The pharmaceutical market is a billon euro industry and the competition on the market is highly intensive. Primarily there are two competitors on the market, partly the originators which provide the market with new drugs, and partly the generics which produce copies of the originators‟ drugs. The originators are able to be granted patent protection of the drug under the European patent system, provided that the drug fulfils the requirements for patentability. During the period of patent protection the generics are not able to produce copies of the drug, but once the duration of the patent has expired the generics are able start the production. Thus, in order to hinder the generics to make copies of the drug, the originators apply various patent strategies. This has been noted by the European Commission, which conducted a sector inquiry of the pharmaceutical market in 2009. The presentation of the competition within the market focused on the applied strategies by the originator and concluded that all measures will be taken to hinder restrictions on the competition. In conjunction, the General Court judged in a recent case that the originator AstraZeneca constituted an infringement of the competition law when their strategies were applied. The complexity of determine whether a strategy is lawful or not, is due to the interface between the intellectual property law and the EC competition law. This implies that the strategy can be lawful under the IP law but unlawful under the competition law. The Court has established that any strategy, regardless of its legality under the IP law, constitutes an infringement of the competition law if it might restrict the competition. The Courts do not provide sufficient guidelines of the conditions that constitute the infringement. Consequently, the strategies‟ legality is at present time uncertain.

The thesis reviews current patent strategies of original pharmaceutical companies and their tangled role in the fabric of European pharmaceutical innovation and competition. It addresses several components of the European pharmaceutical industry such as regulatory framework, patent filing and dispute strategies and competition law. It argues that patent law is embedded in a broader competition law framework however plays on a separate field where it governs primarily the entry to its exclusive space by market actors. However it asserts that competition law should serve as a time referee for the patent law playfield and check if the abusive prolongation of exclusive patent position does not occur. The thesis deliberates that in view of ever rising number of patent applications, abuse of the patent system may become symptomatic to the system. The Commission data presented in the Final Report on the pharmaceutical sector inquiry are again inspected. Although data should be used with caution, it revealed a good quantitative base for assessment of a system which seemingly becomes more entropic, complex and susceptible to abuse. Therefore the underlying principles in both patent and competition law should be upheld more strongly than ever. It is the principle of fairness that should have normative force...

EU Competition Law and Practices Hindering Market Entry of Drugs This thesis deals with the legality of pharmaceutical companies' practices that hinder market entry of drugs, whether within the intra-brand or inter-brand competition, from the EU competition law perspective. The aim of this thesis is to introduce the reader to the issue of different practices aimed at limiting parallel trade and also at delaying or complete prevention of the market entry of a new competing drug, and also to assess whether the competition authorities have established clear guidance on the performance of these practices, i.e. whether they are clearly set boundaries between acceptable restriction of competition which can be justified and distortion which cannot be allowed. For the purpose of this assessment, the relevant decisions of the European Commission and the CJEU are analyzed, identifying the key factors on which the competition authorities place emphasis when assessing the compliance of such practices with the EU competition law, and general conclusions are drawn from these key factors to determine whether there is a sufficient degree of legal certainty for pharmaceutical companies engaging in these practices. The thesis is divided into six chapters, of which chapters three, four and five form the main part....