In Edwards Lifesciences LLC v. Medtronic Corevalve LLC, C.A. No. 12-23-GMS (D. Del. Dec. 27, 2013), Chief Judge Gregory M. Sleet first denied defendants’ (“Medtronic”) motion in limine, which sought a ruling from the Court that Medtronic’s “treated pericardial sacs and coupons, from which the leaflets and skirts in the accused CoreValve product are manufactured” were not “components” under 35 U.S.C. Section 271(f) because the sacs and coupons underwent “additional processing outside of the United States after they [had] been shipped by Medtronic,” including laser-cutting. Id. at 2. In support of its position, Medtronic relied on Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007), in which the Supreme Court ruled “that a master disk sent from the United States to be copied abroad was not a ‘component’ under Section 271(f).” Id. Specifically, Medtronic argued that the Supreme Court’s decision in Microsoft turned on the fact that “an extra step was required after exportation before the software could be installed.” Id. at 3-4. Judge Sleet found, however, that this reading of Microsoft was “too broad,” and that the Supreme Court’s actual inquiry was focused on “the identity of the exact item actually incorporated into the infringing device.” Id. at 4. Judge Sleet concluded that because the same sacs and coupons Medtronic supplied from the U.S. were “the exact ones both intended to be combined and actually combined in Mexico to form the Core Valve device,” the sacs and coupons constituted “components” under Section 271(f). Id.
Judge Sleet next granted plaintiffs’ (“Edwards”) motion in limine, which sought a ruling from the Court that Medtronic must present to the jury “noninfringing uses for ‘treated pericardial tissue that is the same as the pericardial tissue actually supplied by Medtronic’” in order to avoid liability under 35 U.S.C. Section 271(f)(2). Id. at 4-5. Having concluded that the sacs and coupons constitute “components” under Section 271(f), Judge Sleet determined that Medtronic “must show that porcine pericardial sacs and coupons treated with the same glutaraldehyde solution as those that Medtronic supplies from the United States to Mexico are ‘suitable for substantial noninfringing use.’” (citing Golden Blount, Inc. v. Robert H Peterson Co., 438 F.3d 1354, 1364 (Fed. Cir. 2006)). Id. at 5. Judge Sleet also noted that while “much of the case law” addressing “substantial noninfringing use” occurs in the context of 35 U.S.C. Section 271(c), there was “no apparent reason . . . why the Federal Circuit’s guidance regarding the type of evidence sufficient to establish ‘substantial noninfringing use’ under 271(c) should not apply also to 271(f).” Id. at 5 n.3.
Judge Sleet, however, denied without prejudice Edwards’ motion in limine which sought to preclude Medtronic from presenting or arguing to the jury “hypothetical uses of the porcine pericardial tissue that Medtronic supplied and/or supplies from the United States to Mexico.” Id. at 1 n.2, 6. Edwards was granted leave to raise this issue again at trial.