Eagle Pharmaceuticals, Inc. v. Azar

Pursuant to the Orphan Drug Act, the United States Federal Drug Administration (FDA) (defendant) could grant a seven-year market-exclusivity period to a designated and approved orphan drug, meaning a drug that treated rare medical conditions or diseases and therefore did not sell in more than limited quantities. The FDA granted seven years of exclusivity to Teva Pharmaceutical Industries, Ltd., for the drug Treanda, starting in 2008 and ending in 2015. Eagle Pharmaceuticals, Inc. (Eagle) (plaintiff) requested designation and approval by the FDA of its drug Bendeka in 2014. Though Bendeka was essentially identical to Treanda, the FDA granted Eagle’s clinical-superiority claims. In June 2014, Bendeka received its orphan-drug designation. Although the FDA granted approval for Eagle to market Bendeka in December 2015, it denied Eagle’s request for a seven-year market-exclusivity period. The FDA alleged that Eagle did not satisfy a post-approval clinical-superiority requirement, which precluded Bendeka from having market exclusivity. The FDA recognized an ambiguity concerning whether more than one manufacturer could gain the privilege of exclusive approval under the statute. From the FDA’s perspective, requiring applicants to satisfy post-approval clinical superiority would prevent manufacturers from obtaining serial exclusivity and therefore an oligopoly. Eagle brought a claim in district court challenging the FDA’s interpretation of the relevant provision of the Orphan Drug Act. The district court ruled that the FDA could not impose a post-approval clinical-superiority requirement, and the FDA appealed.