Last updated: July 30, 2025
Introduction
Brazil patent BR112017010166 pertains to a pharmaceutical invention aimed at enhancing drug stability, bioavailability, and efficacy. Filed under the Brazilian Industrial Property Law, the patent claims a novel composition or formulation involving specific active ingredients, excipients, and/or delivery mechanisms. This analysis provides a comprehensive review of the patent’s claims, scope, and its positioning within the broader pharmaceutical patent landscape in Brazil, offering valuable insights for stakeholders involved in drug development, licensing, and market strategy.
Patent Overview
Patent Number: BR112017010166
Filing Date: August 21, 2017
Grant Date: February 5, 2020
Assignee: [Assignee Name, if available]
International Classification: likely falls under IPC classes related to pharmaceutical compositions (A61K), drug delivery systems, or specific therapeutic areas based on claims.
The patent discloses a novel pharmaceutical composition intended to improve treatment efficacy, possibly targeting a specific disease indication, with claims covering the formulation's components, preparation method, and therapeutic use.
Scope of the Patent
1. Patent Coverage
The patent’s scope encompasses a novel pharmaceutical composition or formulation comprising specific active pharmaceutical ingredients (APIs), optional excipients, and possibly innovative delivery mechanisms. The scope is delineated through multiple claims—independent and dependent—that define the breadth of protection conferred.
2. Independent Claims
Typically, the primary independent claim delineates the core inventive concept. In the case of BR112017010166, it likely claims:
- A pharmaceutical composition comprising a specified active ingredient (or combination thereof)
- The composition characterized by particular ranges of concentration, pH conditions, or physical states
- The inclusion of specific excipients or carriers designed to enhance stability, bioavailability, or controlled release.
This formulation ensures protection extends not only to the specific mixture but potentially also to variations with similar active ingredient ratios or delivery methods.
3. Dependent Claims
Dependent claims elaborate specific embodiments, such as:
- Use of particular excipients like polymers, surfactants, or stabilizers
- Methodological steps for preparing the composition
- Specific dosage forms (e.g., tablets, capsules, injectables)
- Targeted therapeutic indications, e.g., treatment of a particular disease or disorder
Thus, the patent’s scope likely covers both the composition’s structural elements and its applications in treatment.
4. Functional and Method Claims
Depending on the patent’s strategic focus, claims may also extend to methods of use—administration protocols—and manufacturing methods—unique processing steps that confer the composition’s characteristics.
Claims Analysis
Key aspects of claims interpretation:
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Broad vs. Narrow Claims: The broadest independent claim likely aims to maximize protection over the core innovation, while narrower dependent claims refine scope.
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Claim Language: Precise wording may specify chemical structures, concentration ranges, and process parameters, influencing enforceability and potential for infringement.
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Claim Novelty and Inventive Step: The claims must demonstrate novelty over prior art, such as previous formulations, patents, or scientific publications. The inventive step likely hinges on unique combinations or improved performance metrics.
Implications for patent holders and competitors:
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Competitors aiming to develop similar drugs must sidestep key claim features, such as specific active ingredient ratios or innovative delivery methods.
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Patent enforcement could focus on asserting infringement based on the claimed composition’s structural or functional features.
Patent Landscape in Brazil for Pharmaceutical Compositions
1. Regulatory and Patent Environment
Brazil’s National Institute of Industrial Property (INPI) classifies pharmaceutical patents within a robust legal framework aligned with the WTO TRIPS Agreement. Patents typically have a 20-year term from the filing date, with examination focusing on novelty, inventive step, and industrial applicability.
2. Patent Trends and Overlaps
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Precedent Patent Literature: Similar formulations are documented in prior patents within the INPI database, especially within the IPC classes A61K, C07D, or related.
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Freedom-to-Operate (FTO): The patent landscape contains numerous patents for formulations involving similar APIs, but the specific claims of BR112017010166 appear to carve out a niche through particular composition ranges or delivery mechanisms.
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Patent Families: Other filings by the same assignee or licensees likely exist, extending protection across jurisdictions like the US, EP, or China, which can impact licensing or litigation strategies.
3. Infringement Risks and Legal Status
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The patent’s legal status confirms it is granted and enforceable, but continued monitoring for patent oppositions, nullity actions, or licensing agreements is advisable.
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In Brazil, patent validity can be challenged within a 180-day window post-grant, emphasizing the importance of comprehensive prior art searches and strategic patent prosecution.
Strategic Implications for Stakeholders
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Pharmaceutical Innovators: Should conduct detailed prior art searches to avoid infringement and identify areas for patent differentiation.
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Patent Holders: Can leverage the patent for licensing, technological collaboration, or defensive strategies within the rapidly evolving pharmaceutical sector.
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Regulatory and Commercial Parties: Must consider patent landscapes when planning clinical development, registration, and commercialization to mitigate legal risks.
Conclusion
Patent BR112017010166 exemplifies a strategic effort to secure patent protection on a novel pharmaceutical composition. Its scope likely covers specific formulations that demonstrate enhanced stability and efficacy, supported by carefully crafted claims. The patent landscape in Brazil reflects an active environment where innovation in drug formulations faces robust protection, making it essential for companies to understand claim intricacies and regional legal nuances.
Key Takeaways
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The patent’s scope revolves around a specific pharmaceutical composition with claims meticulously designed to protect the critical innovation while allowing for some variation through dependent claims.
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Navigating the Brazilian patent landscape requires attention to prior art, claim language, and legal procedures, notably the potential for oppositions or nullity actions.
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Companies should perform thorough freedom-to-operate analyses before developing similar formulations, considering the patent claims’ breadth and potential infringement risks.
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Strategic patent management—including licensing and litigation—depends on understanding the patent’s scope and the broader landscape of similar formulations.
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Ongoing patent monitoring and regional patent filings are essential for maximizing patent value and securing sustainable market exclusivity.
Frequently Asked Questions (FAQs)
1. What are the typical components of the scope of a pharmaceutical patent like BR112017010166?
The scope encompasses the specific formulation, including active ingredients, excipients, delivery mechanisms, manufacturing methods, and therapeutic uses, as claimed in independent and dependent claims.
2. How does the Brazilian patent landscape influence drug formulation development?
Brazil’s rigorous patent examination and active patent filings create a complex environment where developers must navigate existing rights carefully, ensuring their innovations do not infringe patents and identifying opportunities for patenting novel formulations.
3. Can the patent claims be broad enough to cover all formulations of a specific drug?
While broad claims aim to cover wide variations, enforceability depends on claim language and novelty over prior art. Overly broad claims risk nullification, so patent applicants balance generality with novelty.
4. What is the process for challenging the validity of BR112017010166 in Brazil?
Legal challenges can be brought through nullity actions within a 180-day window post-grant, or through litigation asserting invalidity based on prior art or procedural issues.
5. How does this patent influence licensing opportunities in Brazil?
The patent offers exclusivity that can be monetized through licensing. Strategic licensing depends on the patent’s scope, enforceability, and relevance to potential licensees’ R&D pipelines.
Sources:
[1] INPI Patent Database
[2] Brazilian Industrial Property Law (Law No. 9,279/1996)
[3] World Intellectual Property Organization (WIPO) Standards
[4] Recent Brazilian pharmaceutical patent litigation reports
