Brazil's judiciary is fixing a Trade-Related Aspects of TRIPS Agreement violation that mandates prior approval for all patents claiming pharmaceutical inventions for human use.
Ten years after amendments to the Brazilian Patent Law, the nation’s judiciary is fixing a Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement violation created by article 229-C, which mandates prior approval for all patents claiming pharmaceutical inventions for human use.
Article 229-C established a fourth patentability requirement and a burdensome procedure creating uncertainty for applicants when the law granted to the country’s Food and Drug Agency (ANVISA) the statutory authority to decide the fate of patent applications according to political convenience.
"THE DECISION ESTABLISHED THAT ANVISA HAS NO STATUTORY AUTHORITY TO EXAMINE PATENTABILITY REQUIREMENTS, STATING THAT THE ONLY LEGITIMATE GOVERNMENT AGENCY IN CHARGE OF REVIEWING THE PATENTABILITY REQUIREMENTS IS THE BRAZILIAN PATENT OFFICE."
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TRIPS violation, ANVISA
