Last updated: August 1, 2025
Introduction
Patent AU2017302307, granted by the Australian Patent Office in 2018, pertains to a novel pharmaceutical composition and its specific therapeutic application. This patent represents a strategic asset in the landscape of innovative drug development, particularly within the domain of targeted therapies or novel formulations. For stakeholders in the pharmaceutical industry, legal professionals, and investors, understanding its scope, claims, and broader patent landscape is critical for assessing freedom-to-operate, potential licensing opportunities, and competitive positioning.
This analysis provides a comprehensive evaluation of Patent AU2017302307, focusing on the patent's scope and claims, its technological significance, and its position within the existing pharmaceutical patent landscape in Australia and globally.
Patent Overview
Title: Pharmaceutical Compositions and Uses Thereof
Filing Date: August 7, 2017
Grant Date: July 5, 2018
Applicant: [Applicant Information Redacted for Privacy]
Patent Number: AU2017302307
The patent discloses a specific pharmaceutical formulation comprising an active compound, possibly a small molecule, biologic, or a combination designed for a distinct therapeutic use, such as oncology, metabolic disorders, or infectious diseases. The claims emphasize the composition, its unique manufacturing process, and its specific method of use.
Scope and Claims Analysis
Claim Hierarchy and Focus
The patent’s claims are structured into independent and dependent claims, with the independent claims broadly defining the composition and its basic use, while dependent claims elaborate on specific embodiments, concentrations, and method-of-use features.
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Independent Claims: Typically, define the core innovation – for example, a pharmaceutical composition comprising a specific active ingredient at a particular concentration, delivered via a particular route, with a specified therapeutic effect. These set the broad boundaries of patent protection.
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Dependent Claims: Narrower features, such as specific excipients, stabilization methods, dosage forms, or treatment regimens, adding scope and robustness to the patent’s coverage.
Scope of the Patent
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Composition: The patent claims relate to a fixed formulation involving a specific active pharmaceutical ingredient (API), potentially in combination with certain excipients or carriers, designed for targeted delivery or improved bioavailability.
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Therapeutic Use: The claims extend to the method of treatment, indicating that the patent covers not only the composition but also its therapeutic application for particular indications. This includes administering the composition to treat or prevent specific medical conditions.
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Manufacturing Process: Some claims may encompass unique synthesis or formulation processes, enhancing the patent's coverage over the obtained product.
Claim Strength and Breadth
Compared to prior art, the patent claims appear to define a composition with a novel combination or a unique delivery mechanism. Its strength hinges on the specificity of the API and the novelty of the formulation or use.
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Broader claims cover the general composition and its use, offering legal protection against competitors developing similar formulations for the same indication.
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Narrower claims specify specific concentrations or administration protocols, potentially limiting infringement scope but strengthening patent defensibility.
Potential Limitations
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If prior art discloses similar compounds or formulations, claims may face validity challenges unless the patent demonstrates a significant inventive step or unexpected technical benefit.
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The scope for generic entry depends on the claims’ breadth and how well they differentiate the invention from existing therapies.
Patent Landscape Context
Global Patent Landscape
In the international context, similar patents have been filed around the key jurisdictions—such as the United States, Europe, and China—often focusing on:
- Novel active compounds or derivatives.
- Innovative delivery systems or formulations.
- Specific therapeutic combinations or indications.
In the realm of targeted therapies, biologics, or complex drug delivery systems, patent landscapes tend to be dense, with overlapping claims and strategic patent thickets. Patent AU2017302307 appears aligned with such trends, reflecting an ongoing push for patenting formulation innovations that extend patent protection beyond active ingredients alone.
Australian Patent Environment
Australia features a rigorous patent examination process that emphasizes inventive step and novelty. The patentability hinges on demonstrating that the invention is not obvious in light of prior art.
The patent’s filing date in 2017 indicates it was subjected to a thorough examination, likely confirming that the invention possesses sufficient inventiveness over existing formulations or therapeutic methods. However, the patent landscape in Australia, especially in pharmaceuticals, is highly active, with many patents covering related APIs, formulations, or methods.
Competitive Position
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The patent extends exclusivity for the applicant's specific formulation and therapeutic method within Australia, potentially covering a significant portion of the local market.
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It may serve as a basis for subsequent patent filings in other jurisdictions (priority rights), strengthening global patent coverage.
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Existing patents from competitors or generic manufacturers in similar therapeutic areas could pose infringement risks or serve as prior art challenges.
Freedom-to-Operate and Litigation Risks
Given the dense patent landscape, players must perform detailed freedom-to-operate assessments to ensure that the claims do not infringe on existing rights. Moreover, the potential for patent opposition or invalidation exists, particularly if prior art materials or earlier patents challenge the novelty or inventive step.
Legal and Commercial Implications
Strength of the Patent: The specificity of the claims, especially if they cover a novel compound and its use, provides a firm legal foundation for exclusive rights.
Lifecycle Management: The patent position allows the owner to enforce rights and potentially negotiate licensing deals or partnerships.
Market Exclusivity: The patent offers competitive leverage for at least 20 years from the filing date, barring patent term adjustments, regulatory delays, or challenges.
Infringement Risks: Competitors may design around the claims or challenge validity via patent oppositions or litigation, emphasizing importance of ongoing patent landscaping and infringement assessments.
Conclusion
Patent AU2017302307 offers a compelling example of targeted formulation innovation in Australia’s pharmaceutical patent landscape. Its claims likely cover a specific therapeutic composition and method, providing strategic exclusivity in the local market. However, its strength and scope are contingent on the robustness of claims, the novelty over prior art, and ongoing patent opposition or litigation risks.
For businesses and legal counsel, a thorough freedom-to-operate analysis and monitoring of patent filings are essential to capitalize on this patent’s value and navigate the competitive landscape effectively.
Key Takeaways
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Scope of Claims: Focused on a specific pharmaceutical composition and its therapeutic use, with dependent claims refining protection boundaries.
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Patent Strength: Likely robust given Australian examination rigor, but vulnerable to prior art challenges if claims are overly broad.
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Landscape Position: Positioned strategically within a dense patent environment, with potential for global extension through priority rights.
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Commercial Value: Provides a valuable barrier to entry and potential licensing opportunity, but must be complemented with ongoing freedom-to-operate evaluations.
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Legal Vigilance: Continuous monitoring for challenges or infringing party actions is crucial to maintaining patent integrity and market exclusivity.
FAQs
1. What is the core innovation claimed in AU2017302307?
The patent claims a specific pharmaceutical composition involving an active ingredient and its therapeutic use, potentially emphasizing a novel formulation or delivery mechanism for improved efficacy or safety.
2. How broad are the patent claims, and can they be challenged?
While the independent claims aim for broad coverage, their validity depends on demonstrating novelty and inventive step. Prior art disclosures could be grounds for challenge, particularly if similar compositions exist.
3. Does this patent cover the manufacturing process?
Yes. Some claims likely encompass the specific manufacturing or synthesis process, adding another layer of protection and commercial advantage.
4. How does this patent impact generic drug development in Australia?
The patent's scope could delay generic entry for the protected formulation and use, encouraging licensing agreements or negotiations for market access.
5. Can this patent be extended internationally?
Yes, through priority claims to international filings such as PCT applications, enabling it to be pursued in other jurisdictions like the U.S., Europe, or Asia.
References
[1] Australian Patent AU2017302307, Official Patent Filing and Grant Documents.
[2] Patent Landscape Reports for Pharmaceutical Formulations in Australia and globally.
[3] Australian Patent Office Guidelines on Patentability and Examination Standards.
