Teva takes 'skinny' label dispute with GlaxoSmithKline to the Supreme Court: reports

As a closely watched “skinny” labeling legal imbroglio rolls on, branded drugmaker GlaxoSmithKline has notched another win against Israeli-American generics juggernaut Teva Pharmaceutical. Industry watchers’ eyes are peeled, given that the decision could send shockwaves through the generics market at large. 

The U.S. Court of Appeals for the Federal Circuit swatted down Teva’s request to rehear its so-called “skinny” labels case on its generic of the GSK heart drug Coreg. As a result, Teva plans to ask the U.S. Supreme Court to overturn the decision, the company said. 

The case comes down to “skinny” labeling, a popular type of carve-out in the world of copycat drugmakers. For decades, generic drugmakers have been able to get their copycats approved for one or several–but not necessarily all–approved indications of their brand-name counterparts. If a generic doesn’t cover all the indications of its reference product, then its label is “skinny.” 

Branded companies, for their part, argue that pharmacists sometimes ignore the skinny labels, leading to infringement when patients take generics for unapproved indications. 

The legal odyssey between Teva and GSK stretches back years. 

Back in 2007, Teva launched its generic version of GSK’s heart drug Coreg in two of the branded med’s three indications: hypertension and ventricular dysfunction after a heart attack. Four years later, the FDA told Teva to add the drug’s third indication for congestive heart failure, despite the fact that GSK had a patent for that use through 2015. 

GSK filed suit in 2014, arguing Teva induced doctors to prescribe the generic for congestive heart failure. Teva, for its part, said it was simply following the FDA’s instructions. 

RELATED: GSK again scores $235M in 'skinny label' case, but court admits it's 'unclear what Teva even did wrong'

Three years later, a jury ruled in GSK’s favor and ordered Teva to fork over $235 million. Teva managed to convince a district court judge to overturn the verdict, but an appeals court reversed that ruling and reinstated the original finding of infringement, plus $235 million in damages. 

In its latest decision, the appeals court reached the same conclusion, writing that it found “sufficient evidence of active encouragement and that Teva never disputed in this court the jury’s finding that it knew that the uses it encouraged, through the partial label and otherwise, infringed.”

In a dissenting opinion, however, several judges called the court’s decision not to rehear the case “disappointing.” 

“Ultimately, if playing by the skinny-label rules doesn’t give generics some security from label-based liability, generics simply won’t play,” one judge wrote in a dissenting opinion. “And who could blame them? The risk is too great.

“It seems implausible that Congress, when enacting the skinny-label provisions against the backdrop of the inducement statute, intended to put generics in this position,” the judge continued.

RELATED: GSK, Teva on-again, off-again lawsuit is back on: Will 'skinny labeling' get a reprieve?

A Teva spokesperson told Fierce Pharma “We are disappointed in this decision and plan to both seek Supreme Court review of this decision and to present additional defenses to the District Court.”

Despite claims that the ruling could reverberate industrywide, DLA Piper’s Geoff Levitt sees things differently.

“The broader takeaway here is that – notwithstanding the dire pronouncements from the dissenting judges and other commentators about the dramatic, 'seismic' effects of this case on generics’ ability to utilize the skinny label – in fact it’s just one of a long series of skinny label cases over the years that have each been decided on the specific merits of the case, as this one was,” Levitt said.

Just last month, a court ruled in favor of generic drugmaker Hikma in its skinny label dispute with Amarin, “further confirming that the skinny label is in fact alive and well,” Levitt added.  

Editor's note: This story has been updated with comments from Teva and Geoffrey Levitt, co-chair of DLA Piper's FDA Regulatory Practice.