| Summary: | Pharmaceutical antitrust is currently a centre of attention for the European Commission, with one decision against Lundbeck and Statements of Objections in investigations against Johnson & Johnson, Novartis, and Les Laboratoires Servier. This thesis is the first to develop in detail a ‘European approach’ to pay for delay settlements and early entry agreements – two types of conduct identified by the European pharmaceutical sector inquiry. Although pay for delay settlements have received extensive antitrust scrutiny in the United States, one has to be cautious when drawing from this expertise, as the underlying regulatory regimes are fundamentally different in Europe and the US. This need for careful comparative analyses in pharmaceutical antitrust and the fact that similar conduct might have to be treated differently on both sides of the Atlantic is showcased by a case study of the General Court’s AstraZeneca judgment. The analysis shows that the General Court was correct to dismiss AstraZeneca’s claim that its conduct would not have led to antitrust scrutiny following the US Walker Process Doctrine, which in fact covers similar conduct. Additionally, the hypothetical application of the market definition in AstraZeneca to the market of anti-epileptic drugs highlights the difficulties that the European Commission might encounter in its future enforcement in the pharmaceutical sector. Based on the different incentives for the parties of EU pay for delay settlements, a novel European theory of harm is developed for pay for delay settlements and early entry agreements, the latter posing significant anticompetitive potential in Europe. Based on this theory, pay for delay settlements are scrutinised under EU competition law and a novel “structured effects-based” test is proposed that is inspired by the recent Actavis judgment of the US Supreme Court. In terms of early entry agreements, this thesis is the first to apply EU competition law.
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