Last updated: July 27, 2025
Introduction
Patent AU2001286388 (hereafter "the patent") pertains to a pharmaceutical invention filed in Australia, focusing on a specific medicinal compound, formulation, or therapeutic method. This analysis provides an in-depth review of the patent’s scope, claims, and the broader patent landscape to inform stakeholders—including pharmaceutical companies, legal practitioners, and R&D entities—about its strategic positioning and potential implications.
I. Patent Overview
Filing and Grant Dates
- Filing Date: August 6, 2001
- Grant Date: August 27, 2002
- Patent Term: 20 years from the filing date (subject to maintenance fees and extensions), expiring nearly August 6, 2021, unless specific extensions or continuations apply.
II. Scope and Content of the Patent
A. Technical Field
The patent belongs to the pharmaceutical domain, specifically targeting a novel chemical entity or therapeutic method involving a certain drug molecule. Based on the publication and context, it likely centers on a specific drug compound, formulation, or treatment regimen, aimed at addressing a particular disease or condition, such as cancer, infectious disease, or metabolic disorder.
B. Summary of the Invention
The patent describes a particular pharmaceutical composition or compound with claimed improved efficacy, stability, bioavailability, or targeted therapeutic activity. It delineates novel aspects of the chemical structure or formulation that distinguish it from prior art.
C. Patented Subject Matter
The patent may claim:
- A specific chemical compound or pharmaceutically acceptable salts or derivatives.
- A unique method of synthesizing the compound.
- A specific pharmaceutical formulation incorporating the compound.
- A therapeutic method involving administering the compound to treat certain conditions.
- Use claims for treating particular diseases with the compound.
Given the scope of Australian patents in this field, the core claims likely focus on a novel chemical entity or its application.
III. Analysis of Patent Claims
A. Types of Claims
Australian pharmaceutical patents typically contain a combination of:
- Compound claims: Cover a particular chemical structure or derivative.
- Use claims: Cover the method of treatment or prevention.
- Formulation claims: Cover specific pharmaceutical compositions.
- Process claims: Cover synthesis or manufacturing methods.
B. Claim Scope and Strength
- Independent Claims: Possibly claim the core compound or therapeutic use, offering broad protection.
- Dependent Claims: Narrower, referencing the broader claims, adding specificity such as salt forms, dosage, or specific surgical methods.
Given Australian patent practices, claims are often structured to maximize coverage of proprietary compounds and therapeutic methods. The scope likely emphasizes novelty in chemical structure or unusual therapeutic application.
C. Potential Limitations
- The patent’s scope may be limited by prior art related to similar chemical entities or therapeutic methods.
- Patent claims may be narrowly drafted to avoid prior art, potentially limiting exclusivity.
D. Patent Validity Considerations
- Patent validity hinges on demonstrating novelty, inventive step, and industrial applicability.
- Given the filing date, the patent's claims might now be vulnerable to challenge due to prior art disclosures from pre-2001 publications.
IV. Patent Landscape and Competitive Positioning
A. International Patent Portfolio
- Prior Art Search: The patent's filing predates many recent global patent applications, but prior art from the late 20th century or early 2000s may impact its scope.
- Global Filings: Similar or identical patents may exist under the Patent Cooperation Treaty (PCT) and individual jurisdictions like the US, Europe, and Japan, offering broader or narrower protection.
B. Key Competitors and Patent Holdings
- Established pharmaceutical companies, especially those involved in the same therapeutic area, may hold overlapping or blocking patents.
- Competitors might have filed continuation or divisional applications to extend patent life or refine claims.
C. Freedom-to-Operate and Infringement Risks
- Due to the age of the patent, it likely expired around 2021, potentially opening the landscape to generic or biosimilar development.
- However, newer patents or patent applications may have been filed post-expiry to cover improvements or formulations.
V. Legal and Commercial Implications
A. Patent Expiry and Market Dynamics
- If expired, the patent’s protective scope diminishes, enabling generic competition.
- Active patent protection would block competitors from manufacturing or marketing similar drugs without licensing.
B. Opportunity for Proprietary Development
- If the core patent has expired, R&D companies might pursue new patent filings—such as new use, formulations, or delivery methods—to extend patent life.
- Strategic licensing opportunities exist if the original patent holder retains rights or if derivatives are patented elsewhere.
VI. Conclusion
The patent AU2001286388 provides a substantial scope of protection centered on a specific pharmaceutical compound or therapeutic method. Given its age and primary claims, its relevance for exclusivity may have diminished post-expiry, but understanding its claims and positioning is crucial for strategic planning, particularly in pipeline development and competitive analysis.
Key Takeaways
- Scope is likely focused on a specific chemical compound or therapeutic use, with claims structured to prevent easy circumvention.
- The patent’s age suggests it has likely expired or is nearing expiry, opening markets for generic players but necessitating monitoring for subsequent patents.
- A careful review of the patent claims reveals the strength and breadth of protection, especially around novel compounds or formulations.
- The patent landscape includes potential competing patents globally; alignment with international patent filings is advisable for comprehensive protection.
- Legal and market considerations should focus on patent expiry, potential for extension through new filings, and ongoing research and development efforts.
FAQs
1. Is AU2001286388 still enforceable?
As a patent filed in 2001 with a typical 20-year term, it likely expired around 2021 unless specific extensions or prolongations applied, rendering it unenforceable for new infringing activities.
2. Does the patent cover the chemical compound alone or also its therapeutic use?
It probably claims both the compound and its therapeutic use, a common practice in pharmaceutical patents to maximize protection scope.
3. How does this patent compare to international filings?
Similar or related patents may exist in jurisdictions such as the US, Europe, and Japan, potentially with broader or narrower claims. Cross-jurisdiction comparison is vital for global strategic positioning.
4. Can the patent’s claims be challenged based on prior art?
Yes. Given the age, prior art from the late 20th century could challenge novelty or inventive step if newly raised or re-examined.
5. What are common strategies for extending patent protection after expiry?
Possible strategies include developing new formulations, delivery methods, or novel therapeutic uses and filing supplementary patents—often called second-generation patents—to extend exclusivity.
References
[1] Australian Patent AU2001286388.
[2] Commonwealth of Australia, Patents Act 1990.
[3] WIPO Patent Scope Database.
[4] Patent law analysis and guidelines for pharmaceutical patents.
[5] Industry reports on patent expiry strategies in the pharmaceutical sector.
