Sham Litigation in the Pharmaceutical Sector

"Concern about anticompetitive practices in the pharmaceutical sector by competition authorities has increased in the past few years. Abusive conducts carried out by both originator and generic producers have led consumers to pay significantly high costs even after the expiration of patent protection for relevant drugs, in both developed and developing countries."

"In order to assess the issues and limitations of the sham litigation test as established in the US (including answering the question on how effective it has proven so far in refraining abusive litigation), an analysis of the development of the concept by US courts as well as its application will be carried out in the third section. The fourth and the fifth sections will assess the implementation of sham litigation, its variants and alternative doctrines adopted by the authorities of the EU and Brazil, respectively. A critical analysis of sham litigation will be carried out, in order to place this doctrine under procedural law and subject it to its principles. Additionally, the relevance and pertinence of the direct determination of intent for the purpose of characterising sham litigation will be evaluated from two perspectives—procedural law and competition law—in order to show that changes in the approach of the sham litigation are not only feasible but rationally justifiable."