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New Brazilian law eliminates the need for prior approval from ANVISA for patent applications related to pharmaceutical products and processes

n August 26, 2021, Brazilian Law No. 14,195 of August 26, 2021 was published, which, among other measures, revokes Article 229-C of the Brazilian Industrial Property Law (BIPL – Brazilian Law No. 9,279, of May 14, 1996).

According to this new law, patent applications related to pharmaceutical products and processes will not require prior approval from the Brazilian Health Surveillance Agency (ANVISA).

This measure will allow a faster examination of the patent applications related to the pharmaceutical field, since only the Examiners of the BPO will be involved in the examination procedures. Thus, the patent applications which were waiting for the ANVISA’s prior approval have now been returned to the BPTO and await to follow their normal prosecution route.

Notwithstanding, the ANVISA can still file observations during the prosecution to assist the BPTO’s exam of the patent applications related to pharmaceutical products and processes that are considered of interest to the drug or pharmaceutical assistance policies in the scope of the Brazilian Health System (SUS).


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