This morning the Supreme Court reversed the Federal Circuit’s holding in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. addressing so-called skinny labeling and inducement of patent infringement. The Federal Circuit had rejected “characterizations that a reversal in this case would ‘effectively eviscerate section viii carve-outs’” of the Hatch-Waxman Act and held that Amarin had “plausibly pleaded that Hikma . . . induced infringement.” The Supreme Court disagreed. In a unanimous opinion authored by Justice Jackson, the Court decided mere plausibility that a physician could read relevant statements “as an instruction or encouragement to” infringe did not rise to the required standard of taking “active steps” to induce patent infringement. Here is the introduction and conclusion of today’s opinion. We plan to post a full opinion summary soon.
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).
Respondent Amarin Pharma, Inc., the manufacturer of brand-name icosapent ethyl, brought an induced-infringement claim against petitioner Hikma Pharmaceuticals USA Inc., a manufacturer of generic icosapent ethyl. Amarin relied on a combination of Hikma’s statements across its skinny label (an abbreviated label used for generic drugs), its website, and its press releases to allege that Hikma took “active steps” to induce infringement of Amarin’s patented uses. After the District Court dismissed the complaint for failure to state a claim, the Court of Appeals for the Federal Circuit reversed, finding it “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement to” infringe.
That was error. The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe. We therefore reverse the judgment of the Federal Circuit and remand the case for further proceedings.
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For the reasons we’ve explained, Amarin has failed to state a claim for active inducement in violation of §271(b), so its complaint cannot withstand Hikma’s Rule 12(b)(6) motion. We therefore reverse the judgment of the Federal Circuit and remand the case for further proceedings consistent with this opinion.