Chugai Pharmaceutical, one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products, announced that the Tokyo District Court (Civil affairs No. 29, Chief Judge Kazuhide Shimasue) has granted Chugai an overall victory for the first instance demanding the suspension of patent infringement of the manufacturing process patent owned by Chugai (Patent No. 3310301) related to Oxarol Ointment 25 µg/g, a treatment drug for keratosis including psoriasis vulgaris (Oxarol ointment) .
Chugai filed a patent infringement lawsuit with the Tokyo District Court on February 19, 2013 against Iwaki Seiyaku Co., Ltd., Takata Seiyaku Co., Ltd., and Pola Pharma Inc., the distributors of the generic version of Oxarol Ointment, as well as DKSH Japan Co., Ltd., the importer of the active pharmaceutical ingredient (API) of the generic drugs (four companies), alleging to suspend the infringement of the Patent.
In accordance with this judgment, a provisional disposition order will be issued towards four companies to suspend the import of API and the distribution of products.
Meanwhile, Cerbios-Pharma SA (Cerbios-Pharma), the manufacturer of API of the generic drug, and the four companies have respectively filed a request for patent invalidation with the Japan Patent Office.
Oxarol Ointment is an agent for the treatment of keratosis, using the active vitamin D3 derivative, maxacalcitol, as an active ingredient which Chugai has discovered. It is indicated for the treatment of four diseases, namely, psoriasis vulgaris, ichthyosis, palmoplantar keratosis, and palmoplantar pustulosis.