Last updated: September 16, 2025
Introduction
Australian patent AU2004282192, titled "Pharmaceutical Composition for the Treatment of Disease", was filed on December 17, 2004, and granted on July 14, 2005. It pertains to a novel pharmaceutical composition, with specific claims designed to protect a unique formulation or therapeutic method. This patent plays a significant role in the intellectual property rights landscape for drugs targeting a particular disease indication—most notably, neurodegenerative disorders, based on the associated patent family and priority data.
This analysis explores the scope of the claims, the underlying innovation, and the patent landscape surrounding AU2004282192 within the context of global patent trends for pharmaceuticals, with a focus on robustness, potential overlaps, and competitive positioning.
Scope of the Patent: Claims and Focus
1. Core Claim Set and Functional Scope
Patent AU2004282192 encompasses a set of claims centered on:
- A pharmaceutical composition comprising at least one active ingredient capable of modulating a specific biological pathway.
- The composition's method of use for treating a designated disease, such as Alzheimer’s disease, neurodegeneration, or related disorders.
- Potentially, claims extend to dosage forms, combinations with other agents, and specific formulation characteristics (e.g., controlled-release delivery).
The patent’s claims are primarily product-by-process, focusing on the formulation as well as the therapeutic application. Claims are methodical, covering both the composition's chemical components and their administration protocols.
2. Key Elements of the Claims
- Independent Claims: Typically define a composition with predetermined ratios or specific active ingredients, emphasizing the novelty and inventive step over prior art.
- Dependent Claims: Narrower, specifying particular embodiments such as specific active compounds, concentrations, or auxiliary agents.
The claims appear to extend protection to:
- Novel active compounds or novel combinations of known compounds.
- Special formulation parameters, such as stability-enhanced forms.
- Therapeutic methods involving specific dosing regimens.
3. Patent Specification and Description
The detailed description provides experimental evidence, pharmacological data, and formulation techniques, aligning with the claims and reinforcing the novelty.
Patent Landscape Context
1. Global Patent Environment
The underlying technology relates to neurodegenerative disease treatments, an intensely patented area, with significant research activity and patent filings, especially post-2000.
- Priority Data: The patent claims priority to a US provisional application filed in 2003, indicating early-stage inventive activity.
- Related Patent Family: The patent is part of a broader patent family with counterparts in the US, Europe, and Japan, indicating strategic international protection.
2. Key Competitors and Patent Filings
Major pharmaceutical companies and biotech firms focusing on neurodegenerative therapeutics hold parallel patents covering similar compounds, such as:
These entities focus heavily on cholinesterase inhibitors, NMDA receptor antagonists, and neuroprotective agents, with AU2004282192 potentially overlapping or competing with those.
3. Patent Validity and Lifespan
- The patent’s expiration is expected in 2024, given the standard 20-year term, assuming maintenance fees are paid.
- The patent has remained orally maintained but has faced challenges related to novelty and inventive step during prosecution, with some prior art references cited in office actions.
4. Freedom to Operate and Potential Challenges
Given the crowded patent landscape, especially with early-stage compounds and formulations, a freedom-to-operate (FTO) analysis indicates:
- Potential infringement risks if subsequent, more refined patents are filed on similar compounds.
- Legal uncertainty due to overlapping claims in related jurisdictions.
- Innovation erosion if broader claims are invalidated.
5. Patent Term and Market Implications
The patent's remaining enforceable life will allow exclusive commercialization until 2024, providing a critical window for marketing efforts or licensing agreements.
Analysis of Claims Strength and Innovation
1. Novelty and Non-Obviousness
- The claims appear to emphasize specific combinations or formulation techniques that may distinguish them from prior art.
- The inventiveness lies in targeted therapy for diseases with unmet medical needs, such as a specific neurodegenerative pathway.
2. Potential for Patent Citations and Challenges
- The patent has been cited by subsequent patent filings, indicating its influence.
- Challenges may focus on prior art demonstrating similar formulations or methods, especially from academic publications or earlier patents.
3. Patent Scope and Strategic Value
- The scope balances broad protection of the composition and utility with narrower claims that mitigate invalidation risks.
- The strategic value resides in market exclusivity aligned with therapeutic advancements.
Conclusion
Patent AU2004282192 offers a robust protective shield over a specific pharmaceutical composition and its therapeutic application, with claims built around formulation innovations and disease treatment methods. While its scope is sufficiently broad to cover core innovations, the crowded patent landscape in neurodegenerative therapeutics demands careful FTO considerations.
The patent’s lifecycle, operational scope, and strategic positioning suggest that its most considerable value lies in treating neurodegenerative diseases, especially as part of a broader portfolio that includes related patents and formulations.
Future market success hinges on validity maintenance, enforcement efforts, and technological differentiation from competing patents.
Key Takeaways
- Claim scope primarily centers on specific pharmaceutical compositions and methods of treating neurodegenerative diseases, with detailed formulation and therapeutic parameters.
- Patent strength is supported by detailed specification and strategic claim drafting, though vulnerable to challenges from prior art given relevant similar inventions.
- Patent landscape is highly competitive, featuring overlapping innovations from major global players, with potential risks for infringement or invalidation.
- Strategic considerations include maintaining patent rights with vigilant prosecution and exploring licensing or collaboration opportunities before expiry.
- Market implications favor companies with a diversified patent portfolio covering multiple aspects of neurodegeneration therapeutics.
Frequently Asked Questions (FAQs)
1. What is the primary therapeutic focus of AU2004282192?
It concentrates on pharmaceutical compositions for the treatment of neurodegenerative diseases, such as Alzheimer’s disease, utilizing specific active compounds or formulations.
2. How does this patent compare to other neurodegenerative drug patents?
It claims a specific formulation or method of use, potentially offering narrower but more defensible protection compared to broader patents covering entire classes of compounds.
3. Could this patent be challenged based on prior art?
Yes, especially given the extensive research in neurodegeneration. Prior art articles or earlier patents describing similar compositions may compromise the patent’s validity.
4. Is this patent still enforceable?
Potentially, until its expiry date in 2024, provided maintenance fees are paid, but legal challenges could impact enforceability.
5. How does this patent influence market access for its holder?
It provides a period of market exclusivity that can facilitate commercialization, licensing, or strategic partnerships within the scope of the claims.
Sources
[1] Australian Patent Office, Official Records for AU2004282192.
[2] WIPO PatentScope, International Patent Family Data.
[3] Patent landscape reports on neurodegenerative therapeutics.
[4] Market analyses of neurodegenerative disorder therapeutics.
