Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶1

Once the Food and Drug Administration (FDA) has approved a new drug, federal law authorizes other manufacturers to seek approval for marketing generic versions so long as they do not infringe on any patented uses. All 50 states and the District of Columbia permit (or require) medical providers to substitute the brand-name drug with the cheaper generic version. Still, generic manufacturers may be subject to liability under federal law if they actively induce infringement of the brand manufacturer’s patent. See 35 U. S. C. §271(b). Amarin Pharma, Inc. developed Vascepa, a drug containing the active ingredient icosapent ethyl. In 2012, the FDA approved Vascepa for the treatment of severe hypertriglyceridemia (the “SH indication”). In 2019, the FDA approved Vascepa for a second, more common use: reducing cardiovascular risk in hypertriglyceridemia patients who already take statins (the “CV…

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