A1 Refereed original research article in a scientific journal
On Pharma Patents and AI: A Review of the Literature
Authors: Mutale, Chisanga; Acquah Daniel; Kumar, Pradeep
Publisher: Thomson Reuters
Publication year: 2026
Journal: European Intellectual Property Review
Volume: 48
Issue: 8
First page : 538
Last page: 549
ISSN: 0142-0461
Publication's open availability at the time of reporting: No Open Access
Publication channel's open availability : No Open Access publication channel
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/526853123
Self-archived copy's licence: All rights reserved
Self-archived copy's version: Final draft
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.
Keywords:
AI-Assisted Inventions, Artificial intelligence (AI), China, comparative jurisprudence, Drug discovery, ethics, European Union, innovation, Inventorship, patentable inventions, Patents, pharmaceuticals, Pharma Patents, regulation, United States
Funding information in the publication:
This project has received funding from the European Union’s Horizon Europe research and innovation programme under the Marie Skłodowska-Curie grant agreement No 101177564 — HAIF. Co-funded by the European Union. Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Research Executive Agency (REA). Neither the European Union nor the granting authority can be held responsible for them.
This work was also supported by the Research Council of Finland project “Technical Assis-tance as an Enabler of the Constitutionalizing of Intellectual Property Norms in Africa” (TACIP) [Decision number 350302].
