SCOTUS Grapples With Marketing of Vascepa Generic With ‘Skinny Label’

How far can a generic drugmaker with a so-called skinny label go in publicizing a generic version of a brand-name drug? The Supreme Court heard arguments on this question Wednesday, but didn’t give a clear indication of which way its members were leaning.

The court was listening to oral arguments in the case of Hikma Pharmaceuticals v. Amarin Pharma, which involves Hikma’s 2023 launch of its generic for icosapent ethyl (Vascepa), 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.

The court is considering 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.

Deputy Solicitor General Malcolm Stewart, arguing in support of generic manufacturer 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.”

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.

“Recognizing that many drugs are approved for both patented and unpatented uses, Congress sought to ensure ‘that one patented use will not foreclose marketing a generic drug for other unpatented ones,'” the report noted. “Generic drugmakers ‘carve out’ patented uses from their labels, leaving only instructions to use generic drugs for their unpatented uses.”

So in effect, Hikma cannot promote its generic for Vascepa’s 2019 indication of reducing the risk of cardiovascular events in adults on statins with elevated triglyceride levels (≥150 mg/dL) and established cardiovascular disease or risk factors. In Hikma’s announcement of its U.S. launch, the company noted that its generic is not approved for any other indication but the severe hypertriglyceridemia indication.

Justice Brett Kavanaugh mentioned that former Rep. Henry Waxman (D-Calif.), one of the bill’s chief sponsors, filed a “friend of the court brief” in the case.

The brief says the lower court’s “decision threatens to decimate the compromise at the heart of the Hatch-Waxman Act, which in turn, threatens to undermine the generic pharmaceutical industry,” Kavanaugh relayed. “[Waxman] points out generics have saved $3.4 trillion over the past 10 years, and that the federal circuit’s decision here leaves generic drug companies in the dark about what might expose them to liability. All which is to say, I think the question is, if this is good enough, then that’s going to have some serious implications market-wide.”

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 said 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, adding there is “no evidence that Hikma somehow intended its … press releases to induce infringement, or its online product catalog to induce infringement. Zero evidence.”

The justices did not indicate which way they were leaning on the case, although Justice Ketanji Brown Jackson did seem to have some sympathy for Hikma. “The risk of liability [here] and what it could do to a generic I would think, would be pretty significant,” she said. “If they’re also liable — absent active inducement for people taking their generic and using it in an infringing way — you would think that could happen a fair amount, and it would really be a risk to the bottom line of this generic company.”