Daiichi Sankyo Company, Ltd., et al. v. Mylan Pharmaceuticals, Inc. et al.

Daiichi Sankyo Company, Ltd., et al. v. Mylan Pharmaceuticals, Inc. et al.

D.N.J. (2009)

Fitzpatrick, Cella Successfully Defends Blockbuster Drug Benicar® on Behalf of Client Daiichi Sankyo

Fitzpatrick, Cella, Harper & Scinto achieved a major victory on behalf of client Daiichi Sankyo Company Limited against generic drug maker Mylan Pharmaceuticals in a Hatch-Waxman patent lawsuit concerning Daiichi Sankyo’s Benicar® family of high blood pressure medicines. Daiichi Sankyo scientists invented olmesartan medoxomil, the active ingredient in Benicar and received a U.S. Patent for their invention. Mylan sought to sell generic copies of Benicar® prior to the patent’s expiration in 2016. The blockbuster drug had worldwide sales of more than $1 billion in 2008.

After a two-week trial, on July 30, 2009, U.S District Judge William J. Martini in New Jersey ruled that Mylan had infringed the patent and rejected Mylan’s argument that the Daiichi Sankyo patent was invalid for obviousness. Judge Martini concluded that the prior art taught away from Daiichi Sankyo’s invention, that the invention was not structurally similar to the prior art, and thus was not obvious. In addition, Judge Martini found that Daiichi Sankyo demonstrated that several objective indicia weighed against a finding of obviousness.

Daiichi Sankyo’s litigation team was led by Fitzpatrick Cella partners Dominick Conde, Joshua Rothman, and Larry Scinto, and associates Lori Wolfe and Feng Xu. Fitzpatrick’s co-counsel on the case were Simpson Thacher & Bartlett and McCarter & English.