On October 5, 2020, Chris Loh was quoted in Bloomberg Law on the issue of skinny labels in a Federal Circuit dispute between GlaxoSmithKline Plc and Teva Pharmaceutical Industries Ltd.
According to the article, Glaxo sued Teva for infringing its patent on using compound carvedilol to lessen the chance of death from congestive heart failure, even when Teva was only selling the generic version of Coreg for hypertension. Teva said it used a “skinny label” that excluded hypertension as an indication for the generic drug.
Even after a drug is approved by regulators, brand companies sometimes discover their medicine can be used for new indications and will obtain a patent on the drug for that use. Skinny labels are used when a generic drugmaker gets Food and Drug Administration approval to sell a medicine, but only for uses that aren’t covered by active patents.
The majority agreed with Glaxo that Teva marketed the drug as the same as Coreg regardless of the skinny label. Chief Judge Sharon Prost, in a dissent longer than the majority opinion, said the majority “nullifies Congress’s statutory provision for skinny labels,” which were meant to shield generics from liability for inducing others to infringe.
“The majority and Judge Prost clearly are at opposite ends of the spectrum on the issue of ‘skinny labels,’” Loh said. This division explains why it took the court over a year to issue an opinion after oral argument, he said.
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