The US Federal Trade Commission’s muscling into the arena of Orange Book patent listings could put pressure on the US Food and Drug Administration to finally issue guidance on whether sponsors can list drug delivery devices. It could also lead to litigation if the FTC takes enforcement action against companies that decline to delist patents the agency deems to be improperly listed.
In one of the most surprising actions of 2023, the FTC sent letters to eight drug manufacturers contending they had improperly listed patents pertaining to 16 drug-device combination products in the FDA’s Orange Book. Three of the manufacturers – GlaxoSmithKline Pharmaceuticals Ltd