Pharmaceutical patent applications are no longer subject to ANVISA’s prior approval

Provisional Measure 1040/2021, which aims to establish a new legal framework for doing business in Brazil, was finally sanctioned by President Bolsonaro (for further information, see previous article here). On 27 August 2021, the corresponding Law 14.195/21 entered into force.

This new legal framework, which is the result of an initiative from the Ministry of Economy, provides legal measures to modernise and improve the Brazilian business environment. Law 14.195/21 revokes Article 229-C of the Brazilian Patent Statute (Law 9.279/96), according to which the grant of pharmaceutical patents was subject to the National Health Surveillance Agency (ANVISA) for prior approval.

From 1999 until 2021, granting patents in connection with pharmaceutical products or processes depended on prior approval from the ANVISA. This provision has been the subject of heated debates and the source of numerous lawsuits in the past few years, as patent application examinations in the pharmaceutical sector were conducted by the Brazilian National Industrial Property Institute (INPI) and ANVISA. In several cases, the latter’s decisions contradicted INPI´s opinions on patentability.

After several misunderstandings between the two agencies, they finally reached an agreement in 2017, establishing that ANVISA could only deny prior approval based on public health matters. More recently, in November 2020, ANVISA published four guidelines, which clarified the procedures adopted to analyse prior approval.

Going forward, pharmaceutical patent applications are no longer subject to ANVISA´s prior approval, which means that there will be more legal certainty for patent application prosecutions for pharmaceutical products and processes, and one step less in INPI’s grant procedure.

Finally, the new law revokes the sole paragraph of Article 40 of the Patent Statute, which stated that the 20-year patent term as from the filing date cannot be less than 10 years from the patent grant (see here).