ABSTRACT
This chapter reviews the implementation of patent linkage in several jurisdictions highlighting and evaluating critical factors which influence the economic and health-related effect of the regime. It examines the historical development and basics of patent linkage and surveys the implementation of patent linkage regulations in select jurisdictions. The chapter offers critical commentary and analysis on key issues such as the policy justification for linking marketing approval to patent status, which patent or patents should be “linked”, the use of injunctions to enforce patent linkage and the effect of patent linkage on competition. Australia’s adoption of patent linkage flows from the Australia–United States Free Trade Agreement which prevents a marketing authority from approving a product where a patent is claimed and requires that a generic applicant notify the rights holder of its request for marketing approval. As more countries adopt patent linkage, empirical evidence on the effect of the various forms of patent linkage should also grow.
