Last updated: July 29, 2025
Introduction
Brazilian patent BR112017023161, granted in 2020 by the National Institute of Industrial Property (INPI), pertains to a novel pharmaceutical composition. Understanding this patent's scope, claims, and position within the patent landscape is essential for drug developers, legal strategists, and market participants navigating Brazil’s bioscience and pharmaceutical sectors.
This analysis dissects the patent's claims, elucidates its scope, explores relevant prior art, and examines its positioning within the broader patent landscape. The goal is to inform strategic decision-making in licensing, research, and competitive intelligence.
Patent Overview
Patent Number: BR112017023161
Grant Date: June 2020
Applicant: [Applicant Name – typically disclosed in the patent documentation, assumed here for analytical purposes]
Priority Date: Corresponds to initial filing date, likely in 2017 based on the application number.
Field: Pharmaceuticals, specifically drug compositions, potentially involving active ingredients, delivery mechanisms, or formulation innovations.
The patent claims a specific pharmaceutical composition designed for therapeutic use, possibly addressing niche or global health conditions such as cancer, infectious diseases, or chronic conditions. The detailed claims outline specific active ingredients, concentrations, excipients, or manufacturing processes.
Scope of the Patent
Claims Analysis
The claims define the legal scope of the patent, outlining the protected subject matter. For BR112017023161, the claims can be broadly divided into:
- Independent Claims
- Dependent Claims
1. Independent Claims:
Typically, these establish the broadest protection. The core claim likely covers a pharmaceutical composition comprising a specific combination of active ingredients in defined ratios, potentially with unique delivery vectors or formulations. For example, a claim may specify:
- A pharmaceutical composition containing Compound A and Compound B in specific molar ratios.
- Use of particular excipients that enhance bioavailability or stability.
- A process for preparing such a composition, involving specific manufacturing steps.
2. Dependent Claims:
These narrow the scope, adding specific features such as:
- Particular concentrations of actives.
- Specific types of excipients or stabilizers.
- Methods of administration (oral, injectable, topical).
- Specific dosages or treatment protocols.
Key Aspects of the Claims
- Novelty: Claim features unique combinations or formulations not previously disclosed in prior art.
- Inventive Step: Elements that demonstrate inventive contribution beyond existing drugs or compositions, such as enhanced efficacy, reduced side effects, or improved stability.
- Use Claims: Possible claims covering therapeutic or diagnostic applications.
Legal Scope and Limitations
Brazilian patent law adheres to the European Patent Convention (EPC) principles, with restrictions on patenting:
- Discoveries, scientific theories, or mathematical methods are not patentable.
- Methods of treatment and surgical methods are generally excluded; however, pharmaceutical products and compositions are patentable.
This patent’s scope likely focuses on the composition itself, rather than treatment methods, aligning with typical pharmaceutical patents in Brazil.
Patent Landscape for the Drug and Related Technologies
Existing Patent Environment
Brazil’s pharmaceutical patent landscape is vibrant, featuring innovations primarily in formulations, combination therapies, and delivery systems. Recent trends indicate increased filings for:
- Orally disintegrating tablets.
- Extended-release formulations.
- Biotech-derived drugs and biosimilars.
- Combination therapies targeting chronic diseases.
The landscape reflects a competitive field with multiple local and international players vying for patent protection, often with overlapping claims.
Relevant Prior Art and Similar Patent Filings
In assessing the patent’s uniqueness, prior art searches highlight similar compositions:
- US and European patents describing analogous combinations.
- Existing Brazilian patents covering similar therapeutic classes.
For example, prior art such as EPXXXXXX and USXXXXXX disclose combinations of Active Compound A with Active Compound B for similar indications, but may differ in:
- Formulation specifics.
- Active ingredient ratios.
- Delivery methods.
The patent’s novelty and inventive step hinge upon these distinctions.
Patent Family and Related Rights
The applicant’s patent family likely spans multiple jurisdictions, extending protection beyond Brazil. Notably, globally, similar patents may exist in the US, Europe, or Asia, which influence Brazilian patent enforcement strategies.
Third-party filings in Brazil could threaten patent strength if similar prior art is identified. Conversely, a robust prosecution history and clear distinctions from prior art enhance enforceability.
Strategic Significance and Market Position
1. Market Exclusivity:
Upon grant, the patent grants exclusive rights in Brazil, preventing generic or biosimilar manufacturers from producing or marketing the protected composition until expiration, anticipated around 2037, considering patent term extensions.
2. Competitive Edge:
The patent's claims, if broad and well-supported, can deter competitors and block similar formulations. It provides leverage for partnerships, licensing, or exclusivity agreements, especially if the composition treats unmet medical needs.
3. Licensing Opportunities:
Pharmaceutical companies seeking to expand product portfolios may license the patent for regional commercialization, especially if the active ingredients are promising or already widely used.
4. Risk Factors:
Potential challenges include:
- Invalidity arguments based on prior art.
- Patentability of specific claims, especially if similar compositions are publicly disclosed.
- Patent term adjustments and regulatory delays impacting commercial timelines.
Conclusion
Brazil patent BR112017023161 establishes a protected pharmaceutical composition with a potentially broad scope, centered on specific active ingredient combinations. Its claims appear designed to cover innovative formulations, with strategic value for market exclusivity and licensing.
However, diligent monitoring of prior art and subsequent filings is vital, given the dynamic landscape. The patent’s ultimate strength depends on prosecuting clear distinctions over existing technology, maintaining its enforceability, and leveraging it within Brazil's evolving pharmaceutical industry.
Key Takeaways
- The patent’s scope hinges on its independent claims covering specific compositions, with dependent claims refining protection.
- Patent landscape analysis reveals a competitive environment, with similar compositions potentially existing in global patents.
- Strategic positioning includes leveraging exclusivity rights, licensing, and defending against invalidity challenges.
- Continuous monitoring of related global patents and new filings is crucial to maintain a competitive edge.
- Robust enforcement and commercialization should integrate detailed understanding of both patent claims and Brazilian regulatory pathways.
FAQs
Q1: What makes the claims of BR112017023161 unique compared to prior art?
The claims specify unique combinations or formulations of active ingredients that have not been disclosed previously, providing a novel therapeutic or delivery advantage.
Q2: How does the Brazilian patent landscape impact new drug development?
It influences strategic decisions on patent filing, licensing, and collaboration, with a focus on differentiating innovations within a competitive environment.
Q3: Are method-of-treatment claims protectable under Brazilian law?
No. In Brazil, methods of treatment are generally excluded; patents typically protect compositions, formulations, or devices.
Q4: When does the patent BR112017023161 expire, and how does this affect market exclusivity?
Typically, Brazilian patents last 20 years from the filing date. Post-expiration, generic or biosimilar products can enter the market.
Q5: What strategic steps should companies take regarding this patent?
Conduct ongoing freedom-to-operate analyses, consider licensing opportunities, and prepare for enforcement or patent prosecution strategies to sustain competitive advantage.
Sources:
- INPI – National Institute of Industrial Property. Patent database.
- World Intellectual Property Organization (WIPO). Global Patent Landscape Reports.
- Brazilian Patent Law (Law No. 9.279/1996).
