The Intersection of Generative AI and Intellectual Property: Rethinking Fair Dealing for Text and Data Mining in Pharmaceuticals

Abstract

The rapid advancement of generative artificial intelligence (AI) has revolutionized text and data mining (TDM) practices in the pharmaceutical industry, raising critical questions about intellectual property (IP) protection and the fair dealing doctrine. This article examines the intersection of generative AI and IP, focusing on challenges related to data ownership, licensing, and regulatory compliance. It highlights the need for updated legal frameworks to balance innovation with IP rights, particularly in drug discovery, clinical trials, and personalized medicine. The study provides recommendations for policy reforms, ethical AI use, and international harmonization to support responsible innovation in pharmaceutical regulatory affairs.