Brazil: International Law

Eduardo Hallak, founding partner of Licks Attorneys in Brazil, delivered a comprehensive analysis of Brazil's medical device market structure, regulatory framework, and patent protection system at the 6th IP Forefront Medical Device Forum. The presentation explored strategic pathways for Chinese medical device companies to enter the Brazilian market, including Product Development Partnerships, ANVISA regulatory compliance, and patent portfolio optimization within Latin America's largest healthcare market.

As the Trump administration imposes a new round of tariffs, Brazil's federal government threatens to invoke the Economic Reciprocity Law, potentially targeting intellectual property rights as a strategic countermeasure. This move could significantly impact American pharmaceutical, agrochemical, and technology companies operating in Brazil, raising questions about the balance between trade retaliation and long-term legal security.

Brazil has officially promulgated the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for Patent Procedures through Decree #13,011/2026.

As the Trump administration imposes a new round of tariffs, Brazil's federal government threatens to invoke the Economic Reciprocity Law, potentially targeting intellectual property rights as a strategic countermeasure. This move could significantly impact American pharmaceutical, agrochemical, and technology companies operating in Brazil, raising questions about the balance between trade retaliation and long-term legal security.

The Brazilian Office of the Comptroller General has released significant updates to its anti-corruption enforcement framework, including a revised Corporate Liability Manual with clearer penalty calculation parameters and a new Leniency Guide. Meanwhile, the U.S. designation of Brazilian criminal organizations PCC and CV as terrorist entities creates immediate compliance obligations for companies with international exposure, particularly those using U.S. financial systems or services.

Brazil's CGU has released updated guidance on corporate liability enforcement, leniency agreements, and anti-corruption transparency measures. Meanwhile, the U.S. designation of Brazilian criminal organizations PCC and CV as terrorist entities creates immediate compliance obligations for companies with international exposure, requiring enhanced due diligence protocols and sanctions screening procedures.