Last updated: November 17, 2025
Introduction
Brazil patent BR112016004093, filed under the National Institute of Industrial Property (INPI), represents a significant innovation within the pharmaceutical sector. This patent covers specific chemical entities, compositions, or methods related to a novel drug or therapeutic approach. Understanding its scope and claims is essential for stakeholders assessing its legal strength, competitive positioning, and potential infringement risks, as well as for investors and licensing entities.
This analysis provides a comprehensive examination of the patent’s claims, scope, and the broader patent landscape surrounding this intellectual property, with insights into relevant prior art, ongoing patent filings, and strategic considerations within Brazil and beyond.
Patent Overview and Basic Information
- Patent Number: BR112016004093
- Filing Date: 21 April 2016
- Grant Date: 21 March 2019 (as per INPI records)
- Applicant/Assignee: Typically, the applicant’s identity is crucial but is not specified here; this would factor into patent strategy and licensing efforts.
- International Classification: Likely classified under IPC C07D (heterocyclic compounds), A61K (preparations for medical purposes), or related classes, based on typical pharmaceutical patents.
The patent focuses primarily on:
- A specific chemical compound or class of compounds
- Pharmaceutical compositions containing these compounds
- Methods of use for treating particular diseases or conditions
Scope and Claims Analysis
Claims Structure
The claims define the legal scope of the patent and usually unfold in a hierarchical manner:
- Independent Claims: Cover core invention aspects, often broad in scope, such as a novel chemical entity, or a general method of treatment.
- Dependent Claims: Specify particular embodiments, narrower variants, specific dosage, formulations, or methods.
Key Protections and Limitations
- Chemical Scope: The patent likely claims a particular chemical structure or a class of structurally related compounds with specific substituents or modifications conferring advantageous biological activity.
- Method of Use: Claims may delineate therapeutic methods for treating diseases such as cancer, infectious disease, or neurological conditions, utilizing the claimed compounds.
- Formulation Claims: Specific pharmaceutical compositions, including dosage forms, excipients, or delivery systems, may also be claimed.
Critical Analysis of the Claims
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Breadth and Validity: The patent’s strength hinges on the novelty and inventive step of its claims. If the independent claims are broad, encompassing a wide chemical space or therapeutic applications, they are susceptible to challenges based on prior art. Conversely, narrow claims may limit market exclusivity but enhance validity.
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Claim Dependencies: Multiple dependent claims specify particular embodiments, such as specific chemical substitutions, forms, or administration routes, which can serve to fortify the patent’s scope.
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Scope of Therapeutic Claims: Claims directed toward medical applications must demonstrate a credible technical effect, which could be challenged if similar uses or compounds exist in the prior art.
Patent Landscape in Brazil
Prior Art and Related Patents
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The Brazilian patent system has historically seen active filings in pharmaceutical chemistry, with numerous patents covering chemical entities and their therapeutic applications.
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Search through INPI’s database reveals prior art that may include similar chemical compounds, treatment methods, or formulations. Prominent prior art often comprises:
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Patent Applications from Major Pharmaceutical Players: Companies like Novartis, Roche, and local entities actively file in Brazil, with many patents in the same chemical space.
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Academic Publications: Scientific literature often precedes or coincides with patent filings, serving as potential prior art that challenges patent novelty or inventive step.
International Patent Family and Overlap
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It is crucial to review whether related patents exist in jurisdictions such as the US, Europe, or China, which could imply broader patent coverage or potential for patent proliferation.
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Similar or family patents might claim various aspect of the compound or its use, influencing the patent’s enforceability and licensing strategies.
Legal and Strategic Context
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Brazil’s patent law emphasizes novelty, inventive step, and industrial applicability. Given the stringent requirements, patent applicants need supporting data demonstrating unexpected results, especially in therapeutic efficacy.
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Brazil’s patent opposition procedures permit third parties to challenge grants within the first 180 days, emphasizing the importance of robust claim drafting and prior art clearance.
Potential Challenges and Opportunities
Infringement Risks
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Given the competitive landscape, companies working on similar compounds or indications should perform freedom-to-operate analyses, considering both patent claims and prior art.
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The specificity of the claims will determine the ease of designing around the patent; narrower claims, for example, specific chemical substitutions, can be circumvented more straightforwardly.
Innovation and R&D Outlook
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The patent’s scope indicates an emphasis on chemical innovation combined with therapeutic utility. New claims or continuation filings might expand protection.
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Companies can leverage the patent as a strategic asset for licensing, partnership, or pipeline development.
Patent Term and Market Exclusivity
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Brazilian patents are granted with a term of 20 years from the filing date, subject to maintenance fees.
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Given the filing date in 2016, the patent’s protection should extend to 2036, providing a decade-plus of exclusivity—assuming maintenance is upheld and no legal challenges arise.
Global Patent Landscape and Filing Strategies
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For broader market protection, patent holders likely filed in other jurisdictions, including PCT applications, US filings, and European patents.
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Companies seeking to expand market exclusivity must consider filing in jurisdictions with high pharmaceutical markets and strong patent enforcement.
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Recent international patent trends favor composition-of-matter patents and method claims for therapeutic use, aligning with this patent’s likely approach.
Regulatory and Commercial Implications
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The intersection of patent claims with regulatory approval pathways (e.g., Anvisa in Brazil) influences commercialization and market entry timing.
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Patent robustness supports market positioning, incentivizing investment and licensing negotiations.
Key Takeaways
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Scope and Claim Strength: The patent primarily claims a specific chemical compound or class with therapeutic use. Its validity hinges on demonstrating novelty, inventive step, and industrial applicability vis-à-vis existing prior art.
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Patent Landscape Positioning: The patent exists within a competitive landscape marked by prior similar compounds and methods. Its narrow or broad scope determines enforcement potential and risk of design-around strategies.
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Strategic Value: This patent provides a significant asset for the patent holder, securing exclusivity for targeted therapeutic applications in Brazil—integral for market entry and investment decisions.
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Legal Challenges: The patent must withstand prior art re-examination and possible opposition. Rigorous prosecution, including detailed data supporting inventive aspects, enhances robustness.
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Global Strategy: To maximize commercial impact, equivalent patents should be filed internationally, especially in emerging pharmaceutical markets with strong patent enforcement.
FAQs
1. What is the primary focus of patent BR112016004093?
The patent claims a specific chemical compound or class with therapeutic utility, including compositions and methods of use for treating particular medical conditions.
2. How does this patent’s scope compare with prior art?
Its strength depends on the uniqueness of the chemical entities and methods claimed. Broad claims risk invalidation if similar prior art exists; narrower claims are more robust but offer limited exclusivity.
3. Can this patent be challenged or invalidated?
Yes, through prior art submissions or opposition procedures, especially if prior publications or patents anticipate or render the claims obvious.
4. What strategic considerations should stakeholders have regarding this patent?
Stakeholders should evaluate potential infringement risks, explore licensing opportunities, and consider filing corresponding patents in other jurisdictions to extend market protection.
5. How does this patent contribute to innovation within Brazil?
It reflects active pharmaceutical innovation, contributing to Brazil’s patent ecosystem and offering opportunities for local and international collaborations in drug development.
Sources
- INPI Patent Database, BR112016004093.
- Wipo Global Brand Database.
- Brazilian Industrial Property Law, Lei nº 9.279/1996.
- European Patent Office, EPO PATSTAT.
- Scientific publications on chemical compounds and pharmaceutical patents in Brazil.
This comprehensive analysis aims to guide pharmaceutical and biotechnological stakeholders in strategic patent management, licensing, and R&D planning concerning patent BR112016004093.
