법무법인(유한) 율촌 | Yulchon LLC

On December 19, 2013, the U.S. Federal Circuit issued a ruling affirming the district court's claim construction, thereby confirming that Hanmi Pharmaceutical Co. Ltd.'s esomeprazole strontium does not infringe two of AstraZeneca's patents. AstraZeneca AB et al. v. Hanmi USA, Inc. et al., case no. 13-1490 (Fed. Cir. 2013). Hanmi's esomeprazole strontium was filed as a new drug application (NDA) under the FDCA Section 505(b)(2) pathway of the Hatch-Waxman regime, which allowed partial reliance on safety and efficacy data of AstraZeneca AB's acid reflux drug Nexium (esomeprazole magnesium). AstraZeneca had appealed an adverse claim construction ruling in the district court (United States District Court for the District of New Jersey, case no. 11-CV-0760), where AstraZeneca agreed to a consent judgment of non-infringement based on the claim construction. This is a historic case, since Hanmi is (i) the first Korean pharmaceutical company to obtain marketing approval under FDCA Section 505(b)(2) from the U.S. F.D.A.; and (ii) the first Korean pharmaceutical company to win patent litigation under the Hatch-Waxman regime.

Attorneys from Yulchon's IP Team worked closely with Hanmi's IP Team, Amneal Pharmaceuticals (Hanmi's U.S. distributor), and Hanmi's U.S. law firms (Sughrue Mion PLLC and McDermott Will & Emery LLP) on virtually every aspect of this case, including helping to prepare Hanmi for trial at the district court level, helping to negotiate the consent judgment, and reviewing and commenting on all pleadings and expert reports. Yulchon's attorneys served in an in-house capacity to efficiently communicate Hanmi's goals and concerns to its US law firms, as well as reporting the needs of the U.S. law firms to Hanmi. The attorneys on this case include Ki Young Kim, Young-Hill Liew and Samuel Lee.