Prioritized Examination of Patent Applications
Resolution 80/2013, issued on 19/03/2013, intends to speed up and reduce the delay in the examination of patent applications considered strategic under the Brazilian Universal Healthcare System.
Under this system, pharmaceutical patents, processes, equipment and materials for use in healthcare are included.
The priority examination of patent applications may be requested by the Ministry of Health, or by any interested party, when they refer to the diagnosis, prophylaxis and treatment of Acquired Immunodeficiency Syndrome (AIDS), Cancer or neglected diseases.
In order to be consider for a priority examination, the patent applications must have had the request for technical examination, and also must have been published in the Brazilian Industrial Property Journal if it has been requested by the applicant or other interested parties
The Committee for Priority Examination shall check whether the related patent applications meet the following mandatory conditions for the priority examination to be granted:
- It does not refer to a patent application, whose examination is suspended for compliance with formal requirements
- It does not refer to a patent application whose priority examination has already been accepted;
- It relates to a patent application that fulfilled the annuities payment obligations.
previously formulated by the Patent Board – DIRPA;
The Patent Board Director is responsible for granting prioritized examination of related patent applications and shall notify, in a specific publication when the priority has or has not been granted.
The prioritized examination provided for in the present Resolution is at no cost to the interested party.
The National Health Surveillance Agency (ANVISA) will continue to analyze patent applications related to pharmaceutical products and processes.
In this respect the applicant must request examination of the patent application for pharmaceutical products and processes within the term established by the Brazilian law and, after a formal preliminary examination of the relevant documentation, the PTO will forward patent application file to ANVISA for analysis.
After receiving the documents from the local PTO, ANVISA will analyze whether the application of pharmaceutical products and processes contradicts the public health:
- When presenting risk to the health, in case the subject matter of the patent application consists or results in substance whose use has been banned in Brazil;
- When the patent application for pharmaceutical products and processes consists or results in substances of interest to the policies of medicines or pharmaceutical care within the scope of the Brazilian Health Care System – SUS (as set forth in ordinances of the Ministry of Health establishing lists of strategic products for the SUS) and if said patent application does not meet the patentability requirements and other criteria of Law. No. 9,279/96.
Patent applications that do not contradict public health in these situations will not be examined by the ANVISA.
Once ANVISA has rendered a final decision, the application will return to the PTO for conclusion of the administrative procedure. In case of approval, the PTO will continue the patent examination. If not, it will be hold aside.