A panel of the US Court of Appeals for the Federal Circuit yesterday reversed the opinion of the District Court for the District of New Jersey and ruled that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Teva Pharmaceutical Industries’ (NYSE: TEVA) generic palonosetron product, says privately-held Swiss drugmaker Helsinn Healthcare.
This means that Israeli generics giant 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 allowing such a launch. This process may take several months, and potentially longer if the Federal Circuit were to grant a petition for review.
Helsinn and partner Eisai (TYO: 4523) say they are disappointed with the court’s ruling. Protecting intellectual property is vital to a company’s ability to continue developing medicines that will make a difference in the lives of patients. Helsinn and Eisai maintain their position that the patents protecting Aloxi are valid and will pursue further legal options to protect and enforce such patents.
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