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Sandoz Sues Novo Nordisk to Head Off Generic Challenge on Diabetes Drug

Sandoz Inc., a unit of the Swiss drug company Novartis AG (NOVN), filed a federal lawsuit in Detroit seeking the court’s finding that its proposed generic version of a Novo Nordisk A/S diabetes drug is non-infringing.

Sandoz plans to market a lower cost version of the Novo Nordisk diabetes drug Prandin, according to a complaint filed yesterday. It has asked the U.S. Food and Drug Administration for permission to do so.

The FDA application puts Sandoz “at considerable risk of being sued,” according to the company’s complaint, because it would bring the drug to market prior to the expiration of a Novo Nordisk-claimed patented element.

In January, Bagsvaerd, Denmark-based Novo Nordisk lost a U.S. court challenge to the patent in a lawsuit brought by Detroit-based Caraco Pharmaceutical Laboratories Ltd. It has challenged that ruling on appeal.

Sandoz has cited that finding of invalidity in its complaint.

“We are examining the suit,” Ken Inchausti, a Novo Nordisk spokesman said by phone today. He declined to comment further saying the company preferred to let the legal process run its course.

The case is Sandoz Inc. v. Novo Nordisk Inc., 11cv13594, U.S. District Court, Eastern District of Michigan (Detroit).

To contact the reporter on this story: Andrew Harris in Chicago at aharris16@bloomberg.net

To contact the editor responsible for this story: Andrew Dunn at adunn8@bloomberg.net

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