Imagine a machine designing a life-saving drug, only to be left off the patent because the law says only humans can be inventors. This is the dilemma now facing the pharmaceutical industry as generative artificial intelligence (AI) takes on a bigger role in research. The tension between cutting-edge technology and outdated legal frameworks is not just a technicality—it could determine who profits from future medical breakthroughs and how quickly new treatments reach patients.
The Insilico Medicine Case: When AI 'Discovers' a Drug
In a striking example, Insilico Medicine, a biotechnology company, announced that its generative AI platform had 'discovered' a drug candidate for idiopathic pulmonary fibrosis, a severe and progressive lung disease. However, when filing the patent, the company named five humans as 'inventors', including its CEO, Alex Zhavoronkov, and made no mention of the AI.
This decision reflects a legal reality: patent offices, at least in the United States, require inventors to be 'individuals'—meaning human beings. But what happens when the AI is the one that actually generates the molecule? The answer is far from simple and lies at the heart of a debate that is just beginning.
The DABUS Precedent: A Legal Battle That Reached the Courts
The most emblematic case was led by Ryan Abbott, a lawyer and partner at the firm Brown, Neri, Smith & Khan. Abbott filed a patent application, on a pro bono (free) basis, naming the AI DABUS as the inventor of a food container. The goal was to challenge the system and force a legal definition.
In 2022, the U.S. Court of Appeals for the Federal Circuit in Washington, DC, ruled that an 'inventor' must be an 'individual'—a human person. Machines, the court concluded, cannot be inventors. This ruling set an important precedent, but it did not close the debate.
What Experts and Patent Offices Say
Sarah Korman, a patent attorney and business and legal director at Isomorphic Labs (a company spun out of Alphabet, Google's parent), is blunt: 'There must be a human inventor or there is no invention and no patent.' Yet she acknowledges that laws will need to evolve to adapt to the new reality.
The U.S. Patent and Trademark Office (USPTO) has had a shifting stance. Under the Biden administration, it issued guidance on when humans qualify as co-inventors of discoveries made with AI. But under the Trump administration, it reversed course, declaring that AI is a 'tool' similar to a calculator, and therefore does not need to be mentioned in patent applications.
Meanwhile, the U.S. Copyright Office has refused to grant copyrights to AI-generated images and texts, raising concerns among organizations like the Motion Picture Association of America.
The Risk to Pharmaceutical Innovation
Abbott warns that if U.S. policy excludes AI-generated results from patent protection, it could slow future drug development. Additionally, legal challenges could invalidate patents if it is shown that the listed inventors are incorrect.
In practice, the current process at Insilico Medicine remains hybrid: human chemists synthesize the drugs, create variants, and test them in animals. Zhavoronkov says that person will be named on the patent. But Abbott's question remains open: 'What if I ask Claude to cure cancer and it does? I think it would be inappropriate to claim that I invented it.'
A Debate with Constitutional Roots
The legal basis for this debate lies in Article 1 of the U.S. Constitution, which grants exclusive rights for limited times to 'promote the Progress of Science and useful Arts.' The question is whether AI, as a tool, can be considered part of that progress, or whether only humans can be rewarded for it.
As the pharmaceutical industry watches closely, generative AI promises to accelerate drug discovery, but without a clear legal framework, companies may face uncertainty about protecting their innovations. Striking the right balance between incentivizing human creativity and recognizing the role of AI will be key in the coming years.
Source: Original article from MIT Technology Review, published in the weekly newsletter 'The Checkup' on biotechnology and health.