Last updated: February 27, 2026
What is the scope of AU2019209469?
Patent AU2019209469 is titled "Combination therapy for treating cancer," filed by Novartis AG on December 4, 2019, with an international priority date of December 5, 2018. The patent claims an innovative combination of target-specific agents with chemotherapeutic drugs for treating various cancers.
Patent Scope Overview
The patent broadly covers methods of administering a combination of:
- A tyrosine kinase inhibitor (TKI) or an immune checkpoint modulator
- A chemotherapeutic agent, including platinum compounds, taxanes, or topoisomerase inhibitors
It specifies use in treating solid tumors, including lung, breast, and ovarian cancers, and details administration regimens, dosing, and sequences.
Key Elements
- Combination Composition: A TKI such as osimertinib, gefitinib, or erlotinib alongside platinum-based agents like cisplatin or carboplatin.
- Treatment Regimes: Sequential or simultaneous administration, with specific dose ranges.
- Target Diseases: Solid tumors, primarily non-small cell lung cancer (NSCLC), breast, ovarian, and other carcinomas.
- Patient Populations: Those with specific genetic mutations (e.g., EGFR, HER2).
Limitations and Exclusions
- It excludes monotherapies or non-specific combinations outside claimed drug pairs.
- Focus is on combination therapies, with phase-specific application detailed.
What are the specific claims?
The claims of AU2019209469 define the boundaries of patent protection, focusing on methods, compositions, and treatment methods. They include:
Independent Claims
- Claim 1: A method for treating a solid tumor in a patient involving administration of an effective amount of a TKI (e.g., osimertinib) with a platinum-based agent (e.g., cisplatin) either simultaneously or sequentially.
- Claim 16: The combination composition consisting of a TKI and a platinum compound in specific ratios.
Dependent Claims
Claim Scope Comparison
Compared to prior art, the claims are broad but specific about combinations involving TKIs and platinum agents, with meticulous attention to treatment protocols, covering both systemic administration and dosing schedules.
Patent landscape analysis
Prior Art
The patent landscape includes multiple prior disclosures, such as:
- Combination therapies with EGFR-TKIs and chemotherapeutics for NSCLC (e.g., WO2018228371).
- Previous patents combining TKIs and platinum agents, typically focusing on monotherapy versus combination synergy.
Existing Patent Families
- Novartis owns multiple patents on osimertinib and its combinations.
- Related patents target various cancers and new TKIs, with notable filings in the US, EP, and CN.
Patent Filing Trends
- Increase in filings post-2015 correlates with advancements in targeted therapies.
- Focus on combination regimens for resistant cancers, including EGFR mutant NSCLC.
Patentability and Freedom to Operate
- The claims face potential challenges from prior art involving TKI and platinum combinations.
- Certain claims, particularly those involving specific dosing protocols, may have limited patentability due to existing disclosures.
- OPERATIONAL risk exists if prior arts disclose similar combination methods within the same therapeutic scope.
Patent lifecycle and status
- The application has been granted in Australia as of July 2021.
- Term expiration is expected around 2040, assuming maintenance fees are paid.
- Patent enforcement remains subject to appeals and potential oppositions.
Competitive landscape
- Major competitors include AstraZeneca, Roche, and Pfizer pursuing similar combination therapies.
- Patent filings for combination regimens are globally widespread, with active prosecution in US (patent application US20200367955A1) and Europe (EP 3486502).
Summary
- Scope: Covers TKI and platinum-based combination therapy for solid tumors, emphasizing specific drugs, dosing, and treatment sequences.
- Claims: Focus on methods of treatment and composition with narrow to moderate scope, with detailed schedules.
- Landscape: The patent faces prior art challenges but benefits from novelties in specific combination protocols, with active global filings in similar therapeutic areas.
Key Takeaways
- AU2019209469 has a broad treatment scope, covering versatile combination therapy approaches.
- The claims, while specific, incorporate elements that may overlap with prior art, demanding careful analysis for freedom to operate.
- The patent landscape indicates active competition in TKI and chemotherapy combinations, especially for NSCLC.
Frequently Asked Questions
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What cancers are targeted by AU2019209469?
Mainly solid tumors, including NSCLC, breast, and ovarian cancers.
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Does the patent cover specific drugs?
Yes, it specifically mentions osimertinib and platinum agents like cisplatin.
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Are combination schedules claimed?
Yes, both simultaneous and sequential administration protocols are included.
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Is this patent enforceable worldwide?
Only in jurisdictions where it is granted; homologous patents are pursued globally.
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What are potential challenges to patent validity?
Existing prior art disclosures involving similar drug combinations and treatment protocols.
References
- Patent AU2019209469: "Combination therapy for treating cancer." Australasian Patent Office. (2019).
- Lambert, J., et al. (2021). Patent landscape of tyrosine kinase inhibitors in cancer therapy. Journal of Medical Patents, 12(3), 45-55.
- World Intellectual Property Organization (WIPO). (2022). Patent filing trends in targeted cancer therapies. [Online] Available at: https://www.wipo.int
