aaiPharma, Inc. v. Thompson

aaiPharma, Inc. (plaintiff) held the '853 patent for a variant of Prozac's active ingredient. After Prozac's exclusivity expired and generic versions appeared, aaiPharma feared infringement and wanted its patent listed in the FDA's (defendant) Orange Book. But only a pioneer (brand-name) manufacturer could submit patents for listing, and the pioneer refused aaiPharma's request. aaiPharma asked the FDA to intervene; the FDA declined, saying it was not responsible for the accuracy of Orange Book listings, though it did ask the pioneer to confirm the listing's correctness. aaiPharma sued, claiming the FDA had a duty to ensure accuracy and that its refusal violated the Administrative Procedure Act. The district court rejected the claim, holding the FDA's role was purely ministerial.

Whether an application holder's refusal to withdraw or amend its Orange Book patient information, in response to an FDA request, creates a legal duty for the FDA to change the listing itself.