Late last month, the Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a case originally decided by the Federal Circuit. The Supreme Court granted review to consider the following two questions:
- “When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a ‘generic version’ and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?”
- “Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?”
This is our argument recap.
Charles B. Klein argued on behalf of Hikma. According to Klein, to “‘actively induce infringement’ when dealing with statements requires a clear message that necessarily promotes infringement.” He argued “[a]ctive inducement cannot depend on whether doctors might read infringing instructions into product descriptions that, on their face, are entirely consistent with non-infringing use.” According to Klein, Amarin’s argument for explicit disclaimers “turns the statute on its head.” Klein further contended that, in “[a]greeing with Amarin, the Federal Circuit basically swapped the statutory term ‘active’ for its antonym, ‘passive.'”
Justice Thomas asked whether “it have been safe to just simply say that . . . the generic drug was . . . only approved for [one] indication and nothing more.” In response, Klein argued that “the law does not require that.” He went on to explain, however, that “Hikma did say that when it launched its product” and “on the accused website.”
Klein complained that, under “the decision below, you can get FDA approval of your skinny product label, but as soon as you put that product into commerce and you say anything about that product, anything, you call it a generic version, even if you have disclaimers, you can be sued.”
Malcolm L. Stewart argued for the United States, which filed an amicus brief supporting Hikma. According to Stewart, the Federal Circuit “erred in giving any weight at all to the label.” He explained that the “contents of a Hatch-Waxman skinny label are largely dictated by federal law, and to treat the generic manufacturers’ compliance with those requirements as any evidence of intentional inducement to infringe,” he argued, “would be wrong.” Stewart emphasized that “it’s a bedrock principle of inducement law that active inducement to infringe is required.” He said “[t]he question is not whether the defendant has adequately warned people away from infringement.”
Michael R. Huston argued on behalf of Amarin. According to Huston, this case is not limited to Hatch-Waxman or skinny-labels, but rather goes “far beyond the pharmaceutical industry.” He argued “Hikma got the full benefit of the Hatch-Waxman compromise when it was permitted to sell its product . . . with an FDA approved skinny label.” But, he continued, “in exchange, Hikma was required to promise not to promote its product for any still patented use.” Huston said this “limitation on generic marketing of . . . products is absolutely vital.” Moreover, he said, it is the “only thing that makes it economically rational for a branded company like Amarin to spend the $300 million” to find “life-changing” drug uses. He emphasized that “Hikma . . . repeatedly used Amarin’s brand name, Vascepa, just at the moment when that name was synonymous in the market with treating cardiovascular risk.” And, he said, Hikma took the required “active steps to encourage that infringement.”
Justice Thomas asked whether there was “anything inaccurate about” the statements Hikma released about its product. In response, Huston said, “[y]es, absolutely.” But, he said, regardless, “truth is not a defense to liability in an induced infringement situation.” Justice Thomas followed up by asking “what if they simply quote you?” Huston responded by arguing that quoting is not a defense because “the whole point of the compromise is that Hikma is allowed to market its product but only for the unpatented use, only as a treatment for severe hypertriglyceridemia.”
Justice Barrett revisited Huston’s opening statement and asked whether the “impact of this case . . . would be more broad,” and in particular whether “it would extend beyond just the pharmaceutical industry.” She suggested “this is a pretty fact-bound case about the plausibility standard.” Huston responded by saying the issue reaches to all patent cases.
Toward the end of his argument, Huston indicated that, in the event the Court disagreed with him, “it would be especially important for the Court to allow the case to proceed back on remand. As for why, he explained that “the Federal Circuit remanded the case and, since Hikma did not stay the mandate, extensive discovery has occurred.” According to Huston, this discovery “has revealed substantial new evidence of Hikma’s intent to infringe and the effect.”
In his rebuttal, Klein criticized the “argument that the conduct element turns on how a physician would understand vague and equivocal statements.” He said that “is not the standard when there’s an obvious alternative explanation.” He also made clear there were affirmative actions taken to prevent infringement. He cited press releases indicating “the product is only approved for the non-infringing indication and not approved for any other indication.”
We’ll report more when the Court decides the case.