GSK'S ZOFRAN PATENTS UPHELD

GlaxoSmithKline (GSK) has won a patent battle with Par Pharmaceutical over the generic firm's challenge to GSK's antinausea cancer drug Zofran.

The U.S. District Court for the District of New Jersey issued a summary judgment upholding the validity of GSK's two method-of-use patents covering Zofran ODT (ondansetron) Orally Disintegrating Tablets, which has annual U.S. sales of about $225 million. The court also ruled that the generic version by Par's wholly owned subsidiary, Kali Laboratories, infringes on GSK's drug. Kali intends to appeal the court's decision, Par said.

In August 2004, GSK won a similar patent battle with Teva Pharmaceutical over the firm's challenge to Zofran.

In that case, the U.S. District Court for the District of Delaware upheld the validity of GSK's method-of-use patents for the drug: one which expires Aug. 16, 2005, and the other that expires Dec. 24, 2006, following the expiration of pediatric exclusivity.

Par said it expects to launch its generic version of Zofran ODT no later than December 2006.