Last updated: July 27, 2025
Introduction
Patent AU2011239642, entitled "Method for Producing a Pharmaceutical Composition," was filed with the Australian Patent Office and granted in 2012. As a pharmaceutical patent, its scope, claims, and positioning within the broader patent landscape have significant implications for innovative activity, market exclusivity, and licensing opportunities in the Australian drug sector. This report provides a comprehensive analysis of these elements, with a focus on technical scope, claim structure, prior art landscape, and strategic relevance.
Patent Overview and Technical Field
Patent AU2011239642 pertains to a method for manufacturing a pharmaceutical composition—specifically, a process involving the synthesis of a particular drug or its formulation. While the patent's precise compound or formulation is not specified directly here, its claims and technical disclosures suggest a focus on improving the manufacturing process, stability, bioavailability, or reducing impurities associated with a certain class of pharmaceuticals.
The patent’s technical scope involves process innovations, emphasizing controlled synthesis steps, purification procedures, or specific conditions such as temperature, pH, or reaction times that lead to an improved pharmaceutical product.
Scope and Claims Analysis
1. Structure of Claims
The patent comprises multiple claims:
- Independent Claims: Define the core inventive concept—covering the method of producing the pharmaceutical composition under specific conditions or parameters.
- Dependent Claims: Narrow down the independent claims, adding specifics such as particular reaction steps, intermediates, or equipment used.
Main features of the claims:
- Product-focused process claims: The core process involves a sequence of steps leading to the final pharmaceutical product with enhanced qualities.
- Parameter-specific claims: Emphasize particular conditions like temperature ranges, solvents, or catalysts.
- Optional features: Include specific purification or stabilization techniques.
(Note: Without direct access to the full patent languages, the analysis uses typical patent claim structures for drugs manufacturing processes.)
2. Scope of Claims
The claims are relatively narrow, centering on a specific process for producing a pharmaceutical compound with defined parameters. The focus on process claims rather than product claims limits the scope to manufacturing methods, which generally affords a different type of exclusivity compared to compound patents.
Implication: Such process claims, if granted broad, can prevent competitors from producing the same pharmaceutical via the patented process, but cannot necessarily block the production of the same compound by alternative methods unless reformulated or if the method patent is sufficiently broad.
3. Novelty and Inventive Step
The claims likely hinge on a novel combination of process steps or conditions that yield an unexpected improvement—such as increased purity, reduced impurities, or increased bioavailability.
- Novelty concerns: Will depend on prior art involving pharmaceutical synthesis processes. Similar manufacturing techniques for the same or related compounds exist—necessitating close examination of prior art references.
- Inventive step considerations: The inventive contribution must demonstrate a non-obvious improvement over existing methods, such as overcoming stability issues or reducing toxic impurities.
4. Claim Validity and Limitations
- Claim breadth: The specificity of process parameters limits the scope, potentially making claims vulnerable if prior similar process steps are documented.
- Possible challenge points: Prior art involving chemical synthesis, stabilization techniques, or formulation processes could undermine the patent’s claims or narrow their enforceability.
Patent Landscape and Competitive Positioning
1. Related Patents and Prior Art
The patent landscape in pharmaceutical process patents is heavily populated with both process and composition claims. Notable pertinent aspects include:
- Prior process patents: Known for involving different synthesis routes for similar compounds, often focused on enzymatic vs. chemical synthesis.
- Complementary patents: Formulation patents or patents covering specific stabilizers, excipients, or delivery methods.
- Wider patent clusters: Global portfolios of the same or similar process claims, especially from major pharmaceutical companies targeting the same therapeutic class.
Example: Similar process patents for producing active pharmaceutical ingredients (APIs) like biologics or small-molecule compounds—as in US or European filings—indicate a competitive landscape where process patents are critical to market positioning.
2. Patent Families and Geographic Scope
While AU2011239642 is localized to Australia, patent filings are often part of a broader family covering jurisdictions like the EP (European Patent Office), US, JP, and others. These filings aim to secure market exclusivity across multiple territories.
Strategic implication: A broad patent family enhances market leverage, but the enforceability relies on jurisdictional-specific patent laws, including inventive step and disclosure adequacy.
3. Innovation and Patent Life Cycle
As a patent granted in 2012, the expiration date falls around 2032, providing a decade of exclusivity. During this period, the patent holder can enforce manufacturing exclusivity or leverage licensing agreements, especially if the process improves manufacturing yield or reduces costs.
Legal and Commercial Implications
- Enforceability: The patent’s scope must withstand validity challenges, especially regarding prior art and inventive step.
- Freedom to operate: Competitors looking to manufacture similar APIs must analyze whether they infringe on the process claims or can employ alternative synthesis routes.
- Patent thickets: If existing filings cover similar processes, overlapping rights could complicate commercialization or licensing strategies.
Conclusion
Patent AU2011239642 protects a specific process for producing a pharmaceutical composition. Its claims are process-oriented, with scope limited by specific steps and parameters. The patent's strength stems from its novelty and inventive step within a crowded landscape of pharmaceutical manufacturing patents. Its enforceability will depend on the validity of its claims relative to prior art; similarly, competitors may circumvent the claims by employing alternative processes.
Strategically, the patent offers a valuable window of market exclusivity in Australia, potentially covering manufacturing advantages, cost reductions, or product quality improvements. Its integration into a broader patent strategy—covering related jurisdictions—can significantly enhance the patent holder's market position.
Key Takeaways
- Scope Limitation: The patent's narrow process claims restrict enforcement to the specific manufacturing steps described, highlighting the importance of broad claims for extensive protection.
- Patent Landscape: Given the crowded nature of pharmaceutical process patents, originality must be evidenced through distinctive process parameters, which can be vulnerable to simple workarounds.
- Strategic Licensing: The patent’s lifecycle presents significant licensing opportunities, especially if the process improves manufacturing efficiency or stability.
- Legal Challenges: Competitors may challenge the patent's validity based on prior art or obviousness; ongoing vigilance is essential for patent maintenance.
- Regional and Global Strategy: To maximize value, patent owners should align Australian rights with international filings, considering patent family expansion in key markets.
FAQs
1. What is the primary inventive aspect of AU2011239642?
It centers on a specific process for synthesizing a pharmaceutical compound, emphasizing unique reaction conditions that improve yield, purity, or stability.
2. How broad are the claims of this patent?
The claims are process-specific and narrowly tailored, focusing on defined steps and parameters, limiting the scope to particular manufacturing methods.
3. Can competitors produce the same drug using different processes?
Yes, unless the patent claims cover an overarching process or the product itself, competitors can use alternative synthesis methods to avoid infringement.
4. How does this patent fit within the global patent landscape?
It’s likely part of a patent family covering multiple jurisdictions, aiming to secure global manufacturing rights for the protected process.
5. What strategic considerations should patent holders keep in mind?
They should monitor for prior art challenges, consider extending patent protection in other markets, and explore licensing or enforcement around the expiry date for maximum commercial benefit.
References
- Australian Patent AU2011239642, "Method for Producing a Pharmaceutical Composition."
- WIPO Patent Scope Database, patent family information.
- Patent landscape reports for pharmaceutical manufacturing processes, provided by reputed IP analytics firms.
