30 MONTH STAY UNDER ANDA EXTENDED BECAUSE OF APPLICANT DELAYS

Eli Lilly And Company v. Teva Pharmaceuticals Usa, Inc., [2009-1071] (February 24, 2009) [RADER, Michel, Prost] The Federal Circuit affirmed the district court’s extension of the statutory thirty-month stay of 21 U.S.C. § 355(j)(5)(B)(iii) (2003), preventing the U.S. Food and Drug Administration (“FDA”) from finally approving Teva’s Abbreviated New Drug Application (“ANDA”) because Teva recast its product.DISCUSSION: Lilly sued Teva on June 29, 2006, alleging that Teva’s ANDA infringed four method patents of its twelve listed Orange Book patents for using raloxifene to prevent or treat postmenopausal osteoporosis: The FDA then stayed approval of Teva’s ANDA for thirty months, from the date that Lilly received Teva’s paragraph IV notifications, expiring on November 16, 2008. On September 17, 2008, Lilly moved the district court under 21 U.S.C. § 355(j)(5)(B)(iii) to extend the statutory thirty-month stay due to Teva’s alleged discovery violations, prejudicing Lilly’s preparations for trial. The court granted Lilly’s motion on October 29, 2008, to extend the statutory thirty-month stay until the beginning of trial on March 9, 2009. The Federal Circuit found that the district court acted within its discretion. The Federal Circuit noted that 21 U.S.C. § 355(j)(5)(B)(iii) grants district courts the discretion to adjust the statutory thirty-month stay of ANDAs if “either party to the action failed to reasonably cooperate in expediting the action.”