he Last Tuesday (February 9th, 2021), the Board of the National Health Surveillance Agency (ANVISA) decided not to comment on the Senate Bill (PLS) 2,410 / 2020, which proposes amendments to Law 9,279 / 1996 (Brazilian Industrial Property Act) addressing fast-track examination of patent applications related to epidemics control.
Such bill establishes that Patent Applicants may reasonably request the Ministry of Health to prioritize the examination of patents related to products, processes, equipment and materials that the Ministry itself recognizes as essential for epidemics control.
As a matter of fact, fast-track of patent applications claiming technologies to fight Covid-19 has already been regulated by the National Institute of Industrial Property (INPI) by means of Ordinance No. 149/2020. In addition, INPI already carries out priority procedures for patent applications related to health products, of public interest or national emergency, according to Resolution 239/2019. However, Bill PLS 2,410 / 2020 would establish a new form of prioritization for epidemics in general.
In his opinion, ANVISA’s President Antônio Barra Torres stressed that the competence of ANVISA's Intellectual Property Coordination is limited to grant prior consent for patent applications claiming pharmaceutical products and processes - in accordance with article 229-C of the Brazilian Industrial Property Act - which is limited to the analysis of risk to public health.
Barra Torres also highlighted that INPI is the sole body with competence to establish the procedures for the analysis and granting of patents the INPI, and this matter falls out of the scope of ANVISA’s legal. Thus, he concluded that ANVISA should not issue an opinion on PLS 2.410 / 2020. The majority of the Board concurred with Barra Torres.
Still in 2020, former Director Alessandra Bastos Soares had issued an opinion stating that ANVISA should not oppose the bill, stating that establishing a fast-track procedure of patent applications by the very Ministry of Health could strengthen ANVISA's participation in issues related to the relationship between industrial property and public health.
PLS 2,410 / 2020 is yet to be voted by the Federal Senate.