ANVISA update - will mandatory review on pharma patent cases continue?


Rana Gosain

The provisions of Brazil's patent law are largely TRIPS-compliant, but there are two major inconsistencies: its working requirements, and ANVISA's mandatory substantive examination on pharma patent applications.

The working requirements under Brazil’s patent law oblige the patentee/licensee to manufacture/ produce/assemble the patented product locally. This is inconsistent with Article 27.1 of the TRIPS Agreement, which states that patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

Curiously, for the past 30 years, the penalty of having a compulsory licence granted on the basis of non-working in Brazil has not been applied.

The second inconsistent provision in Brazilian law is not only a violation of TRIPS, but also adverse to most leading IP legislations. Specifically, Law No. 10.196 of February 2001 introduced a new provision in the existing law making patent grant for pharmaceutical products and processes conditional on ANVISA’s prior approval.

Brazil, ANVISA, TRIPS, patent law, mandatory review