Hikma Pharmaceuticals Usa Inc. v. Amarin Pharma, Inc. - Annotated Opinion

 Our well-established federal pleading standards are not up for debate in this case. In order to proceed to discovery, a plaintiff must “state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U. S. 544, 570 (2007). That plausibility standard “asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 556 U. S. 662, 678 (2009). If the complaint “pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.” Ibid. (internal  quotation marks omitted). Instead, to nudge a claim “across the line from conceivable to plausible,” a plaintiff must plead facts that, if true, “allo[w] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged,” id., at 678, 680 (internal quotation marks omitted), and to rule out “obvious alternative explanation[s]” for the defendant’s conduct, Twombly, 550 U. S., at 567.

 This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took “active steps . . . to encourage direct infringement.” Grokster, 545 U. S., at 936 (internal quotation marks omitted).³ Our case law defining “active steps” thus governs the boundaries of a plausible induced-infringement claim. Most fundamentally, “inducement must involve the taking of affirmative,” as opposed to passive, “steps to bring about the desired result” of patent infringement. Global-Tech., 563 U. S., at 760; see also Grokster, 545 U. S., at 935 (requiring “statements or actions directed to promoting infringement”); Cox Communications, 607 U. S., at ___ (slip op., at 9) (citing lack of “evidence of express promotion [or] marketing” as a reason for no liability (internal quotation marks omitted)). To avoid “trenching on regular commerce,” “ordinary acts incident to product distribution” are insufficient to support liability. Grokster, 545 U. S., at 937.

 Given these standards, Amarin misses the mark in arguing that it need not do more than “allege . . . a plausible chain of events through which statements made by [Hikma] could lead a healthcare provider . . . to prescribe or dispense Hikma’s drug to reduce a patient’s cardiovascular risk.” Brief for Respondents 21 (alterations and internal  quotation marks omitted).⁴ Amarin relies primarily on two cases to press its point. First, it points to our holding in National Rifle Association of America v. Vullo, 602 U. S. 175 (2024), that, “[t]o state a claim that the government violated the First Amendment through coercion of a third party, a plaintiff must plausibly allege conduct that, viewed in context, could be reasonably understood to convey a threat of adverse government action,” id., at 191 (emphasis added). Importing this First Amendment standard into the induced-infringement context, however, would water down the statute’s express requirement of “activ[e] induce[ment].” 35 U. S. C. §271(b).

 Amarin’s second (and more germane) case is Grokster, where we described “[t]he classic instance of inducement” as an “advertisement or solicitation that broadcasts a message designed to stimulate others to commit violations.” 545 U. S., at 937; see Brief for Respondents 21. But statements designed to stimulate others form a narrower category than statements that could stimulate others. And in Grokster, the defendants’ statements fit into that narrower class: Grokster, a distributor of free file-sharing software, “sent users a newsletter promoting its ability to provide particular, popular copyrighted materials.” 545 U. S., at 926. StreamCast, another such distributor, “beamed onto the computer screens of users of Napster,” another  notorious file-sharing service, “ads urging the adoption of its OpenNap program, which was designed, as its name implied, to invite the custom of patrons of Napster.” Id., at 937. “And both companies communicated a clear message by responding affirmatively to requests for help in locating and playing copyrighted materials.” Id., at 938. We held that such overt efforts to “entic[e] or persuad[e] another” to engage in copyright infringement “overc[ame] the law’s reluctance to find liability when a defendant merely sells a commercial product suitable for some lawful use.” Id., at 935–936.

 All in all, inducement cannot be based only on “vague” language “combined with speculation about how [others] may act.” Takeda Pharmaceuticals U. S. A., Inc. v. West-Ward Pharmaceutical Corp., 785 F. 3d 625, 632 (CA Fed. 2015); see also Grokster, 545 U. S., at 937 (requiring “purposeful, culpable expression and conduct”). That said, Hikma overshoots by urging that active inducement must be “express.” See Reply Brief 22–23. A defendant can achieve active inducement through implicit encouragement, as StreamCast did through the “suggestiv[e ]” name of its “OpenNap program.” Grokster, 545 U. S., at 937, 938. But implicit or explicit, the necessary inducement must be “clear” to the relevant audience and “affirmative.” See id., at 937.

 Applying these standards to the complaint here, Amarin fails to allege “more than a sheer possibility” that Hikma actively induced infringement of Amarin’s CV-indication patents. Iqbal, 556 U. S., at 678. Amarin’s allegations, whether viewed together or separately, fail to establish that Hikma took any affirmative steps to encourage infringement.

 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).⁵

 Amarin also finds fault in Hikma’s statements describing its product as “ ‘generic Vascepa’ ” or the “ ‘generic equivalent’ of Vascepa” in the prelaunch press releases. Brief for Respondents 23–24. But as we have explained, it is “normal industry practice” to “truthfully describe” a generic drug as “ ‘equivalent’ ” to the brand-name comparator. See Inwood Laboratories, 456 U. S., at 847–848; §353d(a)(3) (defining the term “generic version ” as “a drug approved under [§355] whose reference listed drug is a covered drug”). We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.

 Second, Amarin may not rely on “mere omissions, inactions, or nonfeasance” to allege active inducement. Twitter, Inc. v. Taamneh, 598 U. S. 471, 489 (2023). With a healthy stretch of the imagination, one might believe that some medical providers could read between the lines and draw improper conclusions from the skinny label’s omission of  the CV Limitation of Use and the press releases’ failure to “mentio[n] that [Hikma’s] approved use was limited to the far-lesser-known SH indication.” Brief for Respondents 23, 26. But we look for affirmative “statements or actions” precisely to avoid “trenching on regular commerce” based on such a contingent chain of events. Grokster, 545 U. S., at 935, 937. Otherwise, “ordinary merchants could become liable for any misuse of their goods and services, no matter how attenuated their relationship with the wrongdoer.” Twitter, 598 U. S., at 489.

 Third, Amarin comes up short in resting the remainder of its inducement claim on “vague” statements “combined with speculation about how [medical providers] may act” in response to those statements. Takeda, 785 F. 3d, at 632. Take, to start, Amarin’s argument that medical providers “would plausibly understand” the label’s patient information leaflet to encourage infringing uses because it identifies potential side effects for people with cardiovascular diseases and notes that medication is sometimes prescribed for uses other than those specifically indicated. Brief for Respondents 31 (internal quotation marks omitted). Again, §271(b) requires “activ[e ],” not passive, inducement. So the question is not merely whether the statements could be “plausibly underst[oo]d” to induce infringement, but whether they plausibly constitute “affirmative steps to bring about the desired result” of infringement. Global-Tech., 563 U. S., at 760. Viewed in that light, the statements in the leaflet (a warning and a disclaimer, really) are implausibly roundabout ways to induce medical providers to infringe. Treating them otherwise would turn any statement extraneous to the unpatented method of use—even one warning people against the patented method of use—into active inducement of infringement. Our case law leaves generic manufacturers more breathing room than that.

  Amarin is wrong to rely on the statements on Hikma’s website for the same reason. The website describes the therapeutic category for its drug as “hypertriglyceridemia,” and indicates that the drug is “AB” rated. It is not plausible that Hikma “designed” these statements “to stimulate others to commit” infringement. Grokster, 545 U. S., at 937. For one thing, describing the therapeutic category as “hypertriglyceridemia” (as opposed to “severe hypertriglyceridemia”) is generally akin to describing a drug for leukemia as a “ ‘cancer drug’ ” (as opposed to a “leukemia drug”). Reply Brief 12. “Cancer drug” is a broad category, not an instruction to prescribe the drug for a patented use treating a specific type of cancer. Furthermore, an “AB” rating means that the product is equivalent to the brand-name drug only “under the conditions specified in the generic’s label,” which excludes unapproved, patented methods of use. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F. 4th 1320, 1335 (CA Fed. 2021). In any event, Hikma’s website clarifies that “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug,” Vascepa. 2 App. 195.

 Finally, the sales figures in Hikma’s press releases are the vaguest of “vague” statements alleged in Amarin’s complaint. Takeda, 785 F. 3d, at 632. Amarin argues that, by including the sales figures attributable to both the SH-indication and the CV-indication methods of use, Hikma encouraged using its generic for the patented CV indication. But there are myriad steps between those statements and induced infringement that Amarin fails to mention. For Amarin’s speculation to bear out, a medical provider would have to look up and read the press releases, which were directed to investors rather than doctors and pharmacists; have enough background knowledge of pharmaceutical sales to understand the quoted sales figures to be attributable to both the SH-indication and the CV-indication methods of use; and draw from this fact a subtle encouragement  to start prescribing Hikma’s generic to hypertriglyceridemia patients who already take statins. Perhaps this chain of events is “possib[le]” (anything is possible). Iqbal, 556 U. S., at 678. But, without more, it is not a “ ‘plausible’ ” scenario of active inducement giving rise to liability under §271(b). Ibid.