Purdue Pharma L.P. v. Ranbaxy Inc.

An action by the FDA during the pendency of the instant actions rendered claims of infringement and the counterclaims asserting non-infringement moot, and the court declined to exercise jurisdiction over counterclaims asserting invalidity.

Fall 2013

GENERICally Speaking

Case Name: Purdue Pharma L.P. v. Ranbaxy Inc., 10 Civ. 3734 (SHS),13 Civ. 684 (SHS), 2013 U.S. Dist. LEXIS 102308 (S.D.N.Y. July 18, 2013) (Stein, J.)

Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone hydrochloride); U.S. Patent Nos. 7,674,799 (“the ’799 patent”), 7,674,800 (“the ’800 patent”), and 7,683,072 (“the ’072 patent”)

Nature of the Case and Issue(s) Presented: The FDA approved the original formulation of OxyContin in 1995. Purdue now manufactures and sells “Reformulated OxyContin,” which is more resistant to abuse than original OxyContin. Reformulated OxyContin is the subject of NDA 22-272, which the FDA approved in April 2010. As of August 2010, Purdue no longer sells original OxyContin in the United States. Plaintiffs sued Mylan and Impax for patent infringement. Mylan and Impax counterclaimed that their respective ANDA products will not infringe plaintiffs’ patents and that those patents are invalid.

In April 2013, before any of the OxyContin or Reformulated OxyContin cases had reached a final resolution, the FDA determined that original OxyContin had been withdrawn from sale for reasons of safety or effectiveness. This determination meant that original OxyContin is no longer a “listed drug” that can be the subject of an ANDA. See 21 U.S.C. § 355(j)(2)(A)(i), (j)(7)(C). As such, the FDA announced that it would “not accept or approve ANDAs that refer to” original OxyContin. In light of the FDA determination, the court ordered Mylan and Impax to show cause as to why the suits concerning original OxyContin should not be dismissed as moot. Mylan filed a two-page response saying simply that the FDA did not moot its declaratory judgment counterclaim for invalidity. Impax did not respond at all. The court dismissed the instant actions concerning OxyContin.

Why Neither Party Prevailed: “There can be no doubt that Purdue’s infringement actions and defendants non-infringement counterclaims are moot. The FDA Determination meted out all of the infringement-related relief that is available in these Hatch-Waxman Act actions. Whether the FDA determination mooted defendants’ declaratory judgment counterclaims for invalidity is a separate question.” The court presumed that defendants’ invalidity counterclaims were not moot, but declined to exercise its discretionary jurisdiction to hear them.

The court held that it had the discretion to decline to exercise jurisdiction over a Hatch-Waxman Act declaratory judgment action, even though the Court has constitutional jurisdiction over that action. It further held that the court can make this discretionary decision even if the dismissed claim is at an advanced procedural posture.

The court reasoned that “Defendants’ currently infringing conduct—their ANDAs seeking to make generic versions of Reformulated OxyContin—has already prompted Purdue to initiate separate lawsuits against them. These suits will give defendants the opportunity to contest the validity of the [patents-in-suit] in this district. Further, allowing the actions concerning defendants’ Reformulated OxyContin ANDAs to go forward will not cause any of the parties to expend any additional resources.” Therefore the cased concerning Reformulated OxyContin are “more fit” to go forward than those concerning original OxyContin.

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