Chugai Pharmaceutical Co., Ltd. announced today that it has filed a patent infringement lawsuit with the Tokyo District Court and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the generic drugs of an osteoporosis agent, active vitamin D₃ derivative Edirol^® Capsule 0.5µg / 0.75µg (generic name: eldecalcitol, hereafter, Edirol Capsule), against Sawai Pharmaceutical Co., Ltd. and Nichi-Iko Pharmaceutical Co., Ltd., the marketing authorization holders of generic versions of the drug, citing such parties’ infringement of a use patent owned by Chugai and Taisho Pharmaceutical Co., Ltd.

1. Date of Complaint
   May 29, 2020
2. Reasons for the Action
   On February 17, 2020, Sawai and Nichi-Iko received approval from the Ministry of Health, Labour and Welfare for their generic drugs of Edirol Capsule, respectively. Chugai and Taisho currently co-market Edirol Capsule wherein Chugai alleged that the generic drugs of Edirol Capsule infringe both companies’ use patent (patent number 5969161) , and filed an injunction with the Tokyo District Court against the manufacture, transfer, import, and offer of any transfer regarding the generic drugs, and disposal of stock.
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
4. Prospects
   No changes are expected to Chugai’s financial prospects at this point.