At the beginning of the month, the Brazilian Patent and Trademark Office (BPTO) Resolution No. 217/2018 came into force, revoking the prior Resolution No. 80/2013, with its primary development being the inclusion of Zika and Chikungunya diseases, as well as rare diseases, which are defined as those that affect up to 65 people in every 100,000 individuals, in the list of disease-related applications eligible for fast-track patent examination.
According to both resolutions, fast-track is granted to new patent applications of pharmaceutical products and processes, as well as equipment and materials for use in the health field, associated with Acquired Immunodeficiency Syndrome (AIDS), Cancer, Rare Diseases and/or Neglected Diseases.
Fast-track examination may be required by the Ministry of Health, when considered strategic within the scope of the Brazilian Unified Health System (SUS), and/or by any interested party, when the request relates to diagnosis, prophylaxis and treatment of such diseases.
The BPTO shares the definition of “rare diseases” with the one provided by the World Health Organization (WHO). “Neglected Diseases” would be those listed in Annex I contained in Resolution No. 217/2018, which included Chikungunya and Zika, added to those listed by the Ministry of Health and WHO.
The BPTO has a significant patent examination backlog, and those resolutions make themselves necessary in order to accelerate patent applications considered strategic, aligning them with public health care policies.