The Glocalization of Pharmaceutical Patent Linkage
Benjamin Liu
With the passage of the Hatch-Waxman Act three decades ago, the United States
endorsed a system of administrative IP protection for pharmaceuticals that links drug approval
with patent exclusivity. Since then, U.S. trade negotiators have promoted patent linkage in
bilateral trade agreements, leading to the simultaneous globalization and localization
(glocalization) of pharmaceutical patent linkage. The most recent trade negotiation, the TransPacific Partnership (TPP) Agreement, continues this effort to spread patent linkage while at the
same time breaking with this tradition—it replaces the glocalization process with the explicit
transplantation of the U.S. regulatory regime. Although this shift may have been designed to
harmonize national regulatory regime, enhance IP protection, and address public health concerns,
it fails to account for local limitations such as administrative capacity, market condition, and
industrial structure. Thus, this new generation of patent linkage is unlikely to achieve its
professed goals and may even reduce welfare and incentive comparing to the status quo ante.