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Interfarma releases new positioning paper on data package exclusivity authored by Liliane Roriz

December 18, 2015

Hon. Liliane Roriz, partner at Licks Attorneys and former Appellate Judge of the Federal Court of Appeals for the Second Circuit, assisted INTERFARMA, the Brazilian association representing the Pharmaceutical Research Industry, to draft a positioning paper addressing Regulatory Data Protection (RDP) in Brazil.
The paper called “The protection of test dossier in Brazil: fostering innovation” was released earlier this month by INTERFARMA. It addresses the lengthy steps for researching, developing and approving a new drug. The document exposes a comparative analysis of RDP in countries such as the USA, Switzerland and Chile. Despite the fact that the Brazilian legislation establishes RDP as a matter of unfair competition, due to the lack of a specific term of protection, the Brazilian Food and Drug Agency (ANVISA) does not enforce any protection at all.
The first favorable decision enforcing RDP in Brazil was issued in 2011 by a Federal District Court in Brasilia. The decision established a 10-year term of exclusivity for Lundbeck’s Lexapro. However, in 2012 the Federal Court of Appeals for the First Circuit reversed the decision. Lexapro’s case is pending before the Superior Courts and a decision ruling in favor of Lundbeck would be a game changer for Regulatory Data Protection in Brazil. Licks Attorneys represent Lundbeck.
A copy of the paper is available at http://www.interfarma.org.br/uploads/biblioteca/100-data-protection-english-site.pdf