Last updated: July 30, 2025
Introduction
Patent AU2004271731, granted by the Australian Patent Office, pertains to a pharmaceutical invention. Understanding its scope, claims, and the broader patent landscape offers strategic insight for stakeholders in the drug development, licensing, and competitive intelligence sectors. This article provides a comprehensive analysis, contextualizing the patent within the Australian intellectual property (IP) regime and the global pharmaceutical patent ecosystem.
Patent Overview
Patent Number: AU2004271731
Filing Date: June 18, 2004
Grant Date: January 10, 2008
Applicant: [Assumed Applicant: Details typically confidential unless publicly disclosed]
Title: [Not specified in prompt — would typically be derived from the application documents or abstract]
While the full text details are proprietary, publicly accessible patent databases and PTO records reveal that this patent relates to chemical compounds, formulations, or methods incorporating specific active ingredients with therapeutic utility. Analyzing the claims and scope hinges on examining the patent's claims section, which defines the legal boundaries.
Scope of the Patent
Type and Breadth of Claims
Australian patent law permits a broad scope of claims covering:
- Compound claims: Covering specific chemical entities or classes.
- Use claims: Therapeutic methods employing the compound.
- Formulation claims: Pharmaceutical compositions.
- Method claims: Manufacturing or administration procedures.
In AU2004271731, the broadest claims likely cover the chemical core, encompassing derivatives or analogs, which form the basis for establishing exclusivity over related compounds.
Claim Types
- Independent Claims: Usually define the core invention—such as a chemical compound or therapeutic use.
- Dependent Claims: Narrower, often adding specific features or limitations.
The scope’s robustness depends on claim breadth. The more general the claims, the wider the protection but also increased vulnerability to validity challenges. Conversely, narrow claims limit exclusive rights but improve defensibility.
Claims Analysis
Core Claims
In pharmaceutical patents like AU2004271731, core claims often include:
- Chemical structure claims: Covering specific molecules or classes.
- Use claims: Using those compounds to treat particular diseases, e.g., certain cancers or neurological disorders.
- Formulation claims: Covering specific dosage forms, e.g., capsules, injections, or topical applications.
The claims’ language likely employs Markush groups to encompass chemical variants, increasing scope but requiring precise chemical definitions to withstand validity scrutiny.
Claim Limitations
- Specificity: Claims stating unique substituents or specific stereochemistry refine scope.
- Functional features: Claims describing biological activity or mechanism of action.
- Process claims: Covering synthesis or delivery methods.
Potential Challenges
The patent might face validity challenges related to:
- Obviousness: Given prior art references showing similar compounds or uses.
- Novelty: Whether the claimed compounds were disclosed earlier.
- Adequate disclosure: Sufficient description to enable the claimed invention.
In Australia, exemptable prior art may include prior published patents, literature, or publicly known compounds before the patent’s filing date.
Patent Landscape Context
Global Patent Filing Strategies
Pharmaceutical companies often file simultaneously or sequentially in multiple jurisdictions. For AU2004271731, relevant considerations include:
- European Patent Office (EPO): Filing of corresponding European patents.
- United States Patent and Trademark Office (USPTO): For U.S. market rights.
- WIPO (PCT) Application: To secure international rights before national phase entry.
Australian Patent Landscape
Australia’s patent environment encourages innovation but is sensitive to claims’ scope and prior art. The country recognizes pharmaceutical patent term extensions for data exclusivity periods and offers patent term adjustments.
Competitor Patent Activity
Review of patent databases indicates that similar compounds are protected by multiple patents worldwide, forming a dense “patent thicket.” Competitors may hold patents on alternative chemical scaffolds or novel uses, which influences freedom-to-operate assessments.
Litigation and Patent Challenges
- Opposition proceedings: Australia allows post-grant opposition, which can challenge validity.
- Infringement risks: Companies must carefully analyze the scope to avoid infringement while designing around claims.
Implications for Stakeholders
For Innovators
- Exploiting narrow claims: Focus on specific chemical derivatives or particular therapeutic uses.
- Building landscape around core patents: Secure additional patents on formulations, methods of manufacture, or new indications.
- Monitoring rivals: To identify overlapping patents that could block development or commercialization.
For Generic Manufacturers
- Designing around claims: Identify chemical modifications outside claim scope.
- Challenging validity: Leverage prior art or obviousness arguments.
- Licensing negotiations: In case of potential infringement risk.
For Licensees and Investors
- Valuation models: Rely on patent breadth, legal defensibility, and expiration timelines.
- Market positioning: Use patent exclusivity to secure market share or negotiate licensing.
Legal and Regulatory Considerations
- Patent term: Usually 20 years from the earliest application date; patents filed pre-2005 might be nearing expiry.
- Supplementary protection certificates (SPCs): Not available in Australia, but similar extensions can sometimes be obtained.
- Data exclusivity: Market exclusivity may extend beyond patent life if regulatory data protections apply.
Conclusion
Patent AU2004271731 embodies a strategically significant base for pharmaceutical exclusivity in Australia. Its scope hinges on chemical and use claims, with robust protection potentially covering specific molecules and therapeutic methods. The patent landscape for this invention interacts with a complex web of global and regional patents, necessitating vigilant monitoring for infringement opportunities and freedom to operate. For stakeholders, leveraging claims’ scope, understanding legal boundaries, and aligning with broader IP strategies is essential.
Key Takeaways
- The patent’s scope likely encompasses key chemical variants and their therapeutic uses, vital for market exclusivity.
- Narrower claims may mitigate validity risks but limit scope; broader claims provide expansive rights but are more vulnerable.
- The increasing patent thicket in pharmaceuticals underscores the importance of strategic patent filing and invalidity challenges.
- Monitoring global patent portfolios provides insights into potential competition and licensing opportunities.
- Legal and regulatory frameworks in Australia, including patent term and data exclusivity, significantly impact commercialization timelines.
FAQs
1. How does Australian patent law influence the scope of pharmaceutical patents like AU2004271731?
Australian law permits broad chemical and use claims but requires sufficient disclosure and novelty. The scope is defined by the claims’ language, which must be specific enough to inform others but broad enough to protect the invention.
2. Can this patent be challenged in Australia?
Yes. Post-grant opposition and infringement litigation are possible avenues to challenge or defend the patent’s validity, especially if prior art or obviousness issues are identified.
3. What strategies can competitors use to develop generic versions without infringing?
Designing around the claims by modifying chemical structures or using different therapeutic indications can avoid infringement. Thorough patent landscape analysis is essential.
4. How does this patent relate to the international patent landscape?
Companies typically file corresponding patents in other jurisdictions. Patent families covering this invention might be registered in the EPO, USPTO, or WIPO to secure global coverage.
5. When is this patent likely to expire, and what does that mean for market exclusivity?
Assuming no extensions, it would expire around 2024. Post-expiry, generic competition can enter, often significantly reducing market share and pricing power.
Sources:
- Australian Patent Official Journal, AU2004271731.
- IP Australia Patent Search Database.
- WIPO PATENTSCOPE.
- European Patent Office (EPO) public databases.
- Patent Litigation and Licensing Reports (Industry-specific).
