On 9 April 2013, the Brazilian PTO (INPI) published Resolution No. 80/2013, in which new rules were enacted to regulate the prioritization of examination for patent applications related to pharmaceutical products and processes relevant to the public health care system. It is consequently now possible for the applicant or any interested third party (including the Ministry of Health) to request the prioritized examination of such applications. A Committee for Prioritized Examination, to be appointed by the PTO's Board of Patents, will be in charge of verifying the compliance of patent applications with the requirements provided by the resolution, to expedite the examination of these applications.

The resolution specifies two situations in which a prioritization request can be made. Firstly, the Ministry of Health may request prioritization of the examination of any application relating to products, processes, equipments or materials for health care related to public assistance policies and which are regarded to be strategic to the Universal Health Care System that exists in Brazil. Secondly, applicants and third parties may request prioritization of examination of any application relating to the diagnosis, prophylaxis and/or treatment of AIDS/HIV, cancer and certain diseases which are listed in Attachment I of Resolution No. 80/2013, including Chagas' disease, malaria and tuberculosis. The right of the Ministry of Health is therefore broader, encompassing any application regarded as being strategic to the public health care system.

In the meantime, according to a public statement made by the Brazilian FDA (ANVISA) on 8 April 2013, ANVISA's Board of Directors has changed the rules regulating the prior approval system, according to which ANVISA must approve pharmaceutical applications before a patent is granted thereon. In light of the new rules, ANVISA will only analyze patent applications (i) related to products that have been banned by ANVISA, or (ii) related to products listed by the Ministry of Health (MoH) as being relevant for the public health system (the MoH still needs to make such list). All other applications should be automatically approved by ANVISA and sent to the PTO for them to continue with the examination procedure.

Please let us know if you require any further information in respect of the above matters.