Luiz Leonardos & Advogados has a specialized team to deal with Food & Drug issues. Our team advises our clients on regulatory matters and enforces our client´s data package exclusivity rights, provided both by the TRIPS Agreement and the local provisions regarding unfair competition. Such rights are especially relevant to the research-based pharmaceutical companies, who must submit a huge amount of information to the Brazilian Food & Drug Agency to demonstrate that their innovative products are safe and effective. In some situations, enforcing the aforementioned data package exclusivity rights is the only way to avoid the freeriding performed by generic industries seeking to rely on the innovator company’s data package to obtain marketing approval of their generic versions, instead of performing their own clinical trials.
