In what has become a classical issue in recent years, the battle between the examination of pharmaceutical patent applications by the Brazilian Patent and Trademark Office (BPTO) and the Health National Surveillance Agency, also known as ANVISA, we may probably have reached its highpoint.
This time, a new player is in the game: the Federal General Attorney and his recently-issued Opinion no 210, after a formal request brought by the BPTO.
The issue is this: what is the role of ANVISA, on the examination of patent applications related with pharmaceutical products and processes? Does it extend to the examination of patentability requirements or is it limited to dealing with public health matters?
At the centre of the discussion is the current draft of article 229º C of the Brazilian Intellectual Property Law that states:
“The granting of patents to pharmaceutical products and processes depends upon the prior approval of the Health National Surveillance Agency.”Under this provision, ANVISA examines pharmaceutical patent applications and, if they meet the patentability requirements (novelty, inventive step and industrial application), as the BPTO currently does, this creates a double examination on the same invention.
The current legal framework has already led the BPTO and ANVISA to issue contradictory decisions, but the final wording belongs to ANVISA, to the despair of patent applicants. This also gave ANVISA the power to substantially interfere on IP policy matters, through an aggressive and effective policy regarding the protection and development of the generics industry, the promotion of the issuance of more compulsory licenses, and the support of Bills against the patentability of second medical use, leaving the BPTO in a less visible position.
Surprisingly, the issued Opinion goes completely in the opposite way, against ANVISA’s interests. The Federal General Attorney understands that ANVISA has indeed the power to examine pharmaceutical patent applications, but only under a public health perspective. Thus the patentability requirements of a pharmaceutical invention can only be examined by the BPTO.
This Opinion also focuses on the issue of the patents granted by the BPTO under the pipeline system and that were not previously forward to ANVISA’s examination. In this case, the Federal General Attorney recommends that ANVISA should be given the opportunity to examine these patents on a public health approach.
The Federal General Attorney submitted this Opinion to Presidential approval. For now, let us wait to see what will be the President’s decision on this matter and the respective consequences for both Agencies.
By Jorge Miguel Arruda da Veiga (Di Blasi, Parente, Vaz e Dias & Asociados); posted by Jeremy
