In August 2017, the Brazilian Health Surveillance Agency
(ANVISA) published Resolution No. 168/2017, which establishes the
administrative procedures related to ANVISA´s "prior
consent" for the granting of pharmaceutical patent
applications, regulated by Joint Ordinance No. 1/2017.
As previously reported in our blog, earlier this year the
Brazilian National Institute of Industrial Property (INPI) and
ANVISA reached an agreement regarding the legal provision of
"prior consent," which establishes that ANVISA needs to
approve the grant of patent applications in the pharmaceutical
field.
Consequently,
Joint Ordinance No. 1 on examination of pharmaceutical patent
applications was signed in April 2017. It is aimed at solving the
long-lasting and controversial conflict regarding the double
examination of pharmaceutical patent applications that the two
entities have been performing for years.