A step into the unknown? Challenges for pharmaceutical companies


Luiz Leonardos and Ricardo Dutra Nunes

Brazil’s patent system is well established, but there are some challenges associated with protecting pharmaceutical products, as Ricardo Dutra Nunes and Luiz Leonardos explain.

The Brazilian patent system is one of the oldest: it was created more than 200 years ago, in 1809, by royal decree. Since then, the country has experienced many changes in this area, with several recent developments to the legal framework.

Our current federal constitution was enacted in 1988, establishing that the law will provide temporary protection for inventions. Brazil is also a member of most of the international treaties governing patent protection. The current intellectual property statute was enacted in 1996, just after Brazil became a member of the World Trade Organization (WTO) in 1995, to adapt the local rules to the minimum standards established by the WTO’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.

For that reason, the Brazilian patent statute is reasonably similar to the ones in force in the US, Europe and other WTO member countries, although its implementation by the Brazilian executive and judiciary can be quite different.

TRIPS, pharmaceuticals, INPI