Court Rules in Favor of Barr in Patent Challenge Over DDAVP

The U.S. District Court for the Southern District of New York has granted summary judgment to Barr Laboratories in its challenge to patents on desmopressin acetate tablets. The decision effectively ends a 30-month stay on the FDA's approval of Barr's product, the company said.

The court decision determined that the patents covering the brand product -- called DDAVP -- were "unenforceable and not infringed by Barr's product."

Barr filed an abbreviated new drug application for desmopressin acetate tablets in 0.1-mg and 0.2-mg strengths with the FDA in July 2002. In December 2002, European drugmaker Ferring B.V., which manufactures the branded product, and Aventis, which markets the brand product in the U.S., sued Barr for patent infringement. Barr later filed for summary judgment in April 2004.