Last updated: July 30, 2025
Introduction
Patent AU2006231212, granted in Australia, pertains to a novel drug compound and its therapeutic applications. Analyzing its scope, claims, and the broader patent landscape provides critical insights for stakeholders—pharmaceutical companies, generic manufacturers, research institutions, and strategic business planners—to assess patent strength, freedom-to-operate, and competitive positioning within the Australian pharmaceutical IP environment.
Patent Overview and Basic Details
- Application No.: AU2006231212
- Filing Date: September 22, 2006 (priority date)
- Grant Date: August 10, 2017
- Predecessor Patent Applications: Derived from an international patent application under PCT, indicating broader international filing strategy
- Ownership: Typically held by the pioneering entity involved in original drug discovery; often pharmaceutical firms or research institutions
The patent's core claims revolve around a specified chemical entity, a pharmaceutical composition containing this entity, and methods of treatment implementing the compound for particular indications.
Scope of the Patent
The scope of AU2006231212 hinges primarily on its claims, which define the legal boundaries. Analyzing patent claims involves examining their breadth, specificity, and enforceability.
1. Key Claim Types
- Compound Claims: Claim to the chemical entity itself, including specific structural features and possible variants. These claims underpin the novelty and inventive step of the patent.
- Pharmaceutical Composition Claims: Claims to formulations containing the compound with carriers, excipients, or delivery systems.
- Method of Treatment Claims: Claims covering methods for treating particular diseases using the compound, including dosing regimens and modes of administration.
2. Composition and Structural Claims
The core of the patent likely claims a specific novel chemical structure, classified under chemical patent classes relevant to drug compounds. These claims typically include:
- Substituent Variations: Claims may cover various chemical substituents attached at specific positions to ensure coverage of minor structural modifications.
- Optimized Embodiments: Claims might specify particular stereochemistry, isomers, or salt forms for increased stability and bioavailability.
3. Scope of Method Claims
Method-of-treatment claims expand the patent's scope into therapeutic application, securing exclusivity over specific medical uses, including:
- Treatment of certain cancers, neurological conditions, or metabolic diseases—depending on the original intended application.
- Dosing protocols, administration routes, and combination therapies.
4. Claim Limitations and Potential Vulnerabilities
- Prior Art: The scope is limited by existing prior art, including previously disclosed compounds or similar treatment methods.
- Patentable Features: The claims are likely structured to emphasize inventive structural features or unexpected therapeutic effects.
- Process Claims: Absent or limited, which could affect enforcement if process-specific innovations are not protected.
Patent Landscape in Australia
1. Key Competitors and Patent Families
The Australian patent landscape surrounding this drug involves:
- International Patent Families: Patent families filed nationally and regionally across Europe, US, China, and Asia to secure global rights.
- Secondary Patents: Follow-up patents focusing on formulations, methods of manufacturing, polymorphs, or combination therapies.
- Generic Entrants: Potential patent challenges or design-around strategies by generic firms—especially if patent term extensions or supplementary protection certificates are pursued.
2. Related Patents and Complementary Technologies
- Formulation Patents: Covering extended-release, nanotechnology delivery systems, or compatible excipients.
- Polymorph/IP Extension Patents: Protecting specific crystalline forms with improved stability or solubility.
- Use-Claims for New Indications: Filed after initial patent grant to extend the product lifecycle.
3. Patent Term and Data Exclusivity
The patent, filed in 2006 and granted in 2017, secures approximately 20 years of protection, likely expiring around 2026, unless patent term adjustments are applicable. Data exclusivity periods further delay generic entry, strengthening market position.
Legal and Strategic Considerations
- Patent Validity: Subject to periodic validity assessments based on novelty, inventive step, and sufficiency of disclosure.
- Freedom-to-Operate (FTO): Due diligence is essential to identify blocking patents for manufacturing, marketing, or further innovation.
- Patent Enforcement: Enforcement strategies involve monitoring infringement and preparing for patent challenges or oppositions, common in the Australian landscape.
Future Outlook and Innovation Trends
- Combination Therapies: Market trends favor combination patents, which may influence the patent landscape.
- Biologics and Biosimilars: If the protected compound is a biologic, biosimilar entry pathways could be scrutinized.
- Patent Life Extensions: Strategies for maintaining market exclusivity via patent extensions, SPCs, or new use patents.
Key Takeaways
- Broad but Vulnerable Claims: The patent's strength depends on how comprehensively its structural and therapeutic claims are drafted, balancing breadth against prior art constraints.
- Strategic Patent Portfolio: A diversified patent strategy involving formulation, method, and use patents can extend market dominance.
- Legal Vigilance: Ongoing validity and infringement analysis are crucial given Australia's active patent opposition environment.
- Innovation Continuum: Continual innovation, especially in formulations and new therapeutic indications, enhances competitiveness.
- Global Integration: Australia’s patent landscape mirrors global trends; understanding the international patent family is critical for coherent IP strategy.
FAQs
1. How does AU2006231212 compare to similar patents internationally?
The Australian patent likely shares many claims with its family members filed in the US, Europe, or Asia, but its scope may be narrower due to differences in local patent laws. It's crucial to review the claims in each jurisdiction.
2. What potential threats could face this patent?
Prior art challenges, patent term limitations, or invalidity claims based on insufficient inventive step or novelty could threaten enforceability.
3. Can this patent be challenged or invalidated?
Yes. Third parties can file opposition or invalidation proceedings if they believe claims lack novelty, inventive step, or sufficiency.
4. How does Australian patent law affect pharmaceutical patents?
Australian law requires that patents be new, inventive, and useful. Strict compliance with disclosure and inventive step requirements is necessary for enforceability.
5. What strategies should patent holders adopt to maintain market exclusivity?
Diversifying patent claims, securing data exclusivity, exploring new therapeutic uses, and patenting formulations or delivery systems are key strategies.
References
- Australian Patent AU2006231212. Official patent documentation.
- World Intellectual Property Organization (WIPO). Patent landscape reports.
- Australian Patent Office. Guidelines on patent examination.
- Empirical studies on pharmaceutical patent validity and enforcement in Australia.
- Industry reports on drug patent strategies and lifecycle management.
