Law no. 14,195 was sanctioned last Thursday (August 27) and it eliminates the requirement of prior consent from the Brazilian Health Surveillance Agency (ANVISA) for patent applications related to pharmaceutical products and processes before the technical examination performed by the Brazilian PTO, which was established in Article 229-C of the Brazilian Industrial Property Law.
The measure (Article 57, XXVI of the aforementioned Law) modifies the current rule for patent applications related to the pharmaceutical field that was in force in Brazil since 2001. In practical terms, it will allow the pharmaceutical industry to prosecute its patent applications without the need for prior consent from ANVISA, which means that the whole prosecution will only take place within the scope of the Brazilian PTO, providing more agility to the procedure.
Only pharmaceutical patent applications were first sent to a regulatory agency to be approved in Brazil. ANVISA's role is to approve the commercialization of drugs and not examining patent applications. There is no similar procedure in other countries. Finally, after 20 years, Brazil will no longer have this bureaucratic stage in the examination of patent applications in the pharmaceutical field.
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