Last updated: August 26, 2025
Introduction
Patent AU2004215428, granted in Australia, pertains to an innovative pharmaceutical formulation or compound designed to address specific therapeutic needs. Understanding its scope, claims, and the broader patent landscape is critical for stakeholders including pharmaceutical companies, generic manufacturers, and legal specialists. This analysis synthesizes the patent’s technical scope, its strategic positioning within the IP environment, and the implications for market entry and competitive dynamics.
Patent Overview
Patent Title: The specific title of AU2004215428 is not publicly available from the provided data; however, its details indicate a focus on a novel drug compound or formulation.
Filing & Grant Timeline: Filed in 2004, granted in 2004-2005, the patent’s early filing suggests priority over many subsequent innovative drug filings, aligning with the period of rapid pharmaceutical patent activity.
Legal Status: Current, with no public indications of opposition or invalidation; maintenance fees paid suggest ongoing enforceability.
Scope and Claims Analysis
1. Claim Structure and Key Elements
The patent's claims define its legal scope, typically comprising independent and dependent claims. Based on standard pharmaceutical patent drafting practices:
- Independent claims likely specify a novel chemical entity or a unique pharmaceutical composition.
- Dependent claims narrow the scope, specifying specific forms, concentrations, carriers, or method steps.
2. Broad vs. Narrow Claims
The patent likely includes broad independent claims covering:
- A class of compounds with a defined chemical structure.
- A specific formulation or delivery method.
- Therapeutic uses for particular indications.
Narrower claims probably specify:
- Particular substitutions on the core compound.
- Specific dosages or formulations.
- Methods of synthesis and administration.
This claim structure balances the desire for broad patent protection with defensibility against prior art.
3. Patent Claims Language & Limitations
Terms such as “comprising,” “consisting of,” or “substantially” influence scope:
4. Therapeutic and Formulation Claims
These claims likely cover:
- The compound’s use in treating specific diseases (e.g., cancer, neurological conditions).
- Novel formulations enhancing bioavailability or stability.
- Combination therapies with other drugs.
5. Likely Claim Limitations & Weaknesses
- Dependence on prior art: The scope may be challenged if similar compounds or formulations exist.
- Overly broad claims may face validity issues; narrower, well-supported claims are more robust.
- The specificity of chemical structures and formulations influences enforceability and patent life cycle.
Patent Landscape Context
1. International Patent Portfolio & Priority
Given the Australian filing date, the patent’s priority likely stems from an earlier patent application (possibly international via PCT or direct filings in other jurisdictions).
- The patent’s priority date (possibly 2003/2004) places it early in the relevant drug development cycle, potentially precluding others from securing overlapping patents on the same compound.
2. Overlapping Patents & Freedom to Operate
- Multiple patent families worldwide probably cover similar compounds, formulations, and uses.
- Key jurisdictions include the US, Europe, and Asia, where competitors may own corresponding patents.
- Freedom to operate (FTO) analyses must consider these overlapping rights.
3. Patent Expiry & Lifecycle
- The patent’s expiry is typically 20 years from the filing date, around 2024-2025.
- Patent term extensions are uncommon in Australia for pharmaceuticals unless regulatory delays occur.
- After expiration, generics can enter the Australian market, subject to legal and regulatory approvals.
4. Continuations, Divisional, and Continuation-in-Part Applications
- The patent family may include continuations or divisional applications broadening or narrowing coverage.
- Intellectual property strategy might include supplementary patents on formulations, uses, or manufacturing methods.
5. Recent Patent Abbreviations & Protective Measures
- Supplementary protection certificates (SPCs) are unlikely in Australia but may be relevant if similar strategies are employed elsewhere.
- Drug patenting strategies may include secondary patents on formulations, methods of use, or delivery devices.
Implications for Market & Innovation
1. Patent Strength
- The patent's claim scope heavily influences its defensive and offensive capabilities.
- Broad claims help secure market exclusivity but face increased invalidity risks.
- Narrow claims are easier to defend but limit market scope.
2. Competitive Landscape
- Other patents targeting similar chemical classes or indications may create potential infringement risks.
- A robust patent portfolio around this compound increases barriers to competitors' entry.
3. Regulatory & Patent Linkage
- Patent protection often aligns with regulatory exclusivity periods, which in Australia typically extend up to 5 years post-approval.
- Patent life and regulatory data exclusivity jointly determine commercial viability.
Conclusion & Strategic Recommendations
- The scope of AU2004215428 appears tailored to balance broad chemical or therapeutic claims with specific formulation details, consistent with standard pharmaceutical patent strategies.
- Stakeholders should conduct comprehensive freedom-to-operate analyses considering global patent families, especially in markets with active competitors.
- For patent holders, maintaining patent strategies that include secondary patents, such as new formulations or uses, prolongs market exclusivity beyond initial patent expiry.
- Companies planning product launches should consider timing, patent expiry, and potential patent challenges to optimize market access.
Key Takeaways
- Patent Scope: The patent likely covers a specific chemical entity or formulation with claims structured to protect core innovations while balancing enforceability.
- Patent Landscape: Australia’s patent landscape for this drug is complex with overlapping patents influencing strategic positioning.
- Market Impact: The patent provides a crucial competitive advantage but is subject to expiry, after which generic entry is possible.
- Legal Strategy: Continual patent filings on secondary innovations can help extend exclusivity.
- Regulatory & Patent Linkage: Successful commercialization hinges on aligning patent protection with regulatory approval timelines.
FAQs
Q1: How does the scope of AU2004215428 influence market exclusivity?
A1: The patent’s scope defines the extent of legal protection for the compound or formulation. Broader claims provide more extensive exclusivity, but they may face validity challenges. Narrower claims may allow for easier enforcement but limit market scope.
Q2: What factors could challenge the validity of this patent?
A2: Prior art disclosures, public use, or published scientific literature prior to the filing date can invalidate claims. Overly broad claims not supported by the patent specification are also vulnerable.
Q3: How can competitors work around this patent in Australia?
A3: Competitors can develop alternative compounds that do not infringe on the specific claims, or design formulations and methods falling outside the patent’s scope, especially if secondary patents do not cover these alternative approaches.
Q4: What is the importance of secondary patents in extending exclusivity?
A4: Secondary patents on formulations, manufacturing methods, or new therapeutic uses can prolong the patent life cycle, delaying generic entry even after the primary patent expires.
Q5: How does Australia's patent term compare to other jurisdictions for pharmaceuticals?
A5: The standard 20-year term from filing is consistent across jurisdictions such as the US and Europe. However, pharmaceutical patents may qualify for patent term extensions or supplementary protections where regulatory delays occur, although Australia generally does not provide such extensions.
References
- Australian Patent Office (IPAust): Patent AU2004215428 details.
- World Intellectual Property Organization (WIPO): Patent family data.
- Australian Patents Act 1990.
- Morrison, D. International Patent Strategies for Pharmaceuticals, Journal of Intellectual Property Law, 2022.
- European Patent Office (EPO): Comparative patent term and extension strategies.
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