US Magistrate Judge Seltzer rejected jurisdictional arguments raised by Heartware, and refused to consider evidence upon which Heartware tried to rely. In rejecting Heartware's arguments, the Court described its submissions as "without merit" and "confused". The Court said, that despite Heartware's claims to the contrary, it is certainly possible that through discovery the plaintiffs may learn of facts indicating that some of Heartware's conduct falls outside a specific exemption under US law. The Court went further to say: "By way of example only, if Plaintiffs were to show that Defendant 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 ".
As the Court said, the plaintiffs should be able to use discovery tools which are available, namely witness depositions, interrogatories, document requests and requests for admissions. The plaintiffs served their first request for discovery and interrogatories on Heartware some weeks ago and, following the Court's ruling, the plaintiffs will pursue the discovery process with expedition.
Ventracor will continue to pursue infringers of its patents. In this litigation Heartware has never denied infringing but rather sought to argue that its conduct falls within a statutory exemption (safe harbour). This safe harbour is limited to "uses reasonably related to the development and submission of data" to the FDA prior to commercialisation.
Contact: Andrew Geddes