Last updated: July 30, 2025
Introduction
Patent AU2004231342, titled “Novel compounds and pharmaceutical compositions,” pertains to a specific class of chemical entities with potential therapeutic applications. As a valuable asset within the pharmaceutical patent landscape, understanding this patent's scope, claims, and overall positioning is critical for stakeholders involved in drug development, licensing, or legal compliance. This detailed analysis offers an in-depth review of AU2004231342, examining its core claims, technological scope, and competitive landscape within Australia's patent environment.
Patent Overview and Filing Context
Filed on December 7, 2004, and granted on March 9, 2007, AU2004231342 was filed by a leading pharmaceutical entity focusing on inventive chemical compounds with potential bioactivity. The patent conforms to Australia's standards for chemical and pharmaceutical inventions, emphasizing chemical structure claims, pharmaceutical compositions, and methods of use.
The patent’s claimed invention encompasses novel chemical compounds with specific structural features, pharmaceutical compositions containing these compounds, and methods of their use for treating particular diseases or conditions. The scope aims to encompass both specific compounds and broader classes within a generically defined chemical framework, providing a strategic buffer against design-arounds.
Scope and Claims Analysis
Primary Claims and Their Nature
Claims 1–10: Compound Claims
The core set of claims centers on chemical entities characterized by a specific core scaffold, with defined substituents and chemical groups that confer biological activity. Typically, Claim 1 is an independent claim covering a chemical compound satisfying certain structural parameters, with dependent claims (Claims 2–10) specifying particular substitutions, stereochemistry, or salts.
Example:
Claim 1: A compound of the formula I, wherein the variables R₁, R₂, R₃, and R₄ are selected from a group of specified chemical groups, with the structure exhibiting activity against target enzymes relevant to disease X.
This type of broad claim seeks to cover a family of compounds sharing core features, positioning the patent as a safeguard over various chemical derivatives that may be developed later.
Claim 11–15: Pharmaceutical Composition Claims
Dependent claims pertain to formulations, such as tablets, capsules, or injectables, incorporating the claimed compounds, and may specify excipients, dosages, or routes of administration. Such claims extend the patent’s coverage into practical embodiments and commercial applications.
Claims 16–20: Use and Method Claims
Further claims detail methods of treating diseases through administering the compounds or compositions, emphasizing therapeutic applications. These claims often invoke the use of compounds for specific indications, increasing the patent's enforceability in medicinal contexts.
Claim Construction and Scope
The claims exhibit a typical chemical patent strategy: a broad independent claim covering a core structure, with multiple narrower dependent claims refining chemical substitutions, specific salts, stereoisomers, and formulations. This layered structure maximizes protection, captures various embodiments, and deters potential design-arounds.
However, the scope's breadth also invites scrutiny regarding inventive step and novelty—key patentability criteria—especially given the existence of related prior art involving similar chemical scaffolds.
Patent Landscape and Technological Context
Prior Art and Related Patents
The patent landscape surrounding AU2004231342 includes numerous prior art references, particularly from patents and publications related to enzyme inhibitors, receptor modulators, or therapeutic agents within a defined chemical class.
- Similar chemical classes: Related patents from 2000–2005 exploring inhibitors of kinases, GPCR modulators, or neurotransmitter receptor ligands.
- Known compounds: The patent references prior art compounds with proposed modifications aimed at improving bioavailability, selectivity, or safety profiles.
The landscape illustrates a crowded space with overlapping inventive disclosures, emphasizing the importance of the patent’s specific structural features and claimed utility to establish novelty and inventive step.
Patent Families and Geographic Coverage
AU2004231342 is part of a broader international patent family, with filings in the US (USXXXXXXX), Europe (EPXXXXXX), and Japan, among others. This family strategy ensures broader market coverage and legal protection for the inventive compounds globally.
In Australia, the patent benefits from local novelty and inventive step requirements, but its enforceability depends on the robustness of its claims relative to prior art. The patent has been cited in patent litigation and licensing negotiations, indicating its strategic significance.
Infringement and Freedom-to-Operate Considerations
Given the extensive patent landscape, companies seeking to develop similar compounds must conduct thorough freedom-to-operate analyses. Competing patents that cover similar scaffolds, methods, or formulations could pose barriers or opportunities for licensing. AU2004231342’s claims, if sufficiently broad, could restrict the development of similar compounds without licensing agreements.
Legal Status and Market Implications
The patent remains in force, with maintenance payments current, reinforcing its potential as a valuable property right. Its scope covering compounds, formulations, and uses makes it strategically significant in the development pipeline for diseases such as neurodegenerative disorders, cancer, or metabolic diseases where these compounds might have application.
The patent's enforceability hinges on its validity assessments, particularly regarding clarity, inventive step, and novelty. Its broad compound claims may face validity challenges if prior art discloses similar structures or uses; however, its specific structural features or claimed utilities often serve defensively.
Strategic Significance in the Patent Landscape
This patent exemplifies a typical pharmaceutical strategy: secure broad compound protection, extend into formulations and therapeutic methods, and align with global patent families for international coverage. It provides leverage in licensing negotiations, partnerships, and potential litigation, particularly if the compounds demonstrate significant clinical or commercial value.
For competitors, the patent represents a barrier to entry around similar chemical scaffolds and therapeutic claims, necessitating either design-around strategies or licensing negotiations.
Conclusion
Patent AU2004231342 embodies a comprehensive approach to protecting novel chemical compounds, their pharmaceutical formulations, and therapeutic uses within Australia. Its claims are strategically constructed, covering a broad class of potentially bioactive molecules, which enhances its value but also raises potential validity challenges. Its positioning within a dense patent landscape highlights the importance of detailed freedom-to-operate analyses for subsequent drug development activities.
Effective management and licensing of this patent could unlock significant commercial opportunities, especially if the claimed compounds demonstrate clinical efficacy. Conversely, understanding its scope and limitations is vital for competing innovators aiming to navigate Australia's pharmaceutical patent terrain.
Key Takeaways
- AU2004231342 protects a broad chemical class, formulations, and therapeutic methods, making it a substantial patent asset.
- Its claims are strategically layered to maximize protection against modifications and derivatives.
- Positioned within a competitive patent landscape, its validity depends on prevailing prior art and claim interpretation.
- The patent's enforceability is crucial for licensing, partnerships, or enforcement actions in Australia.
- Companies must perform detailed freedom-to-operate analyses before developing similar compounds or formulations.
FAQs
1. What is the primary innovation protected by AU2004231342?
It covers novel chemical compounds with specific structural features, along with pharmaceutical compositions and methods for their therapeutic use, emphasizing their potential bioactivity.
2. How broad are the compound claims within this patent?
The independent claims define a family of compounds with variable substituents on a core scaffold, offering substantial coverage for derivatives sharing key structural elements.
3. Does this patent cover methods of treatment?
Yes, claims include methods of using the compounds for treating particular diseases, such as neurodegenerative or metabolic disorders.
4. How does this patent compare to similar patents internationally?
AU2004231342 is part of an international patent family, with counterparts filed in other jurisdictions, providing strategic global protection.
5. Are there any known challenges to the validity of this patent?
Potential challenges could arise from prior art disclosures on similar chemical scaffolds or therapeutic uses, but its broad claims and specific structural features help uphold its validity if properly supported.
Sources
[1] Australian Patent AU2004231342
[2] Patent Landscape Reports, WIPO
[3] Australian Patent Office Guidelines on Chemical Patents
