Exclusion payment agreements between reference and generic drug companies: restrictive practices of competition?

Abstract

The conclusion of agreements between reference medicines and generic companies, especially in the United States, has become a frequent and usual anti-competitive practice, more recurrent than in the European Union and Brazil. Among the most common settlements supposedly deleterious to competition are the agreements known as exclusion payment or reverse payment. The text analyses some agreements concluded in the United States and in the European Union, especially exclusion payment and non-contestation agreements. It situates the matter within the use of indeterminate and descriptive concepts and the case-by-case analysis under the rule of reason, the 180-day period of commercial exclusivity provided by the Hatch-Waxman legislation for the first company to use the abbreviated procedure (ANDA), and the Commission guidelines on the application of Article 81 of the EC Treaty to technology transfer agreements. As regards the system in force in Brazil, it examines the competition principles laid down in Law No. 12,529/2011 and the review of concentrations by CADE.