Eli Lilly and Company has provided the following statement regarding a lawsuit filed by Sanofi in the United States District Court for the District of Delaware alleging patent infringement with respect to LY2963016, a new insulin glargine product for which Lilly is currently seeking approval from the U.S. Food and Drug Administration (FDA).
“Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents,” said Doug Norman, vice president and general patent counsel, Eli Lilly and Company.
Lilly, and its alliance partner Boehringer Ingelheim, recently announced the FDA had accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin.
LY2963016 is a new insulin glargine product developed for the treatment of patients with type 1 and type 2 diabetes. The NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference previous findings of safety and efficacy for an already-approved product (insulin glargine) in addition to the studies of LY2963016.
Under the Hatch-Waxman act, the initiation of the lawsuit automatically invokes a stay on FDA approval of the product for a period of 30 months, or until a court finds in favor of Lilly, whichever is sooner. It is too early to speculate whether a resolution would occur before the end of the 30-month litigation stay in mid-2016.
In July 2013, the companies announced the marketing authorization application (MAA) for LY2963016 was accepted for review by the European Medicines Agency (EMA).