The U.S. Court of Appeals for the Federal Circuit affirmed a district court’s extension of a 30-month FDA stay. Eli Lilly and Company v. Teva Pharmaceuticals, Case No. 09-1071 (Fed. Cir., Feb. 24, 2009) (Rader, J.; Prost, J., dissenting).
Under 35 U.S.C. § 271(e)(2), a generic manufacturer infringes a patent by filing an abbreviated new drug application (ANDA) to obtain approval for a generic drug product claimed by a valid and unexpired patent. As part of the approval process, an ANDA applicant must make a certification addressing each patent listed in the Orange Book that claims the drug. The patentee then has 45 days to sue the ANDA applicant for patent infringement. If the patentee files suit, the FDA may not approve the ANDA until expiration of the patent, resolution of the suit or 30 months after the patentee’s receipt of notice, whichever is earliest. “The court entertaining the suit has discretion under the statute to order a shorter or longer stay if ‘either party to the action fail[s] to reasonably cooperate in expediting the action.’”
Teva Pharmaceuticals (Teva) filed an ANDA and Eli Lilly (Lilly) subsequently sued for patent infringement. Lilly holds the approved new drug application (NDA) for raloxifene hydrochloride (raloxifene) tablets. Lilly alleged that Teva’s ANDA infringed four of its 12 listed Orange Book patents for using raloxifene to prevent or treat postmenopausal osteoporosis.
Lilly amended its complaint, asserting Teva infringed three additional patents covering raloxifene particle size and formulation. Subsequently, Teva amended its ANDA to include a new particle-size measuring methodology for the active pharmaceutical ingredient in its proposed raloxifene tablets and provided Lilly with three batch samples. Two of the batch samples were provided before the expiration of the discovery deadline; one batch sample and 27,000 pages of related documentation were provided after the deadline.
Lilly moved to extend the statutory 30-month stay due to Teva’s alleged discovery violations, prejudicing Lilly’s trial preparation. The court granted Lilly’s motion to extend the stay. The court relied on evidence that Teva altered its proposed raloxifene tablets late in the litigation. The court extended the stay to allow Lilly a reasonable amount of time to test the altered samples and assess that information in preparation for trial. The Federal Circuit affirmed the district court’s decision and distinguished the 2002 Andrx decision by focusing on Teva’s lack of cooperation in expediting the patent litigation.