When AI Designs a Drug, Who Gets the Credit? The Legal Wrinkle in AI-Driven Drug Discovery
核心洞察
US courts have ruled that only humans—not AI systems—can be named as inventors on patents, after a test case involving the AI "DABUS" was rejected in 2022.
The US Patent and Trademark Office now treats AI as a mere tool, reversing earlier Biden-era guidance on human co-inventorship of AI discoveries.
Legal experts warn that excluding AI-generated outputs from patent protection could dampen future drug development, even as companies like Insilico Medicine (搜索) keep humans in the loop.
When the biotech company Insilico Medicine (搜索) used its computer models to propose a promising drug for pulmonary fibrosis (搜索), it enthusiastically claimed in a press release that the molecule had been "discovered by" its generative AI platform. Insilico leads a pack of companies using AI to rapidly come up with drug ideas humans might never think of, potentially speeding the race to new cures. AI models are now able to generate atomic designs for drugs almost as easily as ChatGPT can write a thank-you note.
Yet that marketing language points to a fascinating wrinkle in intellectual-property law. No matter how fundamental an AI is to a discovery, when it comes to winning rights to an invention, it is humans—and only humans—who can take the credit.
The DABUS Test Case and the "Individual" Standard
US courts reached that conclusion after Ryan Abbott, a partner at the LA law firm Brown, Neri, Smith & Khan, brought a pro bono test case naming an AI called DABUS as an inventor of a better food container, whose intricate geometric surface lets it transfer heat well and stack easily. Because no human contributed to the design, Abbott argued that the AI should be named the inventor.
The case might have raised philosophical questions, like whether AIs deserve legal rights or what the true nature is of that eureka moment that leads to a better mousetrap. But in 2022, an appeals court in Washington, DC, said these "metaphysical matters" were beside the point. Instead, it noted that US statutes describe an inventor as an "individual," the plain meaning of which is a human being. Since machines aren't people, they can't be inventors. Case closed.
"There needs to be a human inventor or there's no invention and no patent," says Sarah Korman, a patent attorney who is now chief business officer and legal officer of Isomorphic Labs (搜索), an Alphabet (搜索) spinout with big ambitions for AI cures. Korman, who made her remarks at MIT Technology Review's EmTech event last year, added that there is "no doubt" our laws will need to evolve to keep pace with AI.
A Shifting Regulatory Posture
That's partly because no one is denying that AIs can invent things. In the future, they may do so with less and less human intervention. As the US Patent and Trademark Office has itself acknowledged, "an AI system—like other tools—may perform acts that, if performed by a human, could constitute inventorship under our laws."
Instead, the key question going forward may actually be whether or not any human contributed enough to be named as an inventor. Abbott believes there could be legal challenges to AI-generated drugs, since one way to invalidate a patent is to show it has the wrong inventors listed.
Currently, the US patent office seems to be taking a don't-ask-don't-tell approach to the use of AI. Under the Biden administration, the agency published guidance to help applicants determine whether and when humans would truly qualify as co-inventors of an AI discovery. But after Trump arrived in office, it reversed course. Now the patent office says AI is merely a tool, like a calculator. No need to even mention it.
Implications for Drug Development
Abbott's worry is that if US policy excludes AI-generated outputs from protection, that could put a damper on future drug development. Already, the US Copyright Office is refusing to grant copyrights to images and text generated by AI, raising concerns from organizations like the Motion Picture Association of America, whose members are using those tools.
The point of our intellectual-property laws is to encourage innovation, Abbott says. It's right there in Article 1 of the US Constitution, which says inventors and authors need to be given exclusive rights to their ideas, for a limited time, in order "to promote the Progress of Science and the Useful Arts."
You can bet that pioneering AI drug companies are keeping humans in the loop, at least for now, and documenting everything carefully. At Insilico, Zhavoronkov says, human chemists still have to synthesize the drugs, create variants, and test them on animals. "That's the person who is going to be named on the patent," he says. "And even if you decided to completely roboticize this process, including the experiments, someone will still push the button and give the budget."
Should pushing a button count as being an inventor? Abbott says that's a question for future legal cases. "What if I asked Claude to cure cancer, and it did?" he says. "I think it would be inappropriate to claim that I invented that."