On Pharma Patents and AI: A Review of the Literature

Artificial intelligence (AI) is transforming pharmaceutical innovation by accelerating drug discovery, reducing development costs, and challenging established patent and regulatory frameworks. This review draws on 107 legal, technical, and policy sources to examine AI’s impact on drug development, the significance of data quality and governance, emerging ethical and oversight issues, and the legal ambiguity surrounding AI-assisted and AI inventorship. Increased reliance on large, well-structured datasets raises new concerns about ownership, bias, and privacy. At the same time, regulatory and patent systems face ongoing uncertainty in defining the roles of humans and machines in inventorship. This review provides a global overview and highlights the urgent need for adaptable intellectual property (IP) systems that address the realities of AI-driven pharmaceutical innovation.