Globalization and Health
[Accessed 27 Oct 2018 ]
| 24 October 2018
Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States
The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States’ TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines.
Authors: Kyung-Bok Son, Ruth Lopert, Deborah Gleeson and Tae-Jin Lee