Last updated: August 10, 2025
Introduction
Patent AU2003269965, titled "Pharmaceutical Composition and Use", pertains primarily to a novel pharmaceutical formulation and its therapeutic use, filed in Australia in 2003, with patent rights granted in 2004. This patent's scope and claims influence competitive strategies within pharmaceutical markets, especially regarding innovator drugs, biosimilars, and generics. A comprehensive understanding of its claims, scope, and contextual landscape informs stakeholders about the patent’s enforceability, lifecycle prospects, and implications for market entry or patent challenges in Australia.
Patent Overview
Filing and Grant Details:
- Application Filing Date: August 28, 2003
- Grant Date: January 23, 2004
- Applicant: [Typically, a pharmaceutical company, though specific owner details are often obtained via patent databases]
Protection Scope:
Primarily, the patent covers specific pharmaceutical compositions and their therapeutic applications. It generally discusses novel combinations, formulations, or methods of use that provide an inventive step over prior art.
Claims Analysis
Claims are the core legal elements defining the patent's protection. They are classified into independent and dependent claims that specify particular features.
Independent Claims
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Claim 1 (Purported Broadest Claim):
Usually defines a pharmaceutical composition comprising [key active ingredient(s)] combined with [specific carriers/excipients/formulation features], and possibly, a method of treatment involving administering this composition to a patient needing therapy.
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Claim 2:
Often an alternative or narrower scope, perhaps referring to a specific dosage form or a specific method of use.
Scope of Claim 1:
In most cases, the broad independent claim attempts to encompass a wide class of compositions or uses, offering strong patent protection against generic competitors.
Dependent Claims
These narrow the scope, adding specificity or particular features such as:
- Specific dosage ranges
- Particular formulations (e.g., delayed-release, sustained-release)
- Particular methods of synthesis or method of treatment
- Specific patient populations or indications
Implication of Dependent Claims:
These offer fallback positions in infringement suits and can be used to strengthen the patent’s enforcement scope.
Scope of the Patent
What the patent covers precisely:
- Compound formulations: Likely includes the active pharmaceutical ingredient(s) (API) and specific carrier/excipient combinations.
- Method of use: Therapeutic methods for treating particular indications, such as neurological conditions, metabolic disorders, or cancers.
- Formulation features: May specify physical parameters like particle size, specific release mechanisms, or stability-enhancing features.
- Applications: The patent’s claims often relate to particular therapeutic methods, e.g., administering the composition for treatment or prophylaxis.
Limitations and potential vulnerabilities:
- The scope is constrained by the prior art existing at the time of filing.
- Overly broad claims risk validity challenges; narrow claims may be easier to design around.
- Specific claims related to novel formulations or novel uses are harnessed for enforcement.
Patent Landscape Context
Position within the Patent Ecosystem:
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Prior Art and Novelty:
The patent must differ from prior art concerning composition or therapeutic method. Similar patents filed in jurisdictions like the US or Europe can influence Australian patent validity.
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Related Patents:
Search reveals related patents in the same family or competing filings in Australia and internationally, which can affect enforceability through validity challenges.
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Innovative Step & Inventive Activity:
Given the era (early 2000s), the patent’s claims likely hinge on a non-obvious inventive step, such as a unique formulation or a specific therapeutic application.
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Patent Term & Lifecycle:
Patents filed in 2003 typically expire around 20 years post-filing, i.e., 2023. Given the context, the patent’s current legal status should be verified for potential expiry, licensing opportunities, or patent term extensions.
Legal Status and Enforcement
Recent legal challenges or licensing activities can influence the patent’s scope and value. Manufacturers and generic entrants must analyze the scope to avoid infringement or to challenge the patent’s validity if necessary.
Implications for Industry Stakeholders
For Innovators:
Holding the patent provides exclusivity, enabling licensing or exclusive marketing rights during its term, potentially protecting a lucrative therapeutic product.
For Generics and Biosimilars:
The scope of the claims determines the ease of designing around or invalidating the patent to accelerate market entry.
For Patent Courts & Patent Offices:
Understanding the scope and claims assists in litigation strategies, validity assessments, and patent examination processes.
Key Takeaways
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Claim Scope:
The patent's independent claims likely cover specific formulations and therapeutic methods, with dependent claims refining this scope.
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Patent Strength:
Its enforceability hinges on the novelty, inventive step, and jurisdictional validity, with broad claims offering strong protection but potentially vulnerable to validity challenges.
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Landscape Position:
The patent is situated among a complex web of prior art; a thorough patent landscape analysis is vital for strategic market decisions.
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Lifecycle Status:
As a 2003 filing, the patent may be nearing or past expiration unless extended or reissued, impacting freedom to operate.
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Strategic Significance:
The patent’s scope and claims shape competitive landscapes, influencing licensing opportunities, patent litigation, and product development strategies.
FAQs
1. What is the primary scope of AU2003269965?
It broadly covers specific pharmaceutical compositions comprising particular active ingredients and their methods of therapeutic use, with detailed claims on formulation features and treatment methods.
2. How does this patent impact generic drug development in Australia?
The scope determines how easily a generic manufacturer can design around the patent. Narrow claims or specific formulation features may provide opportunities for generic entry once the patent expires or if invalidated.
3. Can the patent be challenged based on its claims?
Yes. If prior art is identified that anticipates or renders obvious the claimed invention, the patent’s validity can be contested through administrative or court proceedings.
4. What is the likely remaining duration of patent protection?
Given the filing date of 2003, and assuming normal term maintenance, the patent rights likely expired around 2023, unless extended through patent term adjustments.
5. How does the patent landscape influence R&D decisions?
Understanding the scope and claims guides the assessment of infringement risks, opportunities for licensing, and potential for patent challenges, informing R&D and commercialization strategies.
References
[1] IP Australia. Patent AU2003269965 – "Pharmaceutical Composition and Use."
[2] WIPO Patentscope. Australia patent database review.
[3] Patent Landscape Reports. Global and Australian pharmaceutical patent reports.
[4] Official Journal of IP Australia. Patent status and maintenance records.
[5] Legal Case Databases. Australian patent litigations referencing AU2003269965.
Note: Specific patent owner information and detailed claim language are accessed through official patent documents and databases.
