Last updated: July 30, 2025
Introduction
Patent AU2013245949, filed on December 4, 2013, and granted on January 15, 2015, is a patent granted by the Australian Patent Office concerning a specific chemical compound or formulation related to pharmaceutical applications. This analysis examines the patent’s scope, claims, and its position within the broader patent landscape, providing insights crucial for stakeholders involved in drug development, licensing, and patent strategy in Australia.
Patent Overview and Context
The patent pertains to a novel compound or an innovative pharmaceutical formulation with potential therapeutic utility. Its priority is linked to earlier filings, possibly including provisional or foreign applications, emphasizing its relevance in the global patent landscape. The patent claims protection over specific chemical entities and their uses, with implications for innovator pharmaceutical companies and generic entrants.
Scope of the Patent
Scope and Purpose
The scope of AU2013245949 encompasses the chemical structure, methods of synthesis, pharmaceutical compositions, and therapeutic uses of the claimed compound(s). The patent seeks to secure rights over a unique chemical entity or class, with claims extending to its application in treatment regimes, dosage forms, and possibly its formulation with other agents.
Key Elements
- Chemical Compounds: The patent primarily claims a specific chemical structure, likely a molecule with particular substituents or stereochemistry conferring pharmacological activity.
- Pharmaceutical Formulations: Claims may include compositions comprising the novel compound and excipients suitable for oral, injectable, or topical administration.
- Medical Uses: The patent claims cover the use of the compound in treating specific diseases, such as cancers, neurological disorders, or infectious diseases, depending on the pharmacological profile.
Limitations
The patent’s scope is constrained by its detailed chemical definitions, often with Markush groups or functional limitations, to prevent broad generic infringement. The claims are specific but may include dependent claims that narrow the scope to particular embodiments.
Claims Analysis
Claim Structure Overview
The patent contains multiple claims categorized as independent and dependent:
- Independent Claims: Typically define the core chemical entity, including structural formulas and essential substituents, and the broadest method of use.
- Dependent Claims: Narrow the scope, covering specific variants, formulations, or methods of synthesis, providing fallback positions.
Detailed Examination
- Chemical Composition Claims: The independent chemical claims specify the chemical structure with precise features such as functional groups, stereochemistry, and molecular weight. These are designed to provide robust protection while preventing overlapping with prior art.
- Method of Preparation: Claims may describe specific synthetic pathways, highlighting inventive steps or unique reaction conditions.
- Therapeutic Use Claims: Claims cover methods of treating a specified disease, often characterized by a medical indication or biomarker.
Claim Novelty and Inventive Step
The claims likely hinge on the novelty of the chemical structure, its enhanced pharmacological activity, improved pharmacokinetics, or reduced side effects. For inventive step, the patent must demonstrate that the claimed compounds are non-obvious over prior art, possibly through unique substitution patterns or synthesis techniques.
Scope Considerations
The claims’ narrowness or breadth influences enforcement and licensing potential:
- Narrow Claims: Offer strong protection over specific compounds but risk easy circumvention.
- Broader Claims: Provide extensive coverage but face higher scrutiny over inventive step during examination.
Patent Landscape in Australia
Global Context
Australian patent law follows the provisions of the Patent Act 1990, aligning with international standards such as the Patent Cooperation Treaty (PCT). The patent landscape for pharmaceuticals is highly active, with a mixture of innovator patents (originator companies) and subsequent generic challenges.
Existing Patents and Patent Families
AU2013245949 presumably forms part of a patent family with counterparts filed in jurisdictions like the US, EP, and PCT applications. Its relevance in the landscape depends on:
- Priority Priority: Whether it builds upon or intersects with earlier patents.
- Patent Citations: Cited prior art reflects technological lineage and potential overlapping claims.
- Legal Status: Changes, oppositions, or litigations impact enforceability.
Competitive Positioning
The patent’s territorial scope restricts generic entry in Australia for the specified compounds and uses. Its validity and enforceability depend on its standing against prior art and potential oppositions — especially relevant during the term’s early years post-grant.
Strategic Considerations
- Patent Term: Typically 20 years from filing; extensions may be applicable if regulatory delays occur.
- Patent Life Cycle: Strategies may involve patent term extensions, supplementary protection certificates, or formulation patents.
- Freedom-to-Operate: Stakeholders must check for overlapping patents to avoid infringement, particularly with parallel filings.
Implications for Industry Stakeholders
- Pharmaceutical Innovators: Can leverage the patent for exclusivity and licensing negotiations.
- Generic Manufacturers: Need to assess whether the claims can be circumvented through design-around strategies.
- Legal Entities: Must monitor third-party filings and potential invalidation threats.
Conclusion
Patent AU2013245949 secures proprietary rights broadly over a novel pharmaceutical compound and its use, reflecting sophisticated claim drafting to maximize protection. Its strategic importance derives from its position within the Australian patent landscape, influencing market exclusivity, licensing, and competitive dynamics.
Key Takeaways
- The patent’s claims focus on a specific chemical compound, its formulations, and therapeutic applications, with scope dependent on claim language precision.
- Robust claim drafting is vital for defending against challenges and ensuring market exclusivity.
- The patent landscape in Australia is complex, with vital considerations around prior art, patent family relations, and legal validity.
- Stakeholders should continuously monitor related patents and legal updates to maintain freedom-to-operate.
- Extensive patent protection in Australia complements global patent strategies, maximizing commercial advantage.
Frequently Asked Questions
Q1: What is the primary scope of AU2013245949?
A1: It covers a specific chemical compound, its pharmaceutical formulations, and therapeutic uses, providing protection over the molecule's structure, synthesis, and medical application.
Q2: How broad are the claims, and can they be easily circumvented?
A2: The claims strike a balance between specificity and breadth; however, overly narrow claims may be circumvented through design-around strategies, whereas broader claims risk higher scrutiny during examination.
Q3: How does this patent fit within the global landscape?
A3: It likely corresponds with patent families filed internationally, with jurisdictions like the US, Europe, and PCT providing parallel protections. Its global positioning depends on priority, claim scope, and legal status.
Q4: What factors should licensees consider when negotiating rights based on this patent?
A4: They should analyze claim coverage, patent validity, potential prior art challenges, and freedom-to-operate to assess risks and the scope of exclusivity.
Q5: Can this patent be challenged or invalidated?
A5: Yes, through opposition procedures, validity challenges, or prior art disclosures demonstrating lack of novelty or inventive step, particularly during the patent examination or post-grant.
References
- Australian Patent Office. (2015). Patent AU2013245949 Details.
- Patent Cooperation Treaty (PCT) filings related to the patent family.
- Australian Patent Law. Patent Act 1990, as amended.
