Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶32

First, several of the relevant statements have an “obvious alternative explanation,” Twombly, 550 U. S., at 567: Hikma was just complying with the law or with standard industry practice. Start with the law. It is true, as Amarin complains, that Hikma’s label omitted the CV Limitation of Use and retained information about a clinical study involving patients taking statins, just as Amarin’s label did. But that is because, by statute, Hikma’s label must be identical to Amarin’s except for the carved-out use, barring specified circumstances not applicable here. 21 U. S. C. §355(j)(2)(A)(v); see also 21 CFR §314.94(a)(8)(iv); PLIVA, Inc. v. Mensing, 564 U. S. 604, 616 (2011) (explaining the “duty of sameness” for generic drug manufacturers).

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