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Mar 23, 2020

Chugai Files Patent Infringement Lawsuit against Fresenius Kabi in the U.S.

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.
Tel:+81-(0)3-3273-0881

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).

3. Defendants

  • (1) Name: Fresenius Kabi USA, LLC, etc.
  • (2) Address: Three Corporate Drive, Lake Zurich, Illinois 60047, USA, etc.

4. Prospects

  • No changes are expected to be made to Chugai’s financial prospects at this point.
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