A panel of The United States Court of Appeals for the Federal Circuit has ruled that certain patent claims covering Aloxi are not valid.
The Aloxi injection is palonosetron hydrochloride, a therapeutic used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV).
Teva Pharmaceuticals make a generic palonosetron product that is a threat to Aloxi. The court ruled that Teva's generic does not infringe the Aloxi patent.
This decision above reverses a previous opinion of the District Court for the District of New Jersey.
Teva will not be able to launch a generic version of Aloxi until additional steps are taken by the Federal Circuit, the New Jersey Court and the Food and Drug Administration (FDA) allowing such a launch.
However, Helsinn Group and Eisai are disappointed with the court's ruling. The process of launching the generic may take several months; potentially longer if the Federal Circuit were to grant a petition for review. This means there are further legal challenges ahead.
Helsinn Group and Eisai maintain their position that the patents protecting Aloxi are valid and will pursue further legal options to protect and enforce such patents.
