Supreme Court Backs Maker of Generic Heart Drug in ‘Skinny Label’ Case

Amarin Pharma has not done enough to definitively show that its generic competitor, Hikma Pharmaceuticals, is infringing on Amarin’s patents for its anti-hypertriglyceridemia drug icosapent ethyl (Vascepa), the Supreme Court unanimously ruled Thursday.

“Amarin has failed to state a claim for active inducement … so its complaint cannot withstand Hikma’s motion,” Justice Ketanji Brown Jackson wrote in the opinion. “We therefore reverse the judgment of the federal circuit and remand the case for further proceedings consistent with this opinion.”

The case of Hikma Pharmaceuticals v. Amarin Pharma involves Hikma’s 2023 launch of its Vascepa generic, which only carries a more limited indication based on the branded drug’s original 2012 approval — for use along with diet changes to reduce triglycerides in adults with severe hypertriglyceridemia (≥500 mg/dL) — but not the much broader 2019 indication.

Hikma asked the High Court to consider whether calling a drug a “generic version” of a brand-name drug and citing public information about the branded drug — such as its total sales figures, which Hikma mentions in some of its materials for investors — is enough to constitute an inducement for prescribers to infringe the patent and use the generic version for indications patented by Amarin.

Under the federal Hatch-Waxman Act, which governs the generic drug industry, Congress bars generic drugmakers from advertising their drugs for patented uses but allows them to advertise unpatented uses. This is done using a “skinny label,” as the Supreme Court explains in a “questions presented” report on the case.

During oral arguments in April, Deputy Solicitor General Malcolm Stewart, who represented Hikma, said that under the lower court’s decision in favor of Amarin, “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,” he said. “And that sends a terrible message to the generic industry.”

Michael Huston, who argued on behalf of Amarin, said that the seven other generic manufacturers of icosapent ethyl had no other problem complying with the Hatch-Waxman Act restrictions. “Hikma alone was the one who described its product as ‘AB rated’ for ‘hypertriglyceridemia,’ even though that product is not approved for that distinct medical condition,” Huston said. “AB rated” refers to the FDA’s designation for a generic drug that is therapeutically equivalent to a brand-name drug.

“Hikma alone repeatedly [referred to] Amarin’s brand name, Vascepa, just at the moment when that name was synonymous in the market for treating cardiovascular [disease],” he continued. “Those statements and more by Hikma — that other generics did not use,” are reasonable grounds for suing, Huston said.

Huston also noted that if the court isn’t going to rule in Amarin’s favor and drop the case, “it would be especially important for the court to allow the case to proceed back on remand, because since the federal circuit [decided] the case … extensive discovery has occurred. Millions of documents have been exchanged … and that has revealed substantial new evidence of Hikma’s intent to infringe [the patent],” so Amarin would want to amend its complaint to the lower court.

But Charles Klein, the attorney for Hikma, scoffed at that notion. “Just to be clear, there is no such evidence,” he said. There is “no evidence that Hikma somehow intended its … press releases to induce infringement, or its online product catalog to induce infringement. Zero evidence.”

In the decision, Jackson mentioned that Amarin “finds fault in Hikma’s statements describing its product as ‘generic Vascepa’ or the ‘generic equivalent of Vascepa’ in the prelaunch press releases. But as we have explained, it is ‘normal industry practice’ to ‘truthfully describe’ a generic drug as ‘equivalent’ to the brand-name comparator … We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”