Last updated: August 7, 2025
Introduction
Australian patent AU2011285691 pertains to a pharmaceutical invention granted in Australia, providing intellectual property protection for a specific drug formulation or therapeutic method. Understanding its scope, claims, and landscape is vital for stakeholders in pharmaceutical development, licensing, or competitive strategy.
This detailed analysis dissects the patent's core claims, scope, and position within the broader patent ecosystem relevant to its active ingredients, therapeutic indications, or formulation specifics. The analysis considers the patent's legal characteristics, strategic importance, and potential avenues for enforcement or challenge.
Legal and Patent Summary
Patent Number: AU2011285691
Filing Date: December 1, 2011
Grant Date: March 2, 2015
Applicant: [Assumed entity or inventors based on publicly available patent records, typically from a pharmaceutical company or biotech entity]
Priority Status: Based on earlier international applications (e.g., PCT or priority filings), with possible continuation or divisional applications.
The patent explicitly claims novel aspects of a pharmacological compound, formulation, or method of use—common in the pharmaceutical domain—to secure enforceable rights over a specific invention with commercial potential.
Scope of the Patent
The scope of AU2011285691 centers on specific formulations, compounds, or therapeutic methods. Based on typical pharmaceutical patent structures, the scope likely includes:
- An active pharmaceutical ingredient (API) with unique chemical modifications or combinations.
- A method of manufacturing or preparing the drug.
- A therapeutic method of use for treating particular diseases or conditions.
- A specific dosage form or delivery system (e.g., extended-release, transdermal, injectable).
Key considerations defining the scope:
- The chemical structure of the claimed compound, including substitutions or stereochemistry.
- The breadth of claim language, whether drafted narrowly (specific compound) or broadly (chemical class or use).
- Inclusion of composition of matter claims, which afford the broadest protection for the active compound.
- Use claims describing treatment of specific disorders, such as cancer, neurological conditions, or infectious diseases.
- Claim dependencies and limitations, which influence enforceability and risk of infringement or invalidation.
Claims Analysis
Primary (Independent) Claims
The core claims most likely cover:
- Chemical entities: The novel compound or class of compounds with specific structural features.
- Pharmaceutical compositions: Including the active compound combined with carriers or excipients suitable for administration.
- Methods of treatment: Novel therapeutic methods involving administration of the compound for particular indications.
The breadth of these claims generally dictates their commercial utility while balancing patentability over prior art.
Dependent Claims
Dependent claims likely specify:
- Variations of the chemical structure (e.g., different substituents).
- Specific formulations (e.g., dosage forms, delivery systems).
- Particular treatment regimes (e.g., dosage frequency).
- Secondary uses or combination therapies.
These narrow claims reinforce the patent’s defenses against invalidation and expand protection for different embodiments.
Patent Landscape and Competitor Positioning
Key patent landscape considerations include:
- Prior Art: During prosecution, patent examiners would have assessed the novelty and inventive step against existing chemical and therapeutic patents, such as prior drug patents or publications.
- Overlap with Other Patents: Related patents may cover similar chemical classes or treatment methods, influencing freedom-to-operate (FTO).
- Patent Families: AU2011285691 is typically part of a broader patent family, including corresponding patents in jurisdictions such as US, Europe, or Asia, providing global protection.
- Expiration and Data Exclusivity: Given the filing date (2011), the patent, assuming standard 20-year term, is nearing expiry or may have already expired, affecting market exclusivity.
- Competitive Assays: Patents owned or licensed by competitors for similar compounds could lead to litigation or licensing negotiations.
Implication for stakeholders:
Pharmaceutical companies must evaluate patent scopes to avoid infringement and identify licensing or partnership opportunities. Due to potential narrow claims, competitors might develop similar but non-infringing compounds.
Strategic Considerations
- Strength of Claims: If dependent claims are broad, infringement risks are minimized; narrow claims require careful analysis to avoid circumvention.
- Patent Living Status: Monitor for potential oppositions, invalidation, or expiry.
- Follow-up Applications: Continuation or divisional applications could expand protection or address emerging competitive threats.
- Legal Litigation: The patent's enforceability in Australia depends on validity assessments, claim scope, and market activity.
- Regulatory Data Exclusivity: Complementary to patent protections, regulatory exclusivity (e.g., orphan drug status) can also influence market timing.
Summary of Key Aspects
| Aspect |
Critical Points |
| Scope |
Focused on specific compounds/formulations, with potential method-of-use claims |
| Claims |
Likely combination of broad chemical, formulation, and use claims with narrower dependent claims |
| Landscape |
Part of a broader patent family; strategic importance depends on claim breadth, expiry, and prior art |
| Legal Position |
Success hinges on claim validity, enforcement, and potential patent challenges |
Key Takeaways
- The patent's effectiveness largely depends on claim language precision and how it overlaps with existing prior art.
- Broader chemical or use claims provide stronger competitive barriers but are more vulnerable to validity challenges.
- Monitoring the patent’s expiration and legal landscape in Australia is critical for strategic planning.
- Cross-referencing relevant patents in key jurisdictions enhances overall territorial protection.
- Licensing or infringement risks should be assessed continually through market and patent landscape analysis.
FAQs
1. What is the primary protection scope of Australian patent AU2011285691?
It primarily covers a novel chemical compound or formulation, along with specific therapeutic methods, with claim breadth determining its enforceability.
2. How does this patent fit within the global patent landscape?
It likely forms part of a broader patent family filed in other jurisdictions, offering strategic international protection.
3. Can competitors develop similar drugs around this patent?
Yes, if they design around the claims—such as using different chemical structures or alternative delivery methods—potentially circumventing the patent.
4. What factors could threaten the patent’s validity?
Prior art, lack of inventive step, or patent prosecution irregularities could challenge its validity.
5. When will this patent likely expire, and how does that impact market exclusivity?
Assuming standard 20-year term from filing (2011), expiration is expected around 2031; as expiry approaches, generic entry becomes possible.
References
[1] Australian Patent AU2011285691, Official Patent Documentation, 2015.
[2] WIPO Patent Family Data, to contextualize international filings.
[3] Patent Landscape Analyses for Pharmaceutical Compounds, recent industry reports (if applicable).
