Case Explained: GSK, Teva quietly settle Coreg ‘skinny label’ dispute – Legal Perspective

Following a more than decade-long legal back-and-forth over the generic drug carveout practice known as “skinny” labeling, GSK and Teva have put their dispute to bed, new court documents show.

In a joint filing submitted Monday, GSK—the plaintiff in the action—and Teva, in the role of defendant, told the U.S. District Court for the District of Delaware that they have “resolved their disputes being litigated.”

The drugmakers provided several stipulations for their settlement, including dropping all claims, counterclaims, defenses, motions and petitions in the case, denying all pending motions as moot and keeping the Delaware federal court as the exclusive jurisdiction “for the purposes of enforcing this stipulation and order.”

The resolution of the case is more than 10 years in the making, with multiple twists and turns cropping up in recent years.

The lawsuit concerns GSK’s heart med Coreg, also known as carvedilol, and the skinny-label pathway for generic drugs, wherein a company can pursue a generic approval for some but not all of a branded drug’s indications once it has lost certain patent protections.

Teva launched a generic version of Coreg in two of the reference med’s three indications back in 2007, with GSK ultimately suing the Israeli-American drugmaker in 2014 after Teva added a third indication—congestive heart failure—to its generic’s label at the FDA’s instruction.

GSK’s claims largely hinged on its ownership of a method-of-use patent tied to carvedilol treatment for congestive heart failure.

In the intervening years, the Delaware district court in 2017 ruled that Teva’s label encouraged doctors to prescribe its generic for heart failure despite GSK’s ownership of the relevant patent, awarding GSK a $235 million verdict.

That verdict was later tossed and then reinstated, and Teva eventually petitioned the Supreme Court to hear its case. In May of 2023, the High Court declined to take on the matter. 

At the time, a Teva spokesperson told Fierce that the company was “disappointed” that the Supreme Court denied its petition, while stressing that the company “still has additional defenses that it will present to the Delaware District Court once the case is sent back to that court.”

According to court documents from early 2024, Teva and GSK subsequently filed a joint request for a status conference on the case to, among other matters, set a schedule for a bench trial.

While SCOTUS declined to pick up GSK and Teva’s case, the High Court’s expertise will be directed at another legal tangle on the skinny label issue, this time concerning Amarin Pharma and generic drugmaker Hikma.

Last month, the Supreme Court agreed to review the case, which revolves around Hikma’s generic version of Amarina’s fish oil-derived Vascepa (icosapent ethyl). Amarin’s 2020 lawsuit took issue with the fact that Hikma was allegedly able to promote its drug for Vascepa’s add-on indication for cardiovascular risks, despite only winning approval in severe hypertriglyceridemia.