IPT Decided One of 2 Patents on Herceptin (trastuzumab) Listed in Green List of KFDA as being Invalid

Roche launched Herceptin for the treatment of HER2-positive metastatic breast cancer in Korea. And Celltrion, a Korean Pharmaceutical company, developed a biosimilar Herzuma to Herceptin (trastuzumab) and obtained marketing approval (MA) for a biosimilar Herzuma (trastuzumab) from KFDA on January 16, 2014. It has been approved for treatment of early and advanced (metastatic) HER2-positive metastatic breast cancer as well as advanced (metastatic) stomach cancer. Roche filed a patent infringement lawsuit against Celltrion.

Under the bifurcated system about patent invalidity challenge and patent infringement litigation, an invalidation trial against one of 2 listed Herceptin patents was filed to the IPT in KIPO rather than a court.  On May 28, 2014, the IPT decided that Korean Patent No. 1,261,749 on Herceptin is invalid due to obviousness. Korean Patent No. 1,261,749 with the expiry date of August 25, 2020 is based on PCT/US2000/023391 claiming the priority on US60/151,018 application.

The losing party, patentee, appealed the IPT decision to the Patent Court.