Identification of US-pharmaceutical patents expiring between 2018 and 2022 and their effect on the Brazilian domestic market.

This work presents the status, in Brazil, of pharmaceutical patents granted by US Patent and Trademark Office (USPTO) and their role on the Brazilian Pharmaceutical market. Data show that 27.1% of the US-granted patents filed in Brazil are granted by Instituto Nacional da Propriedade Industrial (INPI) and 76.5% of them have their term extended due to provision of article 40 of the Brazilian Industrial Property Law (LPI 9279/96), while 65% of these US-patents are not valid in Brazil, evidencing market openness and independence of patent examination of INPI before USPTO. The effects of INPI backlog of patent examination on pharmaceutical market are also highlighted. These aspects are relevant to stablish better strategies to reduce backlog and to orient public policies to stimulate the Brazilian industry, especially with respect to the production of generic and similar drugs. Image 1 • Brazilian backlog of patent examination and industrial property law have impact on its pharmaceutical industry development. • Many US patent benefit from improper market reserve due to late decisions in Brazil. • Half of granted patents in US are not granted in Brazil, due to independence of examination among offices. [ABSTRACT FROM AUTHOR]