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Year: 2020

Phase II of BRPTO’s PPH program is anticipated on January 1, 2021!

(per BRPTO’s gazette of December 29, 2020) As indicated in our client alert from December 29, 2020, Phase I of the PPH program, originally scheduled to close on November 30, 2022, reached its limit in December 2020. We are glad to advise that the BRPTO has decided to anticipate Phase II of the PPH program, […]

Happy New Year!! New ordinances for 2021 are coming through!

(per BRPTO’s gazette of December 29, 2020) The BRPTO published on December 29, 2020, four new patent application-related ordinances: ‍ Phase II of the PPH program is anticipated in January 2020! – Ordinance #404/2020 As Phase I of the PPH program reached its limit on December 2020 and the new phase was scheduled to be […]

New Patent Applications Examination Guidelines related to Biotechnology Inventions in force as of December 1st, 2020

On December 1st, 2020 the BRPTO issued Normative Instruction #118 from November 12, 2020, which establishes the new version of the Patent Applications Examination Guidelines related to Biotechnology Inventions and revokes the previous guidelines (Rule #144/2015). The main differences between the new (Normative Instruction #118/2020) and former (Rule #144/2015) Guidelines are outlined below: The new […]

ANVISA’s new Board of Commissioners

President Jair Bolsonaro recently made several appointments to the Board of Commissioners at ANVISA (Brazil’s equivalent to the US FDA), a group commonly referred to in Portuguese as ‘DICOL.’  President Bolsonaro’s appointment of three Deputy Commissioners – Cristiane Rose Jourdan Gomes, Alex Machado Campos, and Meiruze Sousa Freitas (who has been occupying the position on […]

Ministry of Health creates IP advisory bodies and changes criteria for ANVISA’s prior approval process

The Ministry of Health has (i) created a new organizational structure to provide technical support for its work on IP in health; and (ii) changed the patent application criteria for pharmaceutical products and processes considered to be of interest under the Public Healthcare System’s (SUS) assistance policy and subject to Brazil’s FDA (ANVISA) prior approval […]