Supreme Court Allows Caraco Challenge Novo Nordisk on Prandin Patent Submissions

The ruling reverses an earlier decision dismissing Caraco’s claim to change Novo Nordisk’s submissions regarding the combination of drugs for diabetes treatments.

Today, Novo Nordisk announced that the US Supreme Court has reversed the US Court of Appeals for the Federal Circuit’s April 2010 decision. That decision dismissed generic manufacturer Caraco Pharmaceutical’s claim to change Novo Nordisk’s patent submissions regarding the combination use of repaglinide and metformin for the treatment of type 2 diabetes.

The Supreme Court concluded today that Caraco may pursue a claim to seek correction of Novo Nordisk’s use code on the ground that it is inaccurate and remanded for further proceedings on such a claim at the Court of Appeals for the Federal Circuit. Today’s 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.

Novo Nordisk markets repaglinide under the trade name Prandin® and a fixed-dose repaglinide/metformin tablet under the trade name PrandiMet® in the US. In 2011, sales of Prandin® and PrandiMet® in the US amounted to approximately 1 billion Danish kroner.

Source: Novo Nordisk

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