Earlier this week, a Brazilian federal court issued an injunction which stripped U.S. pharmaceutical producer Gilead Sciences of its patent over Sofosbuvir, a medication used for the treatment of hepatitis C and sold under the brand name Sovaldi. Higher courts are still to uphold the decision, but the decision already paves the way for cheaper generic drugs.
Last week, Brazil’s National Intellectual Property Institute (INPI) granted the American company the patent, establishing that only Gilead would be allowed to produce the drug in Brazil. Sovaldi has proven to be effective against serious liver diseases, but Gilead was criticized for marketing a drug initially priced at USD 1,000 a pill in the U.S. For the INPI, however, “anticompetitive strategies” and “outrageously high prices” should influence discussions about intellectual property.
The case’s judge begged to differ, stating that preserving Gilead’s patent goes against the country’s goal to eradicate hepatitis C by 2030 – as generic medications could cost as little as six times less than the original drug, according to the decision. It would also damage the public health care system’s budget, as buying Sofosbuvir from a single licensed manufacturer could represent over BRL 1 billion in costs.
The case of Gilead’s hepatitis drug sheds some light on Brazil’s regulations concerning generic drugs. Here, we will explain how these rules work.