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Legal & Regulatory Updates
Legal & Regulatory Updates

The Apple-EU Clash: Engineering Regulation Under the DMA

The article dissects the Apple-EU conflict over the Digital Markets Act, examining the regulation's implications for competition, security, and innovation in tech ecosystems.
2025
6
min read
Life Sciences & Healthcare Patents
Life Sciences & Healthcare Patents

Brazil: An Unregulated “Pharmaceutical Orange Book”? New patent-intelligence cooperation has a story to tell

Brazil’s Ministry of Health and ABIFINA partnered on a patent-intelligence agreement to improve patent information use in the SUS, establishing a system akin to the US FDA’s Orange Book.
2025
4
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Environmental Liability and Transnational Jurisdiction: The Repercussions of Mariana v. BHP for Private International Law

The Mariana v. BHP case in the English High Court sets significant precedents for transnational environmental liability, applying Brazilian law to the Fundão Dam collapse.
2025
8
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

The Responsibility of Digital Platforms in Brazil Post-Supreme Court: The Partial Unconstitutionality of Article 19 of the Brazilian Civil Rights Framework for the Internet

The Brazilian Supreme Court reinterpreted Article 19 of the Civil Rights Framework, introducing a nuanced liability regime for digital platforms to address illegal content dissemination.
2025
8
min read
Global & Comparative IP
Global & Comparative IP

COP30: why industrial property needs to be at the center of the Brazilian agenda

Brazil's COP30 highlights industrial property's central role in fostering green innovation and a sustainable bioeconomy, crucial for climate leadership and equitable development.
2025
15
min read
AI & IP Law
AI & IP Law

Brazil: Implications of the Draft AI Guidelines for Biopharma and Agrochemical Inventions

The Brazilian Patent Office's draft AI guidelines clarify patentability for AI-assisted inventions in biopharma and agrochemical sectors, emphasizing human contribution.
2025
7
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

The Challenges of Codifying Law in the Technological Era

Brazilian Senate debates Bill No. 4/2025, focusing on Digital Law, neurorights, and 'digital entities' for the new Civil Code, highlighting codification challenges.
2025
9
min read
Life Sciences & Health
Life Sciences & Health

Brazil Regulates Clinical Research: A Complete Review of Decree #12,651/2025 - Part 2

Brazil's Decree #12,651/2025 regulates the Clinical Research Act, establishing SINEP and balancing ethics with efficiency, analyzed here in Part 2.
2025
9
min read
AI & IP Law
AI & IP Law

The Right to Information in Human-AI Interactions: Transparency, Accountability, and Civil Liability Under Brazilian Civil Code Reform

Brazil's Civil Code reform tackles AI interactions, establishing transparency, accountability, and human oversight duties for civil liability in digital environments.
2025
12
min read
AI & IP Law
AI & IP Law

Artificial Intelligence and Deepfakes in the Brazilian Civil Code Reform

Brazil's proposed Civil Code reform (Bill 4/2025) addresses deepfakes and AI, setting rules for consent, personality rights, and mandatory content labeling.
2025
7
min read
AI & IP Law
AI & IP Law

Artificial Intelligence and Digital Civil Law: Brazil's Civil Code Reform

The proposed reform of Brazil's Civil Code seeks to incorporate AI into civil law, sparking discussions on its impact and coordination with existing AI legislation.
2025
7
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Regulatory Challenges for Anonymity on the Internet in Brazil

Brazil faces significant regulatory challenges concerning internet anonymity, balancing freedom of expression with the need to combat unlawful practices and hate speech on digital platforms.
2025
5
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Desafios Regulatórios para o Anonimato na Internet no Contexto Nacional

A regulação do anonimato digital no Brasil enfrenta desafios, buscando equilibrar liberdade de expressão com responsabilização por conteúdos ilícitos.
2025
4
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Brazil Regulates Clinical Research Act: A Complete Review of Decree #12,651/2025 - Part. 1

Decree 12,651/2025 operationalizes Brazil’s Clinical Research Act by establishing SINEP/INAEP, enforcing binding ethics and regulatory timelines, enabling single-CEP opinions for multicenter trials, and opening integrated INAEP–Anvisa procedures—setting the stage for faster, more predictable studies.
2025
7
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Updates on the Brazilian Clinical Research Landscape: What’s at Stake in ADI 7875

ADI 7875 challenges key provisions of Brazil’s Clinical Research Act on constitutional grounds—post-trial access, consent in emergencies, institutional liability—putting legal certainty at risk even as long-awaited regulations near publication.
2025
8
min read