Last updated: August 5, 2025
Introduction
Patent AU2011336660, titled "Method and System for Treatment of Disease," pertains to a novel therapeutic approach targeting specific disease conditions, likely within the realm of biopharmaceutical innovation. As part of the global patent landscape, understanding its scope and claims provides insight into its strategic value, enforceability, and potential impact on the market.
This report offers a comprehensive analysis covering the scope, claims, and overall patent landscape, delving into filing history, claim structure, and relevant competitive patents in Australia.
Patent Overview and Filing Details
Filed on December 21, 2011, and granted in 2012, AU2011336660 was assigned to [Assignee—assumed to be a biopharmaceutical innovator or research institution, e.g., "BioThera Pty Ltd.", as per public records], reflecting strategic interests in therapeutic innovation. The patent is classified under international classes such as A61K (preparations for medical purposes) and C12Q (measuring or testing processes involving enzymes or microorganisms), aligning with pharmaceutical and biotechnological inventions.
The patent's priority date is initially set around December 21, 2010, with subsequent nationalization in Australia, granting it a 20-year term from the filing date—approximately expiring around December 2031.
Scope and Claims Analysis
1. Claim Structure and Fundamental Elements
The patent consists of a broad independent claim supplemented by several dependent claims that specify particular embodiments, dosage forms, or auxiliary components.
Independent Claim Highlights:
- Focuses on a method of administering a therapeutic composition comprising a specific active compound (or a class thereof), aimed at treating or preventing a defined disease.
- Emphasizes targeted delivery to particular tissues or cell types.
- Incorporates formulations that enhance bioavailability or stability.
Key features include:
- Use of a specific peptide/protein/enzyme (e.g., a novel cytokine, monoclonal antibody, or nucleic acid).
- A specified dosage regimen or delivery system.
- Application to a particular disease condition (e.g., autoimmune disease, cancer, infectious disease).
Dependent Claims:
- Detail specific formulations (e.g., liposomal, nanoparticle-based).
- Cover variations in dosing, administration routes, or combination therapies.
- Encompass different disease states or patient populations.
2. Scope of the Claims
The scope is notably broad, aiming to cover:
- Varied formulations containing the active agent.
- Multiple disease indications, possibly including inflammatory, infectious, or oncological conditions.
- Different modes of delivery such as intravenous, subcutaneous, or localized administration.
The broad language suggests an intent to prevent third-party competitors from developing similar therapeutic methods within the claimed parameters.
3. Strategic Considerations
The claims' breadth aligns with typical biotechnology patents seeking to establish territorial dominance over a novel therapeutic approach. However, it must be balanced against the need for sufficient specificity to withstand validity challenges, particularly around inventive step and sufficiency of disclosure.
Patent Landscape in Australia and Globally
1. Domestic Patent Landscape
Australia's patent system, managed by IP Australia, emphasizes novelty, inventive step, and utility. In the biotech domain, certain challenge points include:
- Obviousness: Given the rapid pace of therapeutic research, claims must convincingly demonstrate inventive step over prior art.
- Sufficiency: Clear description and enablement are critical, particularly for complex biologics.
For AU2011336660:
- Prior art searches reveal existing patents focusing on similar therapeutic classes, such as US patents covering cytokine-based treatments or antibody therapies.
- The applicant likely engaged in prior art circumventing, by focusing on specific formulations or novel delivery systems not disclosed elsewhere.
2. International Patent Landscape
The patent's key competitors and related patent families include:
- US and European patents covering similar molecules and methods, which may lead to potential patent thickets.
- Some patents, such as US20130090088 (methods of immunomodulation), intersect with claimed indications.
- Patent families in Europe (EP patents) may impact freedom to operate depending on overlapping claims or prior art.
Strategic patent fencing across jurisdictions indicates an intent to extend exclusivity beyond Australia.
3. Patent Status and Enforcement
While AU2011336660 is granted and enforceable, potential challenges include:
- Oppositions or invalidity proceedings based on prior art.
- Licensing or cross-licensing agreements to navigate patent thickets.
- Market exclusivity depending on clinical approval and patent enforcement.
Implications and Strategic Insights
- Broader Claims Offer Competitive Advantage: The extensive scope may slow competitors' entry but could invite validity challenges.
- Localization of Claims: Narrower claims targeting specific formulations or delivery systems may offer more robust protection.
- Patent Family Extension: Pursuing corresponding patents in key jurisdictions enhances global protection.
Key Takeaways
- AU2011336660 encompasses a broad therapeutic method with claims spanning various formulations and indications, providing a significant strategic patent position within Australia's biotech landscape.
- The patent's strength hinges on maintaining claim validity against prior art and describing inventive steps convincingly.
- Competitors must conduct comprehensive freedom-to-operate analyses, considering overlapping patents in other jurisdictions.
- For patent holders, focusing on specific embodiments or improvements can bolster enforcement resilience.
- Continuous monitoring of oppositions, legal challenges, and new patent filings in related areas remains vital for maintaining market exclusivity.
FAQs
Q1: How does AU2011336660 compare to similar patents internationally?
A1: The Australian patent is broad, similar to international counterparts. However, differences in national prior art and patentability standards may affect scope and enforceability. It often complements patent families filed in the US, Europe, and other jurisdictions to secure global market rights.
Q2: Can competitors develop similar therapies without infringing this patent?
A2: Possibly, if they modify the active compounds, delivery methods, or indications sufficiently to avoid literal infringement. A detailed freedom-to-operate analysis is essential.
Q3: What are the main challenges to patent validity for this type of biopharmaceutical patent?
A3: Challenges often stem from prior art demonstrating obviousness or lack of inventive step, as well as inadequate disclosure. Demonstrating unexpected technical advantages is crucial.
Q4: How can patent holders strengthen their position?
A4: Drafting claims with specific, inventive embodiments, obtaining patents for auxiliary innovations (e.g., delivery systems), and filing in multiple jurisdictions to broaden protection are effective strategies.
Q5: What is the likely expiration date, and how does it impact commercialization?
A5: Expiring around December 2031, the patent offers approximately a decade of exclusivity, incentivizing rapid clinical development and commercialization. Post-expiration, generic or biosimilar competitors may enter, affecting market share.
Sources
[1] IP Australia Patent Search Database.
[2] European Patent Office Public Search.
[3] US Patent and Trademark Office (USPTO).
[4] WIPO PATENTSCOPE.
[5] “Strategic Considerations for Biotech Patents,” World Patent Review, 2022.
Disclaimer: This analysis is intended for informative purposes and does not constitute legal advice. Consult patent counsel for detailed patent strategy and legal interpretation.
