On Friday, the Supreme Court granted the petition for certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc, a patent case decided by the Federal Circuit. The Supreme Court will review the following 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?”
Here is more information about the case.
Amarin Pharma’s brief in opposition argued Hikma’s petition fails to identify a genuine issue because the “petitioners provide no reason to disturb the long-standing consensus that patent infringement ‘is a question of fact,’” and the opinion below does not conflict with precedent. Thus, Amarain contended, the petition should be denied. Furthermore, Amarin addressed Hikma’s claim that the Federal Circuit applied the wrong pleading standard by stating that, “[p]utting aside the fact that this argument seeks only fact-bound error correction, the Federal Circuit made no such error.” Amarin suggested the Federal Circuit “cited many factual allegations that together suggested” Hikma encourages the patented use, and the petitioners “simply disagree with the inferences drawn from those allegations.” Amarin also argued that “[w]hat petitioners really want is a heightened pleading standard under which a defendant cannot face discovery for induced infringement unless its communications recite all the patent claim language,” which, they state, “is not the law.” Finally, Amarin maintained the petition should be denied because it “presents no issue worthy of this Court’s review,” the “case turns on facts and any decision would have limited general applicability,” it is a “poor vehicle for the issues raised by the petitioners and their amici,” and “the court of appeals correctly concluded that respondents plausibly pleaded a claim for induced infringement.
Hikma Pharmaceuticals filed a reply brief arguing “[t]he decision below urgently warrants review because it exposes every generic drugmaker marketing the ‘generic version’ of a branded drug to potentially catastrophic damages, even if the generic omits all patented uses from its label.” It contended “Amarin falsely declares that Hikma ‘began marketing [its generic drug] broadly for unpatented and patented uses‘ and ‘actively encouraged physicians to prescribe Hikma’s generic drug so as to infringe Amarin’s patents.’” Hikma explained that it “called its product a ‘generic version’ or ‘generic equivalent’ of Vescepa . . . [and] correctly stated Vascepa is indicated ‘in part’ for the the noninfringing severe hypertriglyceridemia (‘SH’) indication.” Moreover, the brief argued, “Hikma’s website included . . . ‘an express disclaimer that Hikma’s product is FDA-approved for fewer than all uses of Vascepa.’” Hikma argueed that, “[i]f this were enough to assert inducement, Hatch-Waxman’s section vii would be a dead letter—as well as the Patent Act’s requirement for ‘actively induc[ing]’ all claimed method steps.” It asserted “[t]his case is about vague statements in press releases that are not directed to doctors and do not describe any treatment steps.” It stated a circuit “split is undeniable.” It concluded by saying the Supreme Court “need not wait for widespread abuse of the Federal Circuit ruling that misinterprets the Hatch-Waxman Act.”
The United States filed an amicus brief after the Supreme Court called for the views of the Solicitor General. In its brief, the government argued it is “the view of the United States, [that] the petition for a writ of certiorari should be granted.” According to the government, the Federal Circuit’s decision below “subverts Congress’s balance between competing interests by subjecting Hikma to a substantial threat of infringement liability for statements that either (a) are integral to the section viii pathway or (b) have no meaningful likelihood of increasing the prevalence of infringing off-label uses.”
Two amicus briefs were filed in support of the petition. These briefs were filed by Thirty Scholars of Law, Economics, and Medicine and the Association for Accessible Medicines.
We will continue to keep track of this case and report on developments.