Teva v. Sandoz

In a victory for a generic drug manufacturer on Tuesday, October 12, the Southern District of New York declined to require notice of intent and ability to launch a generic drug from defendants Sandoz, Inc. and Momenta Pharmaceuticals, Inc. Plaintiff Teva Pharmaceuticals brought the underlying infringement suit based on the defendants’ filing of a Paragraph IV ANDA for a multiple sclerosis drug, triggering a thirty month stay against FDA approval of the defendants’ generic version. Teva initially requested ninety days notice before defendants’ ability and intent to launch their drug. The defendants offered to notify Teva of FDA approval within two hours of receipt. Teva then asked for ten days prior notice before defendants’ launch of the drug, offering to post a bond against any of defendants’ resulting monetary damage and arguing that ten days would be the minimum amount of time for writing and filing a motion for preliminary injunction.

In denying Teva’s request, the court found no legal obligation for the defendants to provide confidential business information regarding the launch of its drug. The court further reasoned that requiring notice from the defendants “would function as an injunction by prohibiting Defendants from launching their product even if they have FDA approval and the thirty-month statutory stay period has ended.” Acknowledging that Teva may be correct in its belief that the defendants plan to launch their drug as soon as possible after FDA approval, the court seemed to opt for directly addressing the issue on the merits after a request for a temporary restraining order, rather than requiring the defendants to disclose confidential information to their competitor.

The court also acknowledged that other courts may have ordered generic drug manufacturers to provide notice of generic drug launch. Such rulings likely aim to increase certainty by providing earlier rulings on a court’s prohibition against allegedly infringing generics going to market, while rulings such as this Southern District of New York ruling are more concerned with protecting the confidentiality of generic manufacturers’ marketing strategies.