Whether a complaint for active inducement of patent infringement under 35 U.S.C. §271(b) states a plausible claim if it relies on statements that a third party could plausibly read as instructions to infringe. The Court must determine if a generic drug manufacturer's "skinny label," website descriptions, and press releases constitute "active steps" to encourage infringement. Specifically, the issue is whether the plaintiff must allege that the defendant actively encouraged infringing use rather than merely alleging a plausible chain of events through which statements could lead to infringement.

• The complaint failed to state a claim under Federal Rule of Civil Procedure 12(b)(6) because none of the alleged statements constituted "active steps" to encourage infringement.
• Adherence to the "duty of sameness" under 21 U.S.C. §355(j)(2)(A)(v) and normal industry practices, such as describing a drug as a "generic equivalent," should not be treated as building blocks for illegal conduct.
• Active inducement must be "express" rather than implicit.

• The complaint alleged a "plausible chain of events" through which Hikma's statements could lead a healthcare provider to prescribe the drug for the patented CV indication.
• The totality of Hikma's statements—including the omission of the CV Limitation of Use, the patient leaflet's warnings, and the website's "AB" rating—encouraged infringing use.
• Under the standard in *National Rifle Association of America v. Vullo*, a claim is plausible if the conduct, viewed in context, could be "reasonably understood" to convey a message of encouragement.

• The Court held that Amarin failed to state a claim for active inducement in violation of 35 U.S.C. §271(b).
• A claim for active inducement requires three elements: direct infringement by a third party (*Limelight Networks, Inc. v. Akamai Technologies, Inc.*), knowledge that the acts constitute infringement (*Global-Tech Appliances, Inc. v. SEB S.A.*), and "active steps . . . to encourage direct infringement" (*Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.*).
• Applying the pleading standards of *Bell Atlantic Corp. v. Twombly* and *Ashcroft v. Iqbal*, the Court reasoned that a plaintiff must allege more than a "sheer possibility" of liability and must rule out "obvious alternative explanation[s]."
• The Court clarified that "active steps" must be affirmative actions to bring about infringement and specifically exclude "ordinary acts incident to product distribution" (*Grokster*).
• The Court rejected the Federal Circuit's approach, ruling that the central question is whether the defendant actively encouraged infringement, not merely whether a physician could plausibly read statements as instructions to infringe.
• Several statements had obvious alternative explanations: the label's content was required by the "duty of sameness" under 21 U.S.C. §355(j)(2)(A)(v), and describing a drug as a "generic equivalent" is "normal industry practice" (*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 (*Twitter, Inc. v. Taamneh*).
• The remaining statements on the website and in the patient leaflet were too vague to support liability, as inducement cannot be based on "vague" language "combined with speculation about how [others] may act" (*Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp.*).