TRIPS at Thirty: The Evolving Interactional Law of Public Health Exceptions to Intellectual Property Protection

Debates regarding public health and the international protection of intellectual property (IP) often focus on patent protection under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and regional trade agreements, with demands for change being framed as demands for further textual flexibilities. Reviewing the establishment and operation of international law in this field, we submit that the features of this regime are determined and renegotiated principally “interactionally,” rather than through treaty text and adjudication. The key driver behind the strengthening of the regime in the 1990s was not the signature of TRIPS itself, but the earlier US decision to start enforcing IP rights through trade policy. Even within the WTO, self- interpretation, decentralized state conduct, and political negotiations have remained the key drivers of the interpretation and evolution of TRIPS flexibilities, with no dispute settlement rulings on patent flexibilities having been issued since the 2001 Doha Declaration on TRIPS and Public Health. Examining three and a half decades (1988–2023) of struggles over international patent protection and public health flexibilities involving WTO members and other actors, we delineate the operation of what we term the “interactional law” of IP protection and public health. After framing the operation of law in this field in this manner, we suggest paths for those seeking to expand the use of TRIPS flexibilities to promote public health.