US Supreme Court ruling in Novo Nordisk Prandin case favors generic drugmakers

The US Supreme Court yesterday reversed the US Court of Appeals for the Federal Circuit’s April 2010 decision that dismissed Caraco Pharmaceutical’s claim to change Danish insulin giant Novo Nordisk’s (NOV: N) patent submissions regarding the combination use of Prandin (repaglinide) and metformin for the treatment of type 2 diabetes.

USA-based Caraco, a subsidiary of Indian drugmaker Sun Pharmaceuticals (SUN: BO), may now pursue a claim to seek correction of Novo Nordisk’s use code on the ground that it is inaccurate. The Supreme Court ruling does not affect the separate appeal pending before the Court of Appeals for the Federal Circuit, which is now expected to resume, concerning the validity and enforceability of the underlying US patent.

“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.