United States Court of Appeals for the Fourth Circuit
296 F.3d 227 (2002)
On July 10 2001, aaiPharma, Inc. (“aaiPharma”) (plaintiff) obtained the ‘853 patent for a variant of the active ingredient in the brand-name antidepressant drug, Prozac which was manufactured by Eli Lilly & Company (“Lilly”). As soon as Lilly’s exclusivity relating to Prozac expired on August 2, 2001, several drug manufacturers planning to market generic versions of Prozac. aaiPharma was concerned that its ‘853 patent might be infringed by those generic drug makers and sought to have its ‘853 patent included in the U.S. Food & Drug Administration (FDA) (defendant) publication, Approved Drug Products With Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book.” Only a brand-name, or “pioneer,” drug manufacturer could submit patents for inclusion in the Orange Book. aaiPharma asked Lilly to submit the ‘853 patent to be included in the Prozac listing, but Lilly refused. aaiPharma then sent a letter to the FDA asking the agency to intervene and require Lilly to include the ‘853 patent. The FDA claimed that it was not responsible for the correctness of Orange Book listings. However, the FDA did send a letter to Lilly requesting that it confirm the correctness of the Orange Book listing related to Prozac. aaiPharma then sued the FDA in the U.S. District Court for the Eastern District of North Carolina, claiming that the agency had a duty to ensure the accuracy of the Orange Book listings and its refusal violated the Administrative Procedures Act (“APA”). The district court rejected aaiPharma’s claims, concluding that the FDA’s role regarding the Orange Book listings was purely “ministerial.”
Rule of Law
Holding and Reasoning (Michael, J.)
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