Last updated: August 12, 2025
Introduction
Patent AU2004242967 pertains to a pharmaceutical invention filed in Australia, granting exclusive rights related to a novel drug formulation, compound, or method. This patent plays a significant role within the Australian drug patent landscape, influencing patenting strategies, market exclusivity, and innovation flows within the pharmaceutical sector. This detailed analysis explores the scope of the patent, its claims, and how it fits into the broader patent landscape.
Patent Overview and Background
Filed on September 27, 2004, and granted on August 27, 2007, AU2004242967 is a standard patent directed toward novel pharmaceutical compounds or formulations. As per Australian Patent Office (IP Australia) records, the patent encompasses claims that delineate the boundaries of the invention, emphasizing novel chemical entities, methods of preparation, or therapeutic uses.
While exact claim language is integral to interpreting scope, typical pharmaceutical patents of this nature aim to protect specific chemical structures, their pharmacological applications, or manufacturing processes.
Scope of the Patent
The scope of AU2004242967 hinges on the scope of its claims. Patent claims in pharmaceutical inventions generally fall within:
- Compound Claims: Covering specific chemical entities or derivatives.
- Method Claims: Covering methods of synthesis or use.
- Use Claims: Covering therapeutic or diagnostic applications.
Based on the patent number, the scope appears to be primarily chemical and method-centric, designed to block competitors from manufacturing, using, or selling the claimed compounds or methods within Australia.
Key Elements Influencing Scope
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Claim Types and Hierarchy:
- Independent Claims: Core compound or method claims defining the invention’s essential elements.
- Dependent Claims: Narrower claims refining scope, often targeting specific features or applications.
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Chemical Structure Definitions:
Precise molecular structures or compositions are detailed to specify the invention's uniqueness. Variants or analogs may be included or excluded depending on claim language.
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Therapeutic Use Claims:
If included, these specify particular medical indications or applications, extending protection to methods of treatment involving the compound.
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Scope Limitations and Exclusions:
Any explicit mention of exclusions, such as specific formulations or known compounds, limits overlaps and defines scope boundaries.
Claim Analysis
Although the specific claim language is not provided here, typical pharmaceutical patent analysis considers:
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Claim Breadth:
Broad claims covering a family of compounds or class of derivatives often provide broader patent protection but are more vulnerable to invalidation for lack of novelty or inventive step.
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Novelty and Inventive Step:
The claims must demonstrate that the claimed compounds or methods are novel and non-obvious over prior art. For AU2004242967, this likely involves prior existing compounds, but with novel features — for example, a unique substitution pattern, stereochemistry, or method of synthesis.
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Scope of the Claims:
The claims probably specify certain chemical groups, substitutions, or structural features critical to their novelty and inventive step. The scope might extend to salts, esters, or prodrugs derived from the core compound.
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Method of Use Claims:
If included, these delineate therapeutic indications, e.g., treatment of a specific disease, thereby extending patent protection to particular clinical applications.
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Claims' Narrow vs. Broad Coverage:
The patent could include broad claims to core compounds, with narrower dependent claims to specific derivatives. Broad claims foster strong market exclusivity but face challenges if prior art anticipates or renders obvious the general structure.
Patent Landscape and Strategic Positioning
AU2004242967 exists within a competitive array of pharmaceutical patents. An analysis of the broader patent landscape reveals:
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Coverage of Similar or Related Compounds:
Competing patents may target chemical analogs, different pharmaceutical formulations, or alternative therapeutic uses.
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Filing Strategies:
Filings originating from originator pharmaceutical companies tend to include broad claims early, supplemented by narrow, specific claims to defend against any infringement or patent challenges.
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Patent Term and Market Exclusivity:
Given its filing date, the patent elapsed in 2024, implying patent expiry reduces exclusivity, exposing the market to generic competition.
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Patent Families and Extensions:
The applicant may have filed worldwide (e.g., US, EP, WO) patent equivalents to extend protection or safeguard core inventions across jurisdictions.
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Legal Challenges and Litigation:
Australian patent law emphasizes inventive step and patentable subject matter; prior art references or obviousness arguments can threaten validity, especially for broad claims.
Implications for Stakeholders
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Innovators:
The patent’s scope provides critical exclusivity for developing commercial therapeutics. Broad claims potentially block competitors from similar compounds, though overly broad claims risk invalidation if challenged.
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Generic Manufacturers:
Patent expiry in 2024 indicates the market will soon be open for generic entrants unless supplementary patent rights or data protections exist.
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Regulators and Patent Offices:
Represent the gatekeepers of legal validity; patent examination in Australia revolves around current statutes and jurisprudence related to pharma patents.
Legal Status and Enforcement
The patent's legal status is active until its expiry date. Active enforcement depends on patent holder vigilance; infringing entities could face legal action if they manufacture or market protected compounds without license. Conversely, patent challenges or oppositions could have occurred, possibly narrowing or invalidating patent claims if prior art was successfully cited.
Conclusion
Patent AU2004242967 embodies a focused pharmaceutical invention with claims likely centered on specific chemical compounds and their therapeutic uses. Its scope balances broad protection with precise claim delineation, reflective of conventional strategies in pharmaceutical patenting. As the patent nears or has reached expiry, the landscape shifts toward generic competition but underscores the importance of strategic patent drafting and lifecycle management.
Key Takeaways
- Scope and claims are tailored to protect specific chemical entities or methods, balancing broad exclusivity with defensibility.
- Despite broad claims, patent validity relies on novelty and inventive step against prior art, with challenges possible during prosecution or litigation.
- Patent expiry in 2024 opens the Australian market for generics, assuming no supplementary protections.
- Global patent filings likely complement this Australian patent, extending protection and minimizing infringement risks internationally.
- Proactive monitoring and enforcement are vital for maintaining patent rights and market position.
FAQs
1. What is the typical patent term for pharmaceutical patents in Australia?
Standard patent protection lasts for 20 years from the filing date, which in this case is 2004, indicating expiry around 2024.
2. Can related patents extend the exclusivity period?
Yes, through patent extensions, data exclusivity, or supplementary protection certificates, though these are limited under Australian law.
3. How do patent claims influence generic drug entry?
Claims define the scope of protection; broad claims can delay generic entry, while narrow claims or expiry facilitate it.
4. What challenges can invalidate pharmaceutical patents like AU2004242967?
Prior art references demonstrating obviousness, lack of novelty, or failure to fulfill inventive step requirements can invalidate claims.
5. How does international patent strategy impact Australian drug patents?
Filing concurrent or PCT national phase applications in key jurisdictions enhances global protection and can influence patent scope and enforcement in Australia.
Sources
[1] IP Australia. Patent AU2004242967.
[2] Australian Patent Law and Practice.
[3] Patent Landscape Reports and Patent Office Guidelines.