A $235 million judgment against Teva in a case against GSK isn’t part of a run-of-the-mill patent dispute.
To generic drugmakers, the verdict is a threat to their ability to bring products to the market that have “skinny” labels—those that restrict a generic drug’s use to indications for which the branded product’s patents have expired.
It’s a fight that generics maker Teva has taken (PDF) all the way to the Supreme Court. Now GSK has clapped (PDF) back, urging the High Court to reject Teva’s petition.
“Nothing about the potential legal consequences of this case warrants revisiting the fact-specific decision of the Federal Circuit or reversing the jury’s verdict,” GSK argued.
The case involves GSK’s blood pressure drug Coreg, which went off patent in 2007 for its original indication. GSK later found that Coreg could also be used to treat heart failure, triggering a new period of patent exclusivity for that indication until 2015.
Teva began selling its generic version of Coreg in 2007, and four years later, the company added the heart failure indication to its generic's label at the FDA's request. In doing so, Teva improperly took some of GSK’s market for the patented indication, the Federal Circuit found.
In its Supreme Court filing, GSK says that the case should be seen as nothing more than Teva acting outside of its purview as a producer of generic medicine.
“The case presents no threat to generic companies who operate properly under the law of induced infringement as applied to generic drug labels—“skinny” or not,” GSK wrote.
For its part, Teva last month argued the verdict could have “enormous” implications for the common practice of skinny labeling. That, in turn, could sow “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain,” the company said.
And earlier this month, another generics manufacturer, Viatris, jumped on the Teva bandwagon with its appeal to the Supreme Court. The company, formerly known as Mylan, warned that the Teva-GSK verdict has “sparked copycat suits, threatening carveout labels generally.”
Previously in the GSK-Teva fight, a Delaware court in 2017 found that Teva’s label encouraged doctors to use it to treat heart failure and awarded a $235 million judgment to GSK.
A district court judge overturned the verdict, ruling for Teva. But in 2020, a U.S. appeals court restored the $235 million judgment. In February of this year, the U.S. court of appeals declined to reopen the case, compelling Teva to go to the Supreme Court.