Nikhil Pradhan Assesses FDA AI Draft Drug Guidance's IP Impact

Foley & Lardner LLP senior counsel Nikhil Pradhan shared important context on the U.S. Food and Drug Administration’s draft guidelines for AI use in decision making within the pharmaceutical industry in the pharmaphorum article, “Regulating the invisible hand: Inside the FDA’s AI playbook.”

“A lot of the things that the guidance is asking for are probably things that most firms in the industry are already thinking about in terms of having transparency and explainability around the systems they’re developing,” Pradhan explained. “Even though more information might be required for a company that’s implementing something with AI, that additional information is not more onerous than they might have to do with conventional non-AI approaches.”

Pradhan highlighted intellectual property as an area where the draft guidance, if implemented, could prove especially meaningful. Today, companies have two main routes for protecting their proprietary models and algorithms – patenting them or keeping them as a trade secret.

“If a company has an AI model that’s used for drug development and it’s predicting or classifying who should get certain treatments or things like that and, maybe historically, you could just treat it like a black box,” he said, noting that the guidance as written could essentially take away this option for models within the guidance’s scope.

“But now, if they have to tell the FDA about it, then it might be worth putting more resources into their patent protection,” he added.