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, ...

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