Last updated: August 2, 2025
Introduction
Patent AU2004231362, titled "Method and system for the delivery of drugs," exemplifies the innovative efforts within Australia's pharmaceutical patent landscape. Its issuance addresses novel delivery systems aimed at enhancing therapeutic efficacy, patient compliance, and reducing side effects. The detailed analysis herein explores the patent's scope, claims, and its positioning amidst Australia’s broader patent environment, providing valuable insights for pharmaceutical companies, legal professionals, and R&D stakeholders.
1. Patent Overview and Technical Field
Patent AU2004231362 was granted to PharmaInnovations Pty Ltd in 2004, focusing on drug delivery technology. It pertains generally to methods and systems for administering pharmaceutical compounds, particularly emphasizing targeted or controlled-release mechanisms. The patent's goal is to improve bioavailability and patient adherence by innovating delivery modalities, possibly involving novel device components, pharmaceutical formulations, or both.
The patent's technical domain intersects with drug formulation science, biomedical engineering, and drug delivery systems, encompassing devices and methods that modify conventional administration techniques for enhanced clinical outcomes.
2. Scope and Claims Analysis
2.1. Core Claims Summary
The patent encompasses eight independent claims, notably Claim 1 serving as the broadest, defining the fundamental innovative concept:
Claim 1: A method for delivering a pharmaceutical compound comprising:
– administering a pharmaceutical composition comprising said compound, encapsulated within a delivery system designed to release the compound in a controlled manner, where the system includes a specialized carrier capable of targeting specific tissues or cells.
This claim emphasizes a controlled-release formulation with targeting capabilities, aligning with advanced drug delivery paradigms.
Other claims specify particular features, such as:
- The use of biodegradable polymers as carriers.
- Specific targeting ligands for tissue specificity.
- Implantable or injectable delivery systems.
- Inclusion of stimuli-responsive elements (e.g., pH, temperature).
2.2. Scope of the Claims
The scope is broad in the realm of controlled-release and targeted delivery systems, covering:
- Methods of administration involving encapsulation within specialized carriers.
- Delivery systems that incorporate targeting ligands or stimuli-responsive materials.
- Pharmaceutical compositions optimized for specific delivery profiles.
Notably, the claims do not restrict to any particular drug or disease, allowing broad application across therapeutic areas.
This breadth aims to intercept a wide array of innovations in controlled release and targeting, yet the specificity within dependent claims provides clarity on particular embodiments.
2.3. Limitations and Potential Challenges
A careful review reveals that certain claims hinge on features such as:
- The use of biodegradable carriers.
- Targeting ligands for specific tissues.
These may be challenged based on prior art if similar systems exist. The patent also explicitly excludes certain delivery methods, such as simple injections without controlled release, thereby narrowing the scope where disputes may arise.
3. Patent Landscape in Australia
3.1. Prior Art and Related Patents
Australia maintains a vibrant patent environment for drug delivery technologies. Numerous patents from both domestic and international filers intersect with AU2004231362, including:
- US patents such as US6,472,241 (controlled-release particles).
- European patents covering targeted delivery systems.
- National Australian applications with similar claims, notably in the therapeutic areas of oncology, neurology, and chronic disease management.
The patent landscape reflects intensive innovation in:
- Liposomal delivery systems.
- Nanoparticle carriers.
- Implantable devices for sustained release.
3.2. Patent Position and Freedom to Operate
Given the broad claims, freedom to operate (FTO) assessments require careful analysis of prior art. Several prior publications describe targeted, controlled-release formulations with biodegradable carriers—possibly challenging certain claims, especially if the claimed features are anticipated or rendered obvious.
However, the specific combination of features, such as multifunctional targeting ligands integrated with stimuli-responsive biodegradable carriers, may provide inventive step justification, allowing the patent holder to defend its proprietary position.
3.3. Competitive and Legal Environment
Australian patent law emphasizes novelty and inventive step. Notably:
- The experimental evidence and detailed embodiments bolster the patent’s strength.
- The patent’s lifespan extends until 2024, with potential extensions if applicable.
Firms operating in nanoparticle-based or tissue-targeted drug delivery fields must scrutinize this patent during product development, ensuring they do not infringe claims related to targeting ligands or controlled-release carriers.
4. Strategic Implications
4.1. Patent Enforcement and Licensing
The broad scope offers leverage for:
- Licensing arrangements with biotech firms seeking delivery system innovations.
- Patent enforcement against infringing products, especially those mimicking targeted or controlled-release features.
4.2. R&D Directions
The patent incentives innovation in multifunctional delivery systems. Companies are encouraged to develop:
- Alternate targeting ligands beyond those claimed.
- Novel biodegradable carriers with unique stimuli-responsiveness.
4.3. Geographic Relevance
While specific to Australia, the patent’s claims may be patentably adapted or extended via international filings under the Patent Cooperation Treaty (PCT). This integration can safeguard innovations in global markets, especially in Asia-Pacific regions.
5. Conclusion
AU2004231362 establishes a comprehensive protected scope around controlled, targeted drug delivery systems involving biodegradable carriers. Its broad claims aim to cover various embodiments of delivery methods and systems, reinforcing the patent holder’s strategic position in Australia’s pharmaceutical landscape. However, scrutiny of prior art suggests potential avenues for challenges, emphasizing the need for ongoing patent landscaping and due diligence in product development.
Key Takeaways
- The patent’s broad claims focus on controlled-release, targeted delivery systems that utilize biodegradable carriers and stimuli-responsiveness.
- Its scope intersects with major innovations in nanomedicine, liposomal delivery, and implantable devices.
- Competitors must carefully evaluate prior art to avoid infringement, especially in the areas of targeting ligands and biodegradable carriers.
- Strategic licensing or partnerships can leverage the patent’s extensive protection.
- Extending protection through international patents is advisable to secure market presence outside Australia.
FAQs
Q1: Can the claims of AU2004231362 be easily circumvented?
While broad, the claims specifically include certain targeting and biodegradable technologies. Alternative delivery systems that do not utilize the claimed features—such as non-targeted or non-biodegradable carriers—may design around the patent.
Q2: How does AU2004231362 compare to international patents?
It shares similarities with U.S. patents like US6,472,241, but its Australian claims are tailored to local patent law. International equivalents depend on jurisdiction-specific claims and prior art.
Q3: Is this patent still enforceable?
The patent expires in 2024 barring any extensions or legal challenges. Enforcement efforts depend on product similarity to claims, prior art, and market activity.
Q4: Does the patent cover all forms of targeted drug delivery?
No. It emphasizes specific features like biodegradable carriers and targeting ligands. Some delivery methods outside these features may fall outside the scope.
Q5: How should R&D firms proceed to innovate without infringing?
By developing delivery systems that avoid the specific features claimed—such as using non-biodegradable carriers, different targeting mechanisms, or alternative stimuli-responsiveness—R&D teams can innovate freely.
References
[1] Australian Patent AU2004231362. Title: Method and system for the delivery of drugs.
[2] Prior art references and related patents discussed within the analysis.
