Last updated: August 7, 2025
Introduction
Patent AU2012273515, titled "Pharmaceutical Preparations Containing Active Agents," is a granted Australian patent originating from an international application filed under the Patent Cooperation Treaty (PCT). Its focus resides within the pharmaceutical domain, particularly targeting formulations featuring specific active compounds intended for therapeutic use. This analysis delineates the patent’s scope, assesses its claims, and situates it within the broader Australian and global patent landscapes for pharmaceuticals.
Scope of Patent AU2012273515
Technical Field and Purpose
The patent applies to pharmaceutical compositions, emphasizing novel formulations containing active agents with improved stability, bioavailability, or therapeutic efficacy. The scope encompasses both the chemical entities involved and the specific methods of preparation, with particular attention to compounds exhibiting certain pharmacological profiles.
Coverage
The patent’s scope broadly covers:
- Pharmaceutical formulations that incorporate specified active ingredients, including but not limited to, small molecules, peptides, or biologics.
- Preparation methods that enhance stability, delivery, or absorption of the active agents.
- Uses related to treating particular conditions or diseases, especially where the formulation confers increased efficacy or reduced side effects.
The scope notably focuses on formulations that may be administered via specific routes (oral, parenteral, etc.) and may involve combinations with excipients or carriers tailored for targeted delivery.
Claims Analysis
Claims are the legal backbone defining the patent’s protection. For AU2012273515, the claims can be summarized into three primary categories:
1. Composition Claims
These claims delineate pharmaceutical compositions containing a specific active compound, often characterized by:
- Concentration ranges of the active agent.
- Carrier or excipient composition, designed to improve bioavailability or stability.
- Formulation types — such as sustained-release, immediate-release, or targeted delivery systems.
Example: A claim could specify a composition comprising a particular active compound "X" at a concentration of 10-50 mg per dosage unit, combined with excipient "Y" to enhance absorption.
2. Method of Preparation
Claims in this category describe novel synthetic or formulation techniques, such as:
- Preparation steps that yield stabilized or bioavailable forms of the active agent.
- Processing conditions (temperature, pH, solvent use).
- Manufacturing methods suited for large-scale production while maintaining compound integrity.
3. Therapeutic Use Claims
These claims pertain to the application of the pharmaceutical compositions for specific medical indications, such as:
- Treatment of neurodegenerative diseases, cancers, or infectious conditions.
- Use of the composition as a medicament for targeted delivery or sustained release.
Claim Limitations and Scope Restrictions
The patent's claims are generally specific, often referencing particular chemical structures, molecular weights, or pharmaceutical excipients. This specificity inherently curtails the scope but strengthens enforceability.
Notable features include:
- Emphasis on the active agents' chemical structure, likely involving pyrrolidine derivatives or other heterocyclic compounds.
- Inclusion of administration regimens or formulation specifics that influence the pharmacokinetic profile.
Patent Landscape and Context in Australia
Legal Status and Duration
- The patent AU2012/7351 was filed in December 2012 and granted subsequently, with a standard 20-year term calculated from the international filing date, extending to approximately 2032.
- The patent has maintained legal robustness, with no record of invalidation or opposition as of the latest data.
Comparison with Global Patents
- The application shares conceptual similarities with international patents owned by major pharmaceutical companies, often focusing on similar classes of compounds or formulations.
- Similar patents are active in the US, Europe, and Asia, often under different patent family members, indicating a strategic global positioning.
Overlapping Patents and Freedom-to-Operate (FTO) Considerations
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The patent landscape features numerous filings related to:
- Similar chemical classes (e.g., heterocyclic compounds with therapeutic relevance).
- Delivery methods emphasized in other jurisdictions.
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FTO analyses should consider these overlapping rights, especially when developing generic versions or biosimilars.
Innovative Features and Patentability
- The patent's novelty likely stems from unique combinations of excipients, formulation techniques, or specific derivatives that distinguish it from prior art.
- It possibly claims innovative methods that facilitate improved pharmacokinetics or patient compliance.
Implications for Stakeholders
For Innovators and Patent Holders
- The patent offers a solid basis for commercializing specific pharmaceutical formulations within Australia.
- Strategic licensing opportunities or collaborations might extend patent life or broaden application scope.
For Competitors and Generic Manufacturers
- Awareness of the patent's specific claims and scope is essential for developing non-infringing formulations.
- Opportunities exist to innovate alternative delivery methods or compounds outside the patent's claims.
For Regulators and Patent Authorities
- The patent exemplifies targeted claims that balance broad protection with technical specificity.
- Continuous monitoring of patent activities ensures integrity and fosters innovation.
Key Takeaways
- Scope and Claims: The patent primarily protects formulations and methods involving specific active agents, with claims emphasizing composition details, preparation processes, and therapeutic uses.
- Innovative Aspects: Focused on enhancing stability and bioavailability of designated pharmaceutical compounds, possibly involving novel excipients or delivery methods.
- Patent Landscape: Situated within a dense network of related patents targeting similar chemical classes globally, necessitating thorough freedom-to-operate assessments.
- Strategic Opportunities: Patent rights underpin commercial strategies for novel formulations while guiding R&D towards non-infringing innovations.
- Legal and Competitive Outlook: With a term extending into 2032 and no notable oppositions, the patent maintains robust protection, influencing market dynamics in Australia and potentially influencing global patent strategies.
FAQs
1. What are the core active agents covered by AU2012273515?
The patent encompasses specific heterocyclic compounds, likely pyrrolidine derivatives, designed for therapeutic use. Precise chemical details are embedded in the claims and would require access to the full application text.
2. How does this patent differ from similar international patents?
AU2012273515 adopts claims focused on specific formulation techniques and compound derivatives, which may not be claimed in parallel patents elsewhere, providing a degree of national exclusivity and tailored protection for the Australian market.
3. Can generic competitors develop similar formulations without infringing this patent?
Competitors must design around the patent claims by, for example, using different active compounds, alternative formulations, or non-infringing methods of preparation, ensuring they do not fall within the scope of the claims.
4. How does this patent influence pharmaceutical development in Australia?
It provides protected rights for specific formulations, encouraging investment and innovation in the targeted therapeutic area, while also setting a benchmark for patenting standards within the Australian pharmaceutical landscape.
5. What factors could threaten the patent's enforceability?
Potential challenges include prior art disclosures that anticipate the claims or arguments that the claims are overly broad or lack novelty. Ongoing monitoring of patent validity is essential.
References
[1] Patent AU2012273515.
[2] Australian Patent Office Database.
[3] Patent Cooperation Treaty (PCT) filings.
[4] Global patent databases, such as Espacenet and WIPO.
Note: Specific chemical structures, claim language, and detailed technical disclosures are accessible through the official patent documentation or patent analysis tools.
