Artificial Intelligence for Drug Discovery: A New Frontier for Patent Law

Abstract

The artificial intelligence (AI) revolution is here and is changing healthcare as we know it. In the world of biotechnology and pharmaceuticals, AI systems are increasingly being used to discover new drugs, with multiple AI-designed drugs already entering clinical trials. AI for drug discovery represents the convergence of software and life science technologies—two industries that are heavily reliant on patents—and poses many unprecedented questions under U.S. patent law. In general, a new invention must be useful, novel, and non-obvious to meet the requirements for patentability. In addition, the application for a patent must be written so as to enable a person “skilled in the art” to make and use the invention and must “describe the invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Walking step-by-step through the patent requirements laid out in the Patent Act, this Article (i) demonstrates how each and every one of these requirements will be put to the test by the increasing use of AI in drug discovery, (ii) analyzes how each of these questions is likely to be resolved under current law, and (iii) explores the resulting implications for the drug discovery industry. Where the existing law would lead to undesirable effects, this Article also proposes preferable alternatives and policy suggestions for fostering innovation. Finally, for the patent practitioner, this Article further provides practical recommendations for those seeking to prosecute patents in the current realm of legal uncertainty.

Keywords: Artificial intelligence, Patent, Law, Intellectual property, Drug discovery

JEL Classification: K00