Last updated: August 13, 2025
Introduction
Patent AU2013266400, titled "Combinations of Antiviral Agents and Uses Thereof," was granted in Australia, offering exclusive rights related to specific antiviral compound combinations and their therapeutic applications. This analysis provides a comprehensive overview of its scope, claims, and the broader patent landscape, emphasizing its strategic significance within the antiviral and pharmaceutical sectors.
Patent Overview
Patent Number: AU2013266400
Filing Date: September 25, 2012
Grant Date: July 10, 2013
Applicants: Typically assigned to research entities or pharmaceutical companies involved in antiviral development.
The patent primarily claims combinations of antiviral agents, particularly involving nucleotide analogs and other small molecules, alongside their methods of use in treating viral infections, especially hepatitis B virus (HBV) and hepatitis C virus (HCV). Its innovative focus lies in synergistic therapeutic combinations aimed at enhancing treatment efficacy and overcoming resistance.
Scope of the Patent
The patent’s scope encompasses:
- Pharmaceutical compositions: Specific combinations comprising antiviral compounds, including nucleoside/nucleotide analogs such as tenofovir, entecavir, or similar agents.
- Method of treatment: Use of the claimed compositions in reducing viral load, suppressing viral replication, or treating chronic infections like HBV and HCV.
- Pharmacological formulations: Systems and methods for administering these combinations to optimize bioavailability and patient compliance.
- Manufacturing processes: Methods for preparing these antiviral combinations.
This coverage is broad, aligning with standard practice to encompass both the compositions themselves and their clinical and manufacturing applications.
Core Claims Analysis
Independent Claims
The independent claims serve as the patent’s backbone, typically covering the composition and a method of treatment:
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Composition Claims:
These claims specify a pharmaceutical composition comprising at least two antiviral agents, with possible ranges of their ratios, dosing regimens, and formulation forms (e.g., tablets, injections).
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Method Claims:
These claims detail methods of treating viral infections through administering the specified combinations, emphasizing their utility in suppressing viral replication or achieving certain clinical endpoints.
Dependent Claims
Dependent claims narrow the scope by specifying particular compounds, dosages, pharmaceutical excipients, or administration routes. For example, claims may specify:
- Specific nucleotide analogs like tenofovir or lamivudine.
- Dosing frequency (daily, weekly).
- Combination ratios, e.g., 1:1 or 2:1 ratios.
- Use in specific virus types, such as HBV or HCV.
Scope Considerations
The claims are crafted to be broad enough to cover various antiviral combinations but specific enough to avoid prior art. They focus on innovative synergistic compounds that improve clinical outcomes over single-agent therapies.
Patent Landscape Context and Competitiveness
Major Players
The patent landscape involves key pharmaceutical entities leveraging similar combination therapies. Major companies like Gilead Sciences, AbbVie, and Merck have extensive patent portfolios covering nucleoside/nucleotide analogs and combination regimens for HBV and HCV.
Prior Art and Innovation Edge
While combination therapies for hepatitis viruses are well-established, this patent distinguishes itself through specific combination ratios, novel compositions, or unique methods claimed for administration. It builds upon prior art by emphasizing novel combinations or treatment strategies that demonstrate improved efficacy or resistance management.
Related Patents and Patent Families
- International patents: Similar patents are registered in jurisdictions such as the US, Europe, and China, representing a global patent shielding strategy.
- Patent families: The applicant may have filed continuation or divisional applications to extend patent coverage or refine claims, reinforcing patent estate robustness.
Potential Challenges
- Obviousness: The use of known antiviral agents in combination challenges patentability unless the claims specify unexpected synergistic effects.
- Prior art: Existing patents on similar drug combinations may pose validity challenges, emphasizing the importance of precise claim differentiation.
Strategic and Commercial Implications
The patent’s scope supports proprietary rights over specific antiviral combinations, enabling market exclusivity for particular therapies. It positions the holder to:
- Collaborate with pharmaceutical companies for licensing.
- Secure investment for drug development based on patent protection.
- Defend against generic competition through robust claims.
Legal Status and Patent Term
Given the filing date of 2012 and a typical patent term of 20 years from filing, this patent is likely valid until 2032, subject to maintenance fees and legal challenges. Its intellectual property status remains crucial in shaping the competitive landscape in Australia's antiviral drug market.
Conclusion
Patent AU2013266400 constitutes a strategic patent covering innovative combinations of antiviral agents for treating viral infections, notably hepatitis B and C. With broad claims encompassing compositions and methods, it provides a strong IP foothold for the patent owner. Its relevance is reinforced when considering the global landscape, where antiviral combination patents form an integral part of pharmaceutical innovation strategies.
Key Takeaways
- The patent protects specific antiviral compositions and their therapeutic applications, leveraging combination therapies for enhanced efficacy.
- Its broad scope offers significant market exclusivity but faces challenges from prior art and patentability assessments relating to obviousness.
- Strategic value derives from its position within the competitive landscape involving globally predominant antiviral patents.
- The patent facilitates commercialization, licensing, and defensive patenting strategies within Australia’s evolving pharmaceutical market.
- Ongoing patent maintenance and vigilant patent landscape analysis are critical to retain competitive advantage.
FAQs
1. Can this patent be enforced against generic drug manufacturers in Australia?
Yes. If the patent claims are valid and infringed, the patent holder can initiate infringement proceedings to prevent the sale or manufacture of infringing products within Australia.
2. How does this patent compare to international patents on similar antiviral combinations?
It shares common themes with patents filed in the US and Europe but may differ in specific claims related to ratios, formulations, or treatment methods. Comparative analysis confirms the novelty and inventive step of AU2013266400.
3. Are the claims limited to specific drug combinations, or are they broad?
The claims are broad enough to cover various combinations of nucleoside/nucleotide analogs but are specific about certain aspects such as ratios and administration methods, offering strategic flexibility.
4. What is the potential for patent opposition or challenge?
Given the high stakes in antiviral IP, competitors may challenge on grounds of obviousness or prior art. Maintaining detailed documentation of inventive steps and clinical data can bolster defendability.
5. How does this patent influence drug development strategies?
It encourages focused development of combination therapies, incentivizing R&D investments aligned with its claimed inventions, ultimately shaping treatment paradigms for hepatitis infections in Australia.
References
- [Australian Patent AU2013266400, "Combinations of Antiviral Agents and Uses Thereof"].
- World Intellectual Property Organization. Patent Landscape Reports on Antiviral Combinations.
- Australian Patent Office. Patent Examination Guidelines.
