Chugai Pharmaceutical Co., Ltd. announced today that it has filed a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, demanding the suspension of manufacturing, use of materials, and disposal of stock for the active pharmaceutical ingredient (API) of the generic drugs of an osteoporosis agent, active vitamin D₃ derivative Edirol^® Capsule 0.5 g / 0.75 g (generic name: eldecalcitol, hereafter, Edirol Capsule) against Nissan Chemical Corporation (hereafter, Nissan Chemical), also demanding damage compensation against Nissan Chemical, Sawai Pharmaceutical Co., Ltd. (hereafter, Sawai) and Nichi-Iko Pharmaceutical Co., Ltd (hereafter, Nichi-Iko). Concurrently, Chugai filed the petition for provisional disposition order against Nissan Chemical.

1. Date of Complaint
   November 27, 2020
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 of Edirol Capsule, respectively. At this point, only Sawai and Nichi-Iko have launched the generic drug. Nissan Chemical has recently been focusing on the API business of eldecalcitol for the generic drug of Edirol Capsule.

   In response to this situation, Chugai filed a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, demanding the suspension of manufacturing and use of materials, and disposal of stock for the API of the generic drugs of Edirol Capsule against Nissan Chemical, also demanding damage compensation against Nissan Chemical, Sawai and Nichi-Iko. Concurrently, Chugai filed the petition for provisional disposition order against Nissan Chemical.

   In this proceeding, Chugai alleges that Sawai and Nichi-Iko have outsourced the manufacturing of the API to Nissan Chemical and purchased and used the API from Nissan Chemical to manufacture and sell their generic drugs. Additionally, the API produced and used by Nissan Chemical in the manufacturing of the API infringes the substance patent (patent number 3429432) owned by Chugai.

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