Does a generic drug manufacturer's use of a "skinny label," website descriptions, and press releases plausibly allege active inducement of patent infringement under 35 U.S.C. § 271(b)? Specifically, the Court must determine if these actions constitute "active steps" to encourage infringement or are merely consistent with federal law and industry practice. The case asks whether the plausibility standard requires evidence that the defendant actively encouraged infringement rather than just that a third party could plausibly read the statements as encouragement.

• Sought reversal of the Federal Circuit's decision to allow the claim to proceed.
• Argued that the statements in question were either required by law under the "duty of sameness" or were standard industry practice.
• Contended that active inducement requires affirmative steps to bring about infringement, not mere omissions or vague statements.
• Argued that the respondent's claim relied on speculation about how doctors might interpret the statements rather than evidence of active encouragement.

• Sought affirmation of the Federal Circuit's decision to proceed to discovery.
• Argued that it only needed to allege a "plausible chain of events" through which the petitioner's statements could lead a healthcare provider to prescribe the drug for the patented cardiovascular (CV) indication.
• Claimed that the totality of the evidence—including the omission of the CV Limitation of Use and the mention of cardiovascular side effects—constituted active inducement.
• Relied on *National Rifle Association of America v. Vullo* and *Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.* to argue that statements that could be reasonably understood as encouragement are sufficient.

• The Court held that the respondent failed to state a claim for active inducement under 35 U.S.C. § 271(b) because the complaint did not plausibly allege "active steps" to encourage infringement.
• The Court applied the pleading standards from *Bell Atlantic Corp. v. Twombly* and *Ashcroft v. Iqbal*, requiring a claim to be "plausible on its face" and to rule out "obvious alternative explanation[s]."
• The Court defined "active steps" under 35 U.S.C. § 271(b) as "affirmative" actions to bring about infringement, citing *Global-Tech Appliances, Inc. v. SEB S. A.* and *Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.*
• The Court clarified that "ordinary acts incident to product distribution" are insufficient to support liability, as established in *Grokster*.
• The Court found that the petitioner's label was governed by the "duty of sameness" under 21 U.S.C. § 355(j)(2)(A)(v) and 21 CFR § 314.94(a)(8)(iv), providing an obvious alternative explanation for the label's content.
• The Court noted that describing a drug as a "generic equivalent" is "normal industry practice" under *Inwood Laboratories, Inc. v. Ives Laboratories, Inc.*
• The Court ruled that "mere omissions, inactions, or nonfeasance"—such as the omission of the CV Limitation of Use—cannot support a claim for active inducement, citing *Twitter, Inc. v. Taamneh*.
• The Court concluded that the statements on the website and in press releases were too vague and required a "possible" but not "plausible" chain of events to result in infringement, citing *Iqbal*.