Eli Lilly and Company, et al. v. Teva Pharmaceuticals USA, Inc.

Eli Lilly and Company, et al. v. Teva Pharmaceuticals USA, Inc.

Fed. Cir. (2005)

Federal Circuit Affirmed Decision that Eli Lilly's Patent was Infringed and Valid

On July 13, 2005, the Federal Circuit affirmed a decision by Chief Judge Barker of the Southern District of Indiana that Eli Lilly’s patent claiming a method of using fluoxetine to treat PMS was infringed and valid. This case involved Lilly’s highly successful product Sarafem, which is used to treat Premenstrual Dysphoric Disorder (PMDD), a severe form of PMS. The Federal Circuit rejected Teva’s proposed non-infringement defense stating that the claim language was not as restrictive as Teva suggested, and affirmed that Judge Barker’s claim interpretation was consistent with the plain language and patent specification. As to validity, the Federal Circuit affirmed Judge Barker’s findings that the claim at issue was not obvious because, inter alia, while there were publications showing the potential use of fluoxetine to treat several disorders, including depression, nowhere had anyone used or suggested the use of fluoxetine for the purpose of treating PMS prior to the patent-at-issue. The Federal Circuit also rejected Teva’s other arguments as merely supporting an “obvious to try” theory.