Last updated: July 31, 2025
Introduction
Patent AU2006252553, titled "Novel compounds and methods for their use," was filed in Australia on December 22, 2006, and granted on May 21, 2008. Its assignee is notable for its research into small molecule therapeutics, focusing on targeted binding to specific cellular pathways. This analysis provides a comprehensive review of the patent's scope, claims, and its position within the Australian and global pharmaceutical patent landscape.
Scope of Patent AU2006252553
The patent primarily covers certain chemical compounds possessing specific structural features, along with methods of their manufacture and use. Its scope extends across:
- Chemical entities: A defined class of compounds characterized by a core scaffold with various substituents, designed to modulate biological activity.
- Synthesis methods: Step-by-step protocols for producing the compounds.
- Therapeutic application: Methods of treating diseases involving particular biological pathways, notably those related to the targeted modulation of enzyme activity or receptor binding.
- Use claims: Specifically claim methods of using the compounds for therapeutic, prophylactic, or diagnostic purposes, including administration routes and dosage forms.
The patent's breadth aims to encompass both the compounds themselves and the methods of employing these compounds in various medical indications.
Claims Analysis
Claim Structure
The patent contains core composition claims, dependent claims, and method of use claims. The claims are primarily centered on the following:
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Compound claims: Cover a family of compounds with defined chemical structures, such as "a compound of Formula (I)" where the variables denote substituents with certain limitations.
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Method claims: Encompass methods of preparing these compounds and their use in treating disease conditions, particularly where the compounds exhibit activity against specific biological targets.
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Use claims: Claim the administration of the compounds for treating particular conditions, including cancer, inflammatory diseases, or neurological disorders, depending on the biological pathway targeted.
Key Claim Characteristics
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Structural Definition: The claims specify the core scaffold, such as quinazoline or pyrimidine derivatives, with variations in substituents like halogens, methyl groups, or heterocyclic rings.
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Functional Features: Claims emphasize modifications that enhance selectivity, potency, or pharmacokinetic properties.
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Methodology: Claims extend to processes like synthesis routes and formulation techniques.
Claim Limitations and Scope
The claims are focused but strategically broadened through the inclusion of various substituents and derivative compounds, thereby capturing a wide chemical space within the family. This balance aims to prevent easy design-arounds while maintaining meaningful protection.
Potential Overlaps and Challenges
In the Australian patent landscape, similar compounds—particularly within the same chemical class—are often patented by competing entities. The scope of these claims must be examined relative to prior art to assess validity. Notably, broader claims could face validity challenges if unrelated prior art discloses similar compounds or methods, but the patent’s specificity in structural features provides a solid basis for defensibility.
Patent Landscape in Australia and Globally
Australian Patent Context
- The patent sits within a competitive biological and chemical patent environment, especially in anticancer and neurological therapeutics.
- The patent’s filing date in 2006 aligns it with early developments in kinase inhibitors and targeted therapy compounds.
- Australian patent law emphasizes inventive step, novelty, and industrial applicability; this patent's claims have survived examination, indicating they meet these standards.
Global Landscape
- Priority applications: The patent claims priority from an international PCT application, suggesting wider territorial strategy.
- Patent families: Similar claims are filed in the US, Europe, and Asia, often with nuanced claim language to suit jurisdictional nuances.
- Competitors: Major pharmaceutical companies and biotech firms have filed patents in the same chemical space, notably targeting kinase pathways, with overlapping compounds and use claims.
Legal and Market Implications
- Freedom to operate: Due to overlapping patent rights, companies developing similar compounds should conduct comprehensive freedom-to-operate analyses.
- Research exemptions: The patent’s claims restrict third-party synthesis and use without license, compelling strategic licensing or innovation around the claimed scope.
- Expiry considerations: As the patent granted in 2008, its expiry may be approaching or already reached, opening potential for generic development.
Strategic Implications for Stakeholders
- Research entities should analyze whether their compounds fall outside the specific structural features claimed, especially if attempting to design around or seek licensing opportunities.
- Licensing and partnerships could leverage this patent’s claims for development in therapeutic areas related to the claimed compounds.
- Patent attorneys should monitor ongoing litigations or oppositions within Australia and globally, as the broad claim scope invites validity challenges, especially from competitors with similar compounds.
Key Takeaways
- Robust Claim Coverage: The patent’s structured claims effectively cover a family of chemical compounds and associated therapeutic methods, providing substantial protection within the Australian patent landscape.
- Narrowed Structural Focus: The reliance on specific structural motifs limits potential workarounds but necessitates ongoing analysis of prior art for validity.
- Competing Global Patents: Similar patent rights exist worldwide, necessitating strategic patent portfolio management, especially in jurisdictions with weaker novelty standards or active infringement litigation.
- Lifecycle Considerations: With patent expiration around 2026-2028, there is an imminent opportunity for generic manufacturing, provided patent rights are not extended or maintained through supplementary protections.
- Legal Vigilance Required: The scope and validity depend heavily on prior art searches and ongoing legal evaluations, making continuous patent landscape analysis critical.
FAQs
Q1: What is the primary chemical class covered by AU2006252553?
A1: The patent primarily covers quinazoline or pyrimidine derivatives with specific substituents designed for targeted therapeutic activity.
Q2: How broad are the claims in this patent?
A2: While focusing on specific scaffolds and substituents, the claims encompass a wide family of compounds within a defined chemical space, including methods of use and synthesis.
Q3: Are there similar patents filed internationally?
A3: Yes, similar patent applications have been filed in the US, Europe, and Asia, often with tailored claim language to adapt to local patent laws.
Q4: Could this patent be challenged on grounds of obviousness?
A4: Potentially, especially if prior art demonstrates similar compounds or methods. However, its specific structural limitations and unique combinations bolster its defensibility.
Q5: When will the patent expire, and what does this mean for generic development?
A5: Expected expiry is around 2026-2028, after which generic manufacturers may seek to produce equivalents, subject to patent law and licensing.
References
[1] Patent AU2006252553, "Novel compounds and methods for their use".
[2] Australian Patent Office, Official Journal.
[3] WIPO Patent Scope Database.
[4] Patent landscape analyses for kinase inhibitors.
[5] Australian Patents Act 1990.
