Competition between originators and generic producers in the European Union pharmaceutical sector

The main ground which urged me to decide the topic of this study is the fact that in recent years, the competition between originator companies and generic producers has brought to the top of the EU pharmaceutical sector's agenda. This issue is at the interaction point of competition law and intellectual property law in a highly regulated research based industry. The pharmaceutical sector is not only specifically regulated, but also influenced by the special characteristics of the patent system. Therefore, the useful debates concerning the interface between competition law and intellectual property law and background information on the structure and regulatory issues relating to the EU pharmaceutical sector are given in order to facilitate readers to easily comprehend the core questions. This thesis study addresses the major developments in the EU which are the reasons why such level of competition attracts high attention. The first one is the Pharmaceutical Sector Inquiry Report of 2009 in which the European Commission identified "defensive patent strategies" as a potential anti-competitive abuse in the sense of Article 102 TFEU. Such strategies include particularly patent filings that may delay the market entry of generic drugs. Yet, the Report refrains from a thorough legal analysis of such behavior. With the objective of clarifying the legal implications of the Sector Inquiry Report, the study analyses the AstraZeneca case (including the Commission's decision, the judgment of the General Court, the judgment of CJEU) as a precedent for assessing the anti-competitive character of patent filings under EU competition law. This benchmark case sheds light on the applicable approach within the EU. In this regard, it is revealed that competition law takes a very strict view on the pharmaceutical industry.