The Brazilian Patent and Trademark Office (BPTO) and the National Health Surveillance Agency (ANVISA) have recently advanced in the discussion regarding the examination of pharmaceutical patent applications.
Due the Article 229-C of Brazilian IP Law, whenever a patent application claims a pharmaceutical product or process, consent from the National Sanitary Surveillance Agency (ANVISA) is required prior to the granting of the desired patent by the BPTO.
However, ANVISA’s lack technical capability to analyze patentability requirements of pharmaceutical patent applications, and this conflict over the responsibilities of the two entities in the patent application process have generated a backlog in the BPTO’s work of analysis of patents in this field of technology.
Hence, the new proposal clarifies the responsibility of each entity in the process of analysis of pharmaceutical patent applications: ANVISA will continue to issue prior consent declarations, limiting its analysis to the risk of the product or process to the public health and the BPTO, in turn, will evaluate the patentability requirements.
This proposition was approved by ANVISA on March 14, 2017 and we are waiting for the official publication of this decision, in order for it to take immediate effect.
Therefore, rest assured that we will keep you informed about the specifics of this new development and the evolution of its impact on the processing of pharmaceutical patent applications in our care in Brazil.