Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶4
Federal law allows pharmaceutical manufacturers to market generic versions of brand-name drugs, so long as they obtain approval from the Food and Drug Administration (FDA) and do not infringe on any patented uses. Because a generic drug is, by definition, “biologically equivalent to . . . the brand-name drug,” Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U. S. 399, 405 (2012), many medical providers use brand-name and generic drugs interchangeably, regardless of whether the intended use is covered by a patent. Such substitution is allowed (and sometimes required) by state laws across the Nation, but generic manufacturers may be subject to liability under federal law if they “actively induc[e] infringement of [the brand manufacturer’s] patent.” 35 U. S. C. §271(b).Read in context ›
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