Patent protection is a relatively new concept in Brazil, similar to most of Latin America's main markets, with intellectual property legislation enforced only as recently as May 1997.Brazil is committed to bringing its patent legislation in line with international norms through its WTO TRIPS obligations, and the drug authorities have recently tightened regulations regarding generic drugs, although aspects of its current legislation remain the focus of international criticism. A major area of contention is the provision that requires products to be manufactured locally in order to receive full patent protection and the requirement of prior approval from sanitary authorities for pharmaceutical patent applications.

Despite continuing international criticism, the Brazilian drug authorities are unlikely to revise patent legislation to an internationally accepted standard as a result of the country's dependency on low cost, copied products, especially given the economic troubles of recent years. Any serious reform of patent legislation should be considered a long-term aspiration at best.