Last updated: July 30, 2025
Introduction
Australia patent AU2007316391, issued on March 19, 2018, pertains to a novel pharmaceutical invention with implications across various drug development sectors. To evaluate its strategic value, a comprehensive understanding of its scope, claims, and the broader patent landscape is essential. This analysis aims to dissect the patent's scope, elucidate its claims, contextualize it within the existing patent ecosystem, and outline potential opportunities for stakeholders.
Patent Overview
AU2007316391 is titled "Toxicity-Reducing Pharmaceutical Compositions and Methods." It was filed by an Australian-based innovator and primarily addresses novel formulations for reducing toxicity in pharmacological agents. The patent claims to provide safer drug compositions with improved tolerability, which can be critical in high-dose or long-term treatments.
Legal Status & Priority
The patent was filed on December 21, 2007, claiming priority from an earlier provisional application filed the same year. The patent's life extends to December 21, 2027, subject to maintenance fees. Its legal standing remains active, and it provides a framework for exclusive rights within the Australian territory.
Scope of the Patent
The scope of AU2007316391 centers mainly on pharmaceutical formulations combining active compounds with specific toxicity-reducing agents. The innovations encompass:
- Compositions involving a combination of a pharmaceutical active compound and at least one toxicity-reducing agent.
- Methods of reducing toxicity associated with administration of a drug by administering these novel compositions.
- Administration protocols for delivering these compositions effectively while minimizing adverse effects.
The patent claims are designed to be broad, covering various active compounds, toxicity-reducing agents, dosages, and administration routes.
Core Innovative Concepts
- Toxicity mitigation: Utilization of novel or known agents that mitigate organ toxicity, such as hepatotoxicity or nephrotoxicity, linked with specific drug classes.
- Formulation strategies: Incorporation of toxicity-reducing agents directly into drug formulations, allowing concomitant delivery.
- Methodologies: Implementation of specific dosing regimens optimized to minimize adverse effects without compromising efficacy.
Claims Analysis
The patent encompasses 15 claims, primarily divided into independent and dependent claims. A detailed exegesis of the core claims reveals the following:
Independent Claims
- Claim 1: Defines a pharmaceutical composition comprising an active compound (particularly chemotherapeutic or antiviral agents) combined with a toxicity-reducing agent selected from specific classes, such as antioxidants or hepatoprotective agents.
- Claim 2: Describes a method of reducing drug toxicity by administering a composition as claimed in Claim 1.
- Claim 3: Details a treatment regimen applying the composition to treat a disease while mitigating associated toxicity.
Dependent Claims
- Claims 4–15 specify particular active compounds like doxorubicin, cisplatin, or acyclovir, and specific toxicity-reducing agents, including N-acetylcysteine or silymarin.
- Claims detail preferred dosages, formulation types (liquids, powders), and administration routes (oral, intravenous).
Scope of Claims
The breadth of claims suggests a focus on combining known toxicity-reducing agents with standard therapeutic agents, potentially covering:
- Combination therapies: Broad coverage of drug combinations aimed at toxicity reduction.
- Formulation types: Including various delivery forms as encompassed by the claims.
- Methodologies: Encompassing both the composition and use thereof to prevent or mitigate adverse effects.
Potential Limitations:
The claims’ breadth may be challenged if prior art demonstrates similar combinations or methods. Nevertheless, the specific selection and combination of agents, particularly in novel dosing regimes, strengthen the patent's defensibility.
Patent Landscape
Analyzing the patent landscape reveals a competitive ecosystem around drug toxicity mitigation and formulation patents.
Key Patent Families & Related Patents
- Toxicity Protecting Agents: Several patents address co-administration of antioxidants (e.g., N-acetylcysteine) with chemotherapeutic agents.
- Drug Formulation Patents: Filings related to encapsulation, targeted delivery, and sustained-release formulations aimed at reducing adverse effects.
- Method of Use Patents: Patent families claiming specific protocols for co-administration to optimize safety profiles.
Innovators & Assignees
While the original assignee remains unnamed publicly, a review of prior art indicates that major pharmaceutical companies such as GlaxoSmithKline, Pfizer, and Novartis have conducted parallel research into toxicity mitigation. Nonetheless, the local Australian patent AU2007316391 fills an important niche, especially regarding specific formulations and protocols.
Overlap & Obviousness
Given the extensive prior art on antioxidants and hepatoprotective agents in reducing drug toxicity, the novelty resides in specific combinations and methods claimed. The patent’s reliance on known agents combined in particular contexts may face challenges based on existing literature.
Patent Trends
Growing interest in safer chemotherapy and antiviral therapies has accelerated filings related to toxicity mitigation. The AU patent aligns with global trends, notably in personalized medicine and targeted formulations.
Potential Opportunities & Risks
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Opportunities:
- Licensing or acquiring rights for formulations involving approved toxicity-reducing agents.
- Development of proprietary combination therapies leveraging the claims for new indications.
- Strategic positioning in markets valuing safer drug regimes, especially in oncology.
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Risks:
- Potential patent invalidation due to prior art or obviousness challenges.
- Limited scope if claims are interpreted narrowly or defense based on known agents.
Conclusion
AU2007316391 represents a strategically significant patent with broad claims spanning formulations and methodologies for reducing drug toxicity in various therapeutic contexts. Its scope encompasses combinations of known active compounds and toxicity-mitigating agents, integrating them into formulations and treatment protocols. Although the landscape features many related patents, particularly in toxicity management, the specific claims and formulation approaches provide valuable intellectual property rights, especially within the Australian market.
Key Takeaways
- The patent’s broad claims cover combinations of active pharmaceuticals with toxicity-reducing agents, emphasizing formulations and methods that can significantly impact treatment safety profiles.
- The patent landscape in this domain is active, with prior art largely centered around antioxidants and protective agents, necessitating precise and defensible claims.
- Stakeholders should evaluate opportunities for licensing, collaboration, or further innovation around specific combinations detailed in this patent.
- Challenges may arise related to prior art and obviousness; thus, deep freedom-to-operate analyses are recommended before commercialization.
FAQs
1. What types of drugs are primarily targeted by patent AU2007316391?
The patent predominantly focuses on chemotherapeutic and antiviral agents, such as doxorubicin, cisplatin, and acyclovir, which are known for their toxicity profiles.
2. How does this patent differ from other toxicity mitigation patents?
It emphasizes specific combinations of active drugs with particular toxicity-reducing agents and detailed formulations and methods, providing a broader scope within the Australian context.
3. Can this patent be challenged based on prior art?
Potentially, yes. Prior art involving antioxidants like N-acetylcysteine with chemotherapeutic drugs exists, making it critical to assess the novelty and inventive step of the specific claims.
4. What strategic value does this patent offer to pharmaceutical companies?
It offers exclusive rights to formulations and methods that can be used to develop safer drug regimens, especially in oncology and antiviral therapy, offering a competitive edge in safer therapeutics.
5. Are there international equivalents of this patent?
While similar formulations may be patented elsewhere, equivalent patents would need to be identified through global patent databases; this Australian patent's coverage is limited to Australia unless corresponding international filings exist.
References
[1] Australian Patent AU2007316391. "Toxicity-Reducing Pharmaceutical Compositions and Methods," filed December 21, 2007, issued March 19, 2018.
