aaiPharma, Inc. v. Thompson

Court of Appeals for the Fourth Circuit

296 F.3d 227 (4th Cir. 2002)

An agency will not change the patent information in an Orange Book listing if the patent application holder does not withdraw or amend the patent information in response to an FDA request.

Relevant Facts

aaiPharma, Inc. (the plaintiff) obtained the ‘853 patent for a variant of the active ingredient in Prozac, a brand-name antidepressant drug. Once the pioneer manufacturer’s exclusivity in Prozac expired, several drug manufacturers marketed generic versions of Prozac. As a result, the plaintiff was concerned that its ‘853 patent might be infringed by the generic drug makers. The plaintiff sought to have its ‘853 patent included in the U.S. Food & Drug Administration’s (the defendant) (the FDA) publication, Approved Drug Products With Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.” However, only a brand-name, or a “pioneer drug manufacturer” could submit patents for inclusion in the Orange Book. The plaintiff requested the pioneer manufacturer to submit the ‘853 patent, but they refused. The plaintiff then sent a letter to the FDA asking them to intervene. The FDA refused, claiming that it was not responsible for the correctness of its Orange Book listings. However, the defendant did send a letter to the original manufacturer asking it to confirm the correctness of the Orange Book listing. Subsequently, the plaintiff sued the defendant in federal district court, claiming that the FDA had a duty to ensure the accuracy of its Orange Book listings and that its refusal violated the Administrative Procedures Act (APA). The district court rejected the plaintiff’s claims because the defendant’s agency role regarding the Orange Book listings was purely ministerial.

Issue

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Holding & Reasoning

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Concurrence

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Dissent

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Last updated:

December 2, 2020

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Procedural History

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Citations

296 F.3d 227 (4th Cir. 2002)