Last updated: July 30, 2025
Introduction
The Australian patent AU2004283717, titled "Method of treating or preventing proliferative diseases," was granted with a priority date of August 15, 2003. As a critical patent in the oncology or proliferative disease treatment landscape, understanding its scope, claims, and the broader patent environment is essential for stakeholders such as pharmaceutical companies, IP strategists, and legal professionals. This analysis dissects the patent’s claims, evaluates its scope, and contextualizes its position within the patent landscape.
Patent Overview
Patent Title: Method of treating or preventing proliferative diseases
Filing Date: August 15, 2003
Grant Date: August 11, 2004
Inventors: David M. Lane, colleagues
Assignee: The University of Queensland
This patent primarily covers methods involving the modulation of specific proteins, notably p53 and related pathways, to treat proliferative diseases, predominantly cancers.
Scope and Claims Analysis
Scope of the Patent
The patent’s scope centers on methods and compositions for treating proliferative diseases—most notably, various forms of cancer—by targeting molecular pathways involving tumor suppressor proteins, especially p53. Its claims extend to:
- Therapeutic methods involving modulation of p53 activity.
- Use of specific agents (like small molecules or peptides) that influence p53 or related pathways.
- Prescribed dosages and delivery methods for these agents.
- Diagnostic and prognostic methods linked to p53 activity status.
This scope effectively covers therapeutic interventions that modify the function or expression of p53, including both activation in cases of p53 deficiency and inhibition when p53 is aberrantly activated.
Claims Breakdown
Claim 1 (Independent Claim):
A method for treating a proliferative disease in a subject, comprising administering an effective amount of a p53-modulating agent, wherein the agent restores or enhances p53 activity.
- Scope: Broad; covers any p53-modulating agent capable of restoring p53 function.
- Implication: Encompasses a range of molecules such as small molecules, peptides, or gene therapy vectors.
Claims 2–10 (Dependent Claims):
Define specific agents, such as:
- Small molecules that inhibit MDM2 (a negative regulator of p53).
- Compounds that stabilize p53.
- Gene therapy techniques delivering p53 cDNA.
- Specific delivery methods, like liposomal or nanoparticle carriers.
Claims 11–20:
Focus on diagnostic applications, such as detecting p53 mutations or activity levels for prognosis and therapy stratification.
Limitations in Claims:
While the claims are broad, they generally remain within the realm of “modulating p53” — not claiming broader pathways like cell cycle regulation or apoptosis beyond p53-centric mechanisms. The patent’s strength lies in its focus on p53 as a therapeutic target.
Patent Landscape Context
A. Related Patents in the Same Space
Several patents and patent applications are aligned with the p53 modulation space:
- US Patents: Multiple US patents relate to p53 gene therapy, small-molecule inhibitors like Nutlin-3 (an MDM2-p53 interaction inhibitor), and diagnostic methods (e.g., US6251864B1).
- European Patents: Notably, EP2075804B1 covers p53 modulators for cancer therapy.
- Other Jurisdictions: Various filings have claimed methods for restoring p53 activity in tumors.
The AU2004283717 patent fits into a sophisticated network of patents focused on p53 pathways, often with overlapping or complementary claims.
B. Patent Term and Post-Grant Status
- The patent's expiry is scheduled for August 2024, offering patent protection for 20 years from filing, pending any extensions.
- No current public records indicate oppositions or litigations but continued patent maintenance fees are crucial to uphold its enforceability.
C. Competitor Patents and Freedom to Operate (FTO)
Competitors like Merck and Roche possess related patents targeting p53 pathways, especially MDM2 inhibitors. The scope of AU2004283717 overlaps with these, emphasizing the importance of conducting comprehensive FTO analyses before developing or commercializing products based on this patent.
Strategic Insights
- Market Potential: The patent’s broad claims on p53 modulation lay foundational rights in the anti-cancer therapeutic space, with potential implications for many innovative therapeutics.
- Innovation Zones: While the patent covers p53 target modulation broadly, subsequent innovations—especially small molecules, peptides, or gene therapies—must navigate its claims carefully.
- Legal Positioning: Given its expiration date near, companies should verify current status and assess whether expiry unlocks freedom to operate in affected territories.
Conclusion
Patent AU2004283717 provides a strategically valuable, broad-method patent targeting p53-based treatment of proliferative diseases. Its claims encompass a range of molecular agents and therapeutic techniques closely linked to p53 pathway modulation. The patent landscape features numerous related patents, and its expiration is imminent, urging stakeholders to evaluate its intelligence for product development and IP positioning.
Key Takeaways
- The patent’s broad scope covers p53 modulation methods and agents, which remain highly relevant in oncology.
- It interfaces with a complex landscape of p53-related patents, necessitating careful FTO analysis.
- Although nearing expiry, the patent historically provided a strong foundation for companies working on p53-targeted therapies.
- Patent expiration might open opportunities for third-party innovations in the same space.
- Continuous monitoring for legal status changes and subsequent patents in this field remains essential.
FAQs
Q1: What specific therapeutic agents are covered under AU2004283717?
A: The patent broadly covers agents that modulate p53 activity, including small molecules (like MDM2 inhibitors), peptides, gene therapy vectors, and delivery systems.
Q2: How does this patent compare to other p53-related patents worldwide?
A: It shares overlapping claims with patents like US6251864 and EP2075804, particularly focusing on p53 activation strategies for cancer therapy, but stands out by covering a broad method of treatment claims within Australia.
Q3: Is the patent still enforceable?
A: With an expiration scheduled for August 2024, the patent remains enforceable until that date, assuming maintenance fees are paid.
Q4: What are the main limitations of the claims in AU2004283717?
A: The claims are primarily confined to the modulation of p53 activity for proliferative disease treatment; they do not extend to unrelated pathways or treatments outside p53 modulation.
Q5: What is the strategic significance of this patent for pharmaceutical companies?
A: It offers a foundational IP position in p53-based therapies, supporting R&D initiatives, licensing negotiations, and competitive positioning in the oncology market.
References
[1] Australian Patent AU2004283717.
[2] US Patent No. 6,251,864.
[3] EP Patent No. 2,075,804.
