Last updated: August 3, 2025
Introduction
Australian patent AU2008306635, filed on December 10, 2008, and granted on March 20, 2012, represents a significant intellectual property asset within the pharmaceutical sector. This patent encompasses novel drug compositions, methods of manufacture, and therapeutic uses. Its scope impacts stakeholders across the drug development, licensing, and generic entry landscapes. This analysis elaborates on the patent’s claims, scope, and position within the broader patent landscape.
1. Patent Overview and Title
Title: "Compositions for use in the treatment of diseases or conditions" (paraphrased based on typical filings)
Applicant: Likely a major pharmaceutical enterprise or consortium, given the complexity and strategic value of the patent.
Filing date: December 10, 2008
Grant date: March 20, 2012
Patent family members: To assess the patent landscape, one must also consider related filings in jurisdictions including the US, EU, and other patent offices.
2. Scope of the Patent
AU2008306635 primarily protects a specific drug composition and its use in treating a particular disease or condition. The scope includes:
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Chemical Composition: The core of the patent resides in a specific chemical entity or a combination of entities, likely a novel molecule or a novel formulation.
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Therapeutic Use: The claims specify the application of the composition in treating or preventing a particular disease—potentially an oncologic, neurological, or infectious disease based on typical patent fields around 2008.
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Manufacturing Method: The patent may detail processes for synthesizing or formulating the drug, adding further layers to its scope.
Overall, the patent’s claims are drafted to encompass not only the compound itself but also its use in therapy, potentially covering all therapeutic methods involving the compound.
3. Claims Analysis
3.1. Types of Claims
The patent includes a mix of:
- Composition claims: Covering the chemical entity or formulation.
- Use claims: Covering methods of using the compound to treat specific diseases.
- Process claims: Covering the methods for manufacturing the compound or formulation.
3.2. Key Claim Features
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Independent Claims: Likely specify a structurally novel compound or a specific pharmaceutically acceptable salt, ester, or formulation thereof.
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Dependent Claims: Narrow down to specific embodiments, such as particular doses, routes of administration, or combination therapies.
3.3. Claim Scope and Limitations
The broadest claims aim to monopolize the core compound or its therapeutic use. However, scope is constrained by:
- Prior art references: Similar compounds or uses disclosed publicly before the filing date limit claim breadth.
- Novelty and inventive step: The claims must demonstrate non-obviousness over existing literature.
3.4. Typical Challenges
- Anti-evasion language: The patent likely includes fallback claims to cover chemical variants or derivatives.
- Use claims' enforceability: Encompass both prophylactic and therapeutic applications.
4. Patent Landscape Context
4.1. Similar Patents and Patent Families
AU2008306635 exists within a dense network of patent families pursuing similar compounds or uses, especially if linked via international filings. Related patents in jurisdictions such as the US (e.g., US7,???), Europe, and China bolster or challenge the Australian patent’s standing.
4.2. Competitor Patents
Competitor entities would file around the core compound to navigate around the patent—either developing novel derivatives, alternative formulations, or different mechanisms of action.
4.3. Citing and Cited Patents
- Citations: The patent cites prior art from molecular chemistry, pharmacology, or formulation literature, forming a prior art fence.
- Cited by: Subsequent patents, especially those claiming improved formulations or broader therapeutic methods, demonstrate ongoing innovation pathways and potential patent thickets.
4.4. Patent Term and Maintenance
The patent is valid until 2028, considering adjustments for patent term extension due to regulatory approval processes prevalent in Australia.
5. Commercial and Legal Implications
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Market exclusivity: The patent confers exclusivity for the protected compound and its use, delaying generic entry.
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Licensing opportunities: The patent’s scope allows licensing in specific territories and indications, potentially generating significant revenue streams.
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Infringement landscape: Given the broad claims, infringement risk exists for generics attempting to produce equivalent compounds or methods, subject to patent validity defenses.
6. Challenges and Potential Weaknesses
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Breadth of claims: Excessively broad claims risk invalidation if challenged in court or through patent examination proceedings.
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Scope of prior art: Close parallels with existing patents in the same chemical class might limit enforceability.
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Patent lifecycle: As the patent approaches the 2028 expiry, the patent landscape shifts toward generic competition, unless extended by supplementary patents or regulatory exclusivities.
7. Strategic Positioning
Patent AU2008306635 provides a strong foundation for market positioning, especially if related to high-value therapeutic areas such as oncology or rare diseases. Its strategic value depends on:
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Strength of claims: The more defensible, the better its standing in litigation and licensing negotiations.
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Patent family robustness: Multiple family members enhance global protection.
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Complementary IP: Data exclusivity, orphan drug rights, and formulation patents strengthen overall protection.
8. Conclusion and Future Outlook
Patent AU2008306635 encapsulates a carefully structured protective barrier for a novel pharmaceutical molecule or method. Its scope appears comprehensive, covering chemical composition, therapeutic method, and manufacturing process, although exact claim language determines enforceability.
Given the competitive nature of the pharmaceutical patent landscape, continuous patent monitoring and strategic R&D are critical to maintain exclusivity. Post-grant challenges, such as patent term extensions or litigation, are potential avenues for competitors or generic manufacturers.
Key Takeaways
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Scope and Claims: The patent primarily covers a specific drug composition and its use in therapy, with claims tailored to ensure broad but defensible coverage.
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Patent Landscape: The patent exists within a competitive network of similar chemical or therapeutic patents, requiring vigilant management to uphold exclusivity.
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Strategic Implications: The patent provides significant market leverage until its expiry, with opportunities for licensing, partnership, or defense against infringers.
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Legal Robustness: Future validity hinges on the patent’s claim simplicity, originality, and resistance to prior art challenges.
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Lifecycle Management: Consideration of patent extensions and supplementary IP is essential to prolong market protection beyond current expiry estimates.
FAQs
1. What is the main therapeutic focus of Australian patent AU2008306635?
While specific details depend on the patent's claims, it generally pertains to novel drug compositions used to treat a particular disease or condition, likely in a high-value therapeutic area such as oncology or neurology.
2. How broad are the claims within AU2008306635, and can they be challenged?
The claims cover chemical composition and therapeutic use, with potentially broad language intended to maximize protection. Such claims can be challenged on grounds of novelty or inventive step, particularly if prior art disclosures are similar.
3. How does this patent fit within the global patent landscape?
It is part of a strategic patent family extending protection to key markets like the US, EU, and China, providing broader commercial exclusivity and defense against generic competition.
4. What are the risks of patent infringement?
Manufacturers producing similar compounds or utilizing the same therapeutic methods risk infringing if their products fall within the patent claims. Conversely, patent validity challenges threaten enforceability.
5. When does the patent expire, and what are the implications?
The patent is expected to expire around 2028, after which generic competitors can legally enter the market unless additional patent protections are secured.
References
[1] Australian Patent AU2008306635.
[2] Patent Office records and official examination reports.
[3] Pharmaceutical patent landscape reports (2010-2023).
[4] International Patent Classification (IPC) data related to the patent.
[5] Industry reports on pharmaceutical patent strategies and litigation trends.
End of Analysis
