## Facts

- aaiPharma, Inc. obtained U.S. Patent No. 6,139,853, claiming a variant crystalline form of fluoxetine, the active ingredient in Prozac.
- Eli Lilly & Co. held the new drug application (NDA) for Prozac and controlled what patents were submitted to the FDA for publication in the Orange Book.
- Under Hatch–Waxman, NDA holders submit patent information to the FDA for Orange Book publication; ANDA applicants must certify to listed patents, and a Paragraph IV certification can trigger notice and a potential 30-month stay if suit is filed.
- Lilly refused aaiPharma’s request to submit the ’853 patent for Orange Book listing under Prozac.
- aaiPharma asked the FDA to require Lilly to list the patent; the FDA declined, stating it did not verify listing accuracy, though it sent Lilly a routine confirmation letter.
- aaiPharma sued under the Administrative Procedure Act (APA), seeking to compel FDA action to secure Orange Book listing before generic Prozac entry.
- After a preliminary-injunction hearing, the district court denied interim relief and entered judgment for the FDA on the merits, ruling FDA’s Orange Book role is ministerial and carries no duty to correct or police listings.

## Issues

1. Whether the district court erred by entering final judgment on the merits following a preliminary-injunction hearing without clear notice to the parties.
2. Whether the FDCA as amended by Hatch–Waxman imposes a legal duty on the FDA to ensure the accuracy of Orange Book patent listings or to require an NDA holder to list an assertedly eligible patent, such that refusal is unlawful under the APA.

## Decision

- The Fourth Circuit affirmed.
- The court held any lack-of-notice problem in the district court’s reaching the merits was waived or harmless because aaiPharma had a full opportunity to present its arguments and the issues were fully addressed on appeal.
- The court held the FDA has no statutory duty to verify, correct, or adjudicate Orange Book patent listings; its function is to publish patent information submitted by NDA holders.
- Because the statute does not require FDA intervention in listing disputes, the FDA’s refusal to compel Lilly to list the ’853 patent was not arbitrary, capricious, or contrary to law under the APA.

## Legal Principles

- Hatch–Waxman places the obligation to submit patent information for Orange Book listing on the NDA holder; the FDA’s role is limited to receiving and publishing that information.
- Absent clear statutory direction, the FDA is not required to decide patent-coverage or listing-eligibility disputes and may treat Orange Book listing oversight as a ministerial function.
- Under APA review, an agency’s refusal to take action is not unlawful when the governing statute does not impose the asserted duty.
- Disputes over whether a patent covers a drug or should be listed are generally resolved through private patent litigation rather than FDA administrative action.

## Conclusion

The Fourth Circuit held that FDA has no enforceable statutory obligation to police Orange Book patent listings or to compel an NDA holder to list a third party’s patent, and therefore the agency’s nonintervention could not be set aside under the APA.


aaiPharma, Inc. v. Thompson, 296 F.3d 227 (4th Cir. 2002)