The Ministry of Environment published on its website the new templates of Benefit Sharing Agreements in compliance with the Biodiversity Act (Law # 13.123/2015). In light of such Act, the one who carries out activities of research and development accessing Brazilian genetic resources and traditional knowledge must share the benefits arising out of such activities if they originated a finished product or reproductive resources.
On August 8 2017 ANVISA officially published the new Rule RDC Nº 168, related to the prior consent of the Agency on patent applications for pharmaceutical products and processes, regulated by Joint Ordinance ANVISA-INPI No. 1, dated April 12, 2017, aiming to a more efficient way to analyze patent applications.
The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.
A Q&A guide to medicinal product regulation and product liability law in Brazil.