Timing the Valve: How Does Intellectual Property Impact on Early Market Entry for mRNA Vaccines in Australia to Promote Vaccine Equity?
摘要
In this chapter, we use Australia as a case study to examine the role and responsibility of high-income nations in contributing to the global effort to achieve vaccine equity. Through doctrinal analysis, we show a number of flexibilities exist in Australian patent law to facilitate manufacture and supply of vaccines by follow-on developers, in compliance with international obligations. However, equivalent flexibilities do not exist for other forms of intellectual property, particularly exclusivity over the data submitted to the Therapeutic Goods Administration for marketing approval. This is problematic if follow-on developers have to wait for expiry of the exclusivity period or generate their own data. Through empirical analysis of patent databases and the Australian Register for Therapeutic Goods for the most common mRNA vaccine delivery platforms, we examine the extent to which patents or regulatory data exclusivity create binding “timing valves” for follow-on products. We find a complex mix of both forms of intellectual property. We then test whether any permissible flexibilities could alleviate timing valve limitations. We conclude that it would be unwise to rely solely on these flexibilities. Other strategies will be needed to ensure that Australia can meet its obligations with regard to vaccine equity.