News & Events

On December 19, the United States Court of Appeal for the Federal Circuit, in a per curiam decision, affirmed the ruling of Chief Judge Irene Keeley of the U.S. District Court for the Northern District of West Virginia in favor of Daiichi Pharmaceutical Co. and its co-plaintiff (and U.S. licensee) Ortho-McNeil Pharmaceutical, Inc. in a landmark pharmaceutical patent case. The case stemmed from Mylan Pharmaceutical's filing of an ANDA, seeking FDA approval to release a generic version of Daiichi's market-leading anti-infective, Levaquin. Last December, Chief Judge Keeley issued a 116 page decision, rejecting each of Mylan's five separate invalidity and unenforceability defenses and ruling for Daiichi on all counts. Mylan appealed Chief Judge Keeley's decision, contesting each basis for her ruling in the Federal Circuit. The appeal was briefed over the summer and argued by Hank Gutman on December 7, before a packed ceremonial courtroom in the Federal Circuit.

The Federal Circuit decision means that Mylan will continue to be enjoined from producing, importing or selling Levaquin until Daiichi's U.S. patent expires in 2010. Worldwide annual sales of this product by Daiichi's licensees exceed $3 billion and continue to grow. 

The Simpson Thacher team was led by Hank Gutman and Bob Bourque, who were very ably assisted by Buzz Frahn, Jeremy Pitcock, Noah Leibowitz and Amy Semet, summer associates Alex Simkin, Scott Sukenick, Elise Wolinsky and David Zabell, as well as legal assistants Lea Levy and Dan O'Neil and former legal assistants Brian Ferry and Will Geiger.