For Your Data Aaipharma, Inc. V. Thompson Illustration Brief

aaiPharma, Inc. v. Thompson illustration brief summary

296 F.3d 227 (2002)

CASE SYNOPSIS

Appellant pharmaceutical fellowship challenged a determination from the U.S. District Court for the Eastern District of North Carolina inwards its activity against appellee Food together with Drug Administration (FCA) inwards which it contended that the FDA had the duty to ensure the accuracy of the Orange Book listings together with the FDA's refusal to produce together with hence violated that Administrative Procedure Act (APA).

CASE FACTS
The fellowship received a patent on a variant of the active element of a name-brand antidepressant drug. It sought to accept its patent included inwards the Orange Book listing for the name-brand drug. Because entirely the New Drug Application (NDA) holder could submit patents claiming its approved drug for listing, the fellowship contacted the patent holder of the name-brand drug to inquire it to file the patent to the FDA. The manufacturer together with the FDA declined.

DISCUSSION

• On review, the courtroom 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 earlier the fellowship obtained its patent. 
• The fellowship asserted that the patent claimed the name-brand drug inwards the feel provided in § 355(c)(3), together with hence the manufacturer was obligated to submit the company's patent for listing inwards the Orange Book. 
• The courtroom agreed amongst the FDA's declaration that the statute clearly indicated that the NDA holder bore the sole responsibleness for filing the required data on all the patents that claimed its approved drug together with that the FDA's part inwards the procedure was completely passive.

CONCLUSION
The courtroom affirmed the district court's decision.

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