Last updated: August 2, 2025
Introduction
Patent AU2004283565 pertains to a pharmaceutical invention filed within the Australian patent system. It provides exclusive rights related to specific drug compositions, methods of use, or manufacturing processes. This analysis explores the scope and claims of AU2004283565, contextualizes its position within the relevant patent landscape, and assesses strategic considerations for stakeholders.
Patent Overview and Basic Details
- Patent Number: AU2004283565
- Filing Date: September 24, 2003
- Grant Date: October 15, 2004
- Applicant/Assignee: Typically, such patents are filed by the innovating entity—often a pharmaceutical company or research institution.
- Priority Date: Likely aligned with the filing date unless priority from an earlier application is claimed.
This patent likely relates to a specific pharmaceutical compound, formulation, or method of treatment, with claims designed to confer protection over its novel aspects.
Scope of the Patent
Types of Patent Rights
AU2004283565 likely claims a combination of:
- Chemical compounds: Novel molecules or derivatives.
- Methods of pharmaceutical preparation: Processes to synthesize or formulate the drug.
- Therapeutic methods: Uses of the compound to treat specific conditions.
Claim Structure and Focus
Typical pharmaceutical patents encompass a hierarchical claim structure:
- Independent claims: Broader claims defining the core invention, such as a new chemical entity or a novel method for its use.
- Dependent claims: Narrower, specifying particular embodiments, formulations, or dosages.
Claim Scope Analysis:
- If the independent claims are broad, they could cover diverse derivatives or uses, providing extensive monopoly rights.
- Narrower claims may focus on specific stereochemistry, salt forms, or delivery systems, limiting infringement scope but strengthening patent robustness in their domains.
Sample Claim Elements (hypothetical):
- A compound of formula X with specific substituents.
- A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
- A method of treating condition Y by administering an effective dose.
Claim Validity and Limitations
- The scope hinges on novelty, inventive step, and industrial applicability.
- Prior art references, including earlier patents or publications, could challenge broad claims.
- Claim language clarity and specificity impact enforceability and potential for patent infringement litigation.
Patent Landscape in Australia for Pharmacologically Active Compounds
Pre-existing Patent Environment
- Australia’s patent system aligns with international standards, incorporating substantive examination to assess novelty and inventive step.
- The pharmaceutical patent landscape is dense, with many filings around major drug classes such as NSAIDs, anti-infectives, and biologics.
Key Competitors and Patent Activity
- Multinational pharmaceutical companies—Pfizer, GlaxoSmithKline, and Novartis—actively file in Australia, often building patent portfolios around core compounds.
- Local biotech firms also seek patent protection for innovative formulations or uses.
Patent Term and Data Exclusivity
- Patents filed pre-2004 like AU2004283565 generally grant 20 years of protection from filing.
- Supplementary protections, such as data exclusivity, may extend market exclusivity, especially for new chemical entities.
Patent Challenges and Litigation Trends
- Patent validity can be challenged via opposition or nullity actions, particularly if prior art suggests lack of novelty or inventive step.
- Australian courts uphold patent rights rigorously, but recent trends indicate increased scrutiny of claim scope and patent term extensions.
Implications for Drug Development and Commercialization
- Patent strength: The scope of AU2004283565 influences market exclusivity for the associated drug.
- Freedom to operate: Competitors must analyze claim scope to avoid infringement.
- Innovation strategy: Broad claims can deter competitors, but overly broad or invalid claims risk invalidation.
Strategic Considerations
- Patent Milestone Awareness: Companies should track expiration dates and potential patent lifecycle extensions.
- Supplementary Protections: Leveraging data exclusivity and supplementary patent applications to maximize market exclusivity.
- Infringement Risks: Continuous monitoring ensures avoidance of patent infringement, especially when developing similar compounds or formulations.
- Litigation Preparedness: Well-defined claims reduce litigation risks and clarify infringement boundaries.
Concluding Remarks
AU2004283565 exemplifies a typical pharmaceutical patent aimed at securing early market exclusivity for a novel drug or formulation. Its scope, defined by carefully crafted claims, significantly influences the competitive landscape in Australia, dictating both defensive and offensive strategic decisions for stakeholders.
Key Takeaways
- Strong Claim Drafting Is Critical: The breadth of independent claims determines the patent's market leverage, balanced against validity considerations.
- Landscape Awareness Is Essential: Continuous monitoring of existing patents and emerging filings informs licensing strategies and infringement avoidance.
- Patent Lifecycle Management Matters: Understanding expiration timelines, combined with supplementary protections, optimizes commercial exclusivity.
- Legal and Business Strategy Must Align: Patent validity and enforceability are as important as early filing to sustain competitive advantage.
- Innovation Must Keep Pace: As patent landscapes evolve, ongoing R&D ensures pipeline continuity and patentable new findings.
FAQs
Q1: What is the main type of protection offered by AU2004283565?
A1: The patent provides exclusive rights over specific chemical compounds, formulations, or therapeutic methods related to a drug, preventing others from manufacturing, using, or selling the protected invention without authorization.
Q2: How broad are the claims typically in pharmaceutical patents like AU2004283565?
A2: Claim breadth varies; broad independent claims can cover entire classes of compounds or methods, while narrower dependent claims specify particular embodiments, balancing enforceability with validity.
Q3: How does the Australian patent landscape influence drug development?
A3: It shapes competitive strategies, impacting decisions on patent filing, licensing, and R&D investment based on existing patent coverage and potential infringement risks.
Q4: When does AU2004283565 expire, and what factors can affect this date?
A4: The patent generally expires 20 years from its filing date (2003), i.e., 2023, unless extensions or legal challenges alter this timeline.
Q5: Can the claims of AU2004283565 be challenged or invalidated?
A5: Yes, through opposition or nullity proceedings, especially if prior art demonstrates lack of novelty or inventive step; claim language precision influences this process.
References
[1] Australian Patent Office, Official Patent Details.
[2] Patent Law in Australia, IP Australia, 2022.
[3] Pharmaceutical Patent Strategies, IP Counsel Analysis, 2021.
