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

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

S.D. Ind. (2004)

Fitzpatrick Cella client, Eli Lilly, Prevails Against Teva in Sarafem Litigation

In a 90-page decision, Chief Judge Sarah Baker of the Southern District of Indiana ruled that Lilly’s patent covering its highly successful product Sarafem, which is used to treat Premenstrual Dysphoric Disorder (PMDD), a severe form of PMS, is both valid and enforceable. Teva had previously conceded that its product would infringe under the Court’s claim interpretation ruling. The decision followed a two week trial in November 2003.

The ‘998 patent in suit claimed a method of using fluoxetine to treat PMS. The court stated that the claim at issue was novel because, while there were publications showing the potential use of fluoxetine to treat several disorders, including, inter alia, depression and anxiety, nowhere had anyone used or suggested the use of fluoxetine for the purpose of treating PMS prior to the ‘998 patent. The Court also rejected Teva’s assertion that the use of fluoxetine to treat depression or anxiety made its use for treating PMS obvious. The Court found that history had shown that not even those of extraordinary skill, who had ready access to fluoxetine years prior to the ‘998 patent, were motivated to use fluoxetine to treat PMS prior to the ‘998 inventors, and the benefits of using fluoxetine to treat PMS were an unexpected “therapeutic triumph”. Lead attorneys for Lilly were Dominick A. Conde and Steven C. Kline.

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