Eli Lilly Granted Stay Extension, Prevents Teva’s Generic Alternative Until March 9th
By Brian Kozlowski – Edited by Anna Lamut
Eli Lilly & Co. v. Teva Pharma
Federal Circuit, February 24, 2009, No. 2009-1071
On February 24th, the Federal Circuit affirmed two to one an order by the United States District Court for the Southern District of Indiana extending the 30-month statutory stay on FDA approval of Teva Pharmaceuticals‘ generic version of Eli Lilly‘s postmenopausal osteoporosis drug, Evista®. The stay was extended until March 9, 2009, when trial was set to begin for Lilly’s suit against Teva, in which Lilly alleged that Teva infringed four method patents. Teva filed for and received an expedited appeal. Judge Rader, writing for the two-judge majority with Chief Judge Michel, found that Teva “fail[ed] to ‘reasonably cooperate’” in expediting the lawsuit by altering its product last minute and because of multiple delays in producing critical discovery. Controversially, the court based its decision also on allowing Eli Lilly the time to prepare, rather then solely on the factors mandated by the statute.
Patent Baristas notes the importance of even a short stay: Evista accounted for $1.075 billion in sales in 2008, meaning that a two-week extension could mean revenues of $41 million.
Patent Hawk’s Patent Prospector notes surprise at Judge Prost’s dissent, stating that “[f]or a court that regularly takes liberties interpreting the law, Prost strikes a pose as a religious constructionist to statute.”