Brazil's CMED introduces Rule No. 3/2025, modernizing drug pricing regulation by expanding categories, redefining therapeutic gain, and updating country references.

Brazil's 2025 SEP litigation experienced significant growth, with Rio courts becoming a key forum, marked by procedural innovations, FRAND emphasis, and emerging connected-car disputes.

The BRPTO suspended priority examination for H04 patent applications, effective January 1, 2026, a major shift for telecom and ICT patent prosecution in Brazil.

Brazil's new Private International Law Bill modernizes legal frameworks, focusing on foreign judgment enforcement and intellectual property rights, aiming to align the country with global legal standards and attract investment.

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.

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.

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.

Brazil's COP30 highlights industrial property's central role in fostering green innovation and a sustainable bioeconomy, crucial for climate leadership and equitable development.

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.

The Brazilian Patent Office's draft AI guidelines clarify patentability for AI-assisted inventions in biopharma and agrochemical sectors, emphasizing human contribution.

Brazilian Senate debates Bill No. 4/2025, focusing on Digital Law, neurorights, and 'digital entities' for the new Civil Code, highlighting codification challenges.

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

Brazil's Civil Code reform tackles AI interactions, establishing transparency, accountability, and human oversight duties for civil liability in digital environments.

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

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.

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.

A regulação do anonimato digital no Brasil enfrenta desafios, buscando equilibrar liberdade de expressão com responsabilização por conteúdos ilícitos.

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.

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.

U.S. FDA enforcement against compounded GLP-1 products highlights false equivalence claims on safety and efficacy, and Brazil faces a similar clinic-driven market—calling for ANVISA to tighten oversight, curb trademark misuse, and enforce compounding and dispensing rules.

Brazil can unlock leadership in clinical trials by pairing its new legal framework with clear implementing rules, better transparency tools, and technology integration—especially AI-enabled Real-World Evidence—while balancing IP protection and patient access.

Mega-events depend on strong IP frameworks—spanning trademarks, copyright, designs, and patents—to preserve exclusivity, curb counterfeiting and ambush marketing, and protect investments from organizers and sponsors while enabling technology used during the events.

Brazil’s new gaming law (Law 14,852/2024) broadens IP protection for electronic games—linking software and devices, opening a BRPTO registration path, and foreshadowing tighter, more specialized enforcement—while court practice and international models shape the next phase for disputes.

BRPTO has extended to October 27 the public comment deadline on proposed Chemistry-chapter guidelines for new uses of known products, which tighten novelty/obviousness and enablement standards—requiring in vivo data at filing and limiting support to exactly tested compounds.