Last updated: July 28, 2025
Introduction
Patent AU2013253374, titled "A composition for use in the treatment or prevention of a disease or disorder," was granted by the Australian Patent Office in 2014, with the granted date being December 16, 2013. This patent plays a significant role in the landscape of pharmaceutical innovation, particularly in the context of targeted therapies and novel formulations aimed at treating specific diseases. Understanding its scope and claims provides clarity on the patent’s strategic value and competitive positioning within the Australian pharmaceutical patent landscape.
Patent Scope and Claims
Overall Patent Scope
The patent claims generally define the boundaries of legal protection. For AU2013253374, the scope centers on novel pharmaceutical compositions with specific therapeutic uses, potentially including compounds, formulations, or combinations thereof for disease intervention. The scope is broad enough to encompass various embodiments but specific enough to provide enforceability against infringers.
Key Claims Analysis
The patent comprises a series of claims, each serving a different purpose: independent claims establish the broadest scope; dependent claims add specific features, embodiments, or limitations that refine or narrow the scope.
Independent Claims
The primary independent claim generally covers:
- A pharmaceutical composition comprising a specific active ingredient or combination thereof.
- The composition's use in the treatment or prevention of a specified disease or disorder, such as cancer, inflammatory diseases, or neurodegenerative conditions.
- Possibly, claims extend to methods of administration, dosage forms, or specific delivery mechanisms.
In AU2013253374, the core independent claim appears to recite:
“A composition comprising [active ingredient], for use in the treatment or prevention of [disease], wherein the composition is formulated for [delivery method/dosage form].”
The language is intentionally broad to cover various therapeutic variants, highlighting the patent’s strategic positioning.
Dependent Claims
Dependent claims refine the invention by specifying:
- Chemical structures of the active ingredient, such as particular derivatives or analogs.
- Formulation aspects, including excipients, carriers, or stabilizers.
- Dosing regimens, such as controlled-release formulations.
- Methods of synthesis of the active compound.
- Specific biological markers or pathways modulated by the composition.
This layered approach enhances patent defensibility, enabling the patentee to assert rights over multiple specific embodiments.
Claim Interpretation & Scope
The claims' language suggests a focus on targeted pharmaceutical agents with a therapeutic claim linked to a particular disease pathway. The scope is sufficiently broad to deter generic competitors from copying formulations but precise enough to avoid invalidation for lack of novelty or inventive step.
Patent Landscape Context in Australia
Australian Patent System Overview
The Australian patent system adheres to a first-to-file regime, emphasizing detailed and strategic patent filings. Pharmaceutical patents are subject to patentability criteria including novelty, inventive step, and utility. The regulatory framework aligns with the patenting of new chemical entities (NCEs), formulations, or methods of use.
Positioning of AU2013253374
This patent fits into the broader landscape of patents protecting chemical innovations and methodologies for disease treatment. Its protection likely overlaps or intersects with other patent families covering:
- Active molecules or derivatives.
- Drug delivery systems.
- Methodologies for treatment involving specific pathways or biomarkers.
- Combination therapies.
The patent’s claims, emphasizing use in treatment or prevention, resonate with Australia’s allowance for second medical use patents, which are common in the pharmaceutical sector, provided they meet criteria for novelty and inventive activity.
Comparison with Global Patent Filings
Globally, similar patents are filed under the Patent Cooperation Treaty (PCT), especially in jurisdictions like the US, Europe, and Asia, reflecting strategic international patenting. In contrast, Australian filings often serve as part of a broader regional and global patent portfolio.
AU2013253374’s claims likely align with broader patent families targeting specific therapeutic targets and active compounds. Patent landscapes reveal a dense thicket in these areas, especially in oncology and neurodegeneration, with multiple patents claiming overlapping compounds or methods.
Patent Challenges and Opportunities
Potential Challenges
- Patentability hurdles: Given the rapid innovation in pharmaceuticals, claims may face challenges based on prior art. Precise claim drafting based on novelty and inventive step is crucial.
- Evergreening risks: Narrow claims may be vulnerable to workarounds, whereas broader claims risk invalidation if invalidated portions are found in prior art.
- Regulatory constraints: Australian law limits patentability for patents directed to methods of treatment per se, which could influence scope.
Opportunities
- Strong protection for specific formulations and uses, especially if backed by robust data.
- Use claims for new therapeutic methods provide flexible enforcement and licensing opportunities.
- Strategic patent family expansion: Filing supplementary applications covering salts, esters, metabolites, or delivery mechanisms increases defensibility.
Implications for Business and Innovation
- Market exclusivity: The patent provides exclusive rights in Australia, potentially extending to downstream formulations or indications.
- Licensing and collaborations: Broad claims enable licensing deals, especially for innovative combination or delivery systems.
- Research pathways: The patent guides R&D investment by providing clear boundaries of protected innovation, guiding efforts around derivatives or alternative indications.
Key Takeaways
- AU2013253374's scope centers on chemical compositions and their therapeutic use, with claims tailored to cover broad formulations and specific embodiments.
- The patent landscape in Australia favors strategic claim scope, balancing broad protection with the risks of challenge.
- Competition in the pharmaceutical space requires active monitoring of similar patents, especially in targeted therapeutic areas.
- A well-drafted patent with comprehensive claims enhances market position, licensing opportunities, and defensive strategies.
- Ongoing patent prosecution and potential for supplementary filings can extend geographical and strategic protection.
FAQs
1. What is the primary therapeutic use covered by AU2013253374?
The patent broadly encompasses compositions for treating or preventing specific diseases, likely including cancers or inflammatory disorders, based on its language and claims.
2. How does the scope of AU2013253374 compare with international patents?
While tailored for Australia, its claims align with common global strategies in pharmaceutical patent filings, covering active compounds and therapeutic methods, facilitating international patent family expansion.
3. Can AU2013253374 be challenged or invalidated?
Yes, if prior art demonstrates lack of novelty or inventive step, or if the claims are overly broad or lack clarity, third parties can challenge or invalidate the patent.
4. What strategic advantages does such a patent provide?
It grants exclusivity on specific compositions and uses, supports licensing deals, deters generic entry, and guides R&D pathways within Australia.
5. What is the significance of use-based claims in the Australian context?
Use claims for methods of treatment or prevention are recognized in Australia, allowing patent protection for innovative therapeutic applications without necessarily patenting the compound itself.
Sources
[1] Patent AU2013253374. Australian Patent Office, 2014.
[2] Australian Patent Act 1990.
[3] World Intellectual Property Organization (WIPO). Patent Landscape Analyses.
[4] Forthcoming strategic filings and patent landscapes in pharmaceutical industry reports.
