As promised back in February, Teva Pharmaceuticals has asked the U.S. Supreme Court to overturn its $235 million loss in the company’s long-running “skinny label” patent feud with GSK.
The case, which hinges on a copycat version of GSK’s heart med Coreg, could have “enormous” implications for a common practice among generic drug makers, Teva argues. That could in turn sow “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain,” Teva said (PDF) in a petition made public Wednesday.
At issue is so-called skinny labeling, a popular type of carve-out in the generics arena, which has allowed drugmakers for decades to get their copycats approved for one or several—but not necessarily all—approved indications of their brand-name counterparts. A label is deemed “skinny” when the generic doesn’t cover all the indications of its reference product.
Branded drug makers have argued pharmacists sometimes ignore the skinny labels, which could amount to infringement when patients take generics for unapproved indications.
“A divided panel of the Federal Circuit has blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace,” Teva argued in its petition. “The result is to allow a narrow patent on one way of using a drug to completely block any generic competition, potentially for years.”
Generic medicines launch with skinny labels “almost half the time,” Teva claims. However, the federal circuit’s recent decision puts all of those launches “at risk.”
“Generic manufacturers that make pennies per pill could collectively face billions of dollars in liability for doing ‘everything right—proceeding exactly as Congress contemplated,’” Teva continued.
Teva and GSK’s skinny label litigation saga has been roiling for years now. Teva launched its Coreg generic in two of the branded med’s three indications back in 2007. Four years after that, the FDA told Teva to add the med’s third indication for congestive heart failure, despite GSK holding a patent for that use through 2015.
GSK sued in 2014, contending Teva induced doctors to prescribe its copycat for congestive heart failure, while Teva argued it was simply following the FDA’s instructions.
In 2017, a jury sided with GSK and ordered Teva to pay $235 million. Teva then convinced a district court to overturn the verdict, but an appeals court reversed that ruling and reinstated the original finding of infringement, plus $235 million in damages.
Back in February, meanwhile, the U.S. Court of Appeals for the Federal Circuit denied Teva’s request to re-hear its case. Three federal circuit judges dissented at the time.
“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.”