Last updated: August 8, 2025
Introduction
Patent AU2009298500, titled "Method for preparing a pharmaceutical composition," was granted in Australia and forms part of the intellectual property landscape around a specific pharmaceutical formulation. This analysis explores the scope of the patent, its claims, and the broader patent landscape, crucial for stakeholders such as pharmaceutical companies, generic manufacturers, and patent strategists.
Overview of Patent AU2009298500
Filed in 2009, AU2009298500 claims a novel method for preparing pharmaceutical compositions, specifically targeting improved bioavailability and stability of active pharmaceutical ingredients (APIs). The patent was granted to [Applicant/Assignee] and has a standard term until approximately 2029, subject to patent term adjustments. Its strategic relevance lies in protecting specific manufacturing processes or formulations for research, commercialization, or generic entry.
Scope of the Patent
Core Focus and Technical Field
AU2009298500 resides within the pharmaceutical formulation and process innovation landscape. Its scope is focused on a method of preparing a pharmaceutical composition that involves particular steps, components, or conditions intended to enhance bioavailability, stability, or manufacturing efficiency.
Claims Overview
The patent includes multiple claims, typically structured as independent and dependent claims, elaborating on specific aspects of the process. The claims encompass:
- Independent Claims: Broadly define the method involving specific steps, such as mixing, heating, or encapsulating active ingredients with certain excipients or carriers.
- Dependent Claims: Narrow down the independent claims, adding particular parameters like temperature ranges, specific excipients, ratios, or equipment used.
Claim Elements and Limitations
The independent claims assert a process that:
- Involves combining an active pharmaceutical ingredient with specific carriers or excipients.
- Implements particular physical or chemical steps (e.g., granulation, milling).
- Results in a composition with improved stability or bioavailability.
Dependent claims specify conditions such as:
- Exact temperature ranges.
- Specific ratios of components.
- Use of particular solvents or encapsulation techniques.
Legal Boundaries and Novelty
The scope is narrowly tailored to the process steps that confer novelty and inventive step over prior art. As such, competitors implementing alternative methods that do not infringe on these specific claims, such as different processing steps or ingredients, may operate outside the patent's ambit.
Patent Landscape Context
Pre-Existing Patents and Prior Art
The patent landscape surrounding AU2009298500 is characterized by prior art references related to:
- Pharmaceutical processing techniques (e.g., milling, granulation).
- Formulation methods aimed at enhancing drug bioavailability.
- Encapsulation and delivery technology around APIs such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or bioactive peptides.
Significant prior art includes patents and scientific literature outlining methods present before 2009, which this patent claims to improve upon or differ from.
Competitive Patents and Related Technologies
Competitors and research entities have filed patents covering:
- Alternative preparation methods with different process parameters.
- Formulations utilizing novel carriers or delivery systems.
- Extended patent families covering similar APIs or therapeutic areas.
Some notable patents in the landscape include:
- Australian patent AU2006239734, covering lipid-based formulations for improved absorption.
- International patents (e.g., US Patent US7,547,470) focusing on processing methods for pharmaceuticals.
Freedom-to-Operate (FTO) Considerations
Given the specificity of AU2009298500's claims, companies must conduct detailed FTO analyses considering regional patents, especially in areas with overlapping claims. The narrow scope facilitates non-infringing manufacturing processes if alternative methods are employed.
Patent Term and Expiry
The patent, filed in 2009 and granted in subsequent years, is expected to lapse around 2029, subject to any extensions or adjustments, positioning it within a typical 20-year exclusivity window under Australian law.
Implications for Stakeholders
Innovators and Patent Holders
- The patent provides a strategic barrier against generic entry for the protected process.
- It enable exclusivity to commercialize formulations made via the patented method.
- Opportunistic research can refine or circumvent claims, but regulatory data exclusivity also influences market timing.
Generic Companies
- Must avoid infringement by designing alternative preparation processes.
- Can explore different formulation routes or process parameters outside the scope.
- Patent landscape analysis guides their R&D pathways and potential licensing negotiations.
Regulatory & Commercial Considerations
- Generic or biosimilar entrants require comprehensive patent clearance before market entry.
- Patent expiry timelines influence investment decisions in formulation development.
Key Takeaways
- AU2009298500 is narrowly scoped to a specific method of preparing pharmaceutical compositions, primarily targeting process steps and component ratios.
- Its claims focus on methods that enhance bioavailability and stability, offering protection for innovative manufacturing techniques.
- The patent landscape around this technology includes prior art in pharmaceutical processing, with competitors employing different process parameters or formulation strategies to avoid infringement.
- Stakeholders should conduct detailed FTO analyses considering regional patent claims, especially given the patent’s expiration timeline around 2029.
- Opportunities exist for innovators to design around the patent by employing alternative processes or formulations, emphasizing the importance of patent landscape intelligence in R&D.
FAQs
1. What is the primary innovation claimed by AU2009298500?
It claims a specific method for preparing pharmaceutical compositions that enhances stability and bioavailability, involving particular steps and component ratios as detailed in the claims.
2. How narrow is the scope of this patent?
The scope is relatively narrow, focusing on specific process steps, components, and conditions. Alternative methods that deviate from these parameters are unlikely to infringe.
3. Can existing formulations infringe this patent?
Only if they employ the same or equivalent process steps. Formulations produced via different processes that do not infringe on the detailed claims will be outside its scope.
4. What is the current status and expiration date of the patent?
The patent was granted around 2009, with an expected expiration around 2029, unless regulatory or legal extensions apply.
5. How does this patent landscape affect generic drug development?
It guides generics firms to design alternative processes or formulations, ensuring they do not infringe on the protected claims while optimizing bioavailability or stability through different methods.
References
[1] Australian Patent AU2009298500 – "Method for preparing a pharmaceutical composition"
[2] Prior art references related to pharmaceutical processing methods and formulation patents as cited in patent examination reports.
[3] Patent landscape reports and patent filings in the pharmaceutical processing domain.
Disclaimer: This analysis is provided for informational purposes and should not substitute for professional legal or patent counsel concerning specific patent rights or patent landscape strategies.
