This dissertation evaluates some noteworthy current developments in the use of international legal instruments to protect intellectual property rights, with special attention for patents and data exclusivity. In the first part of this dissertation, some examples are discussed of the broadening scope of rights that are directly affected by international legal instruments. To that end, the negotiation and conclusion of the TRIPS agreement are first briefly reconsidered, as well as some of its most impactful provisions on patents. In the subsequent chapter, the mandating of data exclusivity trough a range of TRIPS Plus agreements is examined, thereby reviewing the merits of the key justifications that have frequently been advanced in favour of data exclusivity. In the third and final chapter of part one, another particularly interesting development is critically assessed: the introduction of an abbreviated pathway for biologics and the extension of regulatory exclusivities to biologics, an obligation now included in newly negotiated agreements such as the CTPP and the new NAFTA.
In the second part, the scope of this dissertation is extended by looking into the use international legal instruments for the enforcement of intellectual property rights. This part begins with a brief overview of the use of the WTO dispute settlement mechanism for the enforcement of TRIPS obligations, to lay the foundation for the subsequent chapter: an analysis of the inclusion and recognition of intellectual property rights as ‘investments’ within the scope of international investment agreements. First this evolution is illustrated with an elaborate discussion of the case of Eli Lilly v Canada. In the final chapter of this part, the normative legitimacy of investment arbitration (or Investor-State Dispute Settlement – ISDS) is assessed by looking into the attempts of the EU to reform the system with the establishment of an Investment Court System (ICS).
In the third and final part of this dissertation, the key aspects of the normative analysis of these evolutions are brought together, reflecting on the additional challenges that are posed to the traditional justifications of intellectual property, when considering the codification in international legal instruments of such rights.