Hikma Drug Label Win Still Leaves Generics on Hook for Liability

Generic drugmakers still face the threat of liability over a routine product labeling practice frequently under fire by brand-name companies despite a recent courtroom victory for Hikma Pharmaceuticals Plc.

Drugmakers were relieved when a district court dismissed claims that Hikma was promoting use of a copycat version of Amarin’s Vascepa to reduce heart disease risks, an indication patented by the name-brand company. Some legal experts say the decision mitigated fears that a separate appeals court ruling against Teva Pharmaceuticals’ labeling strategy would spur a wave of lawsuits and block low-cost drugs from entering the market.

But the fact-specific nature of skinny labeling—a practice that involves leaving a name-brand drug’s patented uses off of a generic label to avoid being held liable for infringement—means companies aren’t entirely off the hook.

“GSK v. Teva made induced infringement liability for skinny labeled drugs a reality, and the availability of that infringement theory hasn’t gone away,” said Sara Koblitz, a Hyman Phelps & McNamara PC attorney specializing in drug patent issues.

That case examined whether Teva’s labeling “sufficiently carved out enough of the patented use, as well as the specific language used in the generic sponsor’s promotional materials for the given product,” Koblitz said. “That’s not a framework that the Amarin decision upsets.”

In GlaxoSmithKline v. Teva, the U.S. Court of Appeals for the Federal Circuit twice determined that Teva, through promotional material and language on its label, encouraged doctors to prescribe its generic version of GlaxoSmithKline Plc’s Coreg heart drug for unapproved uses—despite its use of a skinny label. Those rulings put Teva on the line for $235 million in damages.

A district court in Delaware, in Amarin v. Hikma, found that Hikma’s label promoted its drug for severe hypertriglyceridemia, which wasn’t covered by a patent. The court also said public statements that its product is a generic alternative to Vascepa “does not expose Hikma to liability.”

The Amarin decision could provide a “roadmap” for brand-name companies to structure their own labeling so that they have a “better chance of success in future skinny label cases,” said Scott Lassman, a FDA law attorney at Lassman Law + Policy.

“Brand drugmakers can take a look at what didn’t work in Amarin, such as placing information about a protected use in a warning, and adjust their strategies to try to seed potentially problematic language in other parts of the label,” Lassman said.

Diverging Thinking

Generic producers are cautious to prevent doctors from prescribing their drugs for unapproved uses because that could open them up to patent infringement lawsuits and, potentially, massive damage judgments.

Skinny labels are a way to thwart unapproved uses, yet the Teva case illustrates how labels can still put generics at risk of patent infringement. Liability could depend on the particular circumstances surrounding a company’s marketing, however, as shown in the Amarin decision.

“This dismissal confirms the point that GSK v. Teva had some unusual facts and is not an invitation for an inducement lawsuit in every case” involving a skinny label, said Dmitry Karshtedt, a George Washington University law professor specializing in patents and drugs.

U.S. District Judge Richard Andrews “conducted a very fact specific inquiry that easily could have come out the other way,” Lassman said. The court went against the recommendationsof Magistrate Judge Jennifer Hall in dismissing the complaint.

Hall, in recommending that the court deny Hikma’s motion to dismiss Amarin’s lawsuit, wrote that “portions of Hikma’s label, taken together with Hikma’s public statements, instruct physicians to use Hikma’s product in a way that infringes the asserted patents.”

It’s “enough,” she wrote, that “Hikma’s label and public statements could instruct and/or encourage third parties to use its product” for patented purposes, and “that Hikma both knew and intended that third parties would use its product for that purpose,” Hall wrote.

But Andrews said the drugmaker’s label and promoting of the drug far fall short of inducing infringement of Amarin’s intellectual property.

‘Post GSK’

Some attorneys say the Jan. 4 decision in Amarin underscores the fact that Teva won’t serve as an example for future litigation.

GSK succeeded in its case against Teva by demonstrating—through labeling alongside company press releases and other materials—that a doctor could be led to prescribe the drug for unapproved purposes. But the court in Amarin makes clear that generic drugmakers need to actively encourage doctors to use their drug for infringing purposes, attorneys say.

“Counsel advising generics now have a concrete post-GSK example to help their clients end up on the right side of the line,” Karshtedt said.

In Amarin, Hikma’s label doesn’t mention Vascepa’s patented use for cardiovascular risk, yet it does warn of side effects for cardiovascular disease. The court, however, said that wasn’t enough to suggest induced infringement.

In deciding to toss Amarin’s case against Hikma, Andrews relied on existing Federal Circuit precedent on drug labeling, including a 2019 decision in Grunenthal GMBH v. Alkem Laboratories Ltd.

Andrews found that Hikma didn’t directly point to Amarin’s patented uses for Vascepa when describing itself as a generic equivalent. That means under Grunenthal—which found that generic drug labels proposed to the Food and Drug Administration didn’t specifically encourage uses covered by a name brand patent—the company is off the hook.

The court also cited the Federal Circuit’s 2015 decision in Takeda Pharmaceuticals. U.S.A., Inc. v. West-Ward Pharmaceuticals Corp., which rejected the idea that copycat drug labels need a statement clearly discouraging use for purposes patented by a rival drugmaker. Amarin had argued that Hikma’s label induced infringement because it didn’t state the generic shouldn’t be prescribed for the patented use.

An “important impact” of the Amarin decision is that “inducement precedents other than GSK, like Grunenthal and Takeda, still very much matter and can be persuasive to a district court,” Karshtedt added.

Full Court

Teva is asking the full Federal Circuit to take another look at the panel’s decision, arguing the outcome threatens to dissuade generic production for fear of massive jury penalties. The generic drug industry and others have lined up on Teva’s side.

Should the full Federal Circuit turn away the case—as it did once before—Teva could bring its challenge to the Supreme Court.

While the case, as stands, may set the stage for more skinny label lawsuits, Koblitz said the Amarin outcome shows “that at least the District Courts are closely examining the facts and that not all skinny labels automatically induce infringement.”