May 15, 2012

Federal judge rules in favor of Willkie clients in lawsuit over Sandoz Inc.’s bid for approval of a generic version of the sedative Precedex.

A federal judge in New Jersey recently ruled in favor of Willkie clients Hospira Inc. and Orion Corp. with respect to their lawsuit over Sandoz’s bid for approval of a generic version of the sedative Precedex. In Hospira Inc. et al. v. Sandoz Inc. et al., the U.S. District Court for the District of New Jersey held that the patent on the active ingredient in Precedex is valid and enforceable, and barred Sandoz from selling the proposed generic version of the drug until that patent expires. Precedex sales in the United States exceeded $170 million in 2011.

Lake Forest, Illinois-based Hospira, which is the world’s leading provider of injectable drugs and infusion technologies, and Finland-based Orion Corp. filed the lawsuit in September 2009 after Sandoz filed an abbreviated new drug application with the U.S. Food and Drug Administration, requesting approval for generic Precedex (dexmedetomidine HCl).

The court held that the defendants — Sandoz Inc. and Sandoz Canada Inc. — are permanently enjoined from making, using, selling, offering to sell, or importing their generic product until U.S. Patent No. 4,910,214 expires, including any applicable extensions. Orion owns the patent and Hospira is its exclusive licensee in the U.S. Judge Mary L. Cooper’s ruling comes after a two-week bench trial that ended on March 8.

The case was handled by partners Thomas Meloro and Eugene Chang, and associates Colman Ragan, Heather Schneider and Laurie Stempler.

Related Practice Areas