Conflict between ANVISA and BPTO
Regarding the existing conflict between ANVISA and the BPTO on the examination of pharmaceutical patent applications; civil action filed for the nullity of the Legal Opinion 210/PGF/AE/2009 was dismissed.
The Civil action was filed by the District Attorney. The decision issued on September 2013 has the same arguments as the interlocutory appeal Nr. 20120201008196; which declares ANVISA prior consent to the determination of whether patent applications regarding pharmaceutical process and products may be harmful to human health. The District Attorney may appeal this decision.
To understand the conflict it is worth mentioning the following facts:
– Law 9279/96 gives ANVISA the right to issue a prior consent for the granting of patent applications regarding pharmaceutical processes and products. Therefore ANVISA established in a Resolution the requirements needed.
– Legal Opinion Nr. 210 declares that the District Attorneys Office understands that the objective of a prior consent by ANVISA is to avoid the production and marketing of products that are potentially harmful to human health and not to analyze the patentability requirement.