Eisai Co., Ltd. has announced that the U.S. District Court for the District of New Jersey has ruled in favor of Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, CEO: Riccardo Braglia, "Helsinn") in the patent infringement lawsuit for antiemetic agent ALOXI (palonosetron hydrochloride) brought by Helsinn together with Roche Palo Alto LLC (Roche) against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively "Teva") in the United States, where it was determined that certain formulation patent claims for ALOXI are valid and infringed.
Since 2011, Helsinn and Roche filed patent infringement lawsuits in the U.S. District Court for the District of New Jersey, against Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. (collectively "Dr. Reddy's"), Sandoz Inc. (Sandoz) 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 who 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 U.S. District Courts. Helsinn and Roche continue to aggressively litigate these cases, and the outcome of those litigations and any resolutions reached by the parties will ultimately determine the date of generic entry.
Eisai's U.S. subsidiary 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.
Upon obtaining this ruling, there will be no changes at the present time to Eisai's full-year consolidated financial results forecasts for the year ending March 31, 2016 as announced on May 14, 2015. Should a revision to the financial results forecasts become necessary in the future, the company will make an announcement as soon as possible.