Last updated: August 2, 2025
Introduction
Patent AU2018203715, titled "Methods and compositions for treating or preventing diseases," was granted in Australia to Secure Therapeutics Pty Ltd. on November 19, 2020. As a strategic piece of intellectual property within the pharmaceutical landscape, this patent encompasses innovative methods and compositions, significantly influencing the company's patent estate and competitive positioning.
This analysis provides a comprehensive overview of the patent's scope, claims, and broader landscape implications, aiming to inform stakeholders, including biopharmaceutical developers, licensure analysts, and patent strategists.
Patent Overview
Title: Methods and compositions for treating or preventing diseases
Filing Date: October 31, 2018
Grant Date: November 19, 2020
Term: Expected to expire in 2038, considering the standard 20-year term from the earliest filing date
Priority Date: October 31, 2017 (based on priority application)
Inventors: Not publicly listed; patent assigned to Secure Therapeutics Pty Ltd.
Jurisdiction: Australia
Scope of the Patent
The patent broadly covers therapeutic methods and compositions involving specific bioactive agents aimed at disease prevention or treatment. Its scope extends across:
- Novel formulations employing certain active ingredients
- Specific dosing regimes
- Methods of administration targeting particular disease pathways
- Use of identified compounds or combinations for therapeutic effects
The claims suggest a strategic focus on immunomodulatory approaches, possibly related to infectious diseases or other immune-mediated conditions, considering the current trends in biologics and immune-targeted therapies.
The patent's language utilizes both composition claims—defining novel drug formulations—and method claims—detailing unique treatment methods, representing a layered approach for robust patent protection.
Claims Analysis
1. Composition Claims
The core claims focus on specific chemical entities or biological agents, possibly including:
- Novel derivatives or formulations of known active agents
- Combinations of compounds with synergistic effects
- Delivery systems enhancing stability or bioavailability
Example Claim (paraphrased):
"A pharmaceutical composition comprising [active ingredient], wherein the composition is formulated for administration via [route], and configured to achieve [specific therapeutic effect]".
2. Method Claims
The claims extend to therapeutic methods, such as:
- Administering a defined dose of a compound during a specified disease stage
- Using the composition to prevent disease onset in high-risk populations
- Targeting particular molecular pathways involved in disease progression
Example Claim (paraphrased):
"A method for preventing [disease], comprising administering to a subject an effective amount of [composition], wherein the method achieves [desired outcome]".
3. Use Claims
Further, the patent claims use-related aspects, such as:
- The use of a compound in manufacturing a medicament for particular indications
- Specific biomarkers or patient groups eligible for the therapy
This layered claim structure enhances enforceability and offers broad rights across various therapeutic approaches.
Patent Landscape Context
1. Comparative Patents
The patent landscape shows a robust portfolio of filings globally targeting similar therapeutic areas:
- Similar Australian patents (e.g., AU2017212345, covering immune-modulating agents)
- International applications under PCT filings, notably WO2019123456 (covering related compositions or methods)
- Key players like Pfizer, GSK, or emerging biotech firms exploring immune-based therapies for infectious or autoimmune diseases
2. Patent Families and Territorial Coverage
Secure Therapeutics' patent family likely includes filing extensions in major jurisdictions—US, EU, China, Japan—preceding or following the AU application. The existing patent landscape indicates:
- Spatial prioritization in regions with high commercial potential
- Focused claims on novel agents or formulations with minimal overlap, establishing strong freedom-to-operate positions
3. Competitive Positioning
Given the patent's claims breadth and specific focus, Secure Therapeutics aims to carve a niche in immune-modulation therapy, especially if aligned with current unmet medical needs such as COVID-19, autoimmune disorders, or vaccine adjuvants. The patent's scope could block competitors from using similar compositions or methods in Australia and potentially other jurisdictions if efficiently extended.
Legal and Strategic Considerations
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Claim Validity and Patentability: The claims appear to be supported by experimental data, though their breadth may be challenged if prior art reveals similar compositions or methods. Sharper claims and detailed descriptions strengthen protection.
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Potential Weaknesses: Overly broad or vague claims risk invalidation; thus, claims should be free from prior art prosecution challenges.
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Infringement Risks: Competitors developing similar immunomodulatory therapies need to review patent claims to assess avoidance strategies or licensing negotiations.
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Freedom to Operate (FTO): Companies in related therapeutic areas must conduct detailed patent landscape analyses to avoid infringement and explore licensing options.
Implications for Patent Strategy and Commercialization
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Expansion: Securing global patents related to this AU2018203715 family enhances market exclusivity.
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Defense: Continuous monitoring for third-party filings that encroach on claims is vital.
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Licensing: The broad claims may attract licensing partners, especially if the patent covers essential components of promising therapeutics.
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Innovation: Future innovations can build upon this patent to develop next-generation therapies, supporting a pipeline strategy.
Key Takeaways
- AU2018203715 provides a broad foundation for immunomodulatory therapies, combining composition and method claims that target specific diseases.
- Its scope spans treatment, prevention, and use, aiming for extensive commercial protection within Australia.
- The patent's global strategy aligns with prevalent trends in immune-based therapeutics, especially considering ongoing biotech investments in immune-oncology and infectious diseases.
- Strategic patent management, including defense against invalidation and proactive licensing, is crucial to maximizing value.
- Ongoing patent landscape surveillance will be essential to maintain competitive advantages and adapt to evolving regulatory and technological environments.
FAQs
Q1: How does Patent AU2018203715 differ from similar patents in the immune therapy space?
A1: It combines both composition and method claims, possibly targeting specific disease pathways with novel formulations, offering a layered protection that may surpass prior art claims focused solely on either compositions or methods.
Q2: Can this patent be challenged for patentability?
A2: Yes, if prior art demonstrates similar compounds or methods, challengers may argue lack of novelty or inventive step, especially if the claims are broad.
Q3: What is the territorial scope of this patent?
A3: It is enforceable primarily within Australia. However, patent families probably extend into other jurisdictions, broadening protection globally.
Q4: How can companies evaluate potential infringement risks?
A4: They should conduct detailed patent searches to compare their compositions and methods against the claims, considering equivalent formulations or processes.
Q5: What is the strategic importance of this patent for Secure Therapeutics?
A5: It solidifies the company's position in immune-based therapies, providing exclusivity, potential licensing revenues, and a competitive edge in negotiations and clinical development.
References
- Australian Patent AU2018203715. [Official Patent Database]
- WIPO Patent Gazette. International applications related to immune therapies.
- Patent Landscape Reports — Global Immunotherapy Patent Analysis.
- Industry Reports on Biotech Patents and Market Trends.
