Newsletter 2012.04 – Further information on ANVISA’s role

Following our recent newsletter on ANVISA’s role in the examination of pharmaceutical patent applications, this is to briefly inform that the Brazilian PTO has started forwarding cases to ANVISA’s consent before substantive examination has begun, in accordance with the guidelines suggested by the Interministerial Working Group (GTI), through Ordinance No. 1,065, of 24 May 2012.

 

Please note, however, that neither ANVISA nor the Brazilian PTO has yet issued normative acts indicating whether the GTI’s guidelines suggested would actually be adopted and, in the affirmative, to what extent. Yet, the Brazilian PTO has claimed, in the accompanying letters sent to ANVISA with patent applications for prior consent proceedings, that ANVISA’s analysis should indeed be limited to a health-based assessment of the subject matter covered by those applications, as contended by the Attorney-General in his previous legal opinion on this matter. What such sanitary-oriented control will represent in practice is still pending the clarificatory normative acts to come (if any) and ANVISA’s first decisions on these cases.