Should ANVISA be permitted to reject pharmaceutical patent applications in Brazil?

Abstract

Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013, a new workflow came into effect in Brazil which allows the National Sanitary Vigilance Agency (ANVISA), a government agency whose function is to protect public health, to examine and reject any patent application that claims a pharmaceutical product or process before any examination of the application by the Brazilian Patent Office. If a patent application is rejected by ANVISA, the application is returned to the Brazilian Patent Office and filed away, without any further examination, for an unknown period of time. Therefore, the examination of pharmaceutical product and process applications under this new workflow is problematic for local and global pharmaceutical manufacturers for multiple reasons.

Keywords::

• ANVISA
• Brazil
• pharmaceutical patents
• prior consent
• SUS
• two-tier examination