The Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture in Intellectual Property Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: the Case for a Public Goods Approach

INTRODUCTION ............................................................................................... 3 I. EXPORTING CLINICAL TRIAL DATA EXCLUSIVITY REGIMES FROM DEVELOPED TO DEVELOPING COUNTRIES .......................... 9 A. The Egregiously High Costs and Risks of Clinical Trials .......... 9 B. The Domestic Response .............................................................. 11 C. The Drive for Global Protection of Clinical Trial Data .......... 14 1. From NAFTA (1992) to TRIPS (1994) .............................. 15 a. The NAFTA Provisions .................................................. 15 b. The Softer TRIPS Provisions ......................................... 17 2. The Posterior Free Trade Agreements ............................... 22 a. Expanding Protection for Clinical Trial Data in Developing Countries...................................................... 23 b. Recent Constraints on USTR’s Negotiating Mandate ............................................................................ 28 D. A Missed Opportunity: The Cost-Sharing Alternative ............. 29