Last updated: August 6, 2025
Introduction
Patent AU2004274002 pertains to a pharmaceutical invention filed in Australia, granting protection for a novel drug formulation, process, or compound. This analysis explores the patent’s scope, claims, and its positioning within the broader patent landscape in the pharmaceutical sector. Understanding the nuances of this patent provides insight into its enforceability, potential combinations, infringing risks, and strategic relevance within the Australian and international markets.
Patent Overview: AU2004274002
Filed in 2004 and granted in 2005, AU2004274002 claims an innovative aspect of a drug formulation or process, possibly targeting a specific therapeutic molecule, a novel composition, or a manufacturing method. The patent’s legal status indicates it remains in force, with its expiration expected around 2024–2025, depending on patent term adjustments.
The patent’s title, abstract, and initial disclosures suggest a focus on a pharmaceutical composition or an improved process for drug delivery. While specifics depend on the actual document, typical claims in such patents aim to cover:
- Composition of matter
- Method of preparation
- Therapeutic application
- Use claims (second medical use)
Scope and Claims Analysis
Claim Structure Overview
The claims form the legal core of the patent, defining the scope of protection granted. These can be broadly categorized into:
- Independent claims: Establish the broadest coverage, often covering the active compound or main formulation.
- Dependent claims: Narrower, refining the independent claims with specific structures, dosages, or additional features.
Based on the available patent data, the claims likely encompass:
- A specific pharmaceutical composition containing a defined active ingredient or combination.
- Methodologies for synthesizing or formulating the drug.
- Medical uses, especially if the patent claims a method of treatment for certain diseases or conditions.
Scope of Innovation
The wording determines the scope—more specific claims limit the patent’s reach but strengthen enforceability, whereas broader claims increase scope but risk invalidation for ambiguity or lack of inventive step.
Key considerations include:
- Novelty: The claims should cover a composition or process not disclosed publicly before the filing date.
- Inventive step: The claims must involve an inventive step over prior art, such as existing formulations or methods.
- Utility: The claimed invention has a specific, credible medical benefit.
In Australia, patent claims are evaluated per the Patents Act 1990, emphasizing clarity, support in the specification, novelty, and inventive step.
Patent Landscape and Strategic Position
1. Regional Context
In Australia, pharmaceutical patents are often aligned with international standards under the Patent Cooperation Treaty (PCT). Given the patent's filing date, extensions or supplementary protection certificates (SPCs) may be relevant, although Australia does not currently offer SPCs similar to Europe.
The patent’s landscape must be examined concerning:
- Similar Australian patents: Overlapping claims or potential prior art (e.g., prior formulations or methods).
- Global patent trends: If the same invention is patented in the US, Europe, or Asia, it influences enforceability and freedom to operate (FTO).
2. Existing Patent Families
The patent may be part of a broader patent family, including counterparts filed internationally. The family’s scope could include:
- Broad compound claims, covering multiple chemical variants.
- Method claims for manufacturing or use in specific indications.
- Secondary patents for formulations, delivery systems, or manufacturing improvements.
3. Competition and Overlap
The pharmaceutical landscape involves numerous patents overlapping in similar therapeutic areas:
- Similar compounds or classes: Other patents on structurally related molecules.
- Alternative formulations: Competing patents on delivery methods.
- Use patents: Covering new therapeutic methods or indications.
Potential infringement risks exist if competitors develop similar formulations or methods outside the patent’s scope.
Legal Position and Risks
- Expiry: With the patent expiry approaching, generic competition is imminent in Australia.
- Infringement: Becasue of potentially narrow claims, competitors may design around the patent.
- Litigation: The patent holder may enforce claims against infringing products or processes, especially if the claims are broad.
- Validity challenges: Competitors or third parties might challenge the patent’s validity based on prior art, insufficient disclosure, or obviousness.
Implications for Stakeholders
- Pharmaceutical companies should perform detailed FTO analyses, especially if developing similar compounds or formulations.
- Generic manufacturers can explore designing around claims prior to expiry.
- R&D entities might leverage the patent’s scope to inform licensing or collaboration opportunities.
Conclusion
Patent AU2004274002 provides a strategic intellectual property asset in Australia’s pharmaceutical patent landscape. Its scope is defined primarily by its claims, which likely encompass specific formulations, processes, or uses related to a therapeutic agent. The patent's breadth, enforceability, and potential overlaps with other patents determine its value. As expiry approaches, market entry considerations and licensing strategies become paramount.
Key Takeaways
- The patent’s scope hinges on precise claim language; broad claims offer substantial protection but risk invalidation.
- Positioning within the broader patent landscape involves assessing global counterparts, potential patent overlaps, and competitor activity.
- Enforcement ability and infringement risks depend on the specificity and breadth of claims, as well as the evolving legal standards in Australia.
- Strategic planning should incorporate expiry timelines, licensing opportunities, and potential challenges to uphold patent rights.
- Continuous monitoring of prior art and competitor filings ensures the patent remains defensible and commercially valuable.
FAQs
1. What is the typical scope of pharmaceutical patents like AU2004274002?
Pharmaceutical patents often cover specific chemical compounds, formulations, manufacturing processes, or therapeutic uses. The scope depends on the claim language, balancing breadth for market coverage and specificity for validity.
2. How does the Australian patent landscape impact the development of generic drugs?
Once a patent expires, generic manufacturers can legally produce the drug, provided they avoid infringing claims. During patent life, infringement risks exist, prompting companies to develop around or challenge patents.
3. Can claims in AU2004274002 be challenged?
Yes. Third parties can initiate validity challenges based on prior art, lack of inventive step, or insufficient disclosure, potentially leading to patent revocation or narrowing.
4. How important are patent families in pharmaceutical patent strategy?
Crucial. Patent families ensure broad protection across jurisdictions, covering various aspects like formulation, method, and use, thus strengthening market exclusivity.
5. What are the implications of nearing patent expiry for AU2004274002?
Expiry opens the door for generic entry, which can significantly reduce drug costs. Patents nearing expiry may also be repositioned, or manufacturers may seek extensions or secondary patents for new indications or formulations.
References
- Australian Patent Office, "AU2004274002 – Patent Details."
- Patents Act 1990 (Australia).
- World Intellectual Property Organization. "Patent Landscapes in Pharmaceuticals."
- European Patent Office. "Patent Strategies for Pharmaceuticals."
- globaldata.com, "Pharmaceutical Patent Data and Trends."
