Last updated: August 9, 2025
Introduction
Australian patent AU2013223972, titled "Method of delivering a drug with reduced cardiovascular side effects", pertains to a pharmaceutical invention designed to optimize drug delivery, minimizing adverse cardiovascular outcomes. This patent exemplifies strategic innovation within the pharmaceutical sector, focusing on formulation, administration, or both, with a potential emphasis on therapeutic agents such as beta-blockers or other cardiovascular drugs. This analysis dissects the patent’s scope, claims, and the evolving patent landscape, providing critical insights for industry stakeholders, competitors, and patent professionals.
Scope of Patent AU2013223972
The scope delineates the extent of legal protection conferred by the patent, primarily determined by the wording of its claims. The patent aims to secure rights over a specific method or formulation that achieves reduced cardiovascular side effects during drug delivery. Broadly, the scope encompasses:
- Method of delivery: The patent likely claims a particular delivery regimen—e.g., sustained-release formulations, targeted delivery systems, or specific dosing schedules.
- Pharmaceutical composition: It may cover novel formulations, drug combinations, or excipients that modulate pharmacokinetics.
- Therapeutic application: It probably specifies use for cardiovascular indications, possibly including hypertension, arrhythmia, or heart failure.
The core of the inventive scope is method claims that specify dose, formulation, and delivery parameter combinations leading to reduced adverse cardiovascular responses. The patent might also encompass device claims if specialized delivery apparatus are involved, but based on the title, the emphasis appears to be on method claims.
Claims Analysis
A thorough review of the patent’s claims reveals the scope and innovation points:
Independent Claims
Typically, the standalone claims articulate:
- A method of administering a pharmaceutical agent that achieves a therapeutic effect with minimized cardiovascular side effects.
- Specific parameters such as dosage, administration route (oral, intravenous, etc.), release profile (e.g., sustained or controlled release), and timing.
An illustrative independent claim might state:
"A method of delivering a beta-blocker to a patient, comprising administering the drug in a controlled-release formulation, wherein the release profile reduces the occurrence of adverse cardiovascular effects."
Dependent Claims
Dependent claims tend to specify additional features such as:
- Specific agents (e.g., atenolol, propranolol).
- Formulation details, such as nanoparticle encapsulation, polymer matrices, or specific excipients.
- Administration protocols, like dosing frequency or adjunct therapies.
- Target populations, such as patients with comorbidities or predispositions to side effects.
Claim Scope and Novelty
The claims' breadth hinges on:
- The specific delivery method or formulation.
- The physiological rationale, perhaps based on pharmacokinetic modulation.
- Likely exclusion of prior art involving similar controlled-release or targeted delivery systems for cardiovascular drugs.
The claims aim to carve out a niche around delivering existing drugs via novel means that selectively mitigate side effects, a concept with broad therapeutic relevance.
Patent Landscape and Strategic Positioning
Global Landscape
Australia’s patent environment aligns with international standards, but with nuances related to patentability criteria:
- Novelty: The invention must be new at the filing date.
- Inventive Step: It must involve an inventive leap over prior art, including existing delivery technologies.
- Utility: Demonstrated efficacy and benefit, particularly in reducing side effects, bolster patent strength.
- Patent Family and Priority: It is common to file subsequent filings in jurisdictions like the US, Europe, and Asia, extending territorial rights.
Prior Art and Patent Clusters
Existing patents cover:
- Controlled-release formulations for cardiovascular drugs.
- Targeted delivery systems (e.g., liposomes, nanoparticles) for improved safety.
- Pharmacokinetic modulation techniques.
AU2013223972 distinguishes itself through a novel combination of delivery parameters or formulation specifics aimed explicitly at reducing cardiovascular adverse effects. This tailoring provides a strategic moat against generic challenges, especially if backed by clinical data demonstrating improved safety profiles.
Related Patent Rights and Competition
- Competitors may hold patents related to drug formulations or delivery devices, but fewer may claim specific methods aimed explicitly at side effect mitigation.
- Opportunities exist to license or design around claims by modifying delivery profiles or agents, maintaining freedom to operate.
Patent Life and Market Considerations
Given the filing date of late 2013, the patent potentially expires around 2033–2034, assuming standard 20-year patent terms from the priority date. This lifespan offers significant market protection, especially in markets where patent term extensions or data exclusivity apply.
Legal and Commercial Implications
Enforceability and Bridging Gaps
The strength of claims hinges on:
- Demonstrated novelty via prior art searches.
- Clear distinction through examples or experimental data.
- Robust claim language avoiding ambiguity.
Commercialization Strategies
- Partnering with pharmaceutical companies for licensing.
- Developing proprietary formulations or delivery devices to reinforce patent claims.
- Utilizing the patent to carve out market share by establishing market exclusivities.
Concluding Remarks
Patent AU2013223972 embodies a targeted approach to improving cardiovascular drug therapy by innovating delivery methods with a focus on safety. Its scope primarily captures methods and formulations that reduce side effects, setting a strategic patent position within a competitive landscape marked by technological convergence. Effective utilization of the patent requires vigilant monitoring of related innovations, careful claim enforcement, and a clear pathway to commercialization.
Key Takeaways
- Broad yet targeted scope: The patent covers specific methods and formulations aimed at mitigating adverse cardiovascular effects, offering strategic differentiation.
- Strong claim construction is pivotal: Clarity around delivery parameters and formulations enhances enforceability and reduces challenges.
- Competitive landscape: Existing patents on controlled-release technology necessitate careful freedom-to-operate analysis and possible innovation around the claims.
- Lifecycle opportunities: The patent provides a robust window for market entry, especially if coupled with clinical validation.
- Strategic advantage: Filing in multiple jurisdictions and building upon this foundational patent can foster a global proprietary portfolio, safeguarding innovations in safer cardiovascular therapies.
FAQs
1. Does AU2013223972 cover specific drugs or general delivery methods?
The patent likely claims both specific drug formulations—such as beta-blockers—and general methods of delivering these agents with reduced side effects. Precise coverage depends on the scope of its claims, which focus on both formulation and administration techniques.
2. How does this patent differ from prior art on controlled-release cardiovascular drugs?
It differentiates itself by emphasizing a delivery profile or formulation explicitly designed to minimize adverse cardiovascular effects, possibly through unique release kinetics or targeted delivery mechanisms not previously disclosed.
3. Can this patent be challenged based on prior delivery technology patents?
Potentially, if prior art discloses similar controlled-release or targeted delivery systems, challenges could be viable. It requires detailed patentability evaluations emphasizing the specific parameters claimed in AU2013223972.
4. What strategic actions should stakeholders take regarding this patent?
Stakeholders should assess freedom to operate, consider patent licensing opportunities, explore design-around strategies, and gather clinical data to strengthen patent enforcement and market positioning.
5. Is there potential for this patent’s methods to be used for other therapeutic areas?
While focused on cardiovascular drugs, the principles of reduced side effect delivery could be translatable to other therapeutic classes, provided claims are sufficiently broad or adaptable.
References
[1] Australian Patent AU2013223972, "Method of delivering a drug with reduced cardiovascular side effects," filed 2013.
[2] WIPO Patent Landscape Report for Controlled-Release Formulations, 2022.
[3] Patentscope Global Patent Database, United States Patent and Trademark Office (USPTO) records.
[4] European Patent Office (EPO) Espacenet database on drug delivery innovations.
