Introduction

The establishment of the World Trade Organization (‘WTO’) marked an important new chapter in the administration of patent law, especially regarding inventions in the medical arena. Although intellectual property protection has long been governed by international norms, the principal international instrument on patents – the Paris Convention for the Protection of Industrial Property – largely focused on procedural issues. It required each state to accord national treatment to the citizens of other signatories, but it left most details on the scope and the substance of patent rights to the domestic law of each of its members. While many countries provided plenary protection to pharmaceutical products in order to stimulate their discovery, others took the position that medicines were too important to their citizens' welfare to privatize.

In 1994, that regime was significantly modified. Intellectual property, now conceptualized as a trade issue, became the subject of a new international instrument, the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’ or ‘TRIPS’). Under the WTO framework, adherence to TRIPS is not only required of every WTO member, it is also enforceable through the WTO's elaborate Understanding on Dispute Settlement (‘DSU’), an essentially adjudicative mechanism, administered by the Dispute Settlement Board (‘DSB’), complete with an Appellate Body to entertain appeals from Panel decisions and sanctions for non-compliance. Because TRIPS imposes substantive patent law standards, including a requirement that protection be accorded ‘in all fields of technology’, it is no longer possible for a WTO member to exclude medicines from the purview of protection.