Covenant not to sue does not defeat subject matter jurisdiction
Dey, L.P. and Dey, Inc. v. Sepracor, Inc., Civ. No. 08-372-JJF, January 30, 2009.
Farnan, J. Defendant’s motion to dismiss for lack of subject matter jurisdiction is denied.
This is a Hatch-Waxman case where Defendant is the holder of an approved NDA for various forms of levalbuterol hydrochloride inhalation solutions used in the treatment of bronchial disorders sold as Xopenex. A first Paragraph IV ANDA filer settled with Sepracor in other litigation with the agreement that it be allowed to enter the market in 2012 prior to the expiration of Sepracor’s six patents. Here, Sepracor sued on only five of its six patents. Sepracor provided a covenant not to sue on the 6th patent, which is the subject of sepracor’s motion to dismiss. If Dey is successful in invalidating the five patents, Dey may still be unable to enter the market because of the 180-day exclusivity period for the first-ANDA filer. Following Caraco, the court concludes that this action presents a justiciable controversy even though the first ANDA filer could lose its 180-day exclusivity period as a result.
