Medtronic, which inherited the spat when it purchased CoreValve and its transcatheter aortic valve implant in April 2009 for about $700 million, filed a writ of certiorari with the Supremes this week, requesting a review of a U.S. Court of Appeals for the Federal Circuit ruling that upheld the Edwards win last November.
Citing the "enablement" provision in U.S. patent law, stating that a patent must contain a written description of the invention such that any person "skilled in the art" could make and use it, Medtronic argued that Federal Circuit precedent is in conflict on the issue.
"The Federal Circuit’s cases are in conflict over the meaning and application of this core patentability requirement. The patent at issue claims a collapsible prosthetic valve attached to a stent ‘for implantation in a body channel," according to the Medtronic writ. "The specification describes the claimed invention as directed primarily to a valve implanted by catheter in the human heart. Yet the specification does not disclose how to make a valve that is small and stable enough to achieve that purpose. Engineers attempting to apply the patent could not make a valve suitable for human implantation despite many years of effort, and no experimental animal survived implantation for more than a few hours."
The Fridley, Minn.-based medical device company wants the Supremes to decide whether an invention is enabled when "the patent does not describe how to make and use it and engineers could not do so despite years of effort," according to the writ.
Medtronic is also asking the high court to overturn the lower court’s holding that Edwards is free to seek an injunction against Medtronic for the CoreValve device, citing eBay Inc. v. MercExchange, in which the Supreme Court "rejected a general rule favoring the grant of a permanent injunction to a prevailing patent infringement plaintiff," according to the writ.
Last month, Edwards asked a Delaware judge to award further damages in the case, after the U.S. Patent & Trademark Office granted an extension on the patent covering the Sapien valve.