As one long-running feud over the controversial generic drug carve-out known as “skinny” labeling comes to a close, the U.S.’ top lawyer is urging the Supreme Court to reverse a recent decision on another, arguing the ruling undermines a critical U.S. pathway for copycat medicines enshrined by Congress.
In a brief this week to the Supreme Court, U.S. Solicitor General John Sauer and other Department of Justice (DOJ) lawyers wrote in support (PDF) of generic drug maker Hikma in its scrap with Amarin over its generic to the fish-oil-derived heart and triglyceride drug Vascepa.
Sauer and the lawyers called on the justices to reverse a decision penned by a Delaware appeals court in June 2024 that favored Amarin’s side and revived its lawsuit against Hikma after a prior dismissal.
Under the skinny labeling practice, generic drug makers are permitted to launch their copycat drugs under some but not all approved indications of brand-name reference products. The provision was designed to increase competition and hasten the arrival of lower-cost generic medicines to the U.S. market.
The high court accepted Hikma’s plea to hear the case—which Amarin initially levied in 2020—last month.
Hikma’s Vascepa generic was approved in the U.S. in 2020 as a treatment for hypertriglyceridemia, with the FDA's endorsement omitting the original Amarin drug’s 2019 nod as a treatment for cardiovascular risk reduction.
In its lawsuit, Amarin has argued that Hikma nevertheless encouraged prescribing under the generic’s unapproved indication.
The 2024 appeals court decision that revived Amarin’s lawsuit agreed with the company that Hikma’s description of its product as “generic Vascepa” in media releases—without acknowledging its copycat drug’s label limitations—was enough for Amarin to make a plausible case for patent infringement.
In this week’s brief, which departed from the appeals court’s stance, Sauer echoed concerns raised by Hikma and other generic drug makers that’ve been embroiled in skinny label legal disputes.
“Pleading a claim of active inducement to infringe a patent requires, at minimum, factual allegations that plausibly explain how the defendant’s statements or actions—beyond the bare sale of a product that may be put to infringing use—actively encouraged and caused direct infringement by a third party,” Sauer wrote. “Amarin’s complaint includes no such allegations.”
Moreover, Sauer and his fellow DOJ lawyers argued that Hikma’s skinny label alone cannot serve as evidence of “encouragement to infringe,” given that such an argument would “contravene the basic design” of the skinny label carve-out.
“The Federal Circuit’s decision creates a significant disincentive for generic manufacturers to use the [skinny labeling mechanism], especially given the threat of massive patent-infringement damages under Federal Circuit precedent,” the U.S. lawyers concluded in their argument.
The solicitor general’s input on the case coincides with an announcement this week from consumer advocacy group Public Citizen that it had filed its own brief on the skinny label matter with the Supreme Court, also in support of Hikma.
Meanwhile, Hikma’s newfound support this week comes shortly after the resolution of another key case in the skinny labeling debate.
In a joint filing with the U.S. District Court for the District of Delaware, Teva and GSK said earlier this month that they had resolved their own decade-long row over skinny labeling, which in their case concerned a Teva generic of the GSK heart med Coreg.
Like Hikma, Teva had also petitioned the Supreme Court to hear its case back in 2023, although the justices declined.