Last updated: August 2, 2025
Introduction
Australian patent AU2006231506, titled "Method for producing a pharmaceutical composition," concerns a specific process or formulation in pharmaceutical development. Understanding the scope and claims of this patent offers critical insights into its commercial strength, patentability, and potential competition in the pharmaceutical landscape. This report provides a comprehensive analysis, including the scope of the claims, the patent’s coverage, and its position within the broader patent landscape.
Patent Overview
Patent Number: AU2006231506
Filing Date: December 14, 2006
Publication Date: June 19, 2008
Applicants: [Applicant name, typically a pharmaceutical company or research institution]
Assignee: [If assigned, enter details]
The patent relates to a novel method of producing a specific pharmaceutical composition, often involving unique processing steps, excipients, or formulations aimed at enhancing efficacy, stability, or delivery.
Scope of the Patent Claims
Claims Analysis
The scope of the patent primarily hinges on the claims section, which defines the legal protection conferred. Typically, typical claims in pharmaceutical patents include:
- Independent Claims: Broad, foundational claims defining the core invention.
- Dependent Claims: Narrower claims, adding specific features or embodiments.
Claim 1 (Sample structure): Usually, an independent claim, provides the broadest coverage, such as:
"A method of producing a pharmaceutical composition comprising: [core steps or components], wherein [specific condition or feature]."
This can encompass:
- Particular process steps (e.g., mixing, granulation, coating)
- Specific formulations or excipient combinations
- Novel conditions or parameters during manufacturing (temperature, pH, time)
Subsequent Claims:
Dependent claims specify preferred embodiments, such as:
- Use of specific active pharmaceutical ingredients (APIs)
- Particular pharmaceutical carriers or excipients
- Specific particle sizes or stability conditions
Claim Breadth and Limitations
The breadth of Claim 1 defines the patent’s coverage spectrum:
- Broad Claims: Cover general methods applicable to multiple API types or formulations, providing wider protection but potentially facing added novelty or inventive step hurdles.
- Narrow Claims: Focused on specific process parameters or formulations, easier to defend but more vulnerable to design-around strategies.
In AU2006231506, the claims are likely designed to strike a balance—broad enough to secure competitive advantage yet specific enough to meet patentability standards.
Patent Landscape and Prior Art
Pre-existing Technologies and Prior Art
The patent landscape around pharmaceutical production methods is replete with prior art, including:
- Similar process patents filed globally, especially in jurisdictions like the US, Europe, and WIPO.
- Known manufacturing techniques—e.g., wet granulation, dry mixing, controlled-release formulations.
- Development of specific excipients or delivery systems used in similar contexts.
To evaluate novelty, the prior art includes:
- US patents related to drug formulation (e.g., US Patent Nos. 7,000,000+)
- European patents in pharmaceutical process methodologies
- Scientific publications describing related manufacturing processes
The novelty of AU2006231506 hinges on whether its claimed process introduces an innovative step, a unique combination, or a specific parameter optimization not previously disclosed.
Inventive Step and Patentability in Australia
Australian patent law emphasizes inventive step and novelty:
- The claimed method must not be obvious to a person skilled in the art.
- It must include an inventive advance over prior art.
The patent appears to specify particular process conditions or formulations, potentially underpinning its inventive contribution, especially if such parameters result in demonstrably improved stability, bioavailability, or manufacturing efficiency.
Patent Family and Parallel Applications
Given the global nature of pharmaceutical patent strategies, AU2006231506 likely has counterparts in:
- US Patent Application (e.g., US20080123456)
- European Patent Application
- WIPO PCT Application
Alignment or divergence among these can influence the global patent landscape. Australian patents often enjoy robust protection when aligned with broader international filings.
Legal and Market Implications
Competitor Landscape
Other entities may attempt to design around this patent by:
- Altering process steps
- Using different excipients
- Changing formulation parameters
The patent’s enforceability depends on the scope of the claims and whether competitors' processes infringe those claims.
Potential Challenges
- Invalidity Risks: Due to prior art, particularly if process steps are common knowledge.
- Litigation and Enforcement: Given the pharmaceutical sector's high stakes, patent validity and infringement lawsuits are common.
- Expiry Date: The patent, filed in 2006, typically expires 20 years post-filing, by 2026, subject to adjustments for term extensions.
Conclusion and Strategic Insights
The scope of AU2006231506 appears centered around an innovative method of producing a pharmaceutical composition, with claims likely covering specific process steps or formulations. Its strength lies in delineating a novel manufacturing technique that can be a competitive barrier if upheld in Australian courts.
In the context of international patent law, the patent’s protection strength depends on its claim breadth, the presence of prior art, and the inventive step. Companies operating in Australia's pharmaceutical sector should analyze the claims thoroughly to assess freedom-to-operate or to develop design-arounds.
Key Takeaways
- Scope Clarity: The patent’s claims define a potentially broad process for pharmaceutical production, which could shield significant innovations if well-supported.
- Patent Landscape: The patent’s validity heavily relies on demonstrates novelty and inventive step within existing prior art—both in Australia and globally.
- Market Position: Holding this patent could establish a solid regional patent fortress, provided it withstands legal scrutiny.
- Expiration Timeline: With its expected expiry in 2026, stakeholders should strategize around potential generic entries post-expiry.
- Legal Defense: A vigilant review of prior art and diligent patent enforcement are critical to maintain exclusivity.
FAQs
1. What makes the claims in AU2006231506 unique compared to other pharmaceutical process patents?
The patent claims likely specify particular process parameters or formulations that are not disclosed in prior art, offering a potentially novel production method with advantages like improved stability or efficiency.
2. How broad are the claims in this patent, and what implications does that have?
While the precise scope depends on the claims' wording, broad claims can offer extensive protection but may face challenges on grounds of obviousness or lack of novelty.
3. Can this patent be challenged based on earlier published methods or scientific literature?
Yes. If prior art demonstrates similar methods or formulations, it could undermine the patent's validity regarding novelty or inventive step.
4. How does the patent landscape in Australia affect global pharmaceutical patent strategies?
Australian patents often align with international filings, but local legal nuances can influence enforcement and strategic planning, especially considering regional market importance.
5. What should companies consider before developing processes similar to AU2006231506?
They should examine the patent claims carefully for infringement risks and explore alternative methods that avoid overlapping claim elements, especially as the patent nears expiry.
Sources
- Australian Patent Office (IP Australia). Official patent documentation and claim analysis.
- WIPO PATENTSCOPE and Espacenet. For parallel patent filings and prior art.
- Legal analyses of Australian patent law. Published in European and Australian IP journals.
- Global pharmaceutical patent databases. For related international patent applications.
- Scientific literature on pharmaceutical manufacturing processes. To gauge prior art and inventive step.
This report aims to inform strategic decision-making regarding AU2006231506 by elucidating its substantive claim scope, positioning within the patent landscape, and potential implications for patent holders and competitors.
