TRADE SECRETS IN THE PHARMACEUTICAL INDUSTRY: BALANCING CONFIDENTIALITY AND PUBLIC HEALTH

Abstract

In the field of IPR, the pharmaceutical industry faces the enduring theoretical dilemma of trade secrets and public health. The paper analytically reviews the TRIPS Agreement, the US Defend Trade Secrets Act (DTSA), and the EU Trade Secrets Directive to consider their theoretical contributions to the protection of proprietary pharmaceutical information. The paper examines how these frameworks influence the industry’s innovation incentives and the issues they bring to the question of affordable healthcare accessibility. In the Remdesivir patents case, enforcement of such patents during COVID-19 reveals the ethical tension between corporate profit and patient access; in the Amgen vs. Novartis lawsuit, the ethical tension between biologic innovation and biosimilar competition. AstraZeneca’s offer to voluntarily license its COVID-19 vaccine is evidence of how a public health objective can be incorporated into corporate strategy.  The focus of the analysis is on theoretical approaches to the ethical dilemmas of enforcing trade secrets, especially when the lives of people around the world depend on it during epidemics. Moreover, the discussion also provides a theoretical analysis of the issues related to intellectual property rights and corporate social responsibilities for public health. An empirical study of trade secrets legal disputes reveals that the biologics industry has the highest percentage of cases (35%), followed by chemical synthesis (25%) and clinical trials and manufacturing processes (20% each). This theoretical analysis highlights how proprietary information is critical in these fields and the tension between patent protection and patients’ right to receive potentially lifesaving treatments.