BRIEF—Tokyo court upholds Chugai Edirol patent

The Tokyo District Court 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 (eldecalcitol) based on the patent owned by Japanese pharma major Chugai Pharmaceuticals against Sawai Pharmaceutical, Nichi-Iko Pharmaceutical and Nissan Chemical.

On February 17, 2020, Sawai and Nichi-Iko obtained approval from the Ministry of Health, Labor and Welfare for their generic version of 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 processes.

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.