The Brazilian healthcare legislation establishes in the legal definitions of generic drugs (article 3, items XX and XXI, Statute #6,360 of 1976[1]) that their labels must have all and the same therapeutic indications of the reference-listed drug. The law only allow differentiation in characteristics like product’s size and shape, shelf life, package, and excipients[2]. The…
The healthcare sector in Brazil is one of the most important in the world in view of the size of the population (+220 million people) and the availability of a universal public healthcare system. The action of antibodies as therapeutic agents may involve processes of neutralization, opsonization and activation of immune complement system, transforming them…
Innovation in healthcare of all types is on the rise in Brazil. As this article will show, large investments have been made and are continuing to be made across all parts of the sector. With continuing investment, it is more important than ever that all those involved give active consideration to intellectual property rights and…
The Brazilian pharmaceutical market is growing fast and is expected to become the fifth largest in the world by the next decade. While the country struggles to recover from economic downturn, the health care sector plays a key role in political speeches and the overall approach by the government. The Brazilian Constitution establishes access to…
On July 14, a Brazilian Congressman Mr. Alexis Fonteyne presented a Patent Bill proposing key amendments to the Patent Statute (Law No. 9,279 of 1996). The proposal represents an important development for the IP community, especially when it comes to patent term compensation, which may become statutory if the bill is approved (click here for an English…
In September 2021, Brazilian Congress passed a law changing the compulsory licensing landscape as a political answer to the impact of the Covid-19 pandemic. Initially, Congress wanted to include new possibilities to issue compulsory license and tried to create a mandatory tech transfer provision that could severely jeopardize companies doing business in Brazil. In view…
The Brazilian Patent Office (BRPTO) is improving its examination procedure, trying to reduce the backlog. As more decisions are issued, we are learning about the approach of the examiners to different topics in patent law. An ongoing hot topic is whether the examiners are accepting post-filing experimental evidence during patent examination. The Metallurgy and Material…
