In an Ordinance jointly issued by the Brazilian Patent and Trademark Office (BPTO) and ANVISA, the Brazilian Health Surveillance Agency (the Brazilian FDA), ANVISA relinquished its overriding power in the grant of pharmaceutical patents in Brazil; and consequently the prospects of obtaining such patents in this important country has dramatically increased.
As part of the revision of the Brazilian Industrial Property Laws in 2001, provisions were introduced into the Brazilian Patent Law, stipulating that the grant of patents for pharmaceutical products and processes require the prior consent of ANVISA. A procedure was, thus, established whereby, after allowance of a patent application concerning pharmaceutical products and processes by the BPTO, the application was forward to ANVISA for its analysis on patentability; which very often resulted in the denial of the patent application. This practice was a source of big frustration and brought many pharmaceutical innovators to a decision not to attempt to obtain patent protection for their innovations in Brazil.
The aforesaid procedure, which was followed until 2012, resulted in massive rejection of patent applications in the pharmaceutical field, thereby rendering the value of filing patent applications in this field highly questionable. We have reported this issue in an October 1, 2012 newsletter.
The joint Ordinance issued by BPTO and ANVISA on April 12, 2017, is a big deviation from previous practice and considerably increases the chances of obtaining pharmaceutical patents in Brazil. The highlights:
ANVISA's prior consent to grant of a patent is still required; however, it is restricted to analysis relating to public health issues, i.e. whether the patent application covers a substance, the use of which is prohibited in Brazil.
Should ANVISA deny grant on said ground, the application will return to the BPTO for an unequivocal rejection of the patent application.
ANVISA may continue to conduct a patentability analysis in the case of inventions of interest, which will not be binding on the patentability examination carried out by BPTO Examiners. In other words, BPTO may exercise its discretion vis-a-vis accepting patent applications but it is not mandatory.
The agreement between ANVISA and the BPTO will come into effect on June 12, 2017, and it is to be hoped that it will meet the purpose of relieving ANVISA of its overriding role in the procedure for obtaining pharmaceutical-related patents.
Under these circumstances, owners of pharmaceutical inventions cam once again consider filing patent applications in this economically very important country.