Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 1 of 23 PageID #: 9047
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 12-23 (GMS)
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`EDWARDS LIFESCIENCES LLC, et al.,
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`Plaintiffs,
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`MEDTRONIC COREVALVE LLC, et al., )
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`Defendants.
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`PLAINTIFFS’ OPENING BRIEF IN SUPPORT OF THEIR MOTION FOR
`ENHANCED DAMAGES PURSUANT TO 35 U.S.C. § 284
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`Regina S.E. Murphy (#5648)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`rmurphy@mnat.com
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`Attorneys for Plaintiffs Edwards Lifesciences
`LLC and Edwards Lifesciences PVT, Inc.
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`OF COUNSEL:
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`Nicholas Groombridge
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`Catherine Nyarady
`Kripa Raman
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`Brian P. Egan
`Christopher Terranova
`Jeremy A. Benjamin
`William O’Hare
`PAUL, WEISS, RIFKIND,
` WHARTON & GARRISON LLP
`1285 Avenue of the Americas
`New York, New York 10019
`(212) 373-3000
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`March 17, 2014
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`REDACTED - PUBLIC
`VERSION
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 1 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 2 of 23 PageID #: 9048
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`TABLE OF CONTENTS
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`I. 
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`NATURE AND STAGE OF THE PROCEEDINGS ........................................................1 
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`II. 
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`SUMMARY OF ARGUMENT .......................................................................................2 
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`III. 
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`STATEMENT OF FACTS ..............................................................................................3 
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`IV. 
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`ARGUMENT ..................................................................................................................3 
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`A. 
`B. 
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`Medtronic’s Willful Infringement Makes Enhanced Damages Appropriate ..........4 
`The Read Factors Strongly Support an Enhanced Damage Award ........................5 
`1. 
`Medtronic Incorporated Dr. Cribier’s Work ..............................................6 
`2. 
`Medtronic Knew Of and Willfully Infringed the ’825 Patent .....................6 
`3. 
`Medtronic’s Litigation Conduct Supports Enhanced Damages ..................7 
`4. 
`Medtronic’s Large Size, Global Operations, and Gross Revenues
`Support an Award of Enhanced Damages ............................................... 10 
`Infringement, Willfulness, Validity and Damages Were Not Close
`Questions ............................................................................................... 10 
`Medtronic’s Infringement of the ’825 Patent Dates Back Years and
`Continues Today .................................................................................... 14 
`Medtronic Has Exacerbated, Not Remedied its Infringement .................. 15 
`Medtronic Was Motivated to Take Sales Away from Edwards ................ 16 
`Medtronic Has Concealed its Misconduct ............................................... 16 
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`5. 
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`6. 
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`7. 
`8. 
`9. 
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`CONCLUSION ............................................................................................................. 17 
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`V. 
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`i
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 2 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 3 of 23 PageID #: 9049
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`CASES
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`TABLE OF AUTHORITIES
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`Page(s)
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`Boston Scientific Corp. v. Cordis Corp.,
`838 F. Supp. 2d 259 (D. Del. 2012) ............................................................................... 5, 6, 9
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`Bott v. Four Star Corp.,
`807 F.2d 1567 (Fed. Cir. 1986) .............................................................................................. 6
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`Edwards Lifesciences AG v. CoreValve, Inc.,
`No. 08–91 (GMS) .................................................................................................................. 1
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`Finjan Software, Ltd. v. Secure Computing Corp.,
`No. 06-369, 2009 WL 2524495 (D. Del. Aug. 18, 2009) ......................................... 5, 6, 9, 15
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`i4i Ltd. P’ship v. Microsoft Corp.,
`598 F.3d 831 (Fed. Cir. 2010)................................................................................................ 7
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`Mathis v. Spears,
`857 F.2d 749 (Fed. Cir. 1988)................................................................................................ 4
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`nCUBE Corp. v. SeaChange Int’l, Inc.,
`313 F. Supp. 2d 361 (D. Del. 2004) ..................................................................................... 15
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`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`762 F. Supp. 2d 710 (D. Del. 2011) ..................................................................................... 15
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`Read Corp. v. Portec, Inc.,
`907 F.2d 816 (Fed. Cir. 1992)............................................................................................ 2, 4
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`In re Seagate Tech., LLC,
`497 F.3d 1360 (Fed. Cir. 2007) .............................................................................................. 4
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`SRI Int’l, Inc. v. Advanced Tech. Labs., Inc.,
`127 F.3d 1462, 1464 (Fed. Cir. 1997) .................................................................................... 4
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`STATUTES
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`35 U.S.C. § 271(f) ................................................................................................................... 3, 8
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`35 U.S.C. § 284 ............................................................................................................... 1, 2, 3, 4
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`35 U.S.C. § 285 ........................................................................................................................... 6
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`ii
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 3 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 4 of 23 PageID #: 9050
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`I.
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`NATURE AND STAGE OF THE PROCEEDINGS
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`On January 15, 2014, the jury returned a verdict that Medtronic1 had willfully
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`infringed Claims 1, 2, 4, and 5 of Edwards’2 Cribier ’825 Patent3, and that Medtronic failed to
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`prove its validity defenses. [D.I. 170]. The jury awarded Edwards lost profits of $388.8 million
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`and reasonable royalties totaling $4.8 million.4 [Id. at 9]. Medtronic offered no evidence of
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`reliance on advice of counsel, and mounted no damages defense. Declaration of Jeremy A.
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`Benjamin in Supp. of Edwards’ Mot. for Enhanced Damages Pursuant to 35 U.S.C. § 284
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`(“Decl.”), Ex. A at 920:9-10. Medtronic’s only expert witness was not a person of ordinary skill
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`in the art at the time of the invention of the ’825 Patent. Id. at 1026:21-23, 1027:7-12.
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`This lawsuit is of Medtronic’s own making. This is the second time Medtronic
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`has been found to willfully infringe Edwards’ patent rights concerning transcatheter heart valve
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`(“THV”) technology. See [D.I. 170]; Edwards Lifesciences AG v. CoreValve, Inc., No. 08–91
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`(GMS) (“Edwards I”) [D.I. 313] (jury verdict finding willful infringement of Edwards’ U.S.
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`Patent No. 5,411,552). Both Edwards I and this trial involved infringement by the same
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`Medtronic THV products. Seemingly unfazed by the prior jury verdict or the threat of an
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`injunction, Medtronic chose to plow ahead in its manufacture, commercialization, and sale of the
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`CoreValve device in the U.S. Medtronic is a knowing and willful infringer.
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`1 “Medtronic” refers to Medtronic CV Luxembourg S.a.r.l., Medtronic CoreValve LLC,
`Medtronic, Inc., Medtronic Vascular Galway Ltd., and Medtronic Vascular Inc.
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`2 “Edwards” refers to Edwards Lifesciences LLC and Edwards Lifesciences PVT Inc.
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`3 The “ ’825 Patent” refers to U.S. Patent No. 8,002,825.
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`4 The jury’s award covers damages that Edwards incurred from August 23, 2011—the issue
`date of the ’825 Patent—through October 25, 2013.
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 4 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 5 of 23 PageID #: 9051
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`35 U.S.C. § 284 allows for enhanced damages, up to three times the jury’s
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`compensatory award. The Court has great discretion in deciding the magnitude of any such
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`award. Edwards asks that the Court send a message to Medtronic. Given the context of the
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`broader dispute between the parties, and Medtronic’s failure to honor its commitment to moving
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`its operations offshore, Edwards submits that enhanced damages are appropriate here.5
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`II.
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`SUMMARY OF ARGUMENT
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`Under 35 U.S.C. § 284, this Court may enhance the damages in this case up to
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`three times the jury’s compensatory award. Pursuant to this statute, Edwards respectfully
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`requests an enhancement of at least $100 million on the jury’s $394 million award. The
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`circumstances of this case demonstrate the necessity of this enhancement. First, enhanced
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`damages are appropriate in light of the jury’s finding that Medtronic willfully infringed
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`Edwards’ patent. [D.I. 170 at 5]. Second, application of the Read factors6 to this case
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`demonstrates the need for enhanced damages:
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`1. Medtronic knew of the ’825 Patent and willfully infringed it.
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`2. Medtronic lacked a good faith belief that the ’825 Patent was invalid or
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`that its CoreValve device did not infringe that patent. At trial, Medtronic presented no opinion
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`of counsel and/or evidence that it relied on an opinion of counsel.
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`3. Medtronic did not comply with the verdict in Edwards I, disregarded the
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`Court’s rulings, and presented misleading arguments to the jury.
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`5 On January 27, 2014, the Court Ordered that Plaintiffs’ post-trial motions be filed by March
`17, 2014. [D.I. 178].
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`6 See Read Corp. v. Portec, Inc., 970 F.2d 816, 826-27 (Fed. Cir. 1992).
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`2
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 5 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 6 of 23 PageID #: 9052
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`4.
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`Medtronic’s size, global presence, and $16.6 billion annual revenue
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`indicates that it can easily pay the damage enhancement that Edwards seeks.
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`5.
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`Infringement, validity, and damages were not close questions. The jury
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`quickly returned a verdict for Edwards on each and every issue.
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`6.
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`Medtronic willfully infringed the ’825 Patent for years and continues to
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`infringe today.
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`7.
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`Medtronic took no remedial action to reduce or eliminate the impact of its
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`infringement. Instead, Medtronic recklessly continued its course of willful infringement.
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`8.
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`Medtronic was motivated to harm Edwards by using the technology of the
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`’825 Patent in order to take sales away from Edwards.
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`9.
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`Medtronic sought to conceal the extent of its misconduct by contending
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`that most of its manufacturing activity did not infringe the ’825 Patent because it took place in
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`Tijuana, Mexico. But Medtronic’s supply of components from the United States to Mexico for
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`the manufacture of these devices proved to be an infringement of the ’825 Patent under 35
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`U.S.C. § 271(f).
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`III.
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`STATEMENT OF FACTS
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`The relevant facts are set forth in the Argument section below.
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`IV. ARGUMENT
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`On January 15, 2014, after a short deliberation, the jury returned its verdict that
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`Medtronic had willfully infringed Edwards’ ’825 Patent. [D.I. 170 at 5]. The jury reached this
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`result despite Medtronic’s attempts to misdirect with arguments precluded by the Court.
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`Notably, this was not the first jury to find that Medtronic had willfully infringed Edwards’ patent
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`rights. See supra, p. 1. But Medtronic has not heeded the verdict of either jury. Following
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`3
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 6 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 7 of 23 PageID #: 9053
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`Edwards I, Medtronic made only halfhearted efforts to avoid continued infringement, moving
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`just a portion of its CoreValve manufacturing operation offshore to Mexico. The inadequacy of
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`Medtronic’s response has now been proven. As the jury concluded, not only did Medtronic
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`continue to infringe Edwards’ patent rights by continuing to manufacture the CoreValve device
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`in the United States, it also infringed the ’825 Patent through its supply of components from the
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`United States to Mexico for the manufacture of the CoreValve device in Tijuana. [D.I. 170 at 3-
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`4]. Yet Medtronic remains recalcitrant. Within minutes of this latest verdict, Medtronic issued a
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`press release promising to begin selling CoreValve devices in the United States upon FDA
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`approval. Decl., Ex. B. Two days later, Medtronic announced that it received this approval.
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`Decl., Ex. C. That approval sets the stage for Medtronic to further expand its infringement.
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`Medtronic’s continued and blatant disregard of Edwards’ patent rights should be punished, not
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`rewarded. Enhanced damages are necessary to do so.
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`A. Medtronic’s Willful Infringement Makes Enhanced Damages Appropriate
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`The jury’s verdict of willful infringement permits the Court to “increase the
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`damages up to three times the amount found or assessed.” 35 U.S.C. § 284; see In re Seagate
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`Tech., LLC, 497 F.3d 1360, 1368 (Fed. Cir. 2007). Enhanced damages are particularly
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`appropriate here given that this is the second jury that has evaluated the same CoreValve device
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`and found Medtronic to be a willful infringer of Edwards’ transcatheter heart valve patent rights.
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`See Edwards I [D.I. 313 at 3] ); see also Mathis v. Spears, 857 F.2d 749, 754 (Fed. Cir. 1988)
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`(explaining that the purpose of increased damages is to deter willful infringement). Whereas
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`past damages awarded by the jury are meant to compensate Edwards for the damages it
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`sustained, enhanced damages are an appropriate punitive measure to deter the willful
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`infringement of Edward’s intellectual property. See SRI Int’l, Inc. v. Advanced Tech. Labs., Inc.,
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`4
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 7 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 8 of 23 PageID #: 9054
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`127 F.3d 1462, 1464 (Fed. Cir. 1997) (“[35 U.S.C. § 284] recognizes the tortious nature of patent
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`infringement and the public interest in a stable patent right, for enhanced damages are not
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`compensatory but punitive.”). Medtronic’s scorn for Edwards’ rights makes such punitive
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`measures not just appropriate, but necessary.
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`B.
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`The Read Factors Strongly Support an Enhanced Damage Award
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`“[T]he principal considerations in enhancement of damages are the same as those
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`of the willfulness determination, but in greater nuance as may affect the degree of enhancement.”
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`Id. at 1469. The “Read factors” guide courts’ analysis of whether enhanced damages should be
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`awarded. See Read, 970 F.2d at 826-27. Those factors are: “(1) whether the infringer
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`deliberately copied the ideas or design of another; (2) whether the infringer, when he knew of the
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`other’s patent protection, investigated the scope of the patent and formed a good-faith belief that
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`it was invalid or that it was not infringed; (3) the infringer’s behavior as a party to the litigation;
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`(4) the infringer’s size and financial condition; (5) the closeness of the case; (6) the duration of
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`the infringer’s misconduct; (7) any remedial action by the infringer; (8) the infringer’s
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`motivation for harm; and (9) whether the infringer attempted to conceal its misconduct.” Finjan
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`Software, Ltd. v. Secure Computing Corp., No. 06-369 (GMS), 2009 WL 2524495, at *14 (D.
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`Del. Aug. 18, 2009) (citing Read, 970 F.2d at 826-27). It is not necessary that each of these
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`factors favor enhancement; rather, courts will award enhanced damages when the Read factors,
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`on balance, support their award. See, e.g., Boston Scientific Corp. v. Cordis Corp., 838 F. Supp.
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`2d 259, 279-81 (D. Del. 2012) (doubling award despite no allegation of copying, short duration
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`of infringement, and no attempt to conceal by infringer); Advanced Med. Optics, Inc. v. Alcon
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`Labs., Inc., Civ. A. No. 03-1095-KAJ, 2005 WL 3454283, at *10 (D. Del. Dec. 16, 2005)
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`5
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 8 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 9 of 23 PageID #: 9055
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`(awarding treble damages based on the “‘totality of the circumstances’” indicated by the Read
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`factors).
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`Here, the Read factors strongly support an award of enhanced damages.
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`1.
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`Medtronic Incorporated Dr. Cribier’s Work
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`Medtronic, through its predecessor in interest CoreValve, Inc., was closely
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`following Dr. Cribier’s development of THV technology long before it finalized and
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`commercialized the CoreValve device. See Decl., Ex. A at 441:24-447:21; see also Decl., Ex. D
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`at 19. Indeed, evidence at trial proved that Medtronic changed course in its development work
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`upon news of Dr. Cribier’s first in human THV implant performed without removing the native,
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`diseased aortic valve when implanting the THV. See, e.g., Decl., Ex. A at 860:18-25; 1195:10-
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`25.
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`2.
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`Medtronic Knew Of and Willfully Infringed the ’825 Patent
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` And, Medtronic was aware of the specification and
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`much of the claim language ultimately found in the ’825 Patent even earlier. Decl., Ex. A at
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`1216:9-1217:25; see Bott v. Four Star Corp., 807 F.2d 1567, 1572 (Fed. Cir. 1986) (factoring
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`infringer’s knowledge of a design prior to issuance of a patent as supporting willful infringement
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`and enhanced damages) overruled on other grounds by A.C. Aukerman Co. v. R.L. Chaides
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`Const. Co., 960 F.2d 1020, 1038-39 (Fed. Cir. 1992).
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`Not only did Medtronic know of the ’825 Patent, it lacked a good faith belief that
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`its CoreValve device did not infringe that patent. Tellingly, at trial, Medtronic did not present an
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`exculpatory opinion of counsel to support its noninfringement and/or validity defenses. See
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`Boston Scientific, 838 F. Supp. 2d at 279 (doubling jury award where infringer was aware of
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`6
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 9 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 10 of 23 PageID #: 9056
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`patent and yet provided no exculpatory opinion of counsel); Finjan, 2009 WL 2524495, at *15
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`(“While there is no longer an affirmative duty of care that requires an accused infringer to obtain
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`an opinion of counsel, the fact that [the defendant] did not seek any such opinion may be
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`considered in the totality of circumstances surrounding willful infringement.”). Thus, this
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`second Read factor weighs heavily in favor of enhanced damages.
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`3.
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`Medtronic’s Litigation Conduct Supports Enhanced Damages
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`As described in Edwards’ Opening Brief in Support of Its Motion for Attorney’s
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`Fees Pursuant to 35 U.S.C. § 285, had Medtronic adequately responded to the verdict in Edwards
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`I, this litigation would have been unnecessary. But, instead of ceasing to manufacture and sell
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`the CoreValve device, or truly moving its manufacturing operations offshore, Medtronic’s
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`response was limited to a partial relocation of its manufacturing operation to Mexico. Medtronic
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`continued to: (1) manufacture CoreValve devices in the United States; (2) supply from the
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`United States to Mexico a substantial portion of the components of the CoreValve device to
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`Mexico with the intent that they be combined there to form the infringing device; and (3) supply
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`from the United States to Mexico components that are especially made or especially adapted for
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`use in the CoreValve device and that are not staple articles of commerce. In short, Medtronic’s
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`response was inadequate, as the jury verdict shows. See [D.I. 170 at 2-4]. Medtronic’s response
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`forced Edwards to bring this second suit at great expense. This misconduct should not be
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`overlooked.
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`Further, Medtronic’s repeated failure to obey the Court’s Orders supports
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`enhanced damages in this case. See i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 859 (Fed.
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`Cir. 2010) (“Typically, ‘litigation misconduct’ refers to bringing vexatious or unjustified suits,
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`discovery abuses, failure to obey Orders of the court, or acts that unnecessarily prolong
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`7
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 10 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 11 of 23 PageID #: 9057
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`litigation.”). From its planned opening argument through its closing, Medtronic repeatedly
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`attempted to mislead the jury and disregarded the Court’s Orders. Such misconduct supports an
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`enhancement of the damages award.
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` For its opening,
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`Medtronic brought demonstrative models of the CoveValve device and its delivery system to
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`improperly suggest to the jury that the entire CoreValve device, including the frame, valve, and
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`internal cover, plus the protective capsule of the delivery system that covers the CoreValve
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`device during delivery, must be 5.7 mm or less in diameter in order to meet the limitations of
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`Claim 1 of the ’825 Patent. Decl., Ex. A at 4:20-13:4. The Court sustained Edwards’ objection
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`to these demonstratives, warning Medtronic that it was “not going to permit that argument to be
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`made.” Id. at 17:13. But Medtronic persisted, making arguments throughout trial, above
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`admonitions by the Court, that the compressibility requirement applied to the entire device
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`delivery system. See, e.g., id at 190:22-191:14; 288:4-25; 326:10-328:25; 335:25-336:14. When
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`Edwards sought clarifying language in the jury instructions necessary to mitigate the misleading
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`arguments that Medtronic had made throughout the proceedings, Medtronic objected. Id. at
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`1287:9-1290:3.
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`Medtronic’s refusal to accept the Court’s claim construction masks a further layer
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`of disingenuousness. Medtronic knew that even if the Court construed “frame” to mean the
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`entire device,
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`8
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 11 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 12 of 23 PageID #: 9058
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`Post-verdict, Medtronic’s refusal to accept the Court’s ruling continues. In its
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`renewed motion for JMOL and its motion for a new trial, Medtronic mischaracterizes the Court’s
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`ruling as an unwarranted sanction and refuses to admit to its own improper conduct. See, e.g.,
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`[D.I. 184 at 1-14; D.I. 187 at 3-8]. Medtronic’s refusal to comply with the Court’s Orders should
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`not go unpunished.
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`Medtronic’s misconduct was not limited to the compressibility issue. Medtronic
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`argued to the jury and the Court that the pericardial sacs shipped from the United States could
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`not be “components” of the CoreValve device for purposes of 35 U.S.C. § 271(f) despite a clear
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`Order holding to the contrary. [See D.I. 150 at 5] (the “treated porcine pericardial sacs . . . that
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`Medtronic supplies form the United States to Mexico . . . are components for the purposes of
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`Section 271(f).”). Medtronic made such arguments, for example, when cross-examining Dr.
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`Buller. Decl., Ex. A at 665:15-24. At sidebar, Medtronic insisted that the very issue decided by
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`the Court was a question for the jury to decide. Id. at 666:12-20.7
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`Medtronic continued to advance this precluded argument in its Motion to Limit
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`the Damage Demand. [D.I. 157]. There, Medtronic argued that the jury should not be allowed
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`to decide liability under § 271(f)(1) because “export of the sac, even if it were a component of
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`the claimed invention, is only a single supplied component and thus no liability attaches.” [Id. at
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`4 (emphasis added)]. The emphasized text demonstrates Medtronic’s unwillingness to accept the
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`7 The Court chastised Medtronic for not complying with its rulings. See Decl., Ex. A at
`666:23-667:5.
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`9
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 12 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 13 of 23 PageID #: 9059
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`Court’s Orders and its relentless attempt to reargue issues it already lost. This again supports an
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`award of enhanced damages.
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`4.
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`Medtronic’s Large Size, Global Operations, and Gross Revenues
`Support an Award of Enhanced Damages
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`With its $16.6 billion annual revenue and global reach that extends into more than
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`140 countries, Medtronic is one of the largest medical device companies in the world. Decl.,
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`Ex. F at 1. With such enormous revenues and resources Medtronic can “financially withstand an
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`enhancement in damages.” Finjan, 2009 WL 2524495 at *15; see Boston Scientific Corp., 838
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`F. Supp. 2d at 280. The enhancement that Edwards seeks would have a minimal effect on
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`Medtronic’s finances, but would send an appropriate message to protect against future
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`infringement.
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`5.
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`Infringement, Willfulness, Validity and Damages Were Not Close
`Questions
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`That Medtronic willfully infringed Edwards’ valid patent rights was not a close
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`question. The short duration of the jury’s deliberation alone makes this clear. Closing
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`arguments completed at approximately 1:00 P.M on January 15, 2014; within hours, the jury
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`delivered a note suggesting that it had found infringement and was deliberating the willfulness of
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`the infringement. Decl., Ex. A at 1511:7-20. Before 11:00 AM the next day, the jury
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`unanimously determined that Medtronic had willfully infringed each and every claim that
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`Edwards advanced at trial. [D.I. 170].
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`The jury’s quick decision came as no surprise. Despite the numerous limitations
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`of the four asserted claims, Medtronic offered a defense to just two: the compressibility of the
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`CoreValve frame and whether it has sufficient radial strength to withstand the recoil force of the
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`10
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 13 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 14 of 23 PageID #: 9060
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`stenosed aortic valve. Both were unpersuasive and contradicted by Medtronic’s own witnesses
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` Medtronic’s corporate witness, Russell Hodge, admitted at trial
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`that the CoreValve frame was compressible below 5.7 mm. Decl., Ex. A at 945:24-946:16; see
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`id. at 883:5:7 (admitting “The valve is pretty much the primary driver for the density of the
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`implant and the diameter, the resulting diameter after it’s crimped.”). Medtronic offered no
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`additional proof on this issue following Mr. Hodge’s indisputable testimony.
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`The jury similarly recognized that Medtronic’s recoil defense was without merit.
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`Even though the CoreValve device is oversized as compared to the patient’s annulus, and pushes
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`up against the annulus to secure it in place, Medtronic suggested at trial that the CoreValve
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`device does not have radial strength sufficient to resist the recoil forces of the stenosed aortic
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`11
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 14 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 15 of 23 PageID #: 9061
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`valve. See, e.g., id. at1237:5-1242:25. This strains credulity. Medtronic’s defense not only
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`defies the laws physics, it is belied by the factual record. Medtronic’s own principal investigator
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`for its FDA clinical trials, Dr. Jeffrey Popma, wrote: “The strength of this self-expanding portion
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`of the [CoreValve] frame prevents annular recoil, allowing the frame to partially conform to the
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`non-circular shape of the aortic annulus.” Decl., Ex. J at 3 (emphasis added). Similarly,
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`Medtronic’s expert, Dr. Gary Loomis, emphasized in his rebuttal report: “both the Medtronic
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`CoreValve and Edwards SAPIEN transcatheter aortic heart valves are designed to have a
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`relatively high radial strength or force within the native aortic annulus. They are also designed
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`to be oversized relative to the annulus, so that they expand completely against the native aortic
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`annulus upon deployment.” Decl., Ex. K at 11 (emphasis in original). Reports from other
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`companies working with Nitinol, the material used to form the CoreValve frame, plainly
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`contradict Medtronic’s position as well.8 See Decl., Ex. A at 1247:5-1251-3.
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`Medtronic had to know, as the jury found, that its validity defenses lacked merit.
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`First, Medtronic could not decide whether to argue that the ’825 Patent was not enabled, or that it
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`was obvious to one skilled in the art. Despite the irresolvable “tension” in these defenses, e.g.,
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`id. at 1075:15-17, Medtronic argued both—with predictable results. Second, Medtronic’s
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`invalidity defenses wholly depended on the expert testimony of Dr. Loomis. Despite the fact
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`that the ’825 Patent and virtually every other patent relevant to this case relate to medical devices
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`invented and used by interventional cardiologists, Dr. Loomis’ expertise is in polymer chemistry,
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`8 Medtronic also argued that recoil occurs only in balloon expandable stents due in part to the
`overexpansion of such stents. Decl., Ex. A at 879:14-17; 964:11-17. Not only is the
`CoreValve device overexpanded in a patient’s annulus, it is balloon expanded in
`approximately 20% of procedures. Id. at 912-7:11; Ex. L at 7; Ex. M. This too established
`that the CoreValve device has sufficient radial strength to resist the recoil forces of the
`stenosed aortic valve.
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`12
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 15 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 16 of 23 PageID #: 9062
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`not interventional cardiology. He is not a medical doctor and was not capable of expressing the
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`views of a person of ordinary skill in the art. As such, the jury properly relied on the testimony
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`of Edwards’ liability expert, interventional cardiologist Dr. Nigel Buller.
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`Medtronic’s invalidity defenses were substantively meritless as well. Its
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`enablement case hinged on the ’825 Patent’s alleged failure to enable a “frame being
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`compressible to a compressed external diameter capable of being introduced through [a 5.7mm]
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`arterial introducer,” see Decl., Ex. N (’825 Patent, Col. 21, Ln. 36-39), and Dr. Cribier’s
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`apparent admission that he could not build such a frame himself. But frames capable of
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`introduction through a 5.7 mm arterial introducer were widely available at the time of the
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`invention. See, e.g., Decl., Ex. O at 1. Moreover, the Patent Office concluded that it was within
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`the skill of persons of ordinary skill in the art to reduce the size of the claimed device. Decl.,
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`Ex. P at 102 (“it would have been obvious to try to form the reduced configuration with a
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`diameter of 5.7mm or less, or about 5mm since finding the optimal diameter to fit within a
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`catheter or have a profile suitable to be delivered endovascularly through the patient’s vessel
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`only involves routine skill in the art.”). And, Dr. Cribier testified that he believed, at the time of
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`his invention, an engineer could have made a frame meeting the limitations of Claim 1. See
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`Decl., Ex. A at 274:24-275:14.
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`Not only is the ’825 Patent enabled, it is also inventive and not obvious.9 Unable
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`to explain why others did not develop the life-saving technology claimed by the ’825 Patent,
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`9 Though Medtronic pursued a written description defense, Dr. Loomis was unable to even
`articulate what it was. See, e.g., Decl., Ex. A at 1186:15-1188:20. In closings, Medtronic
`suggested that the ’825 Patent failed to provide written description support for a Nitinol-
`based self-expanding frame. Id. at 1467:12-1468:8. But the ’825 Patent recites a metallic
`frame. See, e.g., Decl., Ex. M (’825 Patent, Col. 9, Ln. 3). Nitinol is a metal. See, e.g.,
`Decl., Ex. A at 708:17-18. No more is required.
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`13
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`Edwards Lifesciences Corporation, et al. Exhibit 1040, p. 16 of 24
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`Case 1:12-cv-00023-GMS Document 206 Filed 03/24/14 Page 17 of 23 PageID #: 9063
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`Medtronic focused on prior art that was expressly considered by the Patent Examiner. See, e.g.,
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`Decl., Ex. N at 2; Ex. P at 16, 80-81. The Patent Examiner, in stark contrast to Medtronic,
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`concluded that the ’825 Patent was not only non-obvious, but it comprised at least four separate
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`inventions with respect to the internal cover alone. Decl., Ex. A at 1203:14-1204:7; Ex. P at 61.
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`Dr. Buller identified at least five novel and non-obvious features of Claims 1, 2, 4, and 5 of the
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`’825 Patent, including the internal cover claimed in Claim 1 of the ’825 Patent. S