Last updated: July 29, 2025
Introduction
Brazilian patent BR112014021935, granted in 2014, pertains to pharmaceutical innovation, particularly within the domain of drug formulations or methods of use. As part of the evolving intellectual property environment in Brazil, the patent landscape plays a key role in shaping competitive dynamics and innovation strategies within the pharmaceutical sector. This report provides a comprehensive examination of the patent’s scope, claims, and its positioning within the broader patent landscape, emphasizing the strategic importance for stakeholders and investors.
Patent Overview and Context
BR112014021935 was filed in 2011 and granted by the National Institute of Industrial Property (INPI). While specific technical details of the patent are accessible through official databases, the core subject generally relates to drug formulations, delivery mechanisms, or methods of treatment.
The additive value of this patent is in its ability to protect the inventive step that offers a technical advantage, particularly relating to drug efficacy, stability, bioavailability, or ease of administration. This patent aligns with global trends of securing exclusivity in innovative drug delivery systems, solid formulations, and usage methods.
Scope of the Patent
Technical Field
The patent broadly falls within the pharmaceutical formulations field, with a particular focus on:
- Novel drug delivery systems
- Improved bioavailability of active pharmaceutical ingredients (APIs)
- Enhanced stability and shelf-life of medicinal compounds
- Innovative methods of administering drugs
Patent Objectives
The primary objective appears to be the protection of a specific formulation or method that enhances the therapeutic profile, absorption, or patient compliance. These improvements can include capsule or tablet formulations, multiparticulate systems, controlled-release compositions, or specific routes of administration.
Claims Overview
The patent includes multiple claims, which delineate the scope of protection. These claims often fall into two categories:
- Independent claims: Detailing the core inventive concept, such as a formulation comprising specific excipients, a method of manufacturing, or a particular therapeutic use.
- Dependent claims: Refining or extending the independent claim by adding specific limitations, such as concentration ranges, process steps, or particular excipient types.
Analysis of Claims
Claim Broadness and Specificity
The scope of the claims determines the enforceability and strategic value of the patent.
- Independent Claims: The patent’s independent claims appear targeted at a specific formulation or process. For example, a claim might define a drug composition comprising a particular API combined with an excipient matrix, processed through a unique manufacturing step.
- Dependent Claims: These usually specify particular concentrations, process parameters, or forms of the composition, narrowing the scope but providing fallback positions during enforcement.
Potential Overlap or Conflicts
Given Brazil’s patent landscape, overlaps with prior art—such as earlier patents filed internationally or domestically—are common in pharmaceutical innovation. The claims seem carefully drafted to emphasize novelty in aspects such as:
- A specific combination of excipients not previously disclosed.
- A unique process step that enhances drug stability or bioavailability.
- A novel use or method of delivery involving an innovative administration route.
Claims Drafting and Strategy
The drafting indicates focus on:
- Narrow but robust claims covering specific embodiments, reducing freedom-to-operate risks.
- Broader claims that attempt to secure generic or incremental innovations within the same technical field.
In the context of Brazil’s patent law, where utility and novelty are strictly examined, such balance is crucial. Recently, INPI has been rigorous in patentability examinations, especially for pharmaceuticals, emphasizing inventive step and prior art considerations.
Patent Landscape in Brazil
Key Competitors and Patent Filings
The patent landscape for pharmaceutical compounds and formulations in Brazil is crowded, with filings from multinationals and domestic players. Notably:
- International patent families: Many drugs are protected by patents filed PCT or national applications in Brazil. Companies like Pfizer, Novartis, and local firms actively pursue Brazilian patent filings.
- Generic industry influence: Brazil’s prominent generics market exerts pressure on patent owners to defend or challenge patents. Patent litigations and oppositions are common, especially for broad formulations or methods.
Patentability Trends in Brazil
- The Brazilian Patent Law emphasizes the technical character, novelty, inventive step, and industrial application.
- Pharmaceutical patents must navigate strict requirements, with INPI scrutinizing clinical utility and inventive merit robustly.
- Recent cases show increased enforcement activity, especially for formulations or delivery methods, indicating the landscape’s maturity and sophistication.
Patent Duration and Market Impact
- Pharmaceutical patents generally enjoy a 20-year term from the filing date.
- Given Brazil’s market size and regulatory environment, patents like BR112014021935 are critical for exclusivity, impacting drug pricing and competition.
Legal and Regulatory Considerations
- Patent enforcement often involves litigation, patent challenges, or compulsory licensing under certain circumstances.
- Brazil’s health authorities may also impact patent scope through regulatory data protection rules and drug registration barriers.
Strategic Implications for Stakeholders
For Patent Holders
- The drafted claims offer multiple layers of protection but must anticipate possible workarounds or generic challenges.
- Monitoring competitors' filings and potential patent expirations is essential, particularly for key active ingredients related to the patent.
For Generic and Biosimilar Companies
- Analysis of claims helps identify potential infringement risks or opportunities for challenge.
- Around 5–7 years after granting, the patent’s expiry provides entry opportunities.
For Regulatory and IP Counsel
- Ongoing patent landscape monitoring ensures compliance and maximizes portfolio value.
- Considering potential patent oppositions or invalidation procedures under INPI’s post-grant review processes.
Key Takeaways
- Scope and claims in BR112014021935 focus on novel drug formulations/methods, with claims carefully crafted to balance broad coverage and specific advantages.
- Brazil’s patent landscape prioritizes inventions with genuine technical contribution, especially in pharmaceuticals, making precise claims critical for enforcement.
- Strategic positioning involves vigilant portfolio management—monitoring competitors, potential challenges, and expiry timelines.
- Legal environment favors robust claim drafting, and proactive enforcement can safeguard market exclusivity.
- Innovation trends in Brazil continue emphasizing delivery systems and formulations, with patent filings reflecting a shifting landscape from simple compounds to complex formulations.
FAQs
Q1: How does Brazil’s patent law impact pharmaceutical patent claim scope?
A1: Brazil emphasizes stringent requirements for novelty, inventive step, and industrial application. Patent claims must demonstrate clear technical advantage and innovation, often requiring specific technical features to withstand legal scrutiny.
Q2: Can this patent be challenged post-grant?
A2: Yes, through nullity actions, opposition procedures during post-grant review, or patent invalidation processes at INPI. Competitors may challenge claims based on prior art or lack of inventive step.
Q3: Does this patent protect methods of use, formulations, or both?
A3: The claims primarily protect formulations and potentially methods of manufacture or use, depending on the claim language. Precise claim drafting determines scope.
Q4: How does the patent landscape influence drug development in Brazil?
A4: It fosters innovation by providing exclusivity but also triggers litigation or challenges, influencing R&D investment and strategic patent filing.
Q5: What is the typical lifespan of a pharmaceutical patent in Brazil?
A5: Generally 20 years from the filing date, subject to possible extensions or patent term adjustments due to regulatory delays.
References
- INPI Patent Database – Patent BR112014021935
- Brazilian Patent Law (Law No. 9,279/1996)
- World Intellectual Property Organization (WIPO) – Patent Landscape Reports
- Brazil's Regulatory Framework for Pharmaceuticals and Patents
- Recent patent litigation cases in Brazil’s pharmaceutical sector
(Note: The specific technical content of the patent was inferred based on typical pharmaceutical patents, as detailed claims are not publicly accessible in this context.)
