Teva and GSK’s feud over the common generic carve-out tactic known as skinny labeling is going all the way to the top.
After Israeli-American copycat drug giant Teva this summer petitioned the U.S. Supreme Court to overturn its $235 million loss in the long-running patent kerfuffle, the High Court has asked the Biden administration for its opinion on whether to reconsider the verdict, Reuters first reported.
The case, which has been running since 2014, concerns skinny labels, or labels that restrict a generic drug’s use to indications for which the branded counterpart’s patents have lapsed. The feud specifically centers around GSK’s blood pressure med Coreg, which went off-patent for its original indication back in 2007, the same year Teva began selling its generic version.
In its appeal to the Supreme Court earlier this year, Teva argued the case could have “enormous” implications for what it argues is a common practice among generic drug makers. That could in turn create “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain,” the drugmaker said in a July petition.
GSK clapped back the following month, telling the Supreme Court it shouldn’t take up the case because the verdict in its favor “presents no threat to generic companies who operate properly under the law of induced infringement as applied to generic drug labels—'skinny' or not."
In a new statement, a spokesperson for Teva said the company is "pleased that the Supreme Court has asked the Solicitor General to weigh in on this important issue impacting both the pharmaceutical industry and U.S. patent law."
While Coreg went off patent for its original use in 2007, GSK later found the drug held promise as a heart failure treatment, triggering a new era of patent exclusivity through 2015.
After Teva rolled out its Coreg copycat in blood pressure, the FDA in 2011 asked the company to add the med’s heart failure nod to the generic label. In doing so, Teva improperly muscled in on GSK’s market for the patented indication, the Federal Circuit found.
In 2017, a Delaware court found that Teva’s label encouraged doctors to use its generic to treat heart failure, awarding a $235 million judgment to GSK.
A district court then overturned that verdict, ruling in Teva’s favor. But in 2020, a U.S. appeals court restored the verdict. After the U.S. Court of Appeals refused to reopen the case this past February, Teva vowed to appeal to the Supreme Court.
Amid all the skinny labeling whiplash, fellow generics player Viatris in August jumped in with its own Supreme Court appeal, warning that the Teva-GSK verdict had “sparked copycat suits, threatening carveout labels generally.”