The Supreme Court says the makers of a name brand drug may have to correct a patent that could hinder the approval of a generic drug.
The high court on Tuesday agreed with a court decision that forced Novo Nordisk A/S to correct the patent for repaglinide, which is marketed as the diabetes drug Prandin.
Generic drug maker Caraco Pharmaceutical Laboratories, Ltd., wants to make a generic version. But Novo had its patent description revised and made broader, which blocks Caraco's generic application. A federal judge ruled that Novo's description was too broad and ordered them to change it, although that decision was overturned by the U.S. Court of Appeals for the Federal Circuit.
The high court, in a unanimous opinion written by Justice Elena Kagan, agreed with the original decision. The case now goes back to the lower courts.
"While we are disappointed with the decision, it appears the Supreme Court has held only that Caraco may challenge the use code narrative for Novo Nordisk's patented method of treating diabetes with repaglinide in combination with metformin. Novo Nordisk's use code narrative is, and has always been, correct, and we are confident that further proceedings will show Caraco's challenge to the use code narrative is meritless," says James Shehan, vice president and general counsel of Novo Nordisk Inc, USA.