1 - Introduction

Abstract

Global linkage regulation of pharmaceutical products has emerged under intense political pressure to balance effective patent enforcement over new and innovative drugs with the timely market entry of lower-priced generic competitors. The United States was the first jurisdiction to institute linkage in 1984, following which time pressure was brought to bear on other countries to do so through inclusion of linkage terms in various free-trade agreements. Canada was the second jurisdiction to bring in linkage as part of its perceived obligations under NAFTA and TRIPS. It has now been over two decades since the regulations were enacted and to date there has been little objective assessment as to whether the regulations have, in fact, stimulated innovation and timely generic entry. This book describes the public health implications of the evolution of pharmaceutical linkage worldwide, with a particular focus on empirical studies of the scope of linkage between drug approval and drug patenting. A major goal of the work was to probe in detail the specific legal nexus between the innovative character of new and follow-on drugs approved by domestic regulators, the scope of intellectual property protection afforded to these drugs under the linkage regulations, the effect of linkage on the timing of generic entry, and the impact of linkage on public health. The implications of the data for the legal legitimacy of pharmaceutical linkage as an emerging intellectual property paradigm are discussed in light of the public policy goals to stimulate new and innovative drug development while also facilitating the timely entry of generic products as well as leading patent law jurisprudence.