Article 229-C of the Brazilian IP Law establishes the need of a “prior approval” by the Agência Nacional de Vigilância Sanitária – ANVISA (the Brazilian regulatory agency responsible for the approval of drugs) – for the issuance of a patent in the pharmaceutical area. This requirement was introduced by the Brazilian Law No. 10.196 of February 14, 2001.

“Article 229-C – The grant of patents for pharmaceutical products and processes depend on prior consent from the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária – ANVISA).”

This modification caused several disputes, in the last 10 years, between ANVISA and the Brazilian PTO (INPI), which considered this change as an intervention in its sphere of competence.

Taking into account the absence of definite regulations and, as long as its prior consent was still necessary, ANVISA conducted full patent reexaminations, including the verification of the legal requirements of novelty and inventiveness.

On January 24, 2011, however, the Federal Counsel-General of Brazil (Advocacia-Geral da União – AGU) published a final legal opinion on the matter, which limits the power of ANVISA on the analysis of patent applications in the pharmaceutical sector, putting an end to the conflict with the Brazilian PTO. The Federal Counsel-General is the highest body of assistance of the Executive Power and represents the Federal Government, both judicially and off courts.

According to that final legal opinion, the responsibilities of ANVISA will be limited to the analysis of safety (e.g. the existence of possible health risks) and efficacy of drugs. The fulfillment of legal requirements for patentability will be exclusively verified by the Brazilian PTO. The final opinion of the Federal Counsel-General is not subject to appeal.

The real impact of this final legal opinion is still not clear. In the short term we may hope for a certain reduction of bureaucracy, which could accelerate the patent granting process in the pharmaceutical area.

via Pedro Bhering at Bhering Advogados in Rio de Janeiro – Brazil.

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