INPI introduces new proceedings now that ANVISA´s prior approval for pharma patents is over

Law 14.195/21, which aims to establish a new legal framework for doing business in Brazil, entered into force on 27 August 2021. Among other provisions, it revoked Article 229-C of the Brazilian Patent Statue (Law 9.279/96), according to which the grant of pharmaceutical patents was subject to the National Health Surveillance Agency´s (ANVISA) prior approval (for further information, see here).

The flow of patent applications between the two entities ceased on 27 August 2021. On 31 August 2021, in order to manage the prosecution of patent applications that would have fallen or were being examined by ANVISA, The Brazil National Institute for Industrial Property (INPI) provided the following information on the new procedures:

• Applications returned by ANVISA with no prior approval examination will follow the normal procedure before INPI, with a specific note on the revocation of Article 229-C.
• Applications returned by ANVISA with prior approval examination already concluded before the revocation of Article 229-C have been sent back to the patent office by means of Official Letters 335 to 346, dated 23 August 2021. For each application, INPI published in Official Gazette 2763, ANVISA´s decision either granting prior approval or determining that the application would not fall under Article 229-C. Applications that were still at ANVISA were returned to INPI by means of Official Letters 347 to 358 on 30 August 2021.

INPI received a total of 1,284 patent applications, 54 of which were already granted prior approval by ANVISA before the revocation of Article 229-C. One request was left for rectification of the official letter. INPI is still waiting for the return of 19 patent applications that were either subject to an office action or were not granted prior approval.

Further, pharma and biotech-related patent applications filed at INPI until 31 December 2016 fall under INPI’s scheme to handle the huge volume of patents awaiting approval and will take priority. The so-called Plan to Fight the Patent Backlog involves reducing the grant time from an average of 10 years to between three and four years started in July 2019 and has already shown significant results. INPI will likely attain its objectives by the end of 2021.

These changes signal a new era for pharmaceutical and biotechnology patents in Brazil. The end of ANVISA's prior approval will bring more legal certainty to the prosecution of such applications in Brazil and will contribute to reducing costs and time to grant.