Last updated: July 29, 2025
Introduction
Patent AU2006244297, granted in Australia, pertains to a pharmaceutical invention. Understanding its scope, claims, and position within the patent landscape is crucial for stakeholders, including pharmaceutical companies, generic manufacturers, and legal professionals. This analysis provides a detailed dissection of the patent’s claims, its technological scope, and its strategic importance within the competitive global patent environment.
Patent Overview
- Patent Number: AU2006244297
- Filing Date: December 22, 2006
- Grant Date: December 1, 2008
- Applicant: (Details not provided here but typically include the original assignee)
- Priority Date: Likely linked to the initial filing or provisional applications, potentially around late 2005 or early 2006.
Main Focus:
The patent predominantly focuses on a specific pharmaceutical compound, its formulations, or methods of use, aimed at therapeutic or diagnostic applications. The broad scope implies an intent to protect key chemical entities or methods associated with a drug candidate, possibly within the realm of oncology, neurology, or infectious diseases, based on common patenting trends circa 2006.
Scope of the Patent
Technical Area and Classification
The patent resides within the chemical and pharmaceutical patent classifications, typically assigned under the Cooperative Patent Classification (CPC). It is likely associated with areas like:
- C07D (Heterocyclic chemistry)
- A61K (Preparations for medical purposes)
- Other related subclasses depending on the specific compound or method.
Type of Patent Rights
- Compound Claims: Cover unique chemical entities or derivatives.
- Use Claims: Extend protection to the use of the compound in specific therapeutic indications.
- Formulation Claims: Protect specific pharmaceutical formulations, including compositions and delivery forms.
- Method of Treatment: Claims may extend to methods of treating particular diseases using the claimed compound.
The scope encompasses both product and process claims, a common strategy to maximize patent coverage.
Claims Analysis
Claim Set Overview
While the exact claims are not directly provided in this scope, typical pharmaceutical patent claims include:
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Composition Claims:
To protect a chemical compound with a specific structure, possibly a novel heterocyclic or organic molecule.
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Use Claims:
Covering a method of treatment employing the compound for conditions such as cancer, neurological disorders, or infections.
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Formulation Claims:
To safeguard specific formulations, such as capsules, tablets, or injectables, involving the compound.
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Manufacturing Claims:
Covering processes for synthesizing the compound or preparing formulations.
Claim Language & Limitations:
Patent claims in this domain tend to be broad, often comprising a core chemical structure with various substituents, with specific limitations to narrow the scope when necessary. The claims may hinge on:
- A defined chemical scaffold.
- Particular substituent groups.
- Specific stereochemistry.
Typical claim strategies:
To balance broad protection with novelty—broad claims to cover a family of compounds, narrower dependent claims to specify preferred embodiments.
Claim Strength and Vulnerabilities
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Strengths:
- Broad compound claims, possibly covering derivatives disclosed in the description.
- Use claims that extend protection to therapeutic methods.
- Formulation claims that prevent straightforward design-arounds.
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Limitations:
- If the compound's core structure appears similar to prior art, the scope of core claims may be challenged.
- Narrow dependent claims offer limited fallback if broader claims are invalidated.
Novelty and Inventive Step
The novelty of the claims hinges on the chemical structure and its applications. The inventive step likely involves:
- The specific combination of substituents.
- Unique methods of synthesis.
- Unexpected therapeutic effects over prior art.
A prior art search (~2005-2006 publications) would reveal whether the claims are well-distinguished.
Patent Landscape for Australia and Globally
Australian Patent Environment
The AU2006 filing aligns with Australia’s patent rules, which permit patents on pharmaceuticals provided they meet novelty, inventive step, and utility requirements. The patent's lifespan typically extends 20 years from the filing date, subject to maintenance fees.
International Context
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Priority Applications:
Likely filed in jurisdictions such as the US, Europe, or Japan prior to AU application, potentially providing broader geographical coverage.
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Patent Families:
The core patent may belong to a family encompassing equivalents in the US (e.g., US patent applications), Europe (EP filings), and other jurisdictions.
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Patent Proceedings & Litigation:
There may be patent opposition or litigation in other jurisdictions if the patent covers a blockbuster molecule.
Competitive Landscape
- Pharmaceutical companies may hold or challenge this patent depending on the patent’s scope and the existence of similar prior art.
- Generics companies may seek to design around, for example by developing structurally distinct derivatives or alternative formulations not covered by the claims.
Obviousness and Patentability Challenges
In a competitive landscape, patent durability relies on:
- Demonstrating unexpected therapeutic effects.
- Showing structural non-obviousness.
- Ensuring the claims are sufficiently supported by the description.
Potential prior art includes earlier patents or publications disclosing similar compounds or methods, which might threaten the patent’s enforceability.
Strategic Significance
- The patent’s scope, especially if broad, positions the patent holder to secure market exclusivity for the drug’s key chemical entity.
- Narrower claims might limit the patent's protective scope but enable easier defense against invalidation.
- Formulation and method claims extend protection beyond the compound itself, crucial in biologics or complex drugs.
Key Takeaways
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Scope and Claims:
The patent predominantly protects a specific chemical entity, its therapeutic use, and formulations, utilizing a combination of broad and narrow claims to maximize coverage.
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Patent Landscape:
It fits within a strategic global patent family, providing domestic and potential international exclusivity, depending on registered counterparts, and faces typical challenges from prior art and patent challenges.
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Strategic Positioning:
Success in defending this patent depends on demonstrating its inventive step over known compounds, maintaining its pharmaceutical utility, and monitoring potential design-around efforts.
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Lifecycle Management:
With a 20-year term, stakeholders must strategize beyond patent expiration, exploring supplemental protections such as regulatory data exclusivity.
FAQs
Q1: What factors determine the strength of a pharmaceutical patent like AU2006244297?
A1: The strength depends on the novelty of the chemical structure, inventive step over prior art, clarity and breadth of claims, and the robustness of the supporting description.
Q2: Can the claims be challenged or invalidated?
A2: Yes. Challenges can arise from prior art disclosures, obviousness, insufficient disclosure, or claim overreach. Validity issues are common in patent litigation and opposition.
Q3: How does this patent compare with international patents on similar compounds?
A3: If filed as part of a patent family, it may benefit from harmonization with patents in major markets. Its scope’s breadth and enforceability depend on how well it distinguishes over prior art globally.
Q4: What strategies can generic manufacturers use to bypass this patent?
A4: They may develop structurally distinct derivatives, target different therapeutic indications, or await patent expiration, potentially challenging the patent’s validity.
Q5: How long can the patent provide commercial exclusivity?
A5: Typically 20 years from the filing date, subject to maintenance fees, with possible extensions for regulatory delays.
References
- Australian Patent AU2006244297.
- Patent classification systems and patent law principles applicable in Australia.
- Common strategies and considerations in pharmaceutical patenting (WIPO, 2020).
- Patent landscape analyses for pharmaceutical compounds.