The Intersection Between Intellectual Property and Competition Laws in the Pharmaceutical Sector: A Ukrainian Perspective

Abstract

AbstractRobust protection of competition is particularly important in the field of pharmaceuticals as this may help to improve access to affordable medicines and foster medical innovation. While the Antimonopoly Committee of Ukraine (AMCU) has undertaken certain activities in the pharmaceutical sector aimed at combating price increases, these activities do not cover practices that rely on intellectual property (IP) rights that may have a negative effect on the pharmaceutical market. The aim of this chapter is to explore the current competition law approach to IP-related practices in Ukraine. It will discuss certain exemptions related to IP agreements and will suggest that the current competition law rules may require clarification. Specifically, to ensure that only genuinely procompetitive IP agreements are allowed, it will be suggested that it may be necessary to develop specific guidance on the correct interpretation of the law and its application to IP-related agreements. By way of example, the chapter will discuss anticompetitive IP-related agreements that are unique to the pharmaceutical industry, i.e. “pay-for-delay” agreements. While such agreements have not been the subject of investigation by the AMCU, they have attracted particular attention in the European Union (EU) and the US. The chapter will discuss the approaches for assessing such agreements developed in the EU and the US, and will provide some recommendations that, it is believed, will help to create more effective competition law enforcement in the field of pharmaceuticals for the benefit of Ukrainian patients. The discussion in this Chapter, while focusing on Ukraine, may also be useful to other jurisdictions that seek to improve their competition law enforcement in the field of IP to facilitate access to medicines.