Waiver of Claims in Patent Infringement Lawsuit

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April 11, 2018 (Tokyo) -- Chugai Pharmaceutical Co., Ltd. announced that it has decided to waive its claim in a patent infringement lawsuit against Nippon Kayaku Co., Ltd.

Chugai filed a lawsuit to the Tokyo District Court as of August 17, 2017, 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 marketing approval of the biosimilar of Herceptin® Injection, citing such party's infringement of the application patents for the treatment of breast cancer owned by Genentech Inc. (Head office, California, USA; CEO, Bill Anderson), a member of the Roche group.

Chugai confirmed that the product developed by the defendant received a marketing approval for the indication of "advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection" on March 23, 2018. As a result, Chugai judged that the initial purpose of this lawsuit was achieved, and took the procedure for waiver of its claims on April 10.

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.

Chugai will continue its business while respecting the rights of other companies. As a company that aims to provide innovative drugs, we regard intellectual property rights that protect products and technologies resulting from research and development as very important assets. Chugai will deal rigorously with any acts that infringe them, including taking legal actions.

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