Brazil's National Health Surveillance Agency (ANVISA) has issued a new resolution requiring that all patent applications relating to pharmaceutical products and processes must be approved by the agency prior to allowance by the Brazilian Patent Office.
Under the resolution (RDC 45 of article 229-C, Law 9,279/96), the Patent Office is required to forward applicable patent applications to ANVISA for review.
An ANVISA examiner will then analyze the application to ensure that it complies with Brazil's patentability requirements, and may request additional information, such as search reports and results of examinations in other countries.
If the application is rejected or an office action is issued, applicants must respond within 90 days of notification or the application will be denied. Appeals must be filed within 60 days.
The Brazilian law firm of Di Blasi, Parente, Vaz e Dias & Associados said in a statement that the legality of the resolution might be challenged in court, since the Brazilian Patent Office has jurisdiction over issues of patentability and it therefore exceeds ANVISA's authority.