Rethinking Test Data Protection in China-US Trade War: Integrating Empirical and Normative Analysis

Abstract

Managing Intellectual Property (IP) protection over test data is a growth strategy in the trade competition, embodied as one of the crucial topics of US-China trade negotiations. Accordingly, the US took the trade war as a tool for the rivalry in the pharmaceutical industry and furnishing domestic companies with better protection schemes and more symmetrical access to the Chinese market. Even though the Economic and Trade Agreement Between the Government of the United States of America and the Government of the People’s Republic of China (Phase-one Trade Agreement) quelled the trade war, the dualism protection mechanism – ‘confidential business information’ protection and data exclusivity rules for pharmaceutical test data warrants exploring the legal basis and practical reasons. This article explores and clarifies the China and US trade arguments on test data and specific provisions of the Phase-one Trade Agreement from both empirical and normative perspectives. The empirical study sheds light on the pharmaceutical market competition between the US and China. Then it assesses the test data protection under the Phase-one Trade Agreement in light of US free trade agreements (FTAs), domestic legislation, and the Chinese test data protection legal system. In addition to providing contextual reflections, this article proposes China-US further negotiation for test data protection from a public health-friendly perspective, considering the US and Chinese legal frameworks and priorities regarding pharmaceuticals. Pharmaceutical, intellectual property, test data, confidential business information, data exclusivity, public health, US-China trade war, foreign trade agreements, Phase-one Trade Agreement