Hikma Asks Justices to Protect ‘Skinny Label’ Generic Path (1)

US Supreme Court justices didn’t show all their cards Wednesday during an argument that could influence how legally treacherous or safe it is to sell generic drugs in the US when a brand-name drug maker has a patent on some but not all drug treatments.

Hikma Pharmaceuticals USA Inc. told the high court there were reasonable and legally protected explanations for statements it made as it launched a generic alternative to an Amarin Pharma Inc.'s drug Vascepa. As a result, Hikma argued a district judge was right to quickly dismiss Amarin’s suit accusing it of infringement based on marketing statements combined with Hikma’s drug label, even though it carved out mentions of a drug treatment covered by active Amarin patents.

The US Food and Drug Administration has approved the drug compound, icosapent ethyl, for multiple “indications” including cardiovascular risk—the still-patented use—and severe hypertriglyceridemia—a use not covered by any active patents. Amarin contends its suit deserved to at least get to discovery. Amarin claims Hikma induced doctors to infringe through its “skinny” label, referred to its drug as “generic Vascepa,” and issued a press release that highlighted Amarin’s overall sales data, which included sales to patients with both cardiovascular risk and severe hypertriglyceridemia.

Amarin’s attorney Michael Huston of Perkins Coie said investments into the costly process of finding and guaranteeing the safety of new treatment methods for older drugs could be deterred if generic makers that use skinny labels aren’t constrained in their commercial speech by the law of induced infringement.

“What we are really fighting for in this case, is the opportunity to say, we spent five years, we spent $300 million, and we discovered something that is literally saving people’s lives,” Huston told the court. “Hikma wants to come and—having spent no money basically at all—try to capture all of those gains.”

Hikma’s lawyer, Chuck Klein of Winston & Strawn, countered that the US Court of Appeals for the Federal Circuit, was chilling all generic makers from pursuing skinny label offerings.

“Generic companies won’t choose” the skinny label pathway “if, at best, it means paying millions in legal fees and, at worst, a massive damages award.”

Justice Brett Kavanaugh was one of the few justices to discuss the potential policy consequences of the court’s upcoming decision and the compromise Congress struck when it passed the Hatch-Waxman Act in 1984, which made skinny labels possible.

If Amarin’s lawsuit clears the motion to dismiss stage, “that’s going to have some serious implications market wide,” he said to Huston, referencing an amicus brief submitted by former Rep. Henry Waxman, that made the same point.

Huston emphasized the “other side of that compromise,” which he said “was about protecting the need to encourage branded drugs to take existing products and invest massive resources to discover how those drugs can be used for new cures.” He also downplayed the impact: Amarin would still be “held to the burden to prove everything that we allege,” Huston said.

Other justices seemed hostile to any lines of argument that waded into policy.

Justice Sonia Sotomayer, in particular, said, “I always have problems when we use policy reasons to set a standard.”

“If they’re infringing a patent, they’re infringing a patent,” she continued.

Several patent lawyers said the court appeared likely to act incrementally without giving a complete victory to either side.

“It doesn’t seem like the court’s willing to accept the most strong versions of” either side’s position,” Will Milliken, an attorney at Sterne Kessler, said.

“Many of the justices were really trying to get to the narrow question of the pleading standard, here,” said Taylor Weilnau, a litigator at McDonnell Boehnen Hulbert & Berghoff. “The idea of a safe harbor is seeming less and less possible in this case,” she added.

Jeremiah Helm, a partner at Knobbe Marten, said Deputy Solicitor General Malcolm Stewart did manage to turn the court’s attention, though briefly, to Hikma’s label and whether that was the sort of evidence that could be counted against generic companies in a larger induced infringement analysis.

But still, he said, “the justices had no interest in carving out a special rule for inducement” in this particular patent-law specific context.

Sean Tu, a law professor at the University of Alabama, who has written about skinny label cases and advocated for more freedom for generic makers to operate, said he was disappointed in the tenor of the argument.

He said branded drugmakers have dramatically increased the amount of patents they seek for treatment methods in the last 30 years, and those patents generally extend out the period of time well beyond the life of a patent on the original drug compound and, without skinny labels, can keep generics at bay.

“I was cautiously pessimistic,” Tu said, while waiting to hear the argument. “I’m more pessimistic than cautious, now.”

The case is Hikma Pharm. USA Inc. v. Amarin Pharma Inc., U.S., 24-889, oral argument 4/29/26.