In its submission to the USTR 2014 Special 301, The US Chamber of commerce highlights the major IP challenges for Brazil for 2014 – the role of ANVISA in the granting of patents, patentability criteria, test data protection, compulsory licensing and local content requirements for cable television.
The US Chamber of commerce acknowledges the efforts of the Brazilian government and the Brazilian economy in improving Brazil`s IP rights protection system. On the other hand, there still are challenges that keep the country in the Special 301 Report.
The Chamber underlines that the proposed changes to the Brazil`s Patent Law could violate TRIPS by making the pharmaceutical products dependent from the Brazilian National Health Surveillance Agency ANVISA and, and is inviting US and Brazil to ensure that all proposed changes are TRIPS compliant.
The need of reconsidering the patentability requirements of the proposed law and the fact that data protection for pharmaceuticals made for human use are not covered by the existing regulation are reminded as well. Brazil is encouraged to” implement five years of data protection for pharmaceutical innovators and twelve years for biologic medicines”.
The Chamber supports the possibility of a Patent Prosecution Highway (PPH) between both countries, and the Brazilian private sector and INPI have already shown interest.
