Chugai files patent infringement lawsuit over Herceptin in Japan

Japan’s Chugai Pharmaceutical (TYO: 4519) filed a lawsuit to the Tokyo District Court as of October 12, 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 (trastuzumab) against the Japanese subsidiary of Pfizer NYSE: PFE), the marketing authorization holder of the biosimilar of Herceptin Injection.

Chugai, which is 62% owned by Swiss pharma giant Roche (ROG: SIX), cites Pfizer Japan’s infringement of the application patent owned by Genentech, also 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. The drug generated global sales of $7.2 billion last year, some $300 million of which were achieved in Japan.

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.