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US Supreme Court verdict backs generic challenge to 'use' patents

Success for generics maker Caraco in case to challenge 'method of use' patent covering Novo Nordisk's drug Prandin

Novo Nordisk suffered a defeat in the US Supreme Court yesterday in a lawsuit that could have ramifications across the pharmaceutical industry.

In the case, generic drugmaker Caraco Pharmaceuticals successfully argued that it should be able to challenge the scope of a 'method of use' patent covering Novo Nordisk's drug Prandin (repaglinide) in combination with metformin as a treatment for diabetes.

This is a game-changer and opens up a new avenue for the generics industry to challenge patents held by branded drug developers.

The FDA has approved three uses for Prandin, and Caraco is seeking to introduce a generic version indicated only for the two uses that are not patented.

However, it claims that the dispute patent granted to Novo Nordisk (No. 6,677,358) contains details that are so broad that it effectively blocks any approval of any form of generic competitor.

The 'use' patent had been endorsed by a US Court of Appeals verdict in 2010, but now the Supreme Court has ruled that Caraco can use the counterclaim provisions of the 2003 amendment to the Hatch-Waxman Act to force Novo Nordisk to modify what is known as the "use code narrative" in the patent.

In other words, Caraco can now proceed with a challenge to have the scope of the patent narrowed, potentially allowing it to launch a generic considerably earlier than 2018, when Novo Nordisk's current patent protection for Prandin expires in the US.

The generic company has been trying to revert the patent's use code narrative to its original form, before Novo Nordisk updated the claim in 2007 to read "a method for improving glycaemic control in adults with type 2 diabetes mellitus" from "use of repaglinide in combination with metformin to lower blood glucose".

Novo Nordisk's general counsel James Shehan said the company was disappointed with the verdict, pointed out that "the Supreme Court has held only that Caraco may challenge the use code narrative".

A separate case is pending before the Court of Appeals for the Federal Circuit, which could uphold the use code narrative of the patent and render the Supreme Court verdict moot in this instance.

"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," added Shehan.

The Prandin franchise, including combination product Prandimet (repaglinide plus metformin) achieved sales of around 1 billion Danish kroner ($176m) in 2011.

18th April 2012

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