ABSTRACT
This chapter explores the likely costs of policies that would lengthen the exclusivity period for new pharmaceutical products, using Hong Kong as a case study. It shows that plausible changes in the intellectual property provisions relating to pharmaceuticals would have modest effects on total drug spending. A potential infringer may simply enter the market and start selling, and the patentee has the burden of demonstrating infringement in order to obtain an injunction against the infringer. The effective period of market exclusivity depends on the interplay of four types of intellectual property regulations specific to pharmaceuticals, namely, patents, patent term extension, data protection, and linkage. Data protection provides drug companies with a guaranteed minimum period of market exclusivity. Canada and the EU have negotiated a trade agreement in which the European Union (EU) requested Canada to offer patent term extension and to extend data protection to match EU levels.
