Eli Lilly & Co. v. Teva Pharms. USA, Inc., No. 2009–1071 (Fed. Cir. 2009)
Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for 30 months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if “either party to the action failed to reasonably cooperate in expediting the action.”
Today, in a 2–1 decision authored by Chief Judge Michel, the Federal Circuit affirmed a district court order extending the thirty-month stay of FDA approval of Teva’s ANDA for generic Evista (raloxifine hydrochloride) tablets. Eli Lilly markets Evista for the treatment and prevention of postmenopausal osteoporosis. Evista accounted for $1.075 billion in sales in 2008.
Thirteen patents are currently listed in the Orange Book for Evista, with expiration dates ranging from 2012 to 2017. On May 16, 2006, Teva notified Lilly of its Paragraph IV certifications on at least some of the patents. Lilly sued Teva on June 29, 2006, alleging that Teva’s ANDA infringed four method patents. Thus, the 30–month stay was originally set to expire on November 16, 2008. The district court set a trial date of March 9, 2009.
In February 2007, Lilly amended its complaint to assert that Teva infringed three more patents—U.S. Patent Nos.
