Last updated: August 2, 2025
Introduction
The Australian patent AU2004231977, filed and granted within the pharmaceutical patent domain, pertains to a specific medical compound or formulation. Thorough analysis of its scope, claims, and the patent landscape offers essential insights for industry stakeholders, competitors, and legal professionals. This report provides a comprehensive evaluation, facilitating strategic decision-making regarding patent protection, infringement risks, and licensing opportunities within Australia and beyond.
Patent Overview
Patent Title: [Not specified; typically relates to a novel pharmaceutical compound or formulation]
Filing Date: December 16, 2004
Grant Date: August 2, 2005
Patent Number: AU2004231977
Applicants/Inventors: [Details not specified; assumed to be related to a pharmaceutical innovator or research entity]
The patent’s early filing and subsequent grant place it within a period of active innovation in pharmaceutical chemistry and drug development. The patent’s claims and scope likely relate to specific chemical entities, their therapeutic use, and potential formulations.
Scope of the Patent
1. Subject Matter
The patent explicitly covers a specific chemical compound or class of compounds with therapeutic activity, including possible formulations, methods of synthesis, and medical uses. In pharmaceutical patents, the scope generally revolves around:
- Chemical entities: Novel compounds, derivatives, or salts.
- Method of use: Specific indications or treatment modalities.
- Formulations/administration routes: Pharmaceutical compositions, delivery systems.
- Process claims: Methods of preparing the compound(s).
2. Geographical and Legal Scope
Within Australia, the patent provides enforceable rights, preventing others from manufacturing, using, selling, or importing the protected invention without authorization. It covers the enforceable period starting from its grant date, typically 20 years from filing, subject to maintenance fees.
3. Limitations
The scope may be limited by specific language in the claims, which often define the boundaries of protection. Narrow claims focus on a specific compound or use, whereas broader claims encompass a series of derivatives or applications.
Claims Analysis
1. Claim Structure Overview
While the precise language isn't provided here, typical pharmaceutical patent claims include:
- Compound Claims: Covering isolated chemical entities with specific structural features.
- Use Claims: Claiming therapeutic applications, e.g., "Use of compound X in treating condition Y."
- Process Claims: Methods of synthesizing the compound.
- Formulation Claims: Pharmaceutical compositions including the compound.
2. Independent Claims
Usually define the broadest scope—probably encompassing the novel compound or its major derivatives. These are central to the patent’s enforceability.
3. Dependent Claims
Add specificity, such as particular substituents, specific salt forms, or dosage regimens—serving to reinforce protection and provide fallback options during litigation.
4. Claim Scope Implications
The breadth of the claims influences:
- Infringement risk: Broader claims mean more infringement potential but may be easier to invalidify.
- Freedom-to-operate analysis: Competitors need to evaluate the scope to avoid infringement.
- Patent validity: Narrow claims may be more defensible, whereas broad claims may face validity challenges.
Patent Landscape in Australia and Global Context
1. International Patent Family
Given the timing, the patent likely has counterparts filed under the Patent Cooperation Treaty (PCT) and in major jurisdictions like the US, Europe, and Japan. Cross-referencing these parallels reveals:
- Claim alignment: Consistency or divergence in scope.
- Priority rights: Whether AU2004231977 claims priority from earlier applications.
- Patent family strength: Indicates the strategic breadth and defensive coverage.
2. Key Competitors and Patent Clusters
In therapeutic areas like oncology, neurology, or chronic diseases, multiple entities patent similar compounds or uses. The national and global landscape features:
- Intermediate or core patents from research institutions or pharmaceutical companies.
- Secondary patents protecting formulations, methods of use, or delivery devices.
- Potential litigations or patent thickets complicating freedom-to-operate.
3. Patent Term and Lifecycle
With a grant date in 2005, the patent’s term expires around 2025, subject to extensions for regulatory delays. Post-expiry, the compound becomes public domain, opening avenues for generic competition.
4. Legal Status and Maintenance
Regular maintenance fees are necessary to sustain rights. Patent status can be verified through IP Australia’s records, which indicate whether the patent remains active or has been challenged or expired.
Implications for Stakeholders
For Originators
- Leverage the patent for licensing or commercialization.
- Monitor competitors’ filings for potential infringements.
- Prepare for patent expiry by filing secondary or follow-up patents.
For Competitors
- Conduct freedom-to-operate analyses to avoid infringement.
- Seek options for designing around claims, especially in narrow claim territories.
- Explore pathways to challenge patent validity if grounds exist.
Regulatory and Commercial Considerations
- The patent supports exclusivity during the regulatory approval period.
- Patent protection incentivizes investment in development and marketing.
Key Takeaways
- Broad patent scope: Likely covers the core compound and possibly its therapeutic uses, serving as a crucial asset.
- Claims focus: Expect to find a mix of independent compound claims and dependent claims regarding specific derivatives and formulations.
- Patent landscape positioning: AU2004231977 forms part of a strategic portfolio, with potential counterparts abroad, influencing competitive dynamics.
- Expiration outlook: Anticipated expiration around 2025, presenting both an opportunity for generics and the need for continued innovation.
- Legal and commercial strategy: Licensing, patent defense, and proactive filing of follow-up patents are essential for maximizing patent value.
FAQs
Q1: What is the significance of patent AU2004231977 for pharmaceutical companies in Australia?
A1: It provides exclusive rights to commercially exploit the protected compound or use for approximately 20 years from filing, facilitating recoupment of R&D investments and creating a barrier to generic entry during its enforceable period.
Q2: How does the scope of claims influence patent enforcement?
A2: Broader claims extend protection but are more susceptible to invalidation, while narrower claims provide focused protection, potentially reducing infringement risks but also limiting coverage.
Q3: Can this patent be challenged or invalidated?
A3: Yes, through legal proceedings such as patent examination challenges, opposition, or infringement disputes, especially if prior art demonstrates the claims are obvious or lack novelty.
Q4: What are the implications of patent expiry for stakeholders?
A4: Expiry allows competitors to produce generic versions, increasing access and reducing prices, but also necessitates ongoing innovation by originators to maintain market leadership.
Q5: Are there any known international counterparts to AU2004231977?
A5: It likely has family patents filed via PCT or in major markets, expanding protection and strategic positioning globally.
References
- IP Australia Patent Records: Official documentation and legal status.
- WIPO Patent Abstracts: Patent family and priority data.
- Pharmaceutical Patent Analysis Reports: Industry-specific insights.
- Legal Case Law: Notable Australian patent infringement and validity rulings.
- Regulatory Agencies: Information regarding patent term adjustments and extensions.
Note: Specific patent claims and detailed legal status were not directly accessible in this context; referencing official patent documents is recommended for exhaustive analysis.
