The promise and pitfalls of data exclusivity

This intervention, designed to buttress existing rights for pharmaceutical patent holders, came in the form of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which broadly charged the signatory nations with protecting applicants from unfair competition. Specifically, there is a requirement (laid out in article 39[3]) to keep “undisclosed test or other data, the origination of which involves a considerable effort” secret. One result is the withholding of trial data for a number of years after the launch of the product protected by a pharmaceutical patent.