A Medical Device Daily

Ventracor(Sydney, Australia) has issued a statement saying thatHeartware (Miami) has failed in its motion in the U.S. District Court in Florida to dismiss patent infringement claims brought against it by a Ventracor subsidiary relating to the left ventricular assist heart valve device that Ventracor is developing.Ventracorlate last year filed a patent infringement suit againstHeartware, charging that company with infringing two of Ventracor’s U.S. patents for its cardiac left ventricular assist device (LVAD), the VentrAssist. Ventracor said last week that a magistrate judge rejected jurisdictional arguments raised by Heartware and that it refused to consider evidence and arguments by Heartware, saying those arguments were “without merit” and “confused.” Ventracor said that the court ruled that despite Heartware’s claims, it is possible that through discovery that plaintiffs may learn of facts indicating that some of Heartware’s conduct “falls outside a specific exemption under U.S. law.” It also cited the court as saying: “By way of example only, if [Ventracor] were to show that [Heartware] is selling its LVAD in the United States or abroad solely to make a profit, and not for the purpose of gathering data to be later submitted to the FDA, such conduct would not be exempt . . . “ Ventracor and its subsidiary served their first request for discovery and interrogatories on Heartware, they said, “some weeks ago” and, following the court’s ruling, they will pursue the discovery process “with expedition” and “continue to pursue infringers of its patents.” It said that in the litigation Heartware “has never denied infringing but rather sought to argue that its conduct” is protected by a safe harbor exemption limited to “uses reasonably related to the development and submission of data” to the FDA prior to commercialization. The company said it is pointed toward bringing the VentrAssist to global markets “in record time” and gaining “a significant share” of the LVAS market. It cites independent analysts putting that market at more than $5 billion annually.