Over the past few decades, the pharmaceutical sector has witnessed the occurrence of a particular type of agreement used to settle patent disputes between originator and generic drug manufacturers: so-called reverse payment patent settlements, also known as pay-for-delay agreements. Due to their peculiarities and the context in which they occur, these settlements raise issues at the intersection of patent protection, competition law, and pharmaceutical regulation. This has made them one of the most contentious issues in the pharmaceutical industry from a competition law perspective. At the EU level, while reverse payment patent settlements have been at the centre of the European Commission’s enforcement priorities for years and the target of various infringement decisions adopted since 2013, they have only more recently reached the Court of Justice. Since 2020, the Court of Justice has ruled on the compatibility of such settlements with EU competition rules, particularly Article 101 TFEU, on various occasions, most recently in October 2025. Through a series of judgments that have now addressed all relevant EU cases, the Court of Justice has delineated the criteria for the antitrust assessment of reverse payment settlements and the application of fundamental notions of EU competition law, notably that of restriction by object, to these agreements. Against this background, this article aims to analyse the current status of pay-for-delay agreements under EU competition law, in particular, Article 101 TFEU. To this end, it first frames the pay-for-delay issue within the context in which it emerged and in light of the existing literature. It then examines the approach to these agreements adopted at the EU level, with particular reference to the recent case law of the Court of Justice. In doing so, it focuses on two key points, namely the assessment of potential competition and of the agreements as restrictions by object under Article 101(1) TFEU.
Alessandra Campiglia (Tue,) studied this question.