After being sanctioned by the Presidency, a Brazilian statute suppressing the role played by the National Health Surveillance Agency – ANVISA (the Brazilian FDA) in the examination of patent applications pertaining to the life sciences field was published today in the Official Gazette and is already effective.
The new law revokes Article 229-C of the Brazilian Patent Statute, which established the need for prior approval by ANVISA for the grant of patent applications related to the pharmaceutical area (including biotechnology cases). The now repealed provision was originally introduced in the 1996 statute through a 2001 amendment, giving rise to several controversies ever since. As the affected applications had to be submitted to ANVISA, instead of being processed exclusively at the Brazilian PTO, this double examination often yielded different opinions on patentability, thus contributing to delay prosecution and provoking litigation. As a matter of fact, it was only in 2017, when a Joint Ordinance was issued by ANVISA and the PTO, that the role of each institution was better clarified and pacified.
An official statement from the Brazilian PTO and ANVISA addressing this revocation and its impact should be expected. Our initial impression is that the new statute will contribute to the current efforts towards ending the patent examination backlog at the Brazilian PTO.
We will keep you duly posted on this matter. Should you have any questions, please feel free to contact us.