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Case 1:12-cv-00023-GMS Document 150 Filed 12/27/13 Page 1 of 6 PageID #: 6453

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE EDWARDS LIFESCIENCES LLC, et al., Plaintiffs, v. MEDTRONIC CO REV AL VE LLC, et al., ) ) ) ) ) ) ) ) ) )

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Civil Action No. 12-23 (GMS)

Defendants.

ORDER
At Wilmington, this

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day of December, 2013, having considered the letter brief

submitted by the defendants Medtronic CoreValve LLC, Medtronic CV Luxembourg S.a.r.l., Medtronic Vascular Galway Ltd., Medtronic, Inc., and Medtronic Vascular, Inc. (collectively "Medtronic") regarding their motion in limine 5 (D.I. 134), 1 the letter brief in opposition submitted by Edwards Lifesciences LLC and Edwards Lifesciences PVT, Inc. (collectively "Edwards") (D.I. 143), as well as Edwards' letter brief regarding its motions in limine 4 and 5 (Id.), Medtronic's letter brief in response (D .I. 146),2 and the discussion by the parties during the pretrial conference on December 4, 2013; IT IS HEREBY ORDERED that:
I. Medtronic's motion in limine 5 is DENIED.

Medtronic's motion in limine 5 relates to: "Admissibility of evidence concerning pericardial sacs or coupons under Fed. R. Evid. 402 and 403, given that the pericardial sacs and coupons are not a component of the patented invention as required by 35 U.S.C. §§ 27l(t)(l) and 271(t)(2)." (D.1. 125 at Exhibit W.) Edwards' motion in limine 4 relates to: "Whether Medtronic should be precluded from presenting evidence or argument to the jury concerning tissue other than that which Medtronic supplied and/or supplies from the United States to Mexico, that is, porcine pericardium tissue, treated with Medtronic's specific glutaraldehyde and bioburden reduction solutions." (D.I. 127.) Edwards' motion in limine 5, in tum, relates to: "Whether Medtronic should be precluded from presenting evidence or argument to the jury concerning hypothetical uses of the porcine pericardial tissue that Medtronic supplied and/or supplies from the United States to Mexico." (Id.)

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Medtronic contends that the treated pericardial sacs and coupons, from which the leaflets and skirts in the accused CoreValve product are manufactured, are not "components" under 35 U.S.C. § 271(f) because "[t]he porcine pericardial sacs and coupons undergo additional processing outside of the United States after they have been shipped by Medtronic, including laser-cutting the sacs and coupons into finished leaflets and skirt pieces." (D.I. 134 at 2.) Thus, Medtronic argues, "[i]t is these finished leaflets and skirt pieces that are the 'components' of the CoreValve, not the uncut pericardial sacs and coupons which are merely the material out of which the components are made." (Id.) In support of its arguments, Medtronic relies on the Supreme Court of the United States' decision in 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. at 1-5.) Edwards counters that the treated porcine pericardial sacs and coupons must be considered "components" for the purposes of Section 271(f) because "[t]here can be no dispute that the same treated porcine pericardium supplied by Medtronic from the United States to Mexico is used in the assembly of the infringing CoreValve device." (D.I. 143 at 4.) Edward contends that Microsoft

Corp. v. AT&T Corp. is thus inapposite because that case turned on the fact that the master disk
supplied from the United States was never itself installed in the foreign computers. (Id at 3-4.) Rather, only copies of the master disk were installed in foreign computers to create infringing devices. (Id at 4.) Thus, Edwards argues, the instant case is distinguishable because "[t]here is no suggestion that the material supplied from the United States is 'copied' or cloned for use in the CoreValve device .... Put simply, the tissue supplied by Medtronic is the tissue in the final CoreValve product, which renders Microsoft inapplicable." (Id) The court agrees with Edwards.

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The fact that the master disk that Microsoft sent abroad from the United States was not actually installed in any computer to produce an infringing device was essential to the Supreme

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Court's ruling in Microsoft. 550 U.S. at 442 (Explaining that "[t]he master disk or electronic transmission Microsoft sends from the United States is never installed on any of the foreign-made computers in question. Instead copies made abroad are used for installation."). Rather than the master disk itself being installed in computers upon being received abroad, the master disk was used to make copies and it was these copies that were then installed in foreign-made computers in a manner that infringed AT&T' s patent. Id. This copying, rather than actual installation of the master disk, was the reason why the Supreme Court ruled that the master disk that Microsoft sent abroad did not constitute a component for the purposes of Section 271 (f). Id. ("Because Microsoft does not export from the United States the copies actually installed, it does not 'suppl[y] ... from the United States' 'components' of the relevant computers, and therefore is not liable under § 271(f) as currently written.") As the Supreme Court explained: Section 271(f) prohibits the supply of components "from the United States .. .in such a manner as to actively induce the combination of such components." Under this formulation, the very components supplied from the United States, and not copies thereof, trigger§ 271(t) liability when combined abroad to form the patented invention at issue. Here, as we have repeatedly noted, the copies of Windows actually installed on the foreign computers were not themselves supplied from the United States. Indeed, those copies did not exist until they were generated by third parties outside the United States ....

The absence of anything addressing copying in the statutory text weighs against a judicial determination that replication abroad of a master dispatched from the United States "supplies" the foreign-made copies from the United States within the intendment of§ 27l(t).
550 U.S. at 453-54 (Italics present in original. Citations omitted and boldface added.). In light of the Supreme Court's explicit statement that it was the use of copies in Microsoft that was essential to its decision, Medtronic's claim that "[t]he decision was premised on the fact

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that an extra step was required after exportation before the software could be installed" is too broad a reading of Microsoft. The Supreme Court's focus was not merely on the requirement of an "extra step". Rather, the focus of its inquiry was on the identity of the exact item actually incorporated into the infringing device. In keeping with the Supreme Court's inquiry in Microsoft, the court in the instant matter must ask what are the actual items incorporated into the CoreValve device and whether these items are those that Medtronic supplies to Mexico from the United States. As Edwards points out, and Medtronic does not deny, the treated porcine pericardia! sacs and coupons that Medtronic sends from the United States are exactly what is used to create the leaflets and skirts combined to make the Core Valve device in Mexico. (D.I. 134 at 3; D.I. 143 at 3.) The fact that these sacs and coupons are subject to additional manipulation and "processing" after their arrival in Mexico, (D.1. 134 at 3), avails Medtronic naught. There is no argument made or proof adduced here, as there was in Microsoft, that the sacs and coupons are copied and that it is these copies that are used to make the CoreValve device. Thus, because the same treated porcine pericardia! sacs and coupons that Medtronic supplies from the United States to Mexico are the exact ones both intended to be combined and actually combined in Mexico to form the CoreValve device, these sacs and coupons are components for the purposes of Section 271 (f). See Microsoft, 550 U.S. at 449 ("Section 271(f) applies to the supply abroad of the 'components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components.' The provision thus applies only to 'such components' as are combined to form the 'patented invention' at issue.")

2. Edwards' motion in limine 4 is GRANTED.
Edwards' motion in limine 4 focuses on the type of evidence that Medtronic must present to the jury in order to avoid liability under 35 U.S.C. § 271(f)(2). (D.I. 143 at 5.) Section 271(f)(2)
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renders liable as an infringer anyone who, among other things, "supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use .... " Edwards argues that Medtronic must demonstrate noninfringing uses for "treated pericardia! tissue that is the same as the pericardia! tissue actually
supplied by Medtronic." (D.I. 143 at 5 (emphasis in original).)

As the court has explained above, the treated porcine pericardia! sacs and coupons that Medtronic sends from the United States to Mexico are components for the purposes of Section 271(f). Thus, as Edwards asserts, Medtronic must show that porcine pericardia! 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". See, e.g., Golden Blount, Inc. v.
Robert H Peterson Co., 438 F.3d 1354, 1364 (Fed. Cir. 2006) (Focusing on the defendant's exact

product in concluding that the district court did not err in finding that the infringing product was not suitable for substantial noninfringing use); Mentor HIS Inc. v. Medical Device Alliance, Inc., 244 F.3d 1365, 1379 (Fed Cir. 2001) (same). 3

Much of the case law discussing the requirements of "substantial noninfringing use" arises in the context of Section 27l(c), which predates Section 27l(f). See, e.g., Golden Blount, Inc. v. Robert H. Peterson Co., 438 F.3d 1354, 1364 (Fed. Cir. 2006); Mentor HIS Inc. v. Medical Device Alliance, Inc., 244 F.3d 1365, 1372, 1379 (Fed Cir. 2001). There is no apparent reason, however, 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). As the Federal Circuit has noted, the "substantial noninfringing" language of27l(f) is identical to that in 271(c). See, e.g., Zoltek Corp. v. United States, 672 F.3d 1309, 1334, FN 5 (Fed. Cir. 2012) ("The language of section 27l(f) itself mimics the language of the indirect infringement provisions of sections 27l(b) and (c) ... [C]ompare 35 U.S.C. § 27l(f)(2) (' ... component of a patented invention ... not a staple article or commodity of commerce suitable for substantial noninfringing use ... '), with 35 U.S.C. § 27l(c) ('. .. component ofa patented [invention] ... not a staple article or commodity of commerce suitable for substantial noninfringing use ... ').")

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3. Edwards' motion in limine 5 is DENIED without prejudice.
Edwards is granted leave to raise this issue at trial through timely objections, among other methods.

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