September 8, 2017 (Tokyo) -- Chugai Pharmaceutical Co., Ltd. announced that it has filed a lawsuit to the Tokyo District Court as of August 17, and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the biosimilar of anti-HER2 monoclonal antibody Herceptin^® Injection 60 and 150 (Herceptin^® Injection), against Nippon Kayaku Co., Ltd., the applicant for approval of the biosimilar of Herceptin^® Injection, citing such party’s infringement of the application patent owned by Genentech Inc., a member of the Roche group, as the ground.

Genentech is a patent holder and Chugai is the exclusive licensee of Herceptin^® Injection. Both are the co-plaintiff of the lawsuit.

Herceptin^® Injection is an anti-cancer agent, using anti-HER2 monoclonal antibody trastuzumab (genetical recombination), which Genentech Inc. has created. Herceptin^® Injection is indicated for the treatment of breast cancer that overexpresses HER2, and advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection.

As a company that aims to provide innovative drugs, we regard intellectual property rights that protect products and technologies resulted from research and development as a very important asset. Chugai will deal rigorously with any acts that violate them, including taking legal actions.

There is no impact on Chugai’s financial prospects for this matter at this stage.