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McDermott Wins Important Federal Circuit Patent Appeal for Hanmi

Thursday, December 26, 2013

First U.S. Litigation Win for a Korean Pharmaceutical Company under Hatch-Waxman Act

International law firm McDermott Will & Emery LLP achieved a landmark victory before the U.S. Court of Appeals for the Federal Circuit on behalf of Firm clients Hanmi Pharmaceutical Co., Ltd., Hanmi USA, Inc., Hanmi Fine Chemical Co., Ltd. and Hanmi Holdings Co., Ltd. (Hanmi).

The win represents the first U.S. litigation victory for a Korean pharmaceutical company under the Hatch-Waxman Act.

In the underlying case, the plaintiffs, AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (AstraZeneca), alleged that a pharmaceutical drug Hanmi proposed to market in the U.S. infringed on two asserted patents related to AstraZeneca’s branded product known as “Nexium®.” Based on these claims, AstraZeneca was seeking to bar Hanmi’s generic version of the drug from entering the market.

AstraZeneca asserted two patents that included claim terms “alkaline salt” and “pharmaceutically acceptable salt,” which they argued, covered the salt used in Hanmi’s proposed product. The U.S. District Court for the District of New Jersey disagreed and construed the claim terms in favor of Hanmi and entered a consent order of non-infringement based on construction of these terms. AstraZeneca appealed the District Court’s ruling to the U.S. Court of Appeals for the Federal Circuit.

“We are thrilled and honored to have had been a part of this historic and important victory for Hanmi,” said Blair M. Jacobs, partner and local practice group leader for McDermott’s Intellectual Property Litigation group in Washington, D.C.

McDermott was hired in August 2013 and argued in an expedited appeal that AstraZeneca’s patents were limited to the six specific salts identified in the patent’s written description. The Federal Circuit Judges unanimously agreed with the argument and affirmed the opinion of the District Court. With Judge Taranto writing for the majority, the court held that the patents’ written description clearly disclaimed a broader scope of “alkaline salts” and the doctrine of claim differentiation could not overcome express language in the specification.

In addition to Mr. Jacobs, the McDermott team included partner Soyeon Pak (Karen) Laub and associates Christopher Paulraj and Patrick Stafford. Senior Paralegal Michael Rodgers also provided valuable assistance to the team.

About McDermott Will & Emery

McDermott Will & Emery is a premier international law firm with a diversified business practice. Numbering more than 1,100 lawyers, we have offices in Boston, Brussels, Chicago, Düsseldorf, Frankfurt, Houston, London, Los Angeles, Miami, Milan, Munich, New York, Orange County, Paris, Rome, Seoul, Silicon Valley and Washington, D.C. Further extending our reach into Asia, we have a strategic alliance with MWE China Law Offices in Shanghai.

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