US Court of Appeals reverses District Court’s ruling on Aloxi patent

A panel of the United States Court of Appeals for the Federal Circuit has reversed the opinion of the District Court for the District of New Jersey for Aloxi (palonosetron hydrochloride) injection.

The court decreed that certain patent claims covering Aloxi are not valid or infringed by Teva's generic palonosetron product.

The ruling also stated that Teva can launch a generic version of Aloxi only if the Federal Circuit, the New Jersey Court and the Food and Drug Administration (FDA) take additional steps to allow such a launch.

Aloxi comprises active substance palonosetron and is indicated to be used on patients undergoing chemotherapy to prevent nausea and vomiting.

The medicine should be administered before chemotherapy.

"The court decreed that certain patent claims covering Aloxi are not valid or infringed by Teva's generic palonosetron product."

Earlier in 2011, Helsinn and Roche filed patent infringement lawsuits in the US District Court for the District of New Jersey against Dr Reddy’s, Sandoz and Teva, the first company to submit Abbreviated New Drug Applications (ANDAs) for Aloxi.

Helsinn has already made settlements with Sandoz and Dr Reddy’s, under which both companies cannot introduce a generic version of palonosetron hydrochloride through an ANDA before 30 September next year, except under certain circumstances.

Helsinn and Eisai have exclusive marketing rights of Aloxi in the US and Canada and stated their disappointment with the latest court verdict.

Both companies stated that the patents protecting Aloxi are valid and they intend to pursue further legal options to validate and enforce such patents.