Introduction to Exclusivity Rights
This chapter begins by defining intellectual property rights as the protection of the ‘creation’ of the mind and describing many different rights that are protected by both statute and common law. It divides intellectual property into two broad categories: industrial property and copyright. It also explores the various statutory and common law intellectual property regimes that have their own idiosyncratic criteria in order to qualify for the protection they offer. The chapter distinguishes relevant intellectual property rights for pharmaceutical product marketing authorisation holders from ‘traditional’ intellectual property rights to regulatory exclusivities. It explores the characteristics of regulatory exclusivities that are akin to other intellectual property rights but have their own unique criteria for qualification and enforcement.