Court Decision Limits Role of the Drug Regulatory Authority in Brazil in Refusing Grant of Patents

A recent Federal Court decision in Brazil restricts the authority of ANVISA, the Brazilian Health Surveillance Agency (the Brazilian FDA) to deny patents on pharmaceutical inventions, limiting ANVISA’s scrutiny solely to public health considerations. This decision paves the way for grant of patents on pharmaceutical inventions that have long been denied under the ANVISA practice.

Under the Brazilian Patents Law, the grant of patents on pharmaceutical inventions required the consent of ANVISA. Accordingly, once the Brazilian Patent Office (BPO) decided upon granting a patent, the matter was forwarded to ANVISA for its consent. In recent years, almost as a rule, patents in the pharmaceutical field have been denied time and again in unreasoned decisions by ANVISA.

In a recent appeal to the court against this practice, the court ruled that in providing consent to grant, ANVISA must limit its analysis only to public health considerations. The court also affirmed that the BPO is the sole agency with authority to analyze patentability requirements and it is not within the jurisdiction of ANVISA to make such a determination.

This decision is good news for owners of pharmaceutical inventions, as the authority of ANVISA to deny patents has been now significantly limited. While a different court may, in theory, arrive at a different conclusion in the future, the trend of decisions by Brazilian courts to consistently limit ANVISA’s authority in denying pharmaceutical patents, gives rise to the hope that the arbitrary denial of patents by ANVISA will be a thing of the past.  

This decision reinforces the rationale for filing patent applications for pharmaceutical inventions in Brazil, which is rapidly becoming a world class economic player.