In re: Lamictal Direct Purchaser Antitrust Litigation, No. 19-1655 (3d Cir. 2020)Annotate this Case
GSK’s patent to an anti-epilepsy drug, Lamictal, was to expire in 2009. Teva sought to market a generic version of Lamictal, lamotrigine, before GSK’s patent expired. Teva submitted an Abbreviated New Drug Application. GSK sued for infringement. After Teva received a favorable ruling with respect to one claim in 2005, the parties settled. Teva would begin selling lamotrigine six months before it could have had GSK won but later than if it had succeeded in litigation. GSK promised not to launch an authorized generic (AG) version of Lamictal. Had the parties not settled and had Teva succeeded in litigation, it would have been entitled to a 180-day exclusivity period as the generic first filer but GSK could have launched an AG.
Companies that directly purchased Lamictal or lamotrigine (Direct Purchasers) sued, claiming the settlement violated the antitrust laws because GSK “paid” Teva to stay out of the market by promising not to launch an AG, resulting in Direct Purchasers paying more than they would have otherwise.
The district court certified a class of all companies that purchased Lamictal from GSK or lamotrigine from Teva. The Third Circuit vacated. The district court certified the class without undertaking the required “rigorous” analysis, failing to resolve key factual disputes, assess competing evidence, and weigh conflicting expert testimony, all of which bear heavily on the predominance requirement, and confused injury with damages.