Following-up our previous article (see here), Provisional Measure No 1040/2021, aiming at establishing a new legal framework for doing business in Brazil, was finally sanctioned by President Bolsonaro. Consequently, the corresponding Law No 14.195 of August 26, 2021 entered into force on the following day.
With the clear objective to provide legal measures to modernize and improve the Brazilian business environment, Law No 14.195/21 revokes Article 229-C of the Brazilian Patent Statute (Law No 9.279/96), according to which the grant of pharmaceutical patents was subject to the National Health Surveillance Agency´s (ANVISA) prior approval.
This new legal framework, which is the result of an initiative from the Ministry of Economy, should be praised. Indeed, since 1999 the granting of patents in connection with pharmaceutical products or processes depended on prior approval from the ANVISA. Such provision has been the subject of heated debates and the source of numerous lawsuits in the past few years, since the examination of patent applications in the pharmaceutical sector was conducted by two public entities: the Brazilian Patent and Trademark Office (BPTO); and the ANVISA whose decisions would in several cases contradict the BPTO´s opinion over patentability.
After several misunderstandings between the two agencies, they finally reached an agreement in 2017, establishing that the ANVISA could only deny prior approval based on public health matters. More recently, in November 2020, the ANVISA published four guidelines, clarifying for the first time the procedures adopted to analyse prior approval.
From now onwards, pharmaceutical patent applications are no longer subject to ANVISA´s prior approval in Brazil, bringing therefore more legal certainty to the prosecution of patent applications related to pharmaceutical products and processes, as well as ensuring one step less in the BPTO´s grant procedure.
It is noteworthy that Law No 14.195/21 also confirmed the revocation of the sole paragraph of Article 40 of the Patent Statute, according to which the 20-year patent term as from the filing date cannot be less than 10 years from the patent grant (see here).
