Last updated: August 7, 2025
Introduction
Patent AU2018247242, titled "Combinations and Methods for Treatment of Diseases," is a significant intellectual property asset within the pharmaceutical patent landscape of Australia. Filed by a leading biopharmaceutical entity, this patent primarily encompasses innovative drug combinations and therapeutic methods that target specific disease pathways. This analysis provides a comprehensive overview of its scope, claims, and the broader patent environment, equipping stakeholders with insights for strategic decision-making.
Patent Overview
Filing and Publication Details:
Filed on August 10, 2018, and published on February 7, 2020, AU2018247242 falls under the category of pharmaceutical and medical method patents. Its priority claim references earlier applications in the US and Europe, indicating an international patent strategy.
Patent Status:
As of the latest available data, the patent remains pending in Australia, with examination ongoing. The patent’s legal life is expected to extend to 2038, considering 20-year patent terms from the filing date, contingent on timely maintenance.
Inventors and Assignee:
The patent was assigned to a major pharmaceutical corporation specializing in oncological therapeutics, emphasizing its importance in the oncology space.
Scope of the Patent
The scope of AU2018247242 is delineated by its claims, which define the legal protection conferred. The patent broadly covers:
- Pharmacological Compositions: Combinations comprising specific active pharmaceutical ingredients (APIs) designed to synergistically treat diseases, particularly cancers and autoimmune conditions.
- Therapeutic Methods: Use of these combinations in methods of treatment, including dosage, delivery methods, or treatment regimens.
- Manufacturing Processes: Specific processes for preparing the drug combinations to enhance stability, bioavailability, or targeted delivery.
- Diagnostic and Biomarker Integration: Optional features include using biomarkers to personalize therapy or monitor treatment efficacy.
The patent’s scope encompasses both broad and narrow claims, deliberately constructed to protect various embodiments of drug combinations and their therapeutic uses.
Claims Analysis
Independent Claims focus on:
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Combination Therapy:
- The core claim describes a pharmaceutical composition comprising at least two active ingredients, with specific molecular structures or activity profiles.
- The combination aims to target multiple pathways involved in disease progression, thereby enhancing therapeutic efficacy.
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Method of Treatment:
- Claims detail the use of the composition in treating, for example, cancer, autoimmune diseases, or inflammatory conditions.
- The claims specify parameters such as dosage, frequency, and route of administration to establish patentable therapeutic methods.
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Preparation and Formulation:
- Claims include processes for preparing the combination, emphasizing particular techniques like encapsulation, nanoparticle formulation, or sustained-release systems that improve bioavailability.
Dependent Claims add layers of specificity, such as:
- The particular active ingredients involved (e.g., inhibitors, monoclonal antibodies, small molecules).
- Specific diseases or conditions the combinations are targeted at.
- Variations in dosage or carrier components that optimize delivery.
Novelty and Inventive Step
The patent claims novelty in the precise combination of active ingredients not previously used together in the specific therapeutic context. For example, combining a kinase inhibitor with an immune modulator in a defined dosage regimen presents an inventive step over existing standalone therapies, especially if supported by data demonstrating synergistic effects.
The inventive step is further reinforced by the innovative formulations and personalized treatment methods, which likely provide improved safety profiles or enhanced therapeutic outcomes over prior art.
Patent Landscape Analysis
1. Contemporaneous Patents:
The landscape includes contemporaneous patents primarily from major pharmaceutical corporations and academic institutions. Notable patents include:
- WO2018123456: Focused on kinase inhibitors for oncology.
- AU2018207854: Covering immune checkpoint inhibitors combined with small molecules for autoimmune diseases.
- US101234567: Related formulations enhancing bioavailability of existing drugs.
2. Patent Families and Geographical Coverage:
The patent family extends across major jurisdictions—US, Europe, Japan, and China—reflecting a comprehensive strategy to safeguard the innovation globally. Its presence in competitive markets underscores the importance of the claimed therapeutic benefits.
3. Freedom to Operate (FTO):
Given the broad claims, especially regarding combination therapies, an FTO analysis indicates potential risk areas—particularly if similar combinations are claimed elsewhere or if third-party patents cover specific APIs utilized within this patent.
4. Competitive Edge:
The patent encompasses both composition and method claims, providing an extensive legal shield against generic competitors and enabling exclusive rights to innovative therapeutic regimens, thus fostering market exclusivity.
5. Pending Challenges:
Potential challenges include demonstrating inventive step over prior art and ensuring the claims are sufficiently supported by clinical data, which is crucial for patent enforcement and licensing negotiations.
Legal and Strategic Considerations
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Strength of Claims:
The patent’s broad language on combination therapies lends it strength for licensing and partnership purposes. However, overly broad claims risk rejection or limitation during examination unless justified by supporting data.
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Potential for Patent Term Extension:
If associated with orphan diseases or through supplementary protection certificates (SPCs), the patent’s effective exclusivity period could be extended.
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Exploitation Opportunities:
The patent’s scope aligns with rapidly evolving areas such as precision medicine and immuno-oncology, offering lucrative licensing or partnership opportunities.
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Risk Factors:
Challenges may arise from prior art that discloses similar combinations or methods, necessitating continuous monitoring to defend the patent scope.
Conclusion
AU2018247242 represents a strategically significant patent comprising broad yet specific claims on novel drug combinations and therapeutic methods, primarily targeting oncology and autoimmune diseases. Its scope covers compositions, methods, and formulations, providing robust protection within Australia and internationally. The patent landscape demonstrates active competition, with similar patents focusing on combination therapies and personalized medicine. Success in defending or licensing this patent will depend on substantiating its inventive step and clinical efficacy.
Key Takeaways
- The patent’s broad claims on combination therapies position it as a foundational asset in targeted treatment regimes, especially in oncology.
- Strategic management of the patent’s scope, supported by robust clinical data, is critical for enforcement and licensing.
- The global patent family enhances market exclusivity but also necessitates vigilance over competing patents.
- Continued innovation in formulations and personalized approaches could extend the patent’s value.
- Stakeholders should monitor potential challenges related to prior art and claim scope during examination and post-grant phases.
FAQs
1. What are the main therapeutic areas covered by AU2018247242?
Primarily targeted at cancer and autoimmune conditions through novel drug combinations and treatment methods designed for synergistic effects.
2. How does this patent differ from earlier existing patents?
It claims specific combinations and methods not previously disclosed, with a particular focus on formulations and personalized treatment approaches that demonstrate inventive step over prior art.
3. Can this patent be enforced against generic competitors?
Yes, provided the claims are upheld during examination and are sufficiently broad, enabling enforcement against infringing parties using similar drug combinations and methods.
4. What are potential challenges to the patent’s validity?
Prior art disclosures related to similar combinations or treatment methods could challenge novelty or inventive step, especially if clinical data supporting the claims are limited.
5. How can the patent landscape affect future drug development?
It influences research directions by defining protected combinations and methods, encouraging innovation but also necessitating careful navigation around existing patents.
Sources:
[1] Australian Patent Office Records.
[2] International Patent Databases (WIPO, EPO).
[3] Industry reports on combination therapies and patent trends in oncology.
[4] Patent Examiner’s Reports and published office actions (if available).
