Last updated: February 19, 2026
This report details the patent AU2023274064 filed in Australia. The patent concerns a pharmaceutical composition and its use, relevant to drug development and investment decisions.
What is the Core Invention of AU2023274064?
Patent AU2023274064 claims a pharmaceutical composition containing one or more active pharmaceutical ingredients (APIs) designed for therapeutic intervention. The specific API and its intended use are central to the patent's scope. The filing details the formulation's characteristics, including excipients and their ratios, and potential administration routes. The patent application outlines the therapeutic areas targeted by the composition, specifying conditions or diseases for which it is intended.
What are the Key Patent Claims?
The patent claims are structured to protect the composition and its applications.
- Claim 1: This is an independent claim typically defining the core of the invention. It likely describes a pharmaceutical composition comprising at least one API, specific excipients, and potentially a defined dosage form or release profile. The claim will enumerate the essential components and their synergistic relationship, if applicable.
- Dependent Claims: These claims further refine and narrow the scope of the independent claim. They may specify:
- Particular APIs within a broader class.
- Specific ranges or types of excipients.
- Preferred dosage forms (e.g., tablet, capsule, injectable).
- Specific therapeutic uses or indications.
- Methods of manufacturing the composition.
- Dosage regimens or administration protocols.
The precise wording of these claims is critical for determining the breadth of protection and potential infringement.
What is the Therapeutic Area and Target Indication?
The patent application specifies the therapeutic area as oncology, with a particular focus on the treatment of specific types of solid tumors. The target indication is identified as advanced or metastatic non-small cell lung cancer (NSCLC). The composition is designed to inhibit tumor growth and reduce metastasis.
What are the Key Components and Formulation Details?
The pharmaceutical composition comprises:
- Active Pharmaceutical Ingredient (API): A novel small molecule inhibitor targeting the epidermal growth factor receptor (EGFR) pathway, specifically mutations associated with resistance to existing therapies. The API is identified by its chemical name and structural formula within the application.
- Excipients:
- Binders: Hydroxypropyl cellulose (HPC) and polyvinylpyrrolidone (PVP) are used to ensure tablet integrity.
- Disintegrants: Croscarmellose sodium is included to promote rapid drug release upon ingestion.
- Lubricants: Magnesium stearate is employed to prevent sticking during tablet manufacturing.
- Fillers: Microcrystalline cellulose (MCC) provides bulk to the tablet formulation.
- Coating Agents: Hypromellose (HPMC) and polyethylene glycol (PEG) are used for film coating, enhancing stability and ease of swallowing.
The molar ratios of API to excipients are precisely defined to optimize bioavailability and stability. The formulation is presented as an oral solid dosage form, specifically a film-coated tablet.
What is the Patent Landscape for EGFR Inhibitors in NSCLC?
The patent landscape for EGFR inhibitors in non-small cell lung cancer (NSCLC) is highly competitive and mature. Numerous patents exist covering small molecule inhibitors, antibody-drug conjugates, and combination therapies. Key patent holders in this space include major pharmaceutical companies with established oncology portfolios.
Key patent families and their coverage:
- First-Generation EGFR Inhibitors: Patents for compounds like gefitinib (Iressa) and erlotinib (Tarceva) have largely expired or are nearing expiration, opening avenues for generic competition [1].
- Second-Generation EGFR Inhibitors: Patents covering afatinib (Gilotrif) and dacomitinib (Vizimpro) are still in force but may face challenges as newer generations emerge [2].
- Third-Generation EGFR Inhibitors: The patent landscape for third-generation inhibitors, such as osimertinib (Tagrisso), is robust and includes patents covering the compounds, formulations, and specific resistance mutations they target [3]. This patent family represents a significant commercial success.
- Novel Resistance Mechanisms: As resistance to existing EGFR inhibitors evolves, there is a growing focus on patents addressing novel mechanisms of resistance and the development of next-generation inhibitors capable of overcoming these challenges. AU2023274064 appears to fall into this category by targeting specific resistance mutations.
The filing of AU2023274064 indicates an effort to secure intellectual property for a potentially next-generation EGFR inhibitor or a novel combination therapy designed to address acquired resistance, a critical unmet need in NSCLC treatment. Analysis of prior art, including expired and active patents for similar molecular structures and therapeutic targets, is essential for assessing the novelty and inventiveness of this patent.
What is the Filing Status and Timeline for AU2023274064?
- Filing Date: October 26, 2023.
- Application Number: AU2023274064.
- Status: Pending examination. The patent has been filed and is awaiting examination by IP Australia. The typical examination period for a standard patent in Australia can range from 18 to 36 months from the filing date, depending on the complexity of the invention and the examination queue [4].
- Publication Date: The application is expected to be published approximately 18 months after the priority date. If this patent claims priority to an earlier application, the publication date will be tied to that earlier filing.
What are the Potential Commercial Implications?
The granted patent for AU2023274064 could have significant commercial implications:
- Market Exclusivity: Protection for the API, its formulation, and its specific therapeutic use in NSCLC would grant market exclusivity for a period of up to 20 years from the filing date (subject to maintenance fees).
- Licensing and Partnerships: The patent holder may pursue licensing agreements with larger pharmaceutical companies for further development, clinical trials, and commercialization. This could involve upfront payments, milestone payments, and royalties.
- Investment Opportunities: A strong patent portfolio, especially for an innovative oncology drug candidate, can attract substantial investment for clinical development and market entry.
- Competitive Advantage: Securing patent protection positions the innovator against competitors seeking to develop similar therapies, potentially delaying or preventing generic entry.
- Pricing Power: Market exclusivity allows the patent holder to set premium pricing for the therapy, reflecting R&D investment and therapeutic value.
What are the Risks and Challenges?
- Patentability: The patent's validity will be subject to examination by IP Australia. Rejection or significant narrowing of claims could occur if prior art demonstrates lack of novelty or inventiveness.
- Infringement Litigation: If granted, the patent could face challenges from competitors seeking to design around the claims or asserting invalidity. Litigation can be costly and time-consuming.
- Clinical Trial Success: The commercial success of the drug is contingent on successful clinical trials demonstrating safety and efficacy, which is a high-risk, high-reward endeavor.
- Regulatory Approval: Even with patent protection, the drug must undergo rigorous regulatory approval processes (e.g., by the Therapeutic Goods Administration in Australia) before it can be marketed.
- Market Access and Reimbursement: Securing favorable pricing and reimbursement from health authorities and insurers is crucial for market penetration.
Key Takeaways
- Patent AU2023274064 claims a pharmaceutical composition for treating advanced or metastatic non-small cell lung cancer (NSCLC), focusing on a novel EGFR inhibitor targeting resistance mutations.
- The composition includes specific APIs and excipients detailed in the claims, formulated as an oral solid dosage form.
- The EGFR inhibitor market in NSCLC is highly competitive, with existing patents covering various generations of inhibitors. This patent seeks to address unmet needs related to acquired resistance.
- The patent is currently pending examination, with a potential grant offering market exclusivity for up to 20 years.
- Commercial implications include market exclusivity, licensing opportunities, and potential for significant investment, but also face risks related to patentability, litigation, clinical trial outcomes, and regulatory approval.
Frequently Asked Questions
- What specific resistance mutations does the EGFR inhibitor in AU2023274064 target?
The patent application specifies mutations such as T790M and C797S, which are known mechanisms of resistance to first, second, and third-generation EGFR inhibitors.
- Has this patent been granted yet in Australia?
No, AU2023274064 is currently a pending application and is undergoing examination by IP Australia.
- What is the typical duration of patent protection for pharmaceuticals in Australia?
Standard patent protection in Australia lasts for 20 years from the filing date, subject to the payment of annual renewal fees.
- What is the significance of an oral solid dosage form for this therapy?
An oral solid dosage form, such as a tablet, offers patient convenience, ease of administration, and generally lower manufacturing costs compared to injectable formulations, which can enhance market adoption.
- Are there any known generic competitors actively developing similar EGFR inhibitors for NSCLC?
While many patents for earlier-generation EGFR inhibitors have expired, allowing for generic development, the specific resistance mutations targeted by AU2023274064 are addressed by newer, patent-protected therapies, suggesting the primary competitive landscape involves other innovators rather than immediate generic threats.
Citations
[1] U.S. Food & Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food & Drug Administration.
[2] European Medicines Agency. (2023). European Public Assessment Reports (EPARs). European Medicines Agency.
[3] AstraZeneca. (2023). Tagrisso (osimertinib) Prescribing Information. AstraZeneca.
[4] IP Australia. (2023). Patent Examination Process. IP Australia.
