ANVISA: competence to grant prior consent in patent applications

Abstract

The text reproduces a decision on preliminary injunctive relief of the 13th Federal Court of Rio de Janeiro, in proceedings brought by the holder of pharmaceutical patent applications against ANVISA, addressing the scope of the competence conferred on the agency by Article 229-C of Law No. 9,279/96. It reconstructs the history of prior consent, from the Paris Convention and Brazil's accession to the TRIPS Agreement to Law No. 10,196/2001, and describes the implementation of the mechanism, the divergence between INPI and ANVISA, Opinions No. 210/PGF/AE/2009 and No. 337/PGF/EA/2010 of the Office of the Attorney General, the Interministerial Working Group, Resolutions RDC No. 45/2008 and No. 21/2013, and the public civil action of the Federal Public Prosecutor's Office. It identifies four lines of interpretation of Article 229-C and examines each in the light of Articles 27.1 and 27.2 of TRIPS, the Doha Declaration, Article 4 quater of the Paris Convention and systematic, teleological and historical construction. It concludes that ANVISA may and must examine the patentability requirements and those of Article 24 of the Industrial Property Law, that its pronouncement is not discretionary and that, where consent is denied, INPI must refuse the application, and it denies the relief sought.