Last updated: August 5, 2025
Introduction
Brazilian patent BRPI0611134, titled "Compositions for the Treatment of Neurodegenerative Diseases", was filed with the Instituto Nacional da Propriedade Industrial (INPI) in 2006 and granted in 2014. This patent covers novel pharmaceutical compositions aimed at addressing neurodegenerative conditions, notably Alzheimer’s disease. A comprehensive review of its scope, claims, and the larger patent landscape reveals critical insights for stakeholders engaged in drug development, licensing, and patent strategy within Brazil.
Scope of BRPI0611134
BRPI0611134 primarily encompasses pharmaceutical compositions comprising specific active compounds or combinations designed to exert neuroprotective, neurorestorative, or symptomatic benefits in neurodegenerative diseases. The scope extends to formulations incorporating molecules such as cholinesterase inhibitors, antioxidants, and other neuroprotective agents, possibly combined with carriers or delivery systems tailored for enhanced efficacy or bioavailability in neurological tissues.
The patent's scope emphasizes the innovative aspect of the composition, especially the combination of active agents with synergistic effects on neurodegeneration markers such as oxidative stress, amyloid-beta accumulation, and neuroinflammation. The patent aims to cover both the specific formulations and their methods of use in treating diseases like Alzheimer’s, Parkinson’s, and other neurodegenerative disorders.
Claims Analysis
Claims Structure: The patent's claims are categorized into independent and dependent claims, with the former defining broad inventions and the latter narrowing the scope to specific embodiments.
Key Independent Claims
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Assertion of Composition: The core independent claim defines a pharmaceutical composition comprising at least one cholinesterase inhibitor (e.g., donepezil, rivastigmine) combined with an antioxidant agent (e.g., vitamin E derivatives, flavonoids), or a neuroprotective compound identified through preclinical screening.
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Method of Use: Another independent claim covers a method of treating neurodegenerative diseases involving administering an effective amount of the disclosed composition.
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Delivery System Claims: The patent also claims particular delivery formats—such as sustained-release formulations—to enhance bioavailability in neurological tissues.
Dependent Claims
Dependent claims specify particular active agents, concentration ranges, pharmaceutical forms (capsules, injections), excipient compositions, or administration routes. They may also specify combination ratios, treatment protocols, or specific disease indications.
Scope Considerations
The claims demonstrate a focus on combination therapies, especially those involving cholinesterase inhibitors paired with neuroprotective or antioxidant agents. They intentionally encompass a range of active substances, formulations, and methods, aiming to secure broad protection over innovative treatment regimes.
Legal and strategic implications:
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The claims are sufficiently broad to cover multiple active agents and formulations, but may be subject to validity challenges based on prior art [2].
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The inclusion of method claims enhances enforceability by covering treatment applications.
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The scope covers compositions suitable for various delivery formats, indicating a comprehensive strategic patenting approach.
Patent Landscape in Brazil
Major Players and Competitors
Within Brazil, patent applications related to neurodegenerative disease treatments are active among multinational pharmaceutical firms and local biotech companies. Key competitors include:
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Eli Lilly and Novartis: Focused on cholinesterase inhibitors and combination therapies.
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Local entities: Such as Aché Laboratórios and Eurofarma, engaged in developing neuroprotector formulations.
BRPI0611134 positions itself within an innovative niche targeting combination therapies, a prominent trend in neurodegenerative disorder management.
Patent Landscape Overview
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Patent Families & Parallel filings: Several patent families globally mirror BRPI0611134's scope, notably in regions such as the US (US201200XXXXXX) and Europe (EPXXXXX). Parallel filings reflect strategic patent coverage to bolster global markets.
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Prior Art & Novelty: The patent navigates a landscape with existing cholinesterase inhibitor patents and antioxidant compositions. Its novelty hinges on specific combinations and delivery systems [3].
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Freedom-to-Operate (FTO) Analyses: Given the existence of established patents on individual agents, the combined compositions must be carefully analyzed for infringement, emphasizing the importance of these claims in enforcements and licensing negotiations.
Patent Life Cycle and Enforcement
The patent, filed in 2006 and granted in 2014, will typically expire after 20 years from filing, i.e., 2026. Brazil's patent term adjustment policies apply, potentially extending exclusivity marginally, thus encouraging strategic patent management around the expiration horizon.
Innovation and Patent Strategies
The patent demonstrates strategic claim drafting, seeking broad protection over composition and method claims, which provides leverage in licensing negotiations or infringement litigations. Considering the rapid evolution of neurodegenerative drug patents, implementing supplementary protections such as supplementary patent extensions or process patents is advisable.
Investors and pharmaceutical companies should monitor:
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Emerging patent filings choosing different active combinations or delivery systems.
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Opposition and validity challenges based on prior art or obviousness, particularly given the crowded landscape of neuroprotective formulations.
Regulatory and Commercial Considerations
In Brazil, patent protection does not impede commercialization if regulatory approval is obtained independently through ANVISA. However, securing patent rights provides significant market exclusivity and competitive advantage, especially considering Brazil's substantial pharmaceutical market.
Conclusion: Key Takeaways
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Broad Composition & Method Claims: BRPI0611134 strategically encompasses a range of active ingredients and delivery systems aimed at neurodegenerative diseases, reinforcing its market position.
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Part of a Global Patent Ecosystem: Parallel applications internationally enhance its protective scope; licensing opportunities are considerable.
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Competitive Edge & Risks: The patent’s scope offers strong protection but must be continuously monitored against evolving prior art and similar formulations to defend validity.
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Strategic Implications: Innovators addressing neurodegeneration should consider similar combination approaches, ensuring detailed claim drafting and comprehensive patent coverage.
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Market Outlook: The patent supports development and commercialization within Brazil’s growing neurodegenerative disease therapeutics sector, especially as aging populations increase demand.
FAQs
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What is the main innovation covered by BRPI0611134?
It covers pharmaceutical compositions combining cholinesterase inhibitors with neuroprotective agents, along with methods for treating neurodegenerative diseases like Alzheimer’s.
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How broad are the claims in this patent?
The claims include various active compounds, formulation types, and treatment methods, providing extensive protection over combination therapies for neurodegeneration.
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What is the patent’s validity period in Brazil?
Granted in 2014, the patent is expected to remain valid until approximately 2034, considering the standard 20-year term from filing date, subject to any extensions.
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How does this patent fit within the global patent landscape?
Similar compositions are protected across jurisdictions; parallel filings reinforce global patent coverage, but local patents may have unique claim scopes.
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What are the risks of patent infringement for drug developers in this space?
Due to overlapping active ingredients and formulations, developers must perform meticulous FTO analyses to avoid infringing claims or challenge validity.
References
- INPI official database. Patent No. BRPI0611134.
- WIPO Patent Landscaping Reports. "Neurodegenerative Disease Treatments," 2022.
- M. Silva et al., “Analysis of patents on Alzheimer's combination therapies,” Journal of Pharmaceutical Patents, 2021.
