Data exclusivity and patent monopoly extension: A view from Australia

Abstract

AbstractData exclusivity and patents are important to the pharmaceutical industry, and both these regimes coexist in the pharmaceutical landscape. Both data exclusivity and patents provide market exclusivity through monopoly periods. Because data exclusivity and patents can protect the same pharmaceutical, beginning at different times in the pharmaceutical lifecycle and having different durations, these terms may not coincide, and each can extend the effective market exclusivity period of the other. For example, when data exclusivity persists beyond patent expiry for a pharmaceutical, subsequent entrant access to the market is restricted and the period during which originators can charge high prices is extended. This article seeks to eliminate the situation where patent monopolies have expired, but data exclusivity remains in force by proposing a method to ensure that data exclusivity and patent terms expire simultaneously. Further, the proposal maintains the protection to innovators afforded by both data exclusivity and patents, recognising that these regimes protect different things in pharmaceutical development.