In the recent ruling in Hikma Pharmaceuticals v. Amarin Pharma, No. 24–889., the U.S. Supreme Court applied its pleading standards established in the Twombly and Iqbal line of cases and unanimously held plaintiff, Amarin Pharma, had not satisfied these standards with respect to its claim for induced infringement under 35 U.S.C. § 271(b). The Supreme Court reversed the Court of Appeals for the Federal Circuit’s prior reversal of the district court’s dismissal of Amarin Pharma’s induced patent infringement cause of action for failure to state a plausible claim, and reinstated the district court’s dismissal of the claim. In doing so, it reaffirmed that one who induces another to infringe must take “active steps . . . to encourage direct infringement.” According to the Court, it is not enough that the induced parties could reasonably understand those statements or actions to encourage infringing use.
In 2013, Amarin developed Vascepa. In 2012, the FDA approved Vascepa for a first indication: treatment of severe hypertriglyceridemia (the “SH indication”). Vascepa’s label disclosed that its effect “on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined” (the “CV Limitation of Use”) because Vascepa was not yet approved for other uses. In the meantime, Amarin continued its research into Vascepa’s potential cardiovascular uses. In 2019, the FDA approved Vascepa for a second, more common indication: reducing cardiovascular risk in hypertriglyceridemia patients who already take statins (the “CV indication”). Amarin removed the CV Limitation of Use from Vascepa’s label and obtained two method-of-use patents covering the CV indication.
Hikma Pharmaceuticals is a generic drug manufacturer. In 2016, Hikma submitted an abbreviated new drug application (“ANDA”) for Vascepa. It initially filed a paragraph IV certification, asserting that Amarin’s SH-indication patents were invalid. Hikma eventually prevailed, and a district court invalidated Amarin’s SH-indication patents. After this invalidity ruling, Hikma supplemented its FDA application and sought approval of a skinny label that included only the unpatented SH indication and carved out Vascepa’s still-patented CV-indication method of use. In 2020, the FDA approved Hikma’s application with the skinny label.
Soon after Hikma began marketing its generic drug, Amarin filed suit in district court, alleging that Hikma was liable under 35 U.S.C. § 271(b) by actively inducing others to infringe Amarin’s patent for the CV-indication method of use. These allegations were based on the totality of Hikma’s statements across the skinny label, a patient information leaflet, Hikma’s website, and Hikma’s press releases. The district court granted Hikma’s motion to dismiss for failure to state a claim, explaining that none of these statements constituted active steps to encourage infringement. The Federal Circuit reversed. It held that Hikma’s label, standing alone, did not induce infringement. But the Federal Circuit had found it “at least plausible that a physician could read” the label, website, and press releases “as an instruction or encouragement to prescribe [Hikma’s generic] for any of the approved uses of [Vascepa].”
The Supreme Court reversed the Federal Circuit and found that Amarin had not stated a claim for inducement under § 271(b). To state such a claim, a plaintiff must plead three elements—the first two being an act of direct infringement and the inducer’s knowledge that the induced acts constitute direct infringement.
The third element, and the focus of the Court’s decision, is “active steps . . . to encourage direct infringement.” This element has also been described as “purposeful, culpable expression and conduct.” Illustrative examples of such conduct come from the Court’s precedent in Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U. S. 913 (2005). There, Grokster, a distributor of free file-sharing software, had “sent users a newsletter promoting its ability to provide particular, popular copyrighted materials.” Id. at 926. Another such distributor, StreamCast, had “beamed onto the computer screens of users of Napster,” another 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. Such overt efforts provided a basis for inducement liability.
Amarin sought to show Hikma’s active encouragement through several of its activities:
- Hikma’s generic label, which omitted the CV Limitation of Use and still retained information about a clinical study involving patients taking statins;
- Its patient information leaflet, which warned against possible side effects for “people who have heart (cardiovascular) disease”—the target population for Vascepa’s patented CV-indication method of use;
- Its website, which described its generic drug as “AB” rated, and listed the drug’s therapeutic category as “hypertriglyceridemia,” a category that includes but is broader than SH; and
- Its statements in press releases that its generic drug was “generic Vascepa,” without mentioning that the approved use was limited to the far-lesser-known SH indication,” and touting Vascepa’s U. S. sales figures attributable to both the SH and CV indications.
According to the Supreme Court, these activities (taken together) did not amount to the requisite active encouragement. With regard to Hikma’s generic label, the Supreme Court found that while it was true that it omitted the CV Limitation of Use and retained information about a clinical study involving patients taking statins, this was because the generic had to be identical to Amarin’s brand label, save for the carved-out CV use. Similar could be said for Hikma’s description of its product as a “generic,” as it is “normal industry practice” to “truthfully describe” a generic drug as “equivalent” to the brand-name comparator.
As for the press releases’ failures to mention that Hikma’s approved use was limited to the lesser-known SH indication, the Court rejected this argument, reasoning that “mere omissions” did not rise to the level of "affirmative statements or actions” to show active encouragement.
As for the leaflets’ statements identifying potential side effects for people with cardiovascular diseases (the patented indication) and noting that medication is sometimes prescribed for uses other than those specifically indicated, Amarin urged that medical providers “would plausibly understand” these statements to be encouraging infringing use. But the Court rejected this as off-point. The focus of the inquiry is the inducer’s affirmative steps, not whether others would plausibly understand those statements actions to induce infringement. In the Court’s view, these statements were a warning and disclaimer, and not any basis for liability.
As for the website statements describing the therapeutic category as “hypertriglyceridemia” (as opposed to the unpatented “severe hypertriglyceridemia”), the Court found no fault in describing this broad category; it did not find it to be an instruction to prescribe the drug for a specific patented use.
Last were Hikma’s statements of sales figures attributable to both the unpatented SH use and the off-label, infringing CV use. The Court rejected any causal chain, which began with these press releases directed to investors, and which ended with encouraging doctors and pharmacists prescribing Hikma’s generic for the patented CV use (that is, to the class of hypertriglyceridemia patients who already take statins). The Court made short work of this argument, noting that while this chain of events was “possible” (and “anything is possible”), it needed something more to nudge it over into the realm of plausible events giving rise to inducement liability under §271(b).
