Last updated: September 27, 2025
Introduction
Patent AU2014203484, titled "Use of a Butyrate Compound for Treatment of Neurodegenerative Diseases," was granted by the Australian Patent Office in 2014. It pertains primarily to the use of specific butyrate derivatives for therapeutic purposes, particularly targeting neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s disease, and Huntington’s disease. This analysis evaluates the scope of the claims, the patent’s strategic positioning within the patent landscape, and its potential impact on the pharmaceutical sector.
Scope of Patent AU2014203484
1. Purpose and Field of Invention
The patent focuses on the medicinal use of butyrate compounds, or derivatives thereof, as neuroprotective agents. It emphasizes that the compounds can be employed to prevent, delay, or treat neurodegenerative diseases, leveraging the properties of butyrate as a histone deacetylase (HDAC) inhibitor, which promotes gene expression associated with neuronal health.
2. Core Inventive Concept
The patent claims broadly cover:
- The use of specific butyrate derivatives for treating neurodegenerative diseases.
- The administration of these compounds in effective doses, potentially alone or combined with other therapeutics.
- The invention’s applicability across various disease stages and patient demographics.
3. Key Aspects of the Scope
- Chemical scope: Claims encompass not only natural butyrate but also a broad class of derivatives, analogs, and salts with similar biological activity.
- Therapeutic scope: Claims extend to both prophylactic and therapeutic applications targeting neurodegeneration.
- Delivery methods: Claims include various pharmaceutical forms, such as oral, injectable, or transdermal formulations.
Overall, the patent’s breadth underscores a comprehensive coverage of butyrate-based neurotherapeutics, which is typical in drug patents to protect the core invention while allowing some flexibility in formulation and administration.
Claims Analysis
1. Main Claims
The patent’s independent claims primarily define:
- The use of a specified butyrate derivative in the preparation of a medicament for treating a neurodegenerative disease (e.g., Claim 1).
- The method of treatment involving administering an effective amount of the compound (e.g., Claim 2).
- The specific chemical structures that fall under the scope, including salts, esters, and prodrugs of butyrate (e.g., Claims 3–5).
2. Dependent Claims
Dependent claims refine the scope by specifying:
- Specific derivatives, such as phenylbutyrate or sodium butyrate.
- Dosing regimens, administration frequencies, and formulations.
- Particular neurodegenerative conditions, including Alzheimer’s disease, Parkinson’s disease, Huntington’s disease.
- Combination therapies with other neuroprotective agents.
3. Ambit and Novelty
The claims are relatively broad, asserting the use of a class of compounds for neurodegeneration, anchored in preclinical and early clinical evidence that butyrate derivatives exert neuroprotective effects via epigenetic mechanisms. The novelty arises from prior art not explicitly disclosing these specific derivatives or their use in such comprehensive treatment modalities.
4. Potential Limitations
- The scope may be challenged if prior art discloses similar derivatives or therapeutic methods.
- Specific claims on chemical structures might be narrower if prior literature identifies similar compounds.
Patent Landscape in Australia
1. Patents Related to Butyrate Derivatives
The patent’s landscape involves overlapping patents covering various HDAC inhibitors and neuroprotective agents. Notable related patents include:
- US and European patents on phenylbutyrate derivatives for neurodegenerative diseases.
- Australian patents such as AU2004202232, related to HDAC inhibitors for neurological conditions.
- The existence of generic compounds (e.g., sodium butyrate) being well known in prior art diminishes the likelihood of broad patentability unless specific derivatives or combinations are claimed.
2. Key Competitors and Patent Holders
Major pharmaceutical entities, research institutions, and biotech companies possess overlapping patents, including:
- Cytokine-targeting companies developing HDAC inhibitors.
- Academic institutions holding foundational patents on butyrate-based inhibitors.
- Patent litigation has been minimal in Australia, but there is a landscape of patent filings related to epigenetic modulators.
3. Freedom to Operate and Patentability
While the patent claims a broad scope, possible challenges could arise from prior disclosures of similar derivatives or use cases. The novelty of specific chemical structures and detailed therapeutic methods strengthens the patent’s enforceability within Australia, although comprehensive freedom-to-operate analysis is advisable.
Implications for Business and Innovation
This patent aligns with the burgeoning field of epigenetic therapeutics, offering potential exclusivity in a high-growth niche targeting neurodegeneration. Its broad claims can serve as a foundational patent, blocking competitors from using similar butyrate derivatives for neurodegenerative treatments in Australia, thereby facilitating licensing and commercialization efforts.
Key Takeaways
- Broad Yet Specific Scope: The patent covers multiple derivatives and therapeutic methods, presenting valuable protection but with potential for legal challenges based on prior art.
- Strategic Importance: It secures a foothold in a promising biotech sector focused on epigenetic modifiers for neurodegeneration.
- Patent Strengths: Given the particular chemical claims and comprehensive coverage of therapeutic methods, the patent offers defensibility against infringers.
- Landscape Dynamics: The patent exists within a competitive landscape with overlapping claims and prior disclosures; careful monitoring of related filings is essential.
- Commercialization Pathways: Licensing and partnerships can leverage the patent’s broad claims to develop novel treatments or combinations with existing therapies.
FAQs
1. What is the core innovation of patent AU2014203484?
It claims the use of specific butyrate derivatives as neuroprotective agents to treat neurodegenerative diseases, notably leveraging HDAC inhibition for therapeutic benefit.
2. How broad are the claims, and can they be challenged?
The claims are broad, covering classes of derivatives and various treatment methods. Challenges may arise from prior art if similar compounds or methods have been disclosed, but the patent’s specificity on derivatives and applications provides strong protection.
3. How does this patent fit into the existing patent landscape?
It complements existing patents on HDAC inhibitors and epigenetic drugs but distinguishes itself through specific derivative claims and comprehensive therapeutic scope, creating a strategic position within the Australian patent space.
4. What are the risks associated with patent infringement or invalidation?
Risks include prior disclosures, overlapping claims, or subsequent invalidation based on lack of novelty or inventive step. An ongoing review of prior art is vital.
5. What commercial opportunities does this patent unlock?
It enables licensing agreements with pharmaceutical companies, development of proprietary formulations, and potential collaborations to bring novel neurodegenerative treatments to market in Australia.
References
[1] Australian Patent AU2014203484. "Use of a Butyrate Compound for Treatment of Neurodegenerative Diseases," 2014.
[2] Prior art references on HDAC inhibitors and butyrate derivatives related to neurodegeneration.
[3] Patent databases and legal analyses of the Australian patent landscape in neurotherapeutics.
