# When Isomorphic Files for FDA Approval, It Will Hit a Legal Wall Nobody Has Mapped - Date: 2026-04-26 - Category: Biotech & Life Sciences When Isomorphic Labs files for FDA approval of its first AI-designed drug, it will hit a wall: patent law requires a human inventor, the FDA has never approved a drug where AI was named, and no court has resolved the question. That reckoning just moved closer. ---