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The Brazilian PTO (BRPTO) publishes Rule #217/2018 on the fast-track examination of pharma-related patent applications and patents

May 8, 2018

(BRPTO’s gazette of May 08 th , 2018)

The Brazilian PTO issued today, on its gazette #2470, Rule #217/2018, which modifies Rule #80/2013, on fast-track examination of patent applications and patents related to pharmaceutical products and processes.

In addition to patent applications related to cancer, HIV and neglected diseases, patent applications related to rare diseases are now eligible for fast-track examination in Brazil. According to the World Health Organization (WHO) and Brazilian guidelines for treatments under the National Healthcare System (SUS), a disease is characterized as rare when affecting up to 65 people per 100,000 subjects or 1.3 people per 2,000 subjects.

Rule #217/2018 adds two new diseases, Chikungunya and Zika, to the list of eligible neglected diseases for the fast-track program, complementing the list of neglected diseases.

Patents related to cancer, HIV, neglected diseases and rare diseases are also considered eligible for this fast-track program.

Rule #217/2018 shall be effective as of publication.

The original Portuguese version of Rule #217/2018 is available here. The English version will be available soon.