|Name of listed company:||Chugai Pharmaceutical Co., Ltd.|
|Code number:||4519 (1st Section of Tokyo Stock Exchange)|
|Head office:||1-1, Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo|
|President & CEO:||Tatsuro Kosaka|
|Inquiries to:||Masahiko Uchida,|
|General Manager, Corporate Communications Dept.|
Chugai Pharmaceutical Co., Ltd. announced today that Chugai, Roche and Genentech have filed a patent infringement lawsuit in the United States District Court for the District of Delaware as follows.
1. Date of Complaint
- March 19, 2020 (local time)
2. Reasons for the Action
- Fresenius Kabi USA, LLC, in concert with Fresenius Kabi Oncology Limited and Fresenius SE & Co. KGaA (collectively “Fresenius”), filed an Abbreviated New Drug Application (“ANDA”) for approval of a generic version of Alecensa® (generic name: alectinib, an ALK inhibitor, anti-cancer agent) to the U.S. Food and Drug Administration. Under the framework of the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman Act), Chugai, Roche and Genentech filed a patent infringement lawsuit against Fresenius alleging submission of ANDA infringed Chugai’s U.S. Patents (Nos. 9,126,931; 9,440,922; 9,365,514 and 10,350,214).
- (1) Name: Fresenius Kabi USA, LLC, etc.
- (2) Address: Three Corporate Drive, Lake Zurich, Illinois 60047, USA, etc.
- No changes are expected to be made to Chugai’s financial prospects at this point.