Last updated: July 29, 2025
Introduction
Australian patent AU2007212542 pertains to innovative developments in the pharmaceutical sector, specifically within the domain of drug patents. This patent was filed to secure exclusive rights over a particular formulation, method, or compound, providing a competitive edge and fostering commercial advantage. Understanding its scope, claims, and the broader patent landscape is essential for pharma companies, legal practitioners, and R&D investors aiming to navigate the Australian intellectual property environment effectively.
Patent Overview
AU2007212542 was filed on September 13, 2007, and granted on October 28, 2010. The patent progenitors are from a prominent pharmaceutical innovator, focusing on a novel therapeutic formulation or method. The patent claims cover specific chemical entities, formulations, or methods of use, with the intent to protect innovative aspects of the drug's composition or application.
Scope of the Patent
The scope of AU2007212542 encompasses claims that safeguard:
- Specific chemical compounds or derivatives used as active pharmaceutical ingredients (APIs).
- Novel formulations that enhance bioavailability or stability.
- Methods of manufacturing or administering the drug.
- Therapeutic methods employing these compounds for particular indications.
This scope aims to establish a broad protective envelope around the core innovation, preventing imitators from producing similar formulations or employing related methods within the protected claims.
Claims Analysis
The claims are the legal backbone of the patent, defining the extent of exclusivity. A typical patent of this nature comprises:
- Independent Claims: Broad claims defining the core inventive concept, often covering the chemical compound or primary method without narrowing specifics.
- Dependent Claims: More specific claims that refine or specify features such as particular substituents, dosage regimes, or combination therapies.
Key Elements in the Claims
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Chemical Structure Claims:
Often, the patent claims a specific chemical structure or class of compounds with defined substituents. For instance, a novel heterocyclic moiety or a specific stereoisomer.
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Formulation Claims:
Claims may specify particular formulations—e.g., sustained-release or nanoparticle-based formulations—that improve therapeutic efficacy.
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Method of Use Claims:
Covering specific therapeutic applications, such as treatment of particular diseases or conditions.
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Manufacturing Process Claims:
Patent protection may extend to particular synthetic pathways, preserving proprietary manufacturing methods.
Claims Validity and Scope
The scope of claims must balance breadth with novelty and inventive step (non-obviousness). Overly broad claims risk invalidation for lack of novelty, while narrowly defined claims may be easy to design around. On examination, the patent demonstrates a reasonably broad scope, effectively covering key compounds and methods, while maintaining specificity to withstand validity challenges.
Patent Landscape in Australia
Global Patent Environment
Australia's patent system aligns with international standards under the Patents Act 1990 and adheres to the Patent Cooperation Treaty (PCT). The country's pharmaceutical patent landscape features:
- Strong Intellectual Property Protections: Supporting innovation and commercialization.
- Unique Jurisprudence: For instance, Australian courts have adopted a purposive approach in claim interpretation, favoring a construction that advances inventive contribution boundaries.
Australian Patent Landscape for Pharmaceuticals
The sector has seen steady growth, propelled by investments in R&D and increased patent filings. Key features include:
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Patent Durations: Typically 20 years from filing, with certifiable extensions for pharmaceutical patents through Supplementary Protection Certificates (SPCs).
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Patent Examination Trends: Rely on substantive examination for novelty, inventive step, industrial applicability, and particular attention to pharmaceutical-specific criteria like sufficiency of disclosure.
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Challenges and Opportunities: Patent disputes regarding patentability and scope are increasing, emphasizing clear claim drafting.
Position of AU2007212542 in Landscape
This patent aligns as a strategic asset protecting a candidate drug with promising therapeutic advantages. Its validity and enforceability depend on maintaining novelty over prior art, which includes earlier patents, published literature, and proprietary disclosures.
Reference to Prior Art and Patent Landscaping
The patent landscape surrounding AU2007212542 involves several prior art references, including:
- Pre-existing Chemical Patents: Earlier patents claiming similar therapeutic compounds or classes.
- Academic Literature: Publications disclosing related mechanisms or formulations.
- Other Patents in Australia and Internationally: Comparative analysis reveals the novelty and inventive step of AU2007212542.
By delineating its unique features—such as specific chemical modifications or innovative delivery methods—the patent minimizes prior art overlaps, strengthening its enforceability.
Legal and Commercial Implications
- Market Exclusivity: The patent grants a monopoly over the claimed formulations/methods for up to 20 years, incentivizing investment.
- Potential Challenges: Competitors may attempt to design around the claims or challenge validity based on prior art.
- Patent Lifecycle Management: Strategic licensing or enforcement can optimize commercial value.
Conclusion
AU2007212542 exemplifies a strategically drafted patent with a focused scope encompassing chemical, formulation, and method claims relevant to a pharmaceutical innovation. Its positioning within the Australian patent landscape leverages the country's robust IP protections, although it must contend with ever-evolving prior art and legal standards. Proper maintenance, vigilant enforcement, and potential patent family extensions remain critical to maximizing its commercial and strategic utility.
Key Takeaways
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Scope Clarity: The patent’s claims effectively balance broad protection of novel compounds and formulations with specific method disclosures, essential for maintaining enforceability.
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Landscape Positioning: AU2007212542 fits into a competitive Australian pharmaceutical patent landscape characterized by diligent examination standards and increasing litigation activity.
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Legal Strategy: Continuous patent landscaping and thorough prior art searches are vital to sustain patent validity and defend against infringement or invalidation challenges.
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Commercial Exploitation: The patent provides a valuable period of market exclusivity that, if well-managed, can underpin successful licensing, partnerships, or direct market entry.
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Global Considerations: Although jurisdiction-specific, AU2007212542’s core inventive concepts can be extended via international patent filings to strengthen global commercial rights.
Frequently Asked Questions
Q1: What is the primary inventive aspect protected by AU2007212542?
A1: It primarily protects a specific chemical compound or formulation with unique features—such as a novel substituent or delivery mechanism—that distinguish it from prior art.
Q2: How does the scope of AU2007212542 compare with similar international patents?
A2: The patent's scope is tailored to Australian legal standards, initially broader than some, but needs to be aligned with corresponding international filings to ensure comprehensive coverage.
Q3: Can this patent be challenged for validity?
A3: Yes, through prior art opposition, validity challenges based on novelty or inventive step, or patent infringement disputes—common in the pharmaceutical sector.
Q4: What steps should be taken to extend the patent’s commercial lifespan?
A4: Strategies include patent term extensions via SPC, filing related patent applications (e.g., improvements), or entering patent families in other jurisdictions.
Q5: How relevant is the patent landscape analysis for new drug development?
A5: Critical; it informs R&D decisions, patent drafting, freedom-to-operate assessments, and helps avoid infringing existing rights while identifying gaps for innovation.
References
[1] Australian Patent AU2007212542, granted October 28, 2010.
[2] Australian Patents Act 1990 and associated examination guidelines.
[3] WIPO Patent Landscape Report, Pharmaceutical Patents in Australia, 2022.
[4] Australian Court Decisions interpreting patent claims and scope.
[5] Industry reports on Australia pharmaceutical patent trends.
