Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company today announces that the Tokyo District Court granted Debiopharm an overall victory for the first instance demanding the suspension of patent infringement of the formulation patent owned by Debiopharm (Patent N- 4430229) related to Elplat® (Oxaliplatin) Drip Infusion of 50, 100 and 200 mg a treatment drug for cancer.
The Court ruled that the sale of the generic version of the cancer drug by Nippon Kayaku Co., Ltd. (Nippon Kayaku) infringed Debiopharm’s Japanese patent.
Debiopharm filed a patent infringement law suit with the Tokyo District Court on May 8th, 2015 against Nippon Kayaku, the distributor of the generic version of Elplat® treatment. In accordance with this judgement, a provisional disposition order was issued for the company to suspend the distribution of products. Twelve other pending infringement actions were also filed by Debiopharm against all the generics companies that started to commercialize their generic version of Elplat® in 2015.
Elplat® is an anticancer platinum drug, for which Yakult Honsha, Co., Ltd. acquired development and commercialization rights in Japan from its licensor Debiopharm International SA (Switzerland) in 1997. Elplat® was approved for the indication for the treatment of “curatively unresectable advanced/recurrent colorectal cancer” in March 2005, and launched on the market in April of the same year. In August 2009, Elplat® became indicated for “postoperative adjuvant chemotherapy for colon cancer”. An additional dosage and administration for “curatively unresectable advanced/recurrent colorectal cancer” was approved in September 2009, and an additional dosage and administration for “postoperative adjuvant chemotherapy for colon cancer” was approved in November 2011. Subsequently, Elplat® was approved for the indication for the treatment of “curatively unresectable pancreatic carcinoma” in December 2013. And furthermore, Elplat® was approved for the indication for “unresectable advanced or recurrent gastric cancer” in March 2015 and then “gastric cancer” in November 2015, integrating “unresectable advanced or recurrent gastric cancer” and “postoperative adjuvant chemotherapy for gastric cancer”.