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I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which. ....
Reverse payment cases arise in the context of settlement agreements between brand-name pharmaceutical companies and generic drug manufacturers to resolve patent litigation under the Hatch-Waxman Act. ....
. That decision was anything but a complete victory for the Commission s position. Indeed, Justice Breyer wrote a relatively nuanced opinion holding, most importantly, that such settlements were not a per se antitrust violation (the FTC s original position). Rather, the Court held that such agreements must be evaluated under the rule of reason. However, reasonableness ( i.e., how tightly tethered to reality) of any such determination depends in larger part on the reasoner, and this characteristic (or flaw) is illustrated in the first full-fledged appellate affirmance of the FTC in a reverse payment settlement case, The case arose over a settlement between branded drug maker Endo against Impax over its extended-release oxymorphone opioid drug product, Opana ER. The agreement, entered into before the Supreme Court s ....