The pharmaceutical industry, which is actively integrating artificial intelligence into the drug development process, has encountered a serious legal barrier. American legislation is unwavering: only humans can be listed as inventors in patent applications. This norm creates a paradoxical situation where the key role of AI in creating a molecule is deliberately kept silent.
The case of Insilico Medicine is illustrative: the company stated that its generative platform designed a compound to combat pulmonary fibrosis. However, the patent documentation makes no mention of artificial intelligence—instead, five people are listed, including the CEO. This is not a coincidence but a forced measure based on case law.
As early as 2022, the Washington appellate court ruled in the DABUS case that the term "individual" in a legal context refers exclusively to a human being. At that time, the case concerned an improved food container created by AI. Since then, disputes have shifted to assessing human contribution: the decisive factor is now not the mere fact of using AI, but the degree of human involvement in the process.
This legal uncertainty creates a ticking time bomb. Ryan Abbott, a partner at the law firm Brown, Neri, Smith & Khan, predicts a wave of patent challenges if inconsistencies are found in the documentation. His rhetorical question is telling: "If I asked Claude to cure cancer, and it did so, would it be inappropriate to claim that it was my achievement."
Notably, the position of regulators changes depending on the political climate. The U.S. Patent and Trademark Office, under the new administration, views AI as a "tool like a calculator" that does not require separate disclosure. However, experts, including Sarah Korman from Isomorphic Labs, are convinced that as the role of AI grows, legislation will have to be revised. For now, companies are forced to artificially keep humans in the development chain, documenting their participation in the synthesis and testing of molecules.
My analysis: The current situation is a classic case of law lagging behind technology. The patent system, created to protect human ingenuity, is not ready for an era where key decisions are made by algorithms. I believe that in the coming years we will witness either a radical reform of legislation or a collapse of innovation in this field, as companies will avoid patenting AI developments for fear of legal risks.