CLIENT ALERT
ANVISA establishes optimized procedure applications for registration of medical devices
by Viviane Kunisawa | Apr 9, 2024 | Client Alert, Life Sciences, Regulatory
On April 8th, the Brazilian health regulatory agency ANVISA published a Normative Instruction (290/2024), establishing the optimized procedure on the analysis and decision of applications for the registration of medical devices. As already mentioned in our earlier...
ANVISA approves the use of analyses from equivalent regulatory foreign authorities (EFRA)
by Viviane Kunisawa | Mar 26, 2024 | Client Alert, Regulatory
On March 19th, during a public meeting of the Collegiate Board of Directors, the Brazilian health regulatory agency ANVISA approved a Normative Instruction that establishes criteria and procedures for using the analyses carried out by an Equivalent Foreign Regulatory...
Brazilian PTO publishes a new Ordinance governing amendments and supplementary experimental data in the appeal phase
by Ricardo Nunes | Mar 20, 2024 | Client Alert, Patent
Further to our communications of The Brazilian PTO has announced new rules governing patent applications and Amendments and Supplementary Experimental Data During the Appeal Phase, we report that the Brazilian PTO published yesterday a new ordinance to provide...
Amendments and Supplementary Experimental Data During the Appeal Phase
by Ricardo Nunes | Mar 20, 2024 | Client Alert, Patent
Further to our communication of December 2023, a decision was published today by Mr. Julio Cesar Moreira, President of the Brazilian PTO, regarding the submission of amendments and supplementary experimental data during the appeal phase (administrative second...
Brazilian FDA (ANVISA) adopts a new regulatory framework for the food industry
by Viviane Kunisawa | Mar 11, 2024 | Client Alert, Life Sciences, Regulatory
On February 28th, the Brazilian regulatory agency ANVISA published the Resolution RDC 843/2024 and the Normative Instruction 281/2024, which provide for the regularization of food and packaging under the competence of the National Health Surveillance System (SNVS)...
Meeting between ABPI and BPTO brings clarification on new rules for cancellation requests
by André Oliveira | Feb 8, 2024 | Client Alert, Trademark
On February 5, Daniel Law partner Andre Oliveira attended a meeting with the BPTO among other coordinators of the Trademark Committee of the Brazilian IP Association (ABPI). Along with his colleagues, Andre was able to address concerns related to the recently...
Changes in Transfer Pricing Rules in Brazil
by Antonio Curvello, Guilherme Filho | Jan 10, 2024 | Business Transactions, Client Alert
We would like to inform you that, as of January 1, 2024, Law No. 14,596/2023 has come into effect in Brazil, introducing significant changes to transfer pricing rules. In this context, it is crucial for companies to review their intercompany contracts related to...
Brazilian “Betting” Law approved – Regulation of Fixed-Odds Betting
by Nuria López, Paula Rodrigues | Jan 4, 2024 | Client Alert, Technology
On December 30, Law no. 14,790/2023 was enacted in Brazil, which aims to regulate the lottery modality of fixed-odds betting. The law seeks to regularize and oversees a significant area of betting, with potential economic impact, thus establishing measures to protect...
CONAR publishes rules for advertising in the betting segment
by Isis Moretti | Jan 3, 2024 | Client Alert, Copyright, Advertising and Creative Industries
The Superior Council of CONAR (Brazil’s National Council for Advertising Self-Regulation) announced the creation of Annex "X" of the Brazilian Code for Advertising Self-Regulation (CONAR-Conselho Nacional de Autorregulamentação Publicitária). This progress on the part...
The Brazilian PTO has announced new rules governing patent applications
by Ricardo Nunes | Dec 26, 2023 | Client Alert, Patent
The Brazilian PTO has announced new rules governing patent applications, basically creating further restrictions to claim amendments and auxiliary claim sets filed at the appellate stage. These new rules are expected to come into force on April 2, 2024. According to...
Brazilian PTO plans change to patent examination process
by Gustavo Sartori, Kene Gallois | Dec 14, 2023 | Client Alert, Life Sciences, Patent
On 12 December, the Brazilian PTO (BPTO) patent division issued a statement explaining that the patent application examination queue will be based on the date of the request for examination, which is a processing step that needs to be done within 36 months of the...
New Brazilian Resolution Improves Legal Security for Movement of Microorganisms
by Viviane Kunisawa | Nov 14, 2023 | Client Alert, Life Sciences
On November 13, the CGEN Resolution 41 of October 18, 2023, was published in the Brazilian Government’s Official Gazette. The resolution approved a declaration model establishing that the microorganism intended for transfer abroad is not isolated from substrates of...
Interministerial Group on Intellectual Property (GIPI) approves the National Intellectual Property Strategy (ENPI) action plan for 2023-2025
by Samantha Salim, Kene Gallois | Oct 25, 2023 | Client Alert, Intellectual Property
Rule GIPI/MDIC No. 8, of October 18, 2023, comprising an action plan for the next biennium involving the Brazilian Patent and Trademark Office, was published today in the Official Gazette. Said Rule will come into effect on November 1st, 2023. The ENPI is guided by a...
BPTO Initiates Public Consultation to Expedite Patent Processing in Brazil by 2026
by Gustavo Sartori, Felipe Linhares | Sep 26, 2023 | Client Alert, Patent
On September 14, 2023, the Brazilian Patent and Trademark Office (BPTO) announced the Public Consultation aiming at expediting patent prosecution. It is expected that, by 2026, patents will be granted within 24 months after filing in Brazil, according to the BRPTO's...
The inspection bodies of the National Health Surveillance System may execute commitment agreements with private parties
by Viviane Kunisawa | Sep 15, 2023 | Client Alert, Patent
Law 14671/2023 was published today in the Federal Official Gazette (DOU), amending Law 6437/1977, which deals with violations of federal health legislation and establishes corresponding sanctions. With this change, there is now a specific legal provision for the...