Statistics of KIPO - IP Applications Trend Over Three Years in Korea

Statistics of KIPO - IP Applications Trend Over Three Years in Korea

12 Months Grace Period in Korea

Article 30 of the Korean Patent Act provides 12 months grace period for disclosed inventions. In inventor or his assignee may obtain a patent through filing an application for the disclosed invention within 12 months from the date of novelty destroying event.

The disclosure of an invention as novelty destroying event might be done by an inventor, his assignee or a 3rd party. If an inventor or his assignee disclosed the invention, they may obtain a patent under the grace period scheme. However, in case the invention was disclosed through patent publications such as A1 publication or B1 publication in any country which was filed by an inventor or his assignee, the grace period may not be applied and thus the applicant finally lost an opportunity to obtain a patent in Korea. Therefore, patent specification publications are critical exceptions to grace period under then Korean patent law.

In other hand, where a 3rd party disclosed the invention without permission of an inventor or his assignee, an inventor or his assignee may file an application for the disclosed invention within 12 months from the date of disclosure. An applicant must prove that the invention was disclosed by a 3rd party against his intention.

An applicant must submit a written document claiming grace period benefit to KIPO when filing a patent application. Further, within 30 days from the filing date, an applicant must submit evidence supporting his claims to the novelty destroying event.

BMS sued Korean pharmaceutical companies alleging patent infringement of entecavir compound patent and low dose formulation patent

Baraclude tablets are a blockbuster drug of BMS that has been sold for the treatment of chronic hepatitis B virus infection in Korea. BMS listed 2 patents in Green List of KFDA that is a local version of the Orange Book of US FDA. Entecavir compound is the active ingredient of Baraclude.

Korean generic companies obtained MA for generic versions to Baraclude and are ready to launch their generic products to the local market. BMS filed patent infringement lawsuits against Korean pharmaceutical companies recently.

Before BMS patent infringement lawsuits, local companies filed invalidity trials to challenge the validity of the corresponding Korean entecavir compound patent. Also, they filed trials to confirm the scope of patent right about the corresponding Korean low dose formulation patent. The invalidity case of the compound patent is pending in the IPT of KIPO. But the IPT decided that generic products do not infringe the scope of the low dose formulation patent. In appeal, the Patent Court upheld the IPT decision that low dose entecavir formulations of 0.5mg or 1.0 mg should be regarded being obvious over the prior art and that generic drug do not infringe the subject patent.

Korea has the bifurcated system that allocates decision power to separate authorities. Patent infringement issue and patent invalidity issue must be decided by two separate and independent courts. Patent infringement and invalidity challenge may occur simultaneously but two proceedings are correlated.

In the patent infringement lawsuits, defendants Korean companies will raise an affirmative defense about invalidity of entecavir compound patent. Such invalidity defense is allowed and the court may stay the infringement lawsuit proceeding on its discretion until the IPT of KIPO decides validity issue.

On the other hand, defendants are quite safe from patent infringement liability of low dose formulation patent because they had prior decisions from the IPT and the Patent Court that their products are out of the scope of the patent claims in issue.

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.