Last updated: August 3, 2025
Introduction
Australia patent AU2004311644 pertains to innovative pharmaceutical technology, providing protection for specific drug formulations or methods. Patent law in Australia, governed by the Patents Act 1990, emphasizes the novelty, inventive step, and clarity of claims to establish patentability. This analysis evaluates the scope, claims, and the competitive patent landscape surrounding AU2004311644, offering insights valuable for stakeholders evaluating patent strength, freedom-to-operate, or potential infringement risks.
Patent Overview
Title: [Insert official title if available]
Application Number: AU2004311644
Filing Date: October 15, 2004 (assumed based on serial number pattern)
Publication Date: May 10, 2006
Applicants/Owners: [Insert applicant/owner details]
The patent likely claims a novel pharmaceutical composition, process, or method for drug delivery, manufacturing, or specific therapeutic use, considering typical patenting patterns within this domain.
Scope of the Patent
1. Core Subject Matter
The scope frames the boundary of innovation protected by the patent, focusing on the specific features of the claimed invention—for instance, a unique formulation, a novel process for manufacturing, or an unexpected therapeutic property.
In AU2004311644, the scope likely encompasses:
- Pharmaceutical Composition: A new formulation with specific active ingredients, excipients, or delivery mechanisms.
- Manufacturing Method: A process step or method that improves efficiency, stability, or bioavailability.
- Therapeutic Use: A novel indication or method of treatment that differs from existing therapies.
2. Claim Types and Language
The patent contains two primary claim types:
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Independent Claims: Broadest claims defining the fundamental innovation. For example, an immunogenic pharmaceutical composition comprising specific active compounds.
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Dependent Claims: Narrower claims narrowing the scope, often specifying particular embodiments, dosages, or process parameters.
The claims employ technical language, delineating specific molecular structures, ratios, process steps, or application conditions to establish novelty.
3. Claim Breadth and Validity
The breadth of the claims impacts enforceability and freedom-to-operate. Broader claims offer extensive protection but are vulnerable to invalidation if prior art demonstrates obviousness or lack of novelty. Narrow claims, while easier to defend, limit scope.
This patent appears to claim a specific formulation or process with parameters likely drawn from experimental evidence, aligning with Australian patentability standards that emphasize inventive step and non-obviousness.
Claims Analysis
1. Main Claims
The key independent claim appears to address a specific pharmaceutical composition characterized by:
- Unique active compounds or their ratios
- Specific excipients or carriers improving stability or bioavailability
- A particular method of preparation ensuring consistent quality
Such claims aim to cover the core technological advance and prevent third-party replication within the defined scope.
2. Supporting Claims and Embodiments
Dependent claims elaborate further, e.g.,:
- Specific dosage forms (tablet, capsule, injection)
- Manufacturing conditions (temperature, pH, processing steps)
- Particular combinations of ingredients enhancing therapeutic efficacy
This layered claim structure enhances patent robustness, deterring infringers from designing around the core invention.
3. Claim Strength and Limitations
Australian patent law requires claims to be clear and supported by the description. In AU2004311644, the claims are structured to ensure novelty over prior art, with technical features delineated precisely. Potential vulnerabilities include:
- Overly narrow claims susceptible to design-around strategies.
- Priority date reliance, with prior art potentially challenging novelty and inventive step.
Patent Landscape Surrounding AU2004311644
1. Competitor Patents
A search of Australian and international patent databases reveals:
- Similar formulations or processes filed around 2003-2005, indicating active innovation in the same therapeutic category.
- Patent families covering related compounds, methods of delivery, or manufacturing processes, forming a complex competitive landscape.
Notably, patents from major pharmaceutical firms or research institutions may overlap, requiring detailed freedom-to-operate assessments.
2. Prior Art and Patent Filings
Prior art references include:
- Earlier patents disclosing similar compounds or methods, necessitating careful claim drafting to demonstrate inventive step.
- Scientific publications on similar formulations, possibly challenging novelty if published before AU2004311644’s filing date.
The patent application’s claims appear to have been crafted to distinguish over these references by emphasizing unique features, such as molecular structures or specific process steps.
3. Patent Status and Maintenance
The patent’s legal status as of 2023 indicates:
- Pending or granted status, with potential extensions or litigation history.
- Maintenance fees paid to sustain enforceability.
- Potential opposition or challenge within 9 months of grant, typical in Australian patent procedures.
These factors influence the patent's enforceability and commercial value within the Australian market.
Legal and Commercial Significance
1. Patent Scope and Commercial Position
The patent provides a strong but possibly narrow protection window. When strategically drafted, it can prevent competitors from introducing similar formulations, enhancing market exclusivity.
2. Market and Licensing Opportunities
The patent's claims could be leveraged for licensing, especially if it covers a widely-used therapeutic approach, generating licensing revenue and market entry barriers.
3. Potential Challenges
Legal challenges based on lack of inventive step, prior art, or insufficiency of disclosure remain plausible avenues for competitors to revoke or narrow the patent’s scope.
Key Takeaways
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Scope of Protection: AU2004311644 likely protects a specific pharmaceutical composition or process, with claims carefully structured to withstand legal scrutiny and competitive challenges.
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Claims Strategy: The patent employs a combination of broad independent claims supported by narrower dependent claims—enhancing enforceability and mitigating invalidity risks.
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Patent Landscape: Despite a focused scope, the patent faces a competitive environment with similar filings. Careful monitoring and legal diligence are necessary for freedom-to-operate and enforcement.
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Legal Status and Lifecycle: Maintaining patent validity requires ongoing fee payments and vigilance against potential oppositions or challenges.
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Strategic Value: This patent can serve as a critical asset in Australian drug portfolios, supporting market exclusivity and licensing agreements, provided its scope remains upheld through legal processes.
FAQs
1. How does AU2004311644 differ from other pharmaceutical patents filed around the same time?
The patent distinguishes itself through specific formulation features, such as unique active compound ratios or process steps, which are not disclosed in prior art, thereby establishing novelty and inventive step.
2. What are common vulnerabilities in Australian drug patents like AU2004311644?
Common vulnerabilities include overly narrow claims that can be designed around, prior art that anticipates features, and insufficient disclosure supporting broad claims.
3. How does Australian patent law influence the scope of AU2004311644?
Australian law emphasizes clarity, novelty, and inventive step, requiring claims to be supported by the description, which shapes claim drafting and approval strategies.
4. What is the typical lifecycle of a patent like AU2004311644?
Australian patents are granted for 20 years from the filing date, subject to maintenance fees. The patent can be enforced during this period but may face challenges or expiry considerations.
5. Can this patent be enforced against generic competitors?
Yes, if the patent remains valid and enforceable, it can serve as a basis for legal action against infringing generic products that fall within its scope.
References
- Australian Patent AU2004311644 - Official document.
- Patents Act 1990 (Australia).
- World Intellectual Property Organization (WIPO) Patent Database.
- Australian Patent Office (IP Australia) records.
