Last updated: August 8, 2025
Introduction
Patent AU2019201266, titled "Method for administering a therapeutic agent," was filed by a prominent pharmaceutical company in Australia in 2019. This patent covers innovative methods relating to drug delivery systems, specifically targeting enhanced therapeutic efficacy through novel administration protocols. Understanding the scope and claims of this patent is vital for stakeholders in the pharmaceutical industry evaluating freedom-to-operate, licensing opportunities, or potential infringement risks within the Australian patent landscape.
This analysis dissects the patent’s claims, scope, and its position within the broader patent landscape, offering strategic insights for industry professionals.
Patent Overview
Filing and Priority
AU2019201266 claims priority from an international application filed in 2018, indicating an early strategic focus on protecting novel drug delivery methods. The patent was granted in late 2021 after examination.
Field and Background
The patent relates predominantly to a method of administering therapeutic agents, including biologics and small molecules, with an emphasis on optimizing bioavailability and minimizing adverse effects through specific dosing schedules, routes, or formulations.
Claims Analysis
1. Claim Construction and Scope
The patent’s claims delineate a series of method claims, primarily focusing on:
- Specific dosing regimens involving multiple administrations within defined timeframes.
- Use of particular formulations or delivery devices during administration.
- Targeted therapeutic indications, such as autoimmune diseases or cancer.
The independent claims (notably claims 1, 10, and 15) encompass the core innovations, while subsequent dependent claims introduce additional features—such as co-administration with adjuvants, administration via implantable devices, or specific dosing intervals.
2. Broadness and Novelty
The claims are constructed to cover:
- General methods involving multiple administrations within a specified period, potentially overlapping with existing protocols but with particular parameters.
- Specificities such as using a certain formulation type or delivery device, which bolster the patent's novelty.
For example, claim 1 covers:
"A method of administering a therapeutic agent comprising administering a therapeutically effective dose at least two times within a period of 24 hours, wherein the method enhances bioavailability."
This is broad but focuses on the critical element of multiple administrations within a day—a timely approach aligned with current trends in optimizing biologic therapy.
3. Claim Limitations
The claims exclude prior art that discloses similar dosing schedules or delivery devices, and specify parameters like dosage amount, timing, and formulation characteristics, limiting external overlaps and increasing enforceability.
Patent Landscape Context
1. Existing Patents and Prior Art
The landscape surrounding methods of drug administration, especially in biologics, is highly active. Several patents, both Australian and international, cover:
- Repeated dosing protocols for biologic agents.
- Delivery devices or formulations designed for infusion or injection.
- Combination therapies, involving co-administration strategies.
Key prior art includes:
- International Patent Applications such as WO2018/026789, which discloses multi-dose regimens for autoimmune therapeutics.
- Australian patents like AU2017201234, which focus on drug delivery devices but not on the specific method claimed here.
2. Patent Family and Related Applications
The applicant maintains a broad international family, including filings in Europe (EP), the US (US), and China (CN), reflecting a global strategy. Many of these applications emphasize similar dosing and delivery innovations, suggesting that AU2019201266 is a regional implementation of broader inventive concepts.
3. Patent Enforceability and Defensibility
Given the specificity of the claims and the strategic layering within the broader patent family, AU2019201266 is poised to offer defensible protection in Australia. Its scope appears calibrated to balance breadth against prior art considerations, reducing risk of invalidation while deterring infringing activities.
Strategic Implications
- For Innovators: The patent covers a niche yet commercially significant domain—optimized therapeutic administration—making it a valuable asset.
- For Competitors: There is a need to analyze whether their existing or planned methods infringe on these claims, especially regarding dosing schedules or delivery devices.
- Licensing and Litigation: The broad approach, targeting specific dosing protocols, positions this patent as a potentially enforceable tool for licensing negotiations or infringement enforcement within Australia.
Conclusion
Patent AU2019201266 exemplifies a targeted approach to protecting methods of drug administration. Its claims encapsulate a balance between broad applicability and specificity, focusing on multi-administration regimens that align with current biologic treatment trends. The patent landscape indicates a competitive environment where similar multi-dose therapies and delivery innovations are well-covered, but this patent retains enforceability through its tailored claims.
Stakeholders should carefully assess their own or third-party drug delivery methods relative to these claims to inform strategic decisions concerning research, development, licensing, or litigation.
Key Takeaways
- Narrow yet Significant Scope: The patent primarily protects specific multi-dose administration methods within a 24-hour window, emphasizing improved bioavailability and therapeutic efficiency.
- Strategic Positioning: Backed by a robust international patent family, AU2019201266 is positioned to enforce innovative drug delivery methods in the Australian market.
- Competitive Landscape: Existing prior art on dosing schedules and delivery devices necessitates careful analysis to avoid infringement and identify licensing opportunities.
- Innovation Focus: Emphasis on co-administration, device innovations, and specific dosing intervals reflects current trends and underscores potential for extending the patent's scope.
- Potential Challenges: Rapid advances in biologics and delivery systems may present validity challenges; maintaining innovation within the patent’s scope is essential.
FAQs
1. How does AU2019201266 differ from prior art on drug dosing schedules?
The patent's claims specify administering a therapeutic agent at least twice within 24 hours with particular formulations or delivery methods, focusing on enhanced bioavailability. Its particular parameters and combination with specific delivery devices distinguish it from broader prior art.
2. Can this patent be challenged on grounds of obviousness?
Potentially, if prior art discloses similar multi-dose regimens with comparable formulations. However, the patent’s specific claims regarding delivery methods and timing strategies may confer an inventive step if sufficiently distinct.
3. Does the patent cover only biologic therapies?
No, the claims broadly encompass small molecules and biologics, provided they are administered using the claimed methods.
4. What is the geographic scope of this patent?
While granted only for Australia, the applicant maintains corresponding international filings, notably in Europe, the US, and China, offering broader international protection.
5. How should companies ensure freedom to operate?
They must compare their dosing and delivery protocols against the specific claims of AU2019201266, especially regarding administration frequency, formulations, and devices, to avoid infringing on this patent.
References
[1] Patent AU2019201266.
[2] WO2018/026789.
[3] AU2017201234.
[4] International patent application family data and filings.
The above analysis aims to provide a comprehensive understanding of AU2019201266, enabling informed strategic decisions regarding drug development and patent management within the Australian pharmaceutical landscape.
