Eisai Co., Ltd. reports that the US District Court for the District of New Jersey has ruled in favor of Helsinn Healthcare S.A. in the patent infringement lawsuit for the antiemetic agent, Aloxi (palonosetron hydrochloride) brought by Helsinn together with Roche Palo Alto LLC against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. in the United States, where it was determined that certain formulation patent claims for Aloxi are valid and infringed. Esai’s USsubsidiary, Eisai Inc., gained exclusive marketing rights to Aloxi in the United States and Canada from Helsinn. Aloxi is co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc. while sales of the product in the United States are booked by Eisai Inc.

Since 2011, Helsinn and Roche have filed patent-infringement lawsuits in the US District Court for the District of New Jersey, against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc., Sandoz Inc., and Teva, who were the first to submit abbreviated new drug applications (ANDAs) for Aloxi. Of these companies, Helsinn has already made settlements with Sandoz and Dr. Reddy’s, and under the conditions of the settlements, in principle, neither Sandoz nor Dr. Reddy’s is allowed to launch a generic version of palonosetron hydrochloride via an ANDA prior to September 30, 2018, except under certain circumstances.

In this decision which concerns Teva, the court ruled that the patent claims at issue are valid and are infringed. The term of these formulation patent rights plus pediatric exclusivity currently provides coverage for Aloxi through to July 30, 2024, subject to any appeal.

In addition, patent-infringement lawsuits were brought by Helsinn and Roche against several other companies, which subsequently filed ANDAs or 505(b)(2) applications for Aloxi after Dr. Reddy’s, Sandoz and Teva. Some of these lawsuits have been settled while the remaining lawsuits are currently being disputed in US district courts. Helsinn and Roche continue to litigate these cases, and the outcome of those litigations and any resolutions reached by the parties will ultimately determine the date of generic entry.

Source: Eiasi