Compulsory license: presidential vetoes concerning compulsory supply of raw material and know-how by patent holders maintained

On July 7th, 2022, the National Congress decided to maintain the vetoes of the President of the Republic, Jair Bolsonaro, on 13 bills that had already been approved by the Congress, including veto 48/2021, which deals with the temporary compulsory license of patents relating to vaccines and medicines to address health emergencies (Law No. 14,200/2021).

After intense debate and negotiation between the federal government and opposition, it was decided to maintain the vetoes, which means that any holders of compulsorily licensed patents are not compelled to provide the necessary and sufficient information to reproduce the drug or supply raw material, as well as the results tests and other data needed to grant their registration by the competent authorities.

Also vetoed as the possibility of granting, by law, a compulsory license to combat the causes of emergency, since it contradicts public interest and would entail the non-observance of the due administrative process.

Our specialties

aSee our main areas of expertise