The Brazilian administration signalled a change in policy on the enforcement of Article 39.3 of the World Trade Organization’s Trade-Related Aspects of IP Rights Agreement regarding data package exclusivity.
The Brazilian administration signalled a change in policy on the enforcement of Article 39.3 of the World Trade Organization’s Trade-Related Aspects of IP Rights (WTO TRIPS) Agreement regarding data package exclusivity in the same month the Brazilian patent office (INPI) issued a draft new manual of patent examination procedures.
The Brazilian administration has always failed to comply with the country’s obligations under Article 39.3 of TRIPS, even after implementing ‘TRIPS-plus’ legislation making infringement of IP rights over data packages a criminal felony. However, on May 14, 2012, ANVISA’s (the Brazilian food and drugs administration) solicitor’s office disclosed a significant change in its policy on data package exclusivity for the pharmaceutical industry for human products.
The change was first noted in a brief submitted by ANVISA on litigation before Brazilian federal courts reviewing the issuance of marketing approvals for generics and branded non-interchangeable copies of drugs granted in violation of regulatory requirements.
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TRIPS, INPI, ANVISA, pharmaceuticals, data package exclusivity