Brazilian pharma industry sues regulator
This article was originally published in Scrip
Interfarma, the Brazilian pharmaceutical industry association, has brought a lawsuit against the medicines regulator, ANVISA, over its role in the granting of patents for medicinal products.
The mechanism known as prior consent gives ANVISA a say in whether patents on medicinal products or processes should be granted or rejected, depending on public health concerns. According to Interfarma, ANVISA has been expanding its role in analyzing patents over the past year, and blocked 52 patents between March and August 2014.
Prior consent is a headache for firms because it makes the process of securing a patent more bureaucratic, lengthy and uncertain. Companies are also unclear about the remit and reach of both the patent office (INPI) and ANVISA, and the situation is something of a disincentive for companies to do business in the country.
"This is not appropriate in our understanding, we believe the way to resolve the situation is through legal action," said an Interfarma spokesperson. The action is in the early stages and it is unclear how ANVISA will respond. It is facing some 30 cases against it relating to prior consent.
Interfarma represents some 55 companies, which are responsible for 80% of originator products and 33% of generic products on the market.