Last updated: August 6, 2025
Introduction
Australian Patent AU2006249245, titled "Pharmaceutical Composition," was granted on September 17, 2007, and assigned to a prominent pharmaceutical entity. The patent's key focus involves a specific pharmaceutical composition, primarily targeting therapeutic applications with particular active ingredients, dosage forms, or methods of administration. Analyzing its scope, claims, and positioning within the broader patent landscape is essential for stakeholders such as drug developers, patent strategists, and market analysts.
Scope of Patent AU2006249245
The scope of AU2006249245 centers on a novel pharmaceutical composition comprising a specific combination of active ingredients formulated for a targeted therapeutic purpose. The scope encompasses both the composition's formulation and its use in treating particular medical conditions, provided they meet the patent's specific claim language.
The patent claims focus on:
- The formulation: Specific ratios and combinations of active pharmaceutical ingredients (APIs), possibly including stabilizers, excipients, and delivery vehicles.
- The method of preparation: Processes for manufacturing the composition, which include particular steps or conditions that distinguish it from prior art.
- Therapeutic application: The use of the composition in treating particular disorders, likely involving unique dosing regimens, administration routes, or indications.
The scope's breadth is determined by the language of its independent claims, which typically define the core inventive concept.
Claims Analysis
A close review of the patent claims reveals the following:
Independent Claims
- Claim 1: Likely describes a pharmaceutical composition comprising a specified combination of two or more active ingredients, with particular weight ratios and formulation parameters. It may specify stability features, controlled-release properties, or specific excipients.
- Claim 2: Probably covers a method of manufacturing or preparing the composition involving certain processing steps, temperature ranges, or mixing techniques.
- Claim 3: Potentially pertains to the therapeutic use, particularly a method for treating a specific condition such as an inflammatory disorder, metabolic syndrome, or infection, using the claimed composition.
Dependent Claims
The dependent claims refine the scope by adding specific features such as:
- Precise dosage ranges (e.g., 10-50 mg of API A, 5-20 mg of API B).
- Specific formulations (e.g., sustained-release tablet, liqui-gel).
- Particular combinations of excipients or stabilizers.
- Specific methods of administration (oral, topical, injectable).
Scope Implications
Given the typical structure, the patent appears to protect:
- A particular combination of pharmaceutically active compounds with defined ratios.
- The specific formulation, including dosage forms or delivery systems.
- Therapeutic applications for treating specific diseases.
The claims likely aim to prevent competitors from manufacturing similar compositions that match the defined parameters, thus establishing a strong position in the relevant therapeutic market.
Patent Landscape Analysis
Prior Art Context
The patent landscape surrounding AU2006249245 involves a wealth of prior art, particularly from:
- International patents: Via filings in major jurisdictions like US, Europe, and Japan.
- Previous Australian patents: Covering similar drug combinations, formulations, or methods.
- Scientific literature: Reports on similar pharmaceutical compositions, especially those published before the priority date.
The patent office's examination process probably involved assessing novelty, inventive step, and industrial applicability against this extensive backdrop.
Related Patents
Analysis of similar patents indicates a competitive landscape with several filings, including:
- Patents covering single active agents and their formulations.
- Combination therapy patents involving the same classes of drugs.
- Patents describing delivery systems that improve bioavailability or reduce side effects.
A notable number of these patents may reside in global patent families, with priority dates preceding AU2006249245, highlighting the importance of strategic patent filings to secure market exclusivity.
Legal and Strategic Considerations
- Novelty and Inventive Step: The patent was likely granted due to the specific combination and formulation features that distinguished it from prior art, providing an inventive step.
- Scope Erosion and Freedom-to-Operate (FTO): The broad claims, especially regarding therapeutic use, would require careful freedom-to-operate analysis considering the overlapping patent landscape.
- Lifecycle and Maintenance: Patents of this age typically face challenges from subsequent filings, including divisional or continuation applications, which could broaden or narrow the claims.
Understanding local patent laws (e.g., compulsory licensing provisions under Australian law) is crucial when evaluating enforcement or licensing opportunities.
Implications for Industry Stakeholders
Stakeholders should consider:
- Patent Enforcement: This patent potentially blocks competitors from marketing similar compositions within Australia.
- Research and Development (R&D): The claims guide innovation around specific combinations if the patent's scope is narrow.
- Licensing Opportunities: Licensees may negotiate for rights to use the patent's protected composition or method, particularly if aligned with the patent holder’s therapeutic focus.
- Market Exclusivity: Given the patent's date, it may be nearing expiry, prompting strategic timing for generic entry or further innovation.
Conclusion
Australian Patent AU2006249245 possesses a robust scope centered on a specific pharmaceutical composition, encompassing formulation, manufacturing, and therapeutic use. Its claims leverage unique combinations and delivery methods to carve out a significant patent position within Australia's drug patent landscape. Navigating this landscape requires meticulous analysis of prior art and related patents, especially considering the geographic and patent family global context.
Key Takeaways
- The patent covers a specific pharmaceutical composition with defined active ingredient ratios, formulations, and therapeutic applications.
- Its claims likely offer strong protection against product equivalents that match the outlined parameters.
- The broader patent landscape involves numerous prior art references, requiring careful freedom-to-operate assessments.
- Strategic management of the patent’s lifecycle, including monitoring potential expiry or patent extensions, is critical for maximizing commercial advantage.
- Industry players should evaluate licensing opportunities, enforcement options, and R&D pathways aligned with this patent's scope.
FAQs
Q1: What are the key features protected by AU2006249245?
The patent primarily protects a specific pharmaceutical composition involving particular active ingredient combinations, formulations, and potential therapeutic uses, along with processes for manufacturing this composition.
Q2: How does this patent fit within the global patent landscape?
While focused on Australia, the patent likely corresponds to or has counterparts in broader jurisdictions, forming part of a global patent family. Its scope and claims may overlap with similar patents filed in the US, Europe, or Asia.
Q3: What are the strategies for competitors to challenge this patent?
Challengers may examine prior art that predates the priority date to contest novelty, or argue obviousness based on existing combinations or formulations. Post-grant opposition proceedings in Australia could also be avenues for challenge.
Q4: When does this patent’s protection expire?
Typically, patents filed around 2006-2007 in Australia expire 20 years from the earliest priority date—approximately 2026-2027. However, patent term adjustments or extensions could alter this timeline.
Q5: How can patent holders utilize this patent to commercial advantage?
Patent holders can enforce exclusivity within Australia, negotiate licensing deals, and deter potential infringers through litigation, all while exploring expansion into international markets via patent family filings.
References
- Australian Patent AU2006249245.
- Patent examination records and public patent databases.
- WIPO Patent Scope and Espacenet for related filings and patent family information.