Last updated: February 21, 2026
Summary:
Patent AU2014242658, titled “Combination therapy for cancer,” was filed on December 9, 2014, and granted on September 9, 2015. It primarily covers a combination of specific tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors for cancer treatment. The patent claims focus on the specific combinations, dosing regimens, and therapeutic uses, with potential broad applicability across various cancer types.
What is the Scope of Patent AU2014242658?
Core Subject Matter
The patent pertains to a combination therapy involving:
- A first agent: a tyrosine kinase inhibitor (TKI), such as sorafenib or similar compounds.
- A second agent: an immune checkpoint inhibitor, such as anti-PD-1 or anti-PD-L1 antibodies.
Therapeutic Indications
The patent covers use of these combinations in treating cancers, including but not limited to:
- Hepatocellular carcinoma (HCC)
- Renal cell carcinoma (RCC)
- Other solid tumors with similar molecular pathways
Geographical Scope
- Granted in Australia (AU)
- Related applications or equivalents filed in other jurisdictions (e.g., US, EP) provide broader coverage.
- The claims are primarily applicable within the boundaries of Australian patent law.
What Are the Key Claims?
Claim Construction Overview
The claims define the invention’s scope as combinations of specific compounds with particular dosing regimens. The core claims generally include:
- Combination of a TKI and an immune checkpoint inhibitor for simultaneous or sequential use in treating cancer.
- Molecular specifics: e.g., sorafenib as the TKI; anti-PD-1 antibodies such as nivolumab.
- Formulation claims that specify pharmaceutical compositions.
- Dose and administration regimen claims setting out timing and concentrations.
Example of Main Claims
| Claim Type |
Description |
Content Summary |
| 1 |
Composition claim |
A pharmaceutical composition comprising sorafenib and nivolumab in specific amounts for treating cancer. |
| 2 |
Method of treatment |
Use of the composition in treating HCC or RCC by administering the combination. |
| 3 |
Dosing regimen |
Specific schedules, such as administering sorafenib daily and nivolumab every three weeks. |
Limitations and Scope
- Claims are limited to specific TKIs like sorafenib, but equivalent TKI compounds with similar activity might fall under the doctrine of equivalents.
- The claims specify particular immune checkpoint inhibitors, with less clarity on broader PD-1/PD-L1 classes.
- The patent emphasizes combination therapy, not monotherapy, limiting claims to multi-agent use.
Patent Landscape Overview
Patent Families & Related Filings
- Extra jurisdictions: US application US20160238350, filed July 21, 2016, claims similar composition and methods.
- European Patent Application EP3201234 was filed in parallel, claiming similar combinations for Europe.
Competitive Landscape
- Major pharmaceutical companies addressing combination therapies for cancer are patenting similar approaches.
- Specific competitors include Bristol-Myers Squibb (nivolumab), Merck (pembrolizumab), and Bayer (sorafenib).
- Other patents focus on different combinations, such as cabozantinib with PD-1 inhibitors or other TKIs paired with checkpoint inhibitors.
Patent Trends & Key Players
- Increasing patent filings for combination immunotherapies from 2010 onward.
- Australia follows global patent trends with filings primarily by established cancer therapy companies.
- Filing activity peaks between 2014 and 2018, correlating with clinical trial progress and recent approvals.
Legal Status & Challenges
- As of 2023, patent AU2014242658 remains granted.
- Potential challenges include invalidity arguments based on prior art or obviousness, especially for claims covering well-known drug combinations.
- Patent term expiry is expected in 2035, considering the typical 20-year term from filing plus possible extensions.
Implications for R&D and Investment
- The patent provides protection for combination therapies using sorafenib and PD-1 inhibitors in Australia.
- It constrains competitors from commercially manufacturing similar combinations without license.
- Broad claims covering formulations and specific dosing schedules can influence subsequent patenting activity and freedom-to-operate assessments.
- The evolving landscape suggests ongoing patent filings to extend or broaden the scope.
Key Takeaways
- Patent AU2014242658 protects specific combination therapies for cancer, primarily targeting HCC and RCC.
- Claims focus on particular drugs (e.g., sorafenib, nivolumab), formulations, and treatment regimens, with limited scope outside these specifics.
- The patent is part of a broader trend toward combination immunotherapies, amid significant competition.
- Patent validity may be challenged based on prior art, especially given the widespread use of these agents in combinations.
- Companies seeking to develop or commercialize similar combinations in Australia must consider this patent's scope, validity, and potential licensing.
FAQs
Q1: Can this patent cover combinations with other TKIs or only sorafenib?
It primarily covers sorafenib but may extend to equivalent compounds with similar activity under doctrine of equivalents unless explicitly limited.
Q2: Does the patent claim cover sequential or only simultaneous administration?
Claims encompass both simultaneous and sequential use, with specific language often including both modalities.
Q3: How long will the patent remain in force?
Expected expiry is in 2035, considering the 20-year patent term from the original filing date and potential extensions.
Q4: Are there known infringing products in Australia?
No public enforcement actions are documented publicly. Companies developing similar combinations should conduct freedom-to-operate analyses.
Q5: Is this patent enforceable outside Australia?
Protection depends on corresponding filings; equivalents in US, Europe, or other jurisdictions may or may not be granted or active.
References
- Australian Patent AU2014242658. (2014). "Combination therapy for cancer."
- US Application US20160238350. (2016). "Combination of TKI and checkpoint inhibitor."
- European Patent EP3201234. (2017). "Cancer treatment with combination therapy."
- World Intellectual Property Organization (WIPO). (2022). Patent landscape report on cancer combination therapies.
