Damages Claim Goes Forward in Prilosec Patent Infringement Litigation

In an August 5, 2013 ruling, Judge Denise Cote denied defendant Andrx Pharmaceuticals, Inc.'s summary judgment motion in plaintiff Astra Aktiebolag's long-running patent infringement action over a generic version of Prilosec.  The action began with Andrx filing of an ANDA, before it had actually made any of the allegedly infringing drug.  During the course of the lengthy litigation, Andrx manufactured $41 million worth of "validation batches" of the drug.  After the Court found infringement, Astra supplemented its complaint to allege damages arising from this manufacture.  Andrx moved for summary judgment, contending it never sold any infringing goods, and its mere manufacture of goods without sale could not constitute "commercial manufacture" that could give rise to money damages under the Hatch-Waxman Act.  Judge Cote rejected the argument, ruling that "commercial manufacture" did not mean "commercial marketing" as Andrx asserted, and that if Congress had meant "commercial marketing," it would have used that term.  The Court also rejected Andrx's argument that the earlier entry of a final injunction prohibiting sale of the goods precluded an award of damages for the manufacture of those goods.  Judge Cote ruled that the fact that Andrx was "enjoined from infringing patents going forward does not render any damages award for past infringement 'double recovery,'" and allowed the damages claim to proceed.

Patent Infringement Claims Based on ANDA Filing Dismissed as Moot

In a July 18, 2013 ruling, Judge Sidney H. Stein dismissed the patent infringement claims of Purdue Pharma, L.P. against Mylan Pharmaceuticals Inc. and Impax Laboratories over their Abbreviated New Drug Application filings for generic versions of the original formulation of OxyContin.  After the actions were filed, the Food and Drug Administration determined "that original OxyContin had been withdrawn from sale for reasons of safety or effectiveness," eliminating the ability to file an ANDA to market the drug.  Judge Stein then ordered the defendants to show cause why the suits should not be dismissed as moot, and, after considering their perfunctory responses, ruled that there "can be no doubt that Purdue's infringement actions and defendants non-infringement counterclaims are moot."  The Court also considered whether to dismiss the defendants' invalidity claims, noting that the Court "has discretion to decline to exercise jurisdiction over" a declaratory judgment action, "even though the Court has constitutional jurisdiction over that action."  Since Purdue Pharma had already filed separate suits involving the same patents against the defendants over their ANDA's for a reformulated OxyContin, Judge Stein concluded that the defendants would have the opportunity to litigate the invalidity defenses in those actions.  The Court therefore dismissed the infringement counterclaims and declined to exercise jurisdiction over the invalidity claims.