BRAZIL: End of ANVISA´s prior consent for pharmaceutical patents


End of ANVISA´s prior consent for pharmaceutical patents

The prior consent for pharmaceutical products or processes patents in Brazil was provided by article 229-C of the Brazilian IP Law (Law # 9,279/1996) and has always been a cause of intense debate regarding the double analysis on patentability requirements and also for the delay caused to the substantive examination of the Brazilian PTO.

However, the mentioned article was recently revoked by Law #14.195/2021, which was approved by Brazil’s President and published in the Official Gazette, on August 27, 2021.

By means of Joint Ordinance #1/2017, the attributions of each counterpart were established, stating ANVISA’s would analyze whether a subject matter of a patent application represents a risk to public health, such risk characterized as pharma product comprising, or pharma process resulting in a substance whose use is prohibited in Brazil, such as narcotic substances, whereas the Brazilian PTO’s attribution is to analyze patentability requirements of the subject matter.

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