With a resounding unanimous vote, the U.S. Supreme Court has sided with Hikma Pharmaceuticals, ruling that its generic version of Amarin’s fish oil-derived cardiovascular drug Vascepa does not infringe patents held by the Irish company.
The ruling is a triumph for the generic drug industry and—in particular—for its use of “skinny” labels, which allow cheaper knockoff versions of drugs to be marketed for specific indications, provided they don’t infringe on patents protecting other uses.
With its 9-0 vote, the Supreme Court overturned (PDF) a lower-court decision, which ruled that Hikma had infringed on Amarin’s patents.
The ruling surrounded Amarin’s patent protection for Vascepa, which was approved by the FDA in 2012 to treat severe hypertriglyceridemia, a condition in which triglyceride (fat) levels in the blood are dangerously high and can cause heart problems.
In 2019, the FDA signed onto a label expansion for Vascepa, approving the drug to treat those with less-elevated levels of triglycerides and to reduce the risk of a variety of heart conditions. This secondary expansion opened up Vascepa to millions of patients in the United States as an alternate to statins in lowering cholesterol levels.
While Amarin’s patents for severe hypertriglyceridemia were invalidated in 2020, it still has protection for the less-severe form of the condition. The company reported sales of the treatment at $214 million last year.
Also in 2020, Hikma gained a “skinny label” approval for its copycat version of Vascepa and that same year, Amarin sued the London-based generics specialist. Amarin claimed that the way the Hikma marketed its product, calling it “generic Vascepa” in press releases, encouraged doctors to prescribe it for all its approved indications.
Amarin’s lawsuit was initially rejected by a Delaware court in 2022 but two years later a U.S. appeals court decision revived the complaint.
Amarin claimed that Hikma's marketing efforts differed from those of the other seven companies that have gained approval for their Vascepa generics.
On Thursday morning, however, Justice Ketanji Brown Jackson wrote that “Amarin’s allegations, whether viewed together or separately, fail to establish that Hikma took any affirmative steps to encourage infringement.”
“The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe,” Jackson added.
In the ruling, Jackson echoed similar issues that were brought up by U.S. Solicitor General John Sauer and other Department of Justice (DOJ) lawyers earlier this year in a briefing that supported Hikma’s stance.
“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.”
On Thursday, Patients For Affordable Drugs CEO Merith Basey applauded the decision, saying that it “protects an important pathway for bringing lower-cost generic medicines to patients.”
“Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA. That would have meant fewer generic challenges, delayed competition, and higher drug prices for patients and taxpayers,” Basey added.