A federal judge denied a request by Abbott Cardiovascular Systems Inc and Evalve Inc. for a temporary restraining order against the launch of the PASCAL transcatheter mitral valve repair (TMVr) system by Edwards Lifesciences Corp. and Edwards Lifesciences.
Abbott sued Edwards in the U.S. District Court for the District of Delaware on Jan. 28, alleging that the PASCAL system infringed on five of Abbott’s U.S. patents. Abbott filed for the temporary restraining order on Feb. 18. The order would have stopped Edwards “from manufacturing PASCAL and/or its major component parts in the United States for commercial sale, until the Court resolves Abbott’s Motion for a Preliminary Injunction,” according to the decision issued Tuesday by District Judge Maryellen Noreika.
“Although it appears that Abbott may be able to establish a case on the merits, Abbott has failed to establish that it will likely suffer irreparable harm prior to the hearing on its motion for a preliminary injunction,” Noreika wrote in her decision.
Edwards received the CE Mark for PASCAL in February, allowing it to begin marketing the system in Europe.
“Edwards has agreed that it will not enter the U.S. market prior to the hearing on Abbott’s motion for a preliminary injunction,” Noreika noted in her decision.
Abbott had argued in its motion that, should the restraining order not be granted, “Edwards will have likely manufactured and exported enough PASCAL to allow it to launch, and even supply the market for nearly half a year, even if this Court grants Abbott’s (preliminary injunction).”
Noreika said that Abbott’s language was “articulating theories about harm that ‘could’ result based on speculation” about Edwards’ marketing plans and possible future sales.
The hearing on Abbott’s preliminary injunction motion against Edwards has been expedited and will now take place April 15, about seven weeks earlier than originally scheduled, according to Noreika’s decision.
The PASCAL system is not approved in the U.S. Edwards said in a February news release announcing CE Mark approval for the system that the CLASP IID U.S. pivotal trial is currently enrolling patients with symptomatic primary mitral regurgitation.