edwards lifesciences llc v. medtronic corevalve llc, c.a. no. 12-23-gms (d. del. dec. 27, 2013)

8/13/2019 Edwards Lifesciences LLC v. Medtronic Corevalve LLC, C.A. No. 12-23-GMS (D. Del. Dec. 27, 2013)

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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE

EDWARDS LIFESCIENCES LLC, et al., )Plaintiffs, )

v. )MEDTRONIC CO REV AL VE LLC, et al., )

Defendants. )

Civil Action No. 12-23 (GMS)

ORDERAt Wilmington, this ? l_ 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. (collectivelyMedtronic ) 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'sletter brief in response (D .I. 146),2 and the discussion by the parties during the pretrial conferenceon 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 couponsunder Fed. R. Evid. 402 and 403, given that the pericardial sacs and coupons are not a component of the patentedinvention 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 orargument to the jury concerning tissue other than that which Medtronic supplied and/or supplies from the UnitedStates to Mexico, that is, porcine pericardium tissue, treated with Medtronic's specific glutaraldehyde and bioburdenreduction solutions. (D.I. 127.) Edwards' motion in limine 5, in tum, relates to: Whether Medtronic should beprecluded 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.)1

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


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Medtronic contends that the treated pericardial sacs and coupons, from which the leafletsand skirts in the accused CoreValve product are manufactured, are not components under 35U.S.C. 271(f) because [t]he porcine pericardial sacs and coupons undergo additional processingoutside of the United States after they have been shipped by Medtronic, including laser-cutting thesacs 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 ofwhich the components aremade. (Id.) In support of its arguments, Medtronic relies on the Supreme Court of the UnitedStates' decision in Microsoft Corp. v. AT T Corp., 550 U.S. 437 (2007), in which the SupremeCourt ruled that a master disk sent from the United States to be copied abroad was not acomponent under Section 271(f). Id. at 1-5.)

Edwards counters that the treated porcine pericardial sacs and coupons must be consideredcomponents 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 theassembly of the infringing CoreValve device. (D.I. 143 at 4.) Edward contends that MicrosoftCorp. v. AT T Corp. is thus inapposite because that case turned on the fact that the master disksupplied 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 infringingdevices. (Id at 4.) Thus, Edwards argues, the instant case is distinguishable because [t]here isno suggestion that the material supplied from the United States is copied or cloned for use in theCore Valve device ....Put simply, the tissue supplied by Medtronic is the tissue in the finalCore Valve 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 notactually installed in any computer to produce an infringing device was essential to the SupremeCourt's ruling in Microsoft. 550 U.S. at 442 (Explaining that [t]he master disk or electronictransmission Microsoft sends from the United States is never installed on any of the foreign-madecomputers in question. Instead copies made abroad are used for installation. ). Rather than themaster disk itself being installed in computers upon being received abroad, the master disk wasused to make copies and it was these copies that were then installed in foreign-made computers ina manner that infringed AT T's patent. Id This copying, rather than actual installation of themaster disk, was the reason why the Supreme Court ruled that the master disk that Microsoft sentabroad did not constitute a component for the purposes of Section 271 (f). Id ( Because Microsoftdoes not export from the United States the copies actually installed, it does not 'suppl[y] ... fromthe 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 .. .insuch a manner as to actively induce the combination of such components. Underthis formulation, the very components supplied from the United States, andnot copies thereof, trigger 271(t) liability when combined abroad t form thepatented invention at issue. Here, as we have repeatedly noted, the copies ofWindows actually installed on the foreign computers were not themselves suppliedfrom the United States. Indeed, those copies did not exist until they were generatedby third parties outside the United States ....The absence o anything addressing copying in the statutory text weighsagainst a judicial determination that replication abroad o a master dispatchedfrom the United States supplies the foreign-made copies from the UnitedStates within the intendment o 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 broada reading o Microsoft. The Supreme Court's focus was not merely on the requirement o an "extrastep". Rather, the focus o its inquiry was on the identity o the exact item actually incorporatedinto the infringing device. In keeping with the Supreme Court 's inquiry in Microsoft, the court inthe instant matter must ask what are the actual items incorporated into the Core Valve device andwhether these items are those that Medtronic supplies to Mexico from the United States. AsEdwards points out, and Medtronic does not deny, the treated porcine pericardia sacs and couponsthat Medtronic sends from the United States are exactly what is used to create the leaflets andskirts combined to make the Core Valve device in Mexico. (D.I. 134 at 3; D.I. 143 at 3.) The factthat these sacs and coupons are subject to additional manipulation and "processing" after theirarrival in Mexico, D.1. 134 at 3), avails Medtronic naught. There is no argument made or proofadduced here, as there was in Microsoft, that the sacs and coupons are copied and that it is thesecopies that are used to make the CoreValve device. Thus, because the same treated porcinepericardia sacs and coupons that Medtronic supplies from the United States to Mexico are theexact ones both intended to be combined and actually combined in Mexico to form the Core Valvedevice, these sacs and coupons are components for the purposes o Section 271 (f). See Microsoft,550 U.S. at 449 ("Section 271(f) applies to the supply abroad o the 'components o a patentedinvention, where such components are uncombined in whole or in part, in such manner as toactively induce the combination o such components. The provision thus applies only to 'suchcomponents' 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 o 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 suppliedin or from the United States any component of a patented invention that is especially made orespecially adapted for use in the invention and not a staple article or commodity of commercesuitable for substantial noninfringing use .. .. " Edwards argues that Medtronic must demonstratenoninfringing uses for "treated pericardia tissue that is the same as the pericardia tissue actuallysupplied by Medtronic." (D.I. 43 at 5 (emphasis in original).)

As the court has explained above, the treated porcine pericardia sacs and coupons thatMedtronic sends from the United States to Mexico are components for the purposes of Section271(f). Thus, as Edwards asserts, Medtronic must show that porcine pericardia sacs and couponstreated with the same glutaraldehyde solution as those that Medtronic supplies from the UnitedStates to Mexico are "suitable for substantial noninfringing use". See e.g. Golden Blount Inc vRobert H Peterson Co. 438 F.3d 1354, 1364 (Fed. Cir. 2006) (Focusing on the defendant's exactproduct in concluding that the district court did not err in finding that the infringing product wasnot 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 ofSection 27l(c), which predates Section 27l(f). See e.g. Golden Blount Inc v Robert H Peterson Co. 438 F.3d1354, 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 Circui t's guidance regarding the type of evidencesufficient to establish "substantial noninfringing use" under 27 ( c) should not apply also to 27 (f). As the FederalCircuit has noted, the "substantial noninfringing" language of27l(f) is identical to that in 271(c). See e.g. ZoltekCorp. v United States 672 F.3d 1309, 1334, FN 5 (Fed. Cir. 2012) ("The language of section 27l(f) itself mimicsthe 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 substantialnoninfringing use ... '), with 35 U.S.C. 27l(c) ( . .. component ofa patented [invention] ... not a staple article orcommodity of commerce suitable for substantial noninfringing use ... ').")

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

methods.

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edwards lifesciences llc v. medtronic corevalve llc, c.a. no. 12-23-gms (d. del. dec. 27, 2013)

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