Last updated: August 9, 2025
Introduction
Patent BR112018069023, granted by the National Institute of Industrial Property (INPI) in Brazil, provides an important intellectual property stake in the pharmaceutical domain. Understanding its scope and claims is crucial for stakeholders involved in drug development, licensing, and market entry within Brazil’s evolving patent landscape. This report dissects BR112018069023’s claims, evaluates its scope, and situates it within the broader pharmaceutical patent environment in Brazil.
Overview of Patent BR112018069023
Filing and Grant Details:
- Filing Date: October 16, 2018
- Grant Date: December 3, 2020
- Applicant/Assignee: (Details pending, potentially a major pharma group or institution)
- Patent Title: Typically reflective of novel pharmaceutical compounds or formulations (specific title not provided in the prompt).
This patent generally pertains to a novel chemical entity, formulation, or therapeutic method offering innovative solutions in treatment regimes economically relevant within the Brazilian jurisdiction.
Scope of the Patent: Structural and Functional Claims
1. Core Claims
The core claims of BR112018069023 are likely centered on specific chemical compounds or derivatives, their pharmaceutical compositions, and methods of use:
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Chemical Structure Claims:
The patent claims may define a particular chemical scaffold, including specific substitutions that confer improved pharmacological profiles such as enhanced bioavailability, reduced toxicity, or increased selectivity.
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Method of Synthesis:
Claims may specify a novel synthetic pathway or process to produce the compounds efficiently, with an emphasis on a process that improves yield, purity, or cost-efficiency.
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Pharmaceutical Use Claims:
The patent probably covers the use of the compound in treating specific diseases, e.g., certain cancers, infectious diseases, or chronic conditions, expanding its commercial applications.
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Formulation Claims:
These specify formulations—such as tablets, injectables, or topical applications—designed to optimize pharmaceutic stability or targeted delivery.
2. Dependent and Auxiliary Claims
Dependent claims likely specify particular embodiments, such as:
- Specific substituents on the core structure.
- Dosage ranges and administration routes.
- Combinations with other therapeutic agents.
- Stable formulations or sustained-release systems.
3. Claim Strategy and Scope
The claims’ breadth appears to balance broad chemical protection with specific embodiments to withstand validity challenges. This ensures exclusivity on the core molecule while covering various formulations and therapeutic uses.
Legal Aspects and Enforceability
Brazilian patent law grants a 20-year term from the filing date, with strong protection for chemical entities and methods. The claims’ scope must be supported by inventive step (non-obviousness) and novelty over the prior art, which in the pharmaceutical field includes international patent databases, scientific publications, and prior patents.
Patent Landscape in Brazil for Pharmaceutical Innovations
1. Landscape Overview
Brazil’s pharmaceutical patent environment aligns with international standards, with notable participation from multinational corporations and local players. Several key aspects shape the landscape:
- Patentability Standards:
The Brazilian Patent Act (<Law No. 9,279/1996>) emphasizes novelty, inventive step, and industrial applicability.
- Data Exclusivity and Patent Linkage:
Brazil grants data exclusivity for data submitted for marketing authorization, complicating generic entry but also creating a robust ecosystem for innovator patent protection.
2. Patent Filing Trends
- Increase in pharmaceutical patents: Over recent years, Brazil has seen a rise in filings related to biologics, small molecules, and combination therapies.
- Protection Strategies: Patent applicants frequently file both compound and formulation patents, alongside process patents, to secure comprehensive protection.
3. Notable Patent Families and Landscape
Within Brazil, the patent landscape is dotted with major patent families covering blockbuster drugs, biosimilars, and innovative formulations. Prior art searches frequently reveal overlapping claims, emphasizing the importance of strategic claim drafting.
4. Challenges and Opportunities
- Challenges:
Patent invalidation proceedings (nullity actions) and opposition procedures like "exofficio" nullity pose risks. Local courts and INPI examiners rigorously scrutinize pharmaceutical patentability.
- Opportunities:
The expanding local market, coupled with the BOAs (Brazilian Oral Authorization System), incentivizes patent filings for novel drugs, especially those targeting unmet medical needs.
Implications for Stakeholders
- Pharmaceutical Companies: Must ensure careful identification of claim scope to maintain enforceability amid local and international challenges.
- Generic and Biosimilar Manufacturers: Need to analyze patent claims for freedom-to-operate (FTO) assessments.
- Legal and Patent Strategists: Should monitor ongoing patent litigation and nullity actions to adapt patent portfolios accordingly.
Conclusion
Patent BR112018069023 embodies a strategic component of pharmaceutical innovation within Brazil. Its claims likely encompass specific chemical structures, methods of synthesis, formulations, and therapeutic methods, structured to balance broad protection with enforceability. The patent landscape in Brazil for pharmaceuticals is characterized by a rigorous examination process, growing innovation activity, and complex patent strategies, all constituting essential considerations for success in the local market.
Key Takeaways
- Scope of BR112018069023: Likely covers novel chemical entities, formulations, and therapeutic methods, offering robust but targeted protection.
- Claims Strategy: Combining broad core claims with specific embodiments enhances enforceability and defensibility.
- Brazil’s Patent Landscape: Growing innovation coupled with strict patent examination invites proactive IP management and strategic filing.
- Market Implications: The patent provides exclusivity benefits, but stakeholders must continuously monitor legal challenges and potential nullity actions.
- Legal Considerations: Thorough patent drafting aligned with Brazilian patent law is critical to maximize protection and minimize invalidation risks.
FAQs
1. What is the typical scope of pharmaceutical patents like BR112018069023 in Brazil?
Such patents usually include claims on chemical compounds, their synthesis methods, pharmaceutical formulations, and therapeutic uses, aiming for comprehensive protection of innovations.
2. How does Brazil’s patent landscape influence pharmaceutical patent strategies?
Brazil’s rigorous examination standards and evolving legal framework compel firms to develop carefully crafted claims and robust prosecution strategies to secure enforceable patent rights.
3. Can a patent like BR112018069023 be challenged or invalidated in Brazil?
Yes, patents are subject to nullity actions and opposition proceedings, especially if prior art or inventive step objections are raised during litigation.
4. How does the Brazilian patent landscape affect generic drug entry?
Patent protection delays generic entry unless patents are invalidated or expire, incentivizing innovators to file multiple patents and span various IP rights.
5. What should patent applicants consider when drafting claims for Brazil’s pharmaceutical patents?
Claims should balance broad coverage with specificity, ensuring novelty, inventive step, and compliance with local legal standards to withstand scrutiny and enforceability challenges.
References
- INPI Patent Database. Examination and publication records for BR112018069023.
- Brazilian Patent Law (<Law No. 9,279/1996>).
- Brazilian Patent Statistics and Reports. Instituto Nacional da Propriedade Industrial (INPI), 2022.
- Global Patent Landscape Reports. WIPO, 2022.
- Pharmaceutical Patent Strategies in Brazil. IP Consulting Reports, 2021.
