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. 

Remicade v. Remsima - Trademark Dispute between J&J and Celltrion

Remicade is a monoclonal antibody to treat RA. This blockbuster biopharmaceutical product was developed and has been sold by Centocor that is one of J&J groups.

A Korean company Celltrion developed a biosimilar product to Remicade and obtained a Market Approval (MA) from KFDA in 2013. Further Celltrion filed an application on their biosimilar product to EMA and has been trying to obtain MA, too.

On the other hand, Celltrion filed Remsima as their trademark with KIPO. J&J opposed to the TM application but failed in opposition. And Celltrion succeeded to register Remsima as their trademark for their new biosimilar products.

J&J filed an invalidation trial to Remsima TM registration before the IPT within KIPO. But Celltrion prevailed on the IPT proceeding. The losing party J&J appealed against the IPT decision to the Korean Patent Court. The two subject trademarks in dispute are shown below.

On August 18, 2014, the Patent Court rejected J&J's appeal finally. The Patent Court held that Remsima TM registration shall be valid because Remsima is not similar to Remicade in their sounds, shapes and meanings. The losing party J&J may appeal to the Supreme Court again.

Roche v. Celltrion re: Herceptin Patent Infringement Lawsuit over Biosimilar Herzuma

Celltrion, a Korean company developed a biosimilar Herzuma to Herceptin (trastuzumab) and obtained market 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 has marketed Herception for the treatment of HER2-positive metastatic breast cancer in 150 mg in Korea. However, for high strength of 440 mg, Roche obtained MA just January 26, 2014. Celltrion obtained MA of the first trastuzumab biosimilar for two strengths, 150 mg and 440 mg at the same time and will launch them soon.

Roche filed lawsuit against Celltrion alleging that Herzuma infringes Roche’s patents. More details will follow soon after they are available.