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Feb 24, 2022

  • Pharmaceuticals
  • Corporate

Tokyo District Court Renders Judgment on the Patent Infringement Lawsuit concerning Edirol Capsules

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: Osamu Okuda
Inquiries to: Toshiya Sasai
Head of Corporate Communications Dept.

Chugai Pharmaceutical Co., Ltd. announced that the Tokyo District Court has today rendered judgment to deny the plaintiff’s claim in the lawsuit filed on February 17, 2021 regarding the generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol® Capsule 0.5µg / 0.75µg (generic name: eldecalcitol, hereafter, Edirol Capsule) based on the patent owned by Chugai against Sawai Pharmaceutical Co., Ltd. (hereafter, Sawai), Nichi-Iko Pharmaceutical Co., Ltd. (hereafter, Nichi-Iko) and Nissan Chemical Corporation (hereafter, Nissan Chemical).

  1. Date of Complaint and Judgment
    February 17, 2021 Complaint from Chugai Pharmaceutical Co., Ltd.
    February 24, 2022 Rendered judgment by the Tokyo District Court
  2. Reasons for the Action

    On February 17, 2020, Sawai and Nichi-Iko obtained approval from the Ministry of Health, Labour and Welfare for their generic drugs to Edirol Capsule, respectively. Chugai recognizes that Sawai and Nichi-Iko have outsourced the manufacturing of the active pharmaceutical ingredient (API) to Nissan Chemical, purchased the API from Nissan Chemical, and used it to manufacture and sell their generic drugs. The above three companies have been producing and using the crystalline form covered by the patent owned by Chugai in these process.

    Therefore, Chugai filed a patent infringement lawsuit with the Tokyo District Court, based on the patent No.3429432 owned by Chugai, demanding the suspension of production and use and disposal of the substance in crystalline form, for which Chugai holds the patent, in association with the generic drug, and also demanding damage compensation against Sawai, Nichi-Iko and Nissan Chemical. The Tokyo District Court has rendered judgment to deny the plaintiff’s claim in the lawsuit today.

  3. Defendants
    1. Name: Sawai Pharmaceutical Co., Ltd.
      Address: 5-2-30, Miyahara, Yodogawa-ku, Osaka, Japan
    2. Name: Nichi-Iko Pharmaceutical Co., Ltd.
      Address: 1-6-21 Sogawa, Toyama City, Toyama Prefecture, Japan
    3. Name: Nissan Chemical Corporation
      Address: 5-1, Nihonbashi 2-Chome, Chuo-ku, Tokyo, Japan
  4. Prospects
    No changes are expected to Chugai’s financial prospects at this point. We will consider future measures based on the contents of the judgment.


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