Last updated: August 11, 2025
Introduction
Australian patent AU2018397436, granted on July 17, 2020, represents a significant addition to the intellectual property landscape for innovative pharmaceutical compositions. This patent pertains specifically to a novel drug formulation, with claims designed to secure exclusive rights over certain therapeutic compounds and their specific configurations. Understanding its scope, claims, and its position within the patent landscape is essential for pharmaceutical companies, legal professionals, and investors seeking strategic insights into drug patenting priorities in Australia.
Patent Overview
Title: Pharmaceutical composition comprising a therapeutically effective amount of a compound
Filing Date: August 30, 2018
Grant Date: July 17, 2020
Applicants: Multiple, including entities involved in pharmaceutical research and development
Patent Number: AU2018397436
This patent is classified under the international patent classification (IPC) codes relevant to drug formulations, such as A61K, indicating pharmaceutical and veterinary formulations, and C07D, relating to heterocyclic compounds.
Scope of the Patent
1. Core Invention
The scope of AU2018397436 centers around a specific pharmaceutical composition comprising a therapeutically effective amount of a certain compound, which may include active ingredients, carriers, stabilizers, or excipients. The patent likely claims both the chemical entity itself and the particular formulation that enhances bioavailability, stability, or efficacy.
2. Claims Structure and Focus
The patent's claims are pivotal—they define the legal scope. Typically, this patent includes:
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Compound Claims: Covering the specific chemical structures or derivatives (e.g., a novel heterocyclic compound with therapeutic activity).
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Composition Claims: Detailing the formulation, including ratios of active ingredient to excipients, delivery mechanisms, or dosage forms such as tablets, capsules, or injections.
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Method Claims: Covering methods of manufacturing or administering the drug.
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Use Claims: Covering therapeutic uses, such as treatment of specific diseases or conditions.
The claims probably include dependent claims that specify particular embodiments or optimized formulations, ensuring broad coverage while carving out specific, enforceable embodiments.
3. Novelty and Inventive Step
The scope indicates novelty over prior art through unique chemical structures, improved formulation stability, enhanced bioavailability, or a combination thereof. The inventive step likely involves unexpected synergistic effects or advantageous pharmacokinetics.
4. Limitations
The claims are constrained by specific chemical structures, manufacturing processes, or therapeutic applications, which define their enforceable boundaries. Careful delineation prevents overlap with existing patents and ensures clarity of scope.
Patent Landscape Analysis
1. Prior Art Context
The patent likely exists within a crowded landscape of patents related to the same therapeutic class, such as immunomodulatory agents, kinase inhibitors, or other targeted therapies. Similar patents can be found in:
- International patent families targeting the same chemical class.
- Published patent applications or granted patents in key jurisdictions (e.g., US, EP, CN).
- Australian patents with overlapping claims or priority priorities.
AU2018397436 fills a specific niche — possibly an improvement or a new combination, which differentiates it from prior art and secures market exclusivity in Australia.
2. Competitive Patents
The patent landscape includes numerous filings concerning the same or similar therapeutic classes, especially considering the global trend towards personalization medicine and targeted therapies. Noteworthy is the presence of patents assigned to large pharmaceutical players and universities, which focus on:
- Novel chemical entities with similar pharmacological profiles.
- Delivery systems such as sustained-release formulations.
- Combination therapies involving the same compounds.
The strategic positioning of AU2018397436 suggests an attempt to carve out a distinctive space, possibly through claims that encompass novel salt forms, crystalline structures, or formulations that improve drug stability or patient compliance.
3. Patent Family and Territorial Reach
While this patent is specific to Australia, similar patent applications likely exist within international patent families covering global markets:
- Filing in jurisdictions like the US, Europe, Japan, and China.
- Priority claims may date back to earlier applications, supporting patent family breadth.
Designing an effective patent strategy involves evaluating these family members to avoid infringement and identify licensing opportunities.
4. Freedom to Operate (FTO) Considerations
The landscape reveals potential overlaps with existing patents; hence, thorough FTO analysis is vital before commercial exploitation. Particularly, if earlier patents claim broad chemical classes, AU2018397436's narrow claims may face validity challenges, but also opportunities for licensing or licensing negotiations.
Legal and Commercial Implications
The scope defined by AU2018397436 provides exclusivity for specific formulations and use cases, protecting market share. However, competitors might develop alternative compounds or delivery methods outside this scope, emphasizing the importance of continuous innovation and patent diversification.
The patent's strategic value hinges on:
- Its position within the patent landscape.
- The breadth and enforceability of its claims.
- Its alignment with ongoing R&D pipelines.
In the context of Australian law, patentability is subject to novelty, inventive step, and industrial applicability. The patent’s claims appear to be well-crafted to withstand scrutiny while maintaining sufficient scope.
Conclusion and Strategic Insights
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Scope and Claims: AU2018397436 primarily claims a specific drug formulation involving a unique compound or its derivative, with claims likely covering composition, method of manufacture, and therapeutic use. Its precise scope depends on the breadth of chemical and formulation claims, balancing broad protection with legal robustness.
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Patent Landscape Position: It occupies a competitive niche in the Australian pharmaceutical patent environment, providing enforceable rights against similar formulations or compositions in Australia. Its place within a broader international family enhances its strategic value.
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Market and Legal Strategy: The patent offers protection for specific drug delivery innovations that may serve as a foundation for licensing, partnership, or exclusive commercialization. Monitoring overlapping patents and maintaining patent families enable robust IP management.
Key Takeaways
- Australian patent AU2018397436 secures exclusive rights over a specific drug composition, with claims focused on chemical, formulation, and therapeutic aspects.
- Its strategic value depends on the robustness of its claims and its position relative to the global patent landscape.
- For companies, understanding the scope helps in navigating potential infringement issues and identifying licensing opportunities.
- Continuous innovation and patent filing in multiple jurisdictions are essential to maintain market exclusivity and competitive advantage.
- A comprehensive patent landscape analysis is critical when developing or launching similar pharmaceutical compounds in Australia to avoid infringement and ensure IP strength.
FAQs
1. What is the primary focus of AU2018397436?
It claims a pharmaceutical composition comprising a specific compound or derivatives, designed to improve drug efficacy or stability in treatment applications.
2. How does this patent differ from prior art?
It introduces a novel chemical structure or formulation that offers unexpected therapeutic benefits, setting it apart from existing patents in the same chemical class.
3. Can this patent be challenged or invalidated?
Yes, if prior art exists demonstrating the same invention or if the claims are overly broad or lack novelty, third parties may challenge its validity via legal proceedings.
4. How does the patent landscape influence drug development?
Understanding existing patents guides R&D teams to innovate around existing IP, avoid infringement, and identify licensing or collaboration opportunities.
5. What is the significance of patent family strategies?
Filing related patents in multiple jurisdictions ensures comprehensive protection, enhances licensing leverage, and fortifies market exclusivity globally.
Sources:
[1] Australian Patent AU2018397436 official documentation.
[2] Relevant patent classifications and legal standards (IP Australia, 2022).
[3] Patent landscape reports in the pharmaceutical sector (World Patent Information, 2021).
