BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the proposed rules. BIO appreciates ANVISA’s desire to clarify their role in the review of patent applications for pharmaceutical products and processes.
BIO understands that ANVISA issues these rules as a follow up to the Inter-Ministerial Working Group to clarify the cooperation that will occur between ANVISA and INPI. Finally, BIO understands that ANVISA wishes to remain compliant with the Brazilian Constitution, the Federal Attorney General’s opinions of 2009 and 2010, and with international law. With this understanding, BIO has the following questions and comments regarding the proposed rules.