Stage Set For Generics As Biden Admin Asks SCOTUS To Hear Skinny Labels Case Between GSK, Teva
- The Biden Administration told the U.S. Supreme Court that it should agree to hear a patent appeal over drug labels involving Teva Pharmaceuticals USA Inc and GSK Plc that could have significant consequences on the generic-drug industry.
- With the US solicitor general offering support for Teva over GSK in long-running litigation over skinny-label carve-outs of generic indications, the stage could be set for a major reversal at the Supreme Court that would favor the generics industry.
- The U.S. Solicitor General said Teva's generic version of GSK's heart drug Coreg could not have violated GSK's patent rights because Teva omitted the infringing use of the drug from its labeling.
- Such "skinny labels" typically allow generic drugmakers to launch their products earlier, Reuters reported, while avoiding liability for infringing patents.
- GSK sued Teva for patent infringement in 2014 over its generic version of Coreg. Teva argued that it followed FDA instructions to "carve out" a patented method for using the drug to treat heart failure from its label.
- Reuters noted that in its petition to the Supreme Court last year, Teva said the ruling would cause "havoc" for skinny labels, which it said are "extraordinarily common" and "save patients and the federal government billions." GSK countered that the case does not threaten generic drugmakers that "operate properly under the law."
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