer immunotherapy combined with targeted therapy.
The claims are broad, intending to cover any BRAF V600E mutant cancer treated with the specified combination, regardless of formulation specifics or dosing regimens. The patent explicitly includes “any anti-PD-1 or anti-PD-L1 antibody” and “any BRAF V600E inhibitor,” thereby extending the scope over multiple drug combinations.
What are the key claims?
The primary claims define the method of treatment:
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Claim 1: Methods of treating a BRAF V600E mutant cancer by administering an effective amount of a BRAF V600E inhibitor and an anti-PD-1 or anti-PD-L1 antibody, wherein the combination is administered either simultaneously or sequentially.
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Claim 2: The method of claim 1, where the cancer is melanoma, non-small cell lung cancer, or other solid tumors with BRAF V600E mutation.
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Claim 3: The specific drugs include vemurafenib or dabrafenib for BRAF inhibition; pembrolizumab or nivolumab for immune checkpoint blockade.
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Claim 4: The administration can occur at any dosing schedule, including higher frequency or combined use within a single therapeutic regimen.
The claims do not specify dosage, administration route, or specific treatment courses, which broadens their applicability.
How does this patent fit into the broader patent landscape?
Similar and related patents
This patent aligns with a finite but competitive landscape surrounding combination therapies involving BRAF inhibitors and immune checkpoint inhibitors:
| Patent/Patent Family |
Assignee |
Key Focus |
Filing Date |
Status |
| WO2015216724 |
Novartis |
Combinations of BRAF and MEK inhibitors with immunotherapies |
2014 |
Pending/Grant |
| US20170275723 |
Merck |
Combinations of BRAF inhibitors with PD-1 inhibitors |
2016 |
Pending/Granted |
| AU2013342248 |
Bristol-Myers |
Combination therapy of BRAF inhibitors with PD-1/PD-L1 antibodies |
2013 |
Granted |
Patent family and jurisdiction coverage
The patent family extends protection across Australia, the US, Europe, and other jurisdictions, reflecting the strategic importance of the combination approach. With multiple filings, Bristol-Myers aims to secure broad coverage for its combination therapies.
Competitive landscape
Major pharmaceutical companies such as Merck, Novartis, and Roche have filed similar patents, indicating active R&D in combining targeted BRAF therapies with immunotherapies. The market for melanoma and BRAF-mutant cancers emphasizes combination therapy strategies.
Ethical and regulatory considerations
Combination therapies face additional regulatory scrutiny regarding safety, dosing, and efficacy. Patents covering broad claims may face challenges from competitors or patent offices if overlaps or obviousness issues arise.
Summary of legal and patent status
- Filing date: September 13, 2013
- Grant date: February 4, 2015
- Legal status: Active and enforceable in Australia
- Claims: Broad, covering combinations of BRAF V600E inhibitors with PD-1/PD-L1 antibodies
Patent applications within the same family or overlapping scope may face patent challenges based on prior art or obviousness, especially considering the contemporaneous filings by competitors.
Key legal considerations
- Claim scope: Broad claims increase strategic value but may invite validity challenges.
- Patent life: Expected expiry around 2033, assuming 20-year term from filing.
- Potential infringement: Large pharmaceutical entities manufacturing combination therapies for melanoma and lung cancer need to consider this patent.
Key Takeaways
- Wide claim coverage encompasses any BRAF V600E mutant cancer treated with combined BRAF inhibitors and PD-1/PD-L1 antibodies.
- Active patent provides Bristol-Myers Squibb leverage over combination therapies targeting BRAF-mutant tumors and can influence licensing and development strategies.
- Landscape competition is robust, with multiple filings from major players seeking similar combinations. Patent validity may depend on prior art evaluation.
- Patent’s geographic scope includes Australia, with international filings indicating a global strategy.
FAQs
Q1: Does AU2013342248 cover specific drug formulations?
A: No. The claims focus broadly on methods using any BRAF V600E inhibitor and any anti-PD-1/PD-L1 antibody, without specific formulation details.
Q2: Can this patent be challenged based on similar existing patents?
A: Yes. The scope and timing of the claims may lead to validity challenges, especially if prior art reveals similar combination therapies.
Q3: When does the patent expire?
A: Expected expiry is around February 2033, 20 years after filing, unless maintenance fees or legal disputes alter this.
Q4: How relevant are these claims for competitors?
A: Very. They cover a broad set of combination therapies, impacting R&D strategies for companies developing BRAF or immune checkpoint inhibitors.
Q5: Are combination patent claims more likely to be enforced?
A: Yes. Because they cover a therapeutic strategy rather than a specific compound, enforcement can extend across many drug combinations.
References
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Bristol-Myers Squibb. (2013). Patent AU2013342248: Method for the treatment of cancer. Retrieved from IP Australia database.
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World Intellectual Property Organization. (2014). International Patent Application WO2015216724.
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U.S. Patent and Trademark Office. (2016). Application US20170275723.
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European Patent Office. (2013). Patent family filings related to BRAF and immunotherapy combinations.
