aaiPharma, Inc. v. Thompson case brief

aaiPharma, Inc. v. Thompson case brief summary

296 F.3d 227 (2002)

CASE SYNOPSIS

Appellant pharmaceutical company challenged a decision from the United States District Court for the Eastern District of North Carolina in its action against appellee Food and Drug Administration (FCA) in which it contended that the FDA had the duty to ensure the accuracy of the Orange Book listings and the FDA's refusal to do so violated that Administrative Procedure Act (APA).

CASE FACTS
The company received a patent on a variant of the active ingredient of a name-brand antidepressant drug. It sought to have its patent included in the Orange Book listing for the name-brand drug. Because only the New Drug Application (NDA) holder could submit patents claiming its approved drug for listing, the company contacted the patent holder of the name-brand drug to ask it to file the patent to the FDA. The manufacturer and the FDA declined.

DISCUSSION

• On review, the court noted that the controlling statute was 21 U.S.C.S. § 355(c)(2) because the manufacturer's NDA for the drug was approved long before the company obtained its patent. 
• The company asserted that the patent claimed the name-brand drug in the sense provided in § 355(c)(3), so the manufacturer was obligated to submit the company's patent for listing in the Orange Book. 
• The court agreed with the FDA's argument that the statute clearly indicated that the NDA holder bore the sole responsibility for filing the required information on all the patents that claimed its approved drug and that the FDA's role in the process was completely passive.

CONCLUSION
The court affirmed the district court's decision.



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