The Legal Status of AI-Generated Biotech Inventions: Who Owns Life Engineered by Algorithms?

The convergence of artificial intelligence (AI) and biotechnology has unlocked unprecedented capabilities in scientific discovery, exemplified by tools like AlphaFold and generative protein models that can design novel biological structures. However, this technological leap has created a profound legal lacuna. Current intellectual property frameworks, designed in an era of human-driven invention, are ill-equipped to address ownership and authorship for inventions autonomously generated by AI. This paper confronts the central question: Who, if anyone, holds the legal rights to life-engineered algorithms? The analysis begins by establishing the human-centric foundation of patent and copyright law in major jurisdictions, including the United States, the United Kingdom, and the European Union, which legally define inventors and authors as natural persons. It then examines the landmark legal challenges, most notably the global campaign for the DABUS AI system, which culminated in decisions like Thaler v. Vidal that have affirmed this principle by denying inventorship status to AI. Compounding this issue are the unique intellectual property challenges inherent to biotechnology, such as the “product of nature” doctrine established in cases like Diamond v. Chakrabarty and Association for Molecular Pathology v. Myriad Genetics. The paper argues that the legal distinction between a natural discovery and a human-made invention becomes increasingly blurred when an AI is the agent of discovery. Several alternative ownership models are evaluated, attributing rights to the AI’s user, its developer, or the owner of its training data, revealing significant practical and theoretical shortcomings for each. The paper concludes that the existing legal paradigm is fundamentally inadequate and that clinging to it risks stifling innovation. It calls for urgent consideration of legislative reform, potentially through the creation of a sui generis intellectual property right, to provide the legal clarity and incentive structures necessary to foster continued progress at the intersection of AI and biotechnology.