Competition and patent law in the pharmaceutical industry: crossing paths between the European Union and the United States

The thesis addresses a topic that has been extensively debated in the competition law practice, namely its interface with the various paradigms of intellectual property rights. As this especially involves innovation-driven sectors, the research has focused on the interplay between competition policies and patent laws in the pharmaceutical industry, which calls into question a further level of human rights-based considerations when trying to strike a balance between the conflicting interests at stake. The inquiry considers the outlined topic primarily from a European perspective, by carrying out a thorough analysis of case law and practice of both the European Union and Member States. However, given that the first theoretical studies and judicial decisions on these issues have actually emerged in the legal system of the United States, the relevant case law and literature is also taken into account in order to assess differences and similarities between the US and the EU approaches. In the first chapter the scope and purpose of the thesis is presented. Then, the main features of the economic and regulatory framework underlying the pharmaceutical sector in the EU and the US are specifically dealt with in order to provide a general background for the subsequent assessment. The second chapter addresses the relevant case law concerning the two main competition law infringements, restrictive agreements and abuses of dominance, as emerged from the practice in the EU, the US and the Member States (in particular, the UK and Italy). The problematic issues arising from the analysed case law are then thoroughly assessed in the third chapter. Indeed, many questions emerge regarding the proper standard to structure the antitrust scrutiny in this patent-intensive sector, where pharmaceutical companies face high investments in research and development and try to put in place strategies aimed at extending the patent protection on their products. Finally, some broader conclusions are drawn on the overall balancing between the various sets of rules that characterise the industry at issue, namely competition, patent systems and regulation.