The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits infringing uses of a brand-name drug.
In 2014, GSK sued Teva in Delaware federal court over its generic version of GSK’s heart drug Coreg. Teva argued it followed FDA instructions to “carve out” a patented method for using the drug to treat heart failure.
A jury awarded GSK $235 million in 2017. The ruling was overturned but then reinstated in 2020 by the U.S. Court of Appeals. The court determined Teva’s label combined with its marketing encouraged physicians to prescribe the generic in a way that constituted patent infringement.
In Teva’s Supreme Court appeal, it told the court the ruling would cause “havoc” and discourage the use of skinny labels which it claimed are “extraordinarily common” and “save patients and the federal government billions.” The Biden administration also urged the Supreme Court to hear the case. However, the Supreme Court declined.
GSK said in a court brief that it “presents no threat to generic companies who operate properly under the law.”
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