The Brazilian courts are analysing lawsuits whereby research-based companies are seeking the enforcement of data package protection for new drugs against the Brazilian food and drug agency (ANVISA) and infringers.
The Brazilian courts are currently analysing a few lawsuits whereby research-based companies are seeking the enforcement of data package protection for new drugs against the Brazilian food and drug agency (ANVISA) and infringers.
However, ANVISA’s defence in these lawsuits has been that there is no such data package protection to drugs for human use in Brazil.
ANVISA makes this statement despite the fact that Brazil entered the TRIPS agreement on December 30, 1994, after the enactment of Decree 1.355/94, incorporating the Final Act of the General Agreement on Tariffs and Trade (GATT’s) Uruguay Round, and that the then newly-created World Trade Organisation (WTO’s) framework ensures a single undertaking approach to the TRIPS agreement, meaning that the membership in the WTO entails accepting all of its results without exception.
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