법무법인(유한) 율촌 | Yulchon LLC

Yulchon successfully represented Celltrion in a patent invalidation proceeding filed against Roche Diagnostics AG (“Roche”) regarding Celltrion’s biosimilar of Herceptin® originally developed by Roche.

Although the Korean Intellectual Property Trial and Appeal Board (“KIPTAB”) held that the patent covering Herceptin® (“Herceptin Patent”) was invalid, the Korean Patent Court vacated the KIPTAB’s decision after Roche amended the independent claims in the Herceptin Patent. Yulchon then appealed the Patent Court’s decision to the Korean Supreme Court.

While the case was pending before the Supreme Court for about two and a half years, Yulchon presented airtight arguments and effectively compared the Herceptin Patent and other prior art references by submitting six briefs. As a result of Yulchon’s effective representation, the Supreme Court held on December 13, 2018 that the Herceptin Patent is invalid.

In the meantime, in addition to the invalidation proceeding, Yulchon also represented Celltrion in a separate patent infringement lawsuit and a preliminary injunction proceeding filed by Roche against Celltrion. In the foregoing proceedings, Yulchon also zealously asserted the invalidity of the Herceptin Patent, despite the Patent Court’s decision that the Herceptin Patent was valid. As a result, Yulchon successfully persuaded the civil court deciding issues of infringement that the amended Herceptin Patent was invalid, thereby dismissing both of Roche’s infringement claim and the preliminary injunction proceeding. This was a highly unusual decision, since the Patent Court’s decision was still ongoing before the Supreme Court. Soon after the Supreme Court in the invalidation proceeding held that the patent at issue was invalid, the infringement suit pending before the Patent Court was dismissed.

Herceptin® is a “blockbuster” biologic used to treat breast cancer. The market for Herceptin® is approximately USD 7.2 billion worldwide, which ranks Herceptin a “top 10 blockbuster biologic.” While Celltrion had already completed its research and all administrative procedures to release its biosimilar product, the launch of the product was delayed due to this litigation with Roche. In this regard, Yulchon’s successful representation helped Celltrion add billions of Won in revenues.

In addition to Yulchon’s significant contribution to Celltrion, Yulchon believes that this case will provide valuable insight to other drug manufacturers in the biosimilar industry particularly those who are involved in legal disputes.