Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 1 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 1 of 21
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
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`Case No. 1:18-cv-12029-ADB
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`Leave to File Granted on
`Feb. 22, 2022 (ECF No. 272)
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`Leave to File Under Seal Granted on
`Mar. 28, 2022 (ECF No. 285)
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Plaintiffs,
`
`V.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
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`DEFENDANT ELI LILLY AND COMPANY’S MEMORANDUMIN SUPPORT OFITS
`DAUBERT MOTION TO PARTIALLY EXCLUDE TESTIMONY OF
`
`DR. ELAN RUBINSTEIN AND DR. MARK BERKMAN
`
`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 2 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 2 of 21
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`TABLE OF CONTENTS
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`INTRODUCTION000000... coc ccccceececccccccccccecesssseeeeeeeeeeeeesaaeeeececeeesesssaeeeeeceseeesesseeeeeeeeeeeeeesesaees 1
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`LEGAL STANDARD 0.00022. cccccecceesceeceesceeseesceeseesseseeesecsseeseeeaeeaeeseeeseceaeeeeeaeeeseeeesensenseeseess 2
`
`OPINIONSOF DR. ELAN RUBINSTEIN RELATING10
`
`SHOULD BE EXCLUDED...........0..ccocccc ccc ccccccccsecceeceeeeeeseseeneeeeeceeeeeesessneeeeeeeeeeeseessseeeeeeeers 2
`
`A.
`B.
`
`Summary ofDr. Rubinstein’s Opinions Related iimveceeeeeeseeesseessceeeeesseeeseees 2
`Dr. Rubinstein’s Opinions RelatingTEAcc Unreliable
`and Should be Excluded ...............ccccccccccccccesceeseceesceeseceseeeseeeeseeeaeceaeeeseeeeeeesseeeeeees 3
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`1.
`
`2.
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`Dr. Rubinstein’s Opinion Is Based on a Clear Misstatement of Fact
`That Will Not Assist a Jury in Determining AnyFact..........0....0....0.:.0 4
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`Dr. Rubinstein’s Admitted Error Warrants Exclusion of All
`Associated Opinions with Respect toPoveceeseeeeseeeseeeeseeees 5
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`DR. MARK BERKMAN’S OPINIONS ON
`SHOULD BE EXCLUDED....20...0.eeeeeeeeeeeeeteeteeteetees 7
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`
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`A. Dr. BerkmanIs Unqualified to Opine 0i_ beceeeeees 8
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`Is
`Dr. Berkman’s Estimation of|
`Purely Speculative and Should Be Excluded ..............00cccecccceecceecceseceeseeesseeeeeeees 11
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`1.
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`2.
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`Governing Case Law Sets a High Bar for Future LostProfits ................. 12
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`Dr. Berkman’s
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`Are Unreliable and Speculative....................... 12
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`a.
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`b.
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`Dr. Berkman Improperly Relies on
`
`veceuceceeeecetceecteeeees 13
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`De BerkmanUses
`Ce ul
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`CONCLUSION 0.0oo ieee cc ccc cc ccccccecccceecccceccceeccceeecceeeceutecccececsececceeceseceeeecatececteeseteeceteeeeuees 15
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 3 of 21
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc.,
`No. CIV.A. 09-40089-FDS, 2014 WL 7330777 (D. Mass. Dec. 19, 2014) ..............................5
`
`BIC Leisure Prods., Inc. v. Windsurfing Int’l, Inc.,
`1 F.3d 1214 (Fed. Cir. 1993)......................................................................................................7
`
`Bogosian v. Mercedes-Benz of N. Am., Inc.,
`104 F.3d 472 (1st Cir. 1997) ......................................................................................................2
`
`Brooktree Corp. v. Advanced Micro Devices, Inc.,
`977 F.2d 1555 (Fed. Cir. 1992)................................................................................................12
`
`Carrozza v. CVS Pharmacy, Inc.,
`391 F. Supp. 3d 136 (D. Mass. 2019), aff’d, 992 F.3d 44 (1st Cir. 2021) ...............................11
`
`Cipollone v. Yale Indus. Prods., Inc.,
`202 F.3d 376 (1st Cir. 2000) ......................................................................................................2
`
`Dart v. Kitchens Bros. Mfg. Co.,
`253 F. App’x 395 (5th Cir. 2007) ..............................................................................................6
`
`Daubert v. Merrell Dow Pharms., Inc.,
`509 U.S. 579 (1993) ......................................................................................................... passim
`
`Dzielak v. Whirlpool Corp.,
`No. 2:12-0089(KM)(JBC), 2017 WL 1034197 (D.N.J. Mar. 17, 2017) ....................................6
`
`Earley Info. Sci., Inc. v. Omega Eng’g, Inc.,
`No. CV 19-10364-FDS, 2021 WL 5868249 (D. Mass. Dec. 10, 2021) ..............................6, 11
`
`Fail-Safe, L.L.C. v. A.O. Smith Corp.,
`744 F. Supp. 2d 870 (E.D. Wis. 2010) .....................................................................................14
`
`Gen. Elec. Co. v. Joiner,
`522 U.S. 136 (1997) ...................................................................................................................5
`
`Legendary Art, LLC v. Godard,
`No. CIV.A. 11-0674, 2012 WL 3550040 (E.D. Pa. Aug. 17, 2012) .......................................14
`
`Odetics, Inc. v. Storage Tech. Corp.,
`185 F.3d 1259 (Fed. Cir. 1999)..................................................................................................2
`
`ii
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 4 of 21
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`Oiness v. Walgreen Co.,
`88 F.3d 1025 (Fed. Cir. 1996)..................................................................................................12
`
`Ponca Tribe of Indians of Okla. v. Cont’l Carbon Co.,
`No. CIV-05-445-C, 2009 WL 5842042 (W.D. Okla. Jan. 23, 2009) ..................................9, 11
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`711 F.3d 1348 (Fed. Cir. 2013)..................................................................................................5
`
`Richmond Steel Inc. v. Puerto Rican Am. Ins. Co.,
`954 F.2d 19 (1st Cir. 1992) ......................................................................................................10
`
`Rothbaum v. Samsung Telecommc’ns Am., LLC,
`52 F. Supp. 3d 185 (D. Mass. 2014) ..........................................................................................6
`
`Shockley v. Arcan, Inc.,
`248 F.3d 1349 (Fed. Cir. 2001)................................................................................................15
`
`Smith v. Jenkins,
`732 F.3d 51 (1st Cir. 2013) ....................................................................................................2, 5
`
`Thorndike v. DaimlerChrysler Corp.,
`266 F. Supp. 2d 172 (D. Me. 2003) .........................................................................................11
`
`Water Techs. Corp. v. Calco Ltd.,
`850 F.2d 660 (Fed. Cir. 1988)....................................................................................................7
`
`Rules
`
`Fed. R. Evid. 702 .............................................................................................................................2
`
`iii
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 5 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 5 of 21
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`L
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`INTRODUCTION
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`In this patent infringementaction, Plaintiffs Teva Pharmaceuticals International GmbH and
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`Teva Pharmaceuticals USA,Inc. (“Teva”) contend that Defendant Eli Lilly and Company (“Lilly”)
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`has indirectly infringed the patents-in-suit by marketing and selling its accused product
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`Emgality®—the only biologic approved by the FDA forboth the preventive treatment of migraine
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`and the treatment of episodic cluster headachein adults. In forming their opinions regarding Teva’s
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`alleged for its own biologic, Ajovy®, Teva’s experts Drs. Elan B. Rubinstein and Mark
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`P. Berkman relied on (1) certain erroneous facts and (2) purely speculative assumptions.
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`First, Dr. Rubinstein opines that Teva would haveee Ajovy® if
`Emgality® were notontherk,
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`opinions will not assist the jury in deciding any fact. Thus, Dr. Rubinstein’s opinionsrelating to
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`I «1 8 excincea
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`In addition, despite having no relevant expertise, Dr. Berkman opines extensively on the
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`I 1s 120 opinions on
`a includingat least those premised on Dr. Rubinstein’s erroneous opinionsP| are
`unreliable and should be excluded. Moreover, Dr. Berkman made assumptionsPo
`a:-:
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`on nothing more than rank speculation. Amounting to blindly throwinga dart at a large numberto
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`bias the jury, Dr. Berkman’sPo are mere guesses and should also be
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`excluded.
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 6 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 6 of 21
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`II.
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`LEGAL STANDARD
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`Rule 702 of the Federal Rules of Evidence permits expert testimony “‘if...the expert’s
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`scientific, technical, or other specialized knowledge will help the trier of fact to understand the
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`evidence or to determine a fact in issue.” Rule 702 codifies the standard of Daubert v. Merrell
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`Dow Pharmaceuticals., Inc., 509 U.S. 579 (1993). Rulings on admissibility of expert testimony
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`are governed by the law of the regional circuit, here, the First Circuit. See, e.g., Odetics, Inc. v.
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`Storage Tech. Corp., 185 F.3d 1259, 1276 (Fed. Cir. 1999). Courts are given broad discretion to
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`determine whetherexperts are qualified by “knowledge,skill, experience, training, or education.”
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`Bogosian v. Mercedes-Benz ofN. Am., Inc., 104 F.3d 472, 476 (1st Cir. 1997) (internal citations
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`omitted). If the expert is qualified, the next step is evaluating the proposed testimony, which must
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`(1) be based on sufficient facts or data; (2) be the product of reliable principles and methods; and
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`(3) reliably apply the principles and methods to the facts. Smith v. Jenkins, 732 F.3d 51, 64 (1st
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`Cir. 2013) (citing Daubert, 509 U.S. at 592-94). The “ultimate purpose of the Daubert inquiry is
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`to determine whetherthe testimony of the expert would be helpful to the jury in resolving a fact in
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`issue.” Cipollone v. Yale Indus. Prods., Inc., 202 F.3d 376, 380 (1st Cir. 2000).
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`II.
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`OPINIONS OF DR. ELAN RUBINSTEIN RELATING
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`SHOULD BE EXCLUDED
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`Summary of Dr. Rubinstein’s Opinions Related toi
`A.
`Dr. Rubinstein’s opening report states that he wasPO
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`EE?I Fhe. Rdinstein was askea
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` 2
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`es |ee
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 7 of 21
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`(Id.) He ultimately concluded that
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`Id. at § 109. As a result, Dr. Rubinstein alleged that
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`See id. at §VIL, §§ 66-70. Dr. Rubinstein confirmedat his
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`deposition that his opinionsin this regard are limited
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`For Prime, Dr. Rubinstein opined that Teva was
`
`Bo
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`°
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`cS
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`=a>=
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`Dr. Rubinstein also
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`B.
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`Dr. Rubinstein’s Opinions Relating toPo Are
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`Unreliable and Should be Excluded
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`Dr. Rubinstein’s opinion that
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 8 of 21
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`rebate payments” (Ex. D (Rubinstein Reply Rep.) at § 16) is based on a fundamental misreading
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`
`
`
`
`1.
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`Dr. Rubinstein’s Opinion Is Based on a Clear Misstatement of
`Fact That Will Not Assist a Jury in Determining Any Fact
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`Dr. Rubinstein’s ultimate opinion thatPg
`is fundamentally flawed, at least with respect to
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`becauseit is based ona clear, uncorrected factual mistake. In particular, his conclusion that Teva’s
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`This is not a case wherethe factfinder
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`ee2
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`4
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 9 of 21
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`is tasked with resolving a battle of experts. This is a clear error that will not help the jury to decide
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`any fact. When there are “analytical gaps between the data and the opinion proffered by an expert,”
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`those gaps “may undermine the reliability of an expert’s testimony.” Abbott Biotechnology Ltd. v.
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`Centocor Ortho Biotech, Inc., No. CIV.A. 09-40089-FDS, 2014 WL 7330777, at *5 (D. Mass.
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`Dec. 19, 2014) (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)).
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`Part of the Court’s gatekeeping function under Daubert and the Federal Rules is to ensure
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`that testimony with the imprimatur of an expert is reliable and based on sound facts. But when that
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`testimony is unreliable, as here, it “frustrates a primary goal of expert testimony in any case, which
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`is meant to place experience from professional specialization at the jury’s disposal, not muddle the
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`jury’s fact-finding with unreliability and speculation.” Power Integrations, Inc. v. Fairchild
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`Semiconductor Int’l, Inc., 711 F.3d 1348, 1374 (Fed. Cir. 2013). Dr. Rubinstein only advances
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`opinions
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`Dr. Rubinstein’s
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`opinion is founded on a mistake and is therefore unreliable and unhelpful to a jury.
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`2.
`
`Dr. Rubinstein’s Admitted Error Warrants Exclusion of All
`Associated Opinions
`
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`Dr. Rubinstein’s unreliable opinions
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`will only confuse the jury and
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`could result in a decision on damages based on factual misrepresentations. For that reason, Dr.
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`Rubinstein should be precluded from expressing any opinion at trial relating to
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`
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` See, e.g., Smith, 732 F.3d at 68-69 (remanding for new damages
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`trial when a “disconnect” between expert’s “methodology and the facts of the case rendered the
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`testimony unhelpful to the jury.”); Rothbaum v. Samsung Telecommc’ns Am., LLC, 52 F. Supp. 3d
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`185, 195 (D. Mass. 2014) (precluding opinion when expert “repeatedly draws conclusions that are
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`not supported by the documents on which he relies.”). This exclusion amounts to one-third of Dr.
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`Rubinstein’s ultimate opinions: (i) ¶¶ 86-89 as well as portions of ¶ 90 and Exhibit C that reference
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`5
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 10 of 21
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` in Dr. Rubinstein’s Opening Report (Ex. A),3 and (ii) ¶¶ 14-23 as well as
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`portions of ¶¶ 4, 5, 8, 11, 36, and 63 that reference
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` in Dr. Rubinstein’s
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`Reply Report (Ex. D). Lilly is not seeking an overreaching preclusion of other opinions. But given
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`the unreliability of Dr. Rubinstein’s opinions
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` they should not go to the jury.4
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`This is not a situation where cross-examination and careful jury instruction can fix the
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`deficiencies in Dr. Rubinstein’s opinions
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` Dr. Rubinstein did not attempt to revise
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`his opinion at his deposition after conceding his error, and Teva has not served a corrected report.
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`The time to do so has long passed. Under similar facts, a court in this district recently granted a
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`Daubert motion and precluded all testimony. Earley Info. Sci., Inc. v. Omega Eng’g, Inc., No. CV
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`19-10364-FDS, 2021 WL 5868249, at *6 (D. Mass. Dec. 10, 2021) (precluding expert opinions in
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`full when half of the opinions “were based on material mathematical mistakes” and expert
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`“abandoned” portions of opinions at deposition after errors were noted) (citing Dart v. Kitchens
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`Bros. Mfg. Co., 253 F. App’x 395, 399 (5th Cir. 2007) (excluding testimony based on “basic
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`mathematical errors and flaws in methodology”)); see also Dzielak v. Whirlpool Corp., No. 2:12-
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`0089(KM)(JBC), 2017 WL 1034197, at *27 (D.N.J. Mar. 17, 2017) (stating that “mathematical
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`errors and flawed data can of course be significant in the Daubert calculus”). Dr. Rubinstein should
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`similarly be precluded from presenting the portion of his opinions
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` at trial.
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`3 The portion of Footnote 100 that refers to
`should also be excluded.
`4 As discussed further in §IV, infra, Dr. Berkman should similarly be precluded under Daubert
`from presenting the portion of his opinions relying on Dr. Rubinstein
` at trial,
`including at least ¶ 55 of his Reply Report (Ex. F). Further, to the extent that Dr. Berkman’s
`calculations
` incorporate assumptions and data
` based
`on Dr. Rubinstein’s unreliable opinions, those calculations are also unreliable and excludable.
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`6
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 11 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 11 of 21
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`IV.
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`DR. MARK BERKMAN’S OPINIONS ON
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`SHOULD BE EXCLUDED
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`A patent holder may recoverits actual damages in the form oflost profits as opposed to a
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`royalty only if it can prove without speculationthat “but for” the infringement, there is a reasonable
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`probability it would have madethe sales that the infrimger made. B/C Leisure Prods., Inc. v.
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`Windsurfing Int’l, Inc., 1 F.3d 1214, 1218 (Fed. Cir. 1993) (citing Water Techs. Corp. v. Calco
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`Ltd., 850 F.2d 660, 671 (Fed. Cir. 1988)). In support of its damages claim, Teva submitted opening
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`and reply expert reports in this case from Dr. Berkman.’ Dr. Berkmanopines in his opening report
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`ee ©x. G (Berkman Op. Rep.) at §§135, 140, 149, Table 2.
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`NS 159,1301
`11. Across all timeframes, Dr. Berkman further subdividesPo
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`WE 1. at 99 135-49, Tables 2, 8, 10, 11.
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`> Infringement, validity, and enforceability have not yet been decided for any asserted claim in this
`case. For purposes of expert discovery, the parties have exchanged reports from their damages
`experts that assumethat the patents-in-suit are valid, enforceable, and infringed.
`° A “but-for world”refers to a hypothetical scenario where Emgality® is never brought to market.
`7 Dr. Berkmandid not alter any of his opinions on
`from his opening report in his reply
`report orat his deposition. See, e.g., Ex. F (Berkman Reply Rep.
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`§
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`

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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 12 of 21
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`All of Dr. Berkman’s
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` analyses that related to
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`should be excluded under Daubert and the
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`Federal Rules of Evidence. First, Dr. Berkman does not possess the specialized expertise to present
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`any
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`opinions related to
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` Second, to the extent Dr. Berkman presents any
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` his analysis is based
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`on unverified data and amounts to pure speculation.
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`A.
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`Dr. Berkman Is Unqualified to Opine on
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`
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`Substantial portions of both of Dr. Berkman’s expert reports present facts, assumptions,
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`and inferences about
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`about specific materials that he considered in forming his opinions, Dr. Berkman
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` When asked
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`In forming his opinions, Dr. Berkman not only failed to “fairly” go through entire
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`documents but also lacked the requisite experience to offer those opinions at all. Dr. Berkman
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`As another court has recognized, Dr. Berkman’s specialized expertise lies in urban affairs and
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`8
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 13 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 13 of 21
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`public policy, namely the calculation of damages from pollution. See Ponca Tribe ofIndians of
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`Okla. v. Cont’l Carbon Co., No. CIV-05-445-C, 2009 WL 5842042,at *2, 7 (W.D. Okla. Jan. 23,
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`2009) (summarizing Dr. Berkman’s credentials). This is a completely different industry, with few,
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`if any, transferable skills or experience to the analysis of dynamic pharmaceutical drug markets.
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`Indeed, Dr.Berk
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`Dr. Berkman also testified that hews
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`supra. His education does not compensate forthis lack of experience as his doctoral degree is in
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`public policy, not economics, let alone pharmacy. Jd. at 46:20-24; see also Ex. G (Berkman Op.
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`Rep.) at § 5. Unsurprisingly, he has also neverwritten on topics that relate to the economics of the
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`pharmaceutical industry. See Ex. H (BerkmanTr.) at 43:1-9.
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 14 of 21
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`Despite this lack of relevant experience, Dr. Berkman then calculated
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`
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` using unsupported facts, unreliable assumptions, and
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`inferences suggested to him by counsel.11 See Ex. G (Berkman Op. Rep.) at §VII.B, ¶¶ 135-49,
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`Tables 8, 10, 11. Dr. Berkman simply has no specialized expertise to offer the jury regarding
`
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`
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` He has never served as an expert on those topics before and has no
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`relevant professional or academic experience in that field. Curiously, although Dr. Berkman refers
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`to Dr. Rubinstein as
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` These limited citations were
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` Under these circumstances, it is proper for the Court to exclude Dr. Berkman from
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`testifying on areas outside of his expertise. See Richmond Steel Inc. v. Puerto Rican Am. Ins. Co.,
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`954 F.2d 19, 21 (1st Cir. 1992) (affirming exclusion of unqualified expert based on “broad
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`discretionary powers in determining the qualification, and thus, admissibility, of expert
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`witnesses.”). Dr. Berkman should not be permitted to offer any opinions on
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`
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` because he has no specialized experience in the relevant field on which to ground
`
`11
`the reasons discussed in §IV.B.2, infra.
`12 Neither Dr. Berkman nor Dr. Rubinstein knew why Dr. Berkman referred to Dr. Rubinstein in
`this manner. See Ex. H (Berkman Tr.) at 72:16-22; Ex. C (Rubinstein Tr.) at 45:20-46:9.
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`are also separately excludable for
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`10
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 15 of 21
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`those opinions. To the extent Teva argues Dr. Berkman did rely on Dr. Rubinstein for any such
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`opinions, at the outset, those citations are largely absent from Dr. Berkman’s reports and from his
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`deposition testimony. Second, Dr. Berkman, with no relevant experience of his own, is not
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`permitted to simply “parrot” opinions belonging to another expert. Carrozza v. CVS Pharmacy,
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`Inc., 391 F. Supp. 3d 136, 145 (D. Mass. 2019), aff’d, 992 F.3d 44 (1st Cir. 2021) (“[a] witness
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`who has no relevant expertise or familiarity with a subject matter may not, however, simply parrot
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`the conclusions of an expert who does.”); Thorndike v. DaimlerChrysler Corp., 266 F. Supp. 2d
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`172, 185 (D. Me. 2003) (excluding expert testimony when proponent “fails utterly to explain where
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`methodology is involved here as opposed to simply the parroting of other experts’ conclusions.”).
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`Any argument from Dr. Berkman that he somehow acquired this expertise during his career has
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`also been rejected by the courts. See, e.g., Earley, 2021 WL 5868249, at *5 (“[g]eneric appeals to
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`an expert’s experience are no substitute for reliable principles and methods.” (citations omitted)).
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`At the very least, to the extent the Court grants Lilly’s Daubert motion regarding Dr.
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`Rubinstein, see §III, supra, Dr. Berkman should similarly be precluded from
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`
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`
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`is unreliable and should be excluded to the same extent for this additional, independent reason. Dr.
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`Berkman’s opinions have been precluded under Daubert before on similar facts. See Ponca Tribe,
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`2009 WL 5842042, at *7 (excluding Dr. Berkman’s opinions when, after another expert was
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`excluded, “there [was] no evidentiary foundation for Dr. Berkman’s opinions.”).
`
`B.
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`Dr. Berkman’s Estimation of
`Purely Speculative and Should Be Excluded
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`As discussed above, Dr. Berkman’s calculated
`
`11
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` Is
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`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 16 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 16 of 21
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`ex. G (Berkman Op.Rep.) at § 149. But in reachingthat figure, Dr. Berkman impermissibly
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`relies on
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`Dr. Berkman
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`should be precluded from presenting this prejudicial, speculative opinion to the jury.
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`1.
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`Governing Case Law Sets a High Bar for Future Lost Profits
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`Projected future losses are recoverable under certain circumstances, but “the amountoflost
`
`profits awarded must not be speculative.” Brooktree Corp. v. Advanced Micro Devices, Inc., 977
`
`F.2d 1555, 1581 (Fed. Cir. 1992). Accordingly, “[t]he burden of proving future injury is
`
`commensurately greater than that for damages already incurred, for the future always harbors
`
`unknowns,” including uncertainties
`
`surrounding future pricing, competition, and market
`
`dynamics. Jd. Mere extrapolation of past sales figures does not amount to adequate evidentiary
`
`support; “reliable economic testimony relevant to [the] market” is required. See Oiness v.
`
`Walgreen Co., 88 F.3d 1025, 1031-32 (Fed. Cir. 1996).
`
`2.
`
`Dr. Berkman’s
`
`DeBerks
`
`Are Unreliable and Speculative
`
`are impermissibly speculative and unsupported by sound
`
`methodological principles. First, Dr. Berkman assumes that
`
`3
`
`— N
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`

`

`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 17 of 21
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`a.
`
`Dr. Berkmana Relies ona
`
`
`
`Calendar year 2021 alone shows how unpredictable this market canbe.
`
`I i 20: 2 could n01 forsee th
`
`Omicron variant of COVID-19, whichsignificantly affected the U.S. in December2021.!* Nordid
`
`EEforesee the >2%increase in inflation since July 1,
`
`2021, and how that would affect consumer demandorcosts incurred by either party. See Ex. L
`
`(U.S. Bureau of LaborStatistics, CPI-U, Feb. 2022, https://data.bls.gov/timeseries/
`
`CUURO0000SA0&output_view=pct_12mths, last accessed March 23, 2022).
`
`‘4 The Omicronvariant wasidentified by the time Dr. Berkman submitted his reply report, but he
`madeno changesto his calculations. See, e.g., Ex. F (Berkman Reply Rep.) at §§V, VIL.
`
`es |ee
`
`13
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`

`

`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 18 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 18 of 21
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`On similar facts, courts have excluded opinions from damages experts that relied on
`
`internal business documents without independent verification of their assumptions, data, and
`
`methodology. F.g., Fail-Safe, L.L.C. v. A.O. Smith Corp., 744 F. Supp. 2d 870, 887-88 (E.D. Wis.
`
`2010) (future lost profits opinions excluded based on reliance on defendant’s “early hopes” for
`
`market potential without independent verification); Legendary Art, LLC v. Godard, No. CIV.A.
`
`11-0674, 2012 WL 3550040,at *4 (E.D. Pa. Aug. 17, 2012) (future lost profits opinions excluded
`
`when expert “assumed the validity of [internal] projections” and admitted that conclusions were
`
`“predicated upon successful implementation”of the projections).
`
`Dr. Berkmanalso
`
`5
`
`14
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`

`

`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 19 of 21
`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 19 of 21
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`Expert discount rates that were similarly vulnerable to speculation have
`
`previously led Courts to exclude future lost profits opinions. Shockley v. Arcan, Inc., 248 F.3d
`
`1349, 1363-64 (Fed. Cir. 2001) (a future lost profit award “based on evidence derived from
`
`speculative assumptions. ..runs counterto the great weight of record evidence and cannotstand.”).
`
`Po compoundsspeculation on top ofspeculation. The endresult is that a dramatically
`
`inflated, unreliable damages number would bepresented to the jury that finds no grounding in
`
`economic principles. Needless to say, the past two years have demonstrated anything 1s possible
`
`and nothing is certain. Blindly throwing a dart at a future lost profits numberfive years into the
`
`future is unsupportable and should be excluded under Daubert.
`
`V.
`
`CONCLUSION
`
`Lilly respectfully requests that the testimony of Dr. Rubinstein and Dr. Berkman attrial be
`
`limited as set forth in this motion pursuant to Daubert and the Federal Rules of Evidence.
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 20 of 21
`
`Dated: March 28, 2022
`
`William B. Raich
`Danielle A. Duszczyszyn
`Denise Main
`Pier D. DeRoo
`Matthew Luneack
`Yoonjin Lee
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`William.Raich@finnegan.com
`Danielle.Duszczyszyn@finnegan.com
`Denise.Main@finnegan.com
`Pier.DeRoo@finnegan.com
`Matthew.Luneack@finnegan.com
`Yoonjin.Lee@finnegan.com
`
`/s/Andrea L. Martin
`Andrea L. Martin (BBO 666117)
`BURNS & LEVINSON LLP
`125 High Street
`Boston, MA 02110-1624
`(617) 345-3000
`amartin@burnslev.com
`
`Charles E. Lipsey
`Ryan O’Quinn
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`1875 Explorer Street
`Suite 800
`Reston, VA 20190-6023
`Charles.Lipsey@finnegan.com
`Oquinnr@finnegan.com
`
`Emily R. Gabranski (BBO 694417)
`Marta Garcia Daneshvar
`Lulu Wang (BBO 704042)
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`2 Seaport Lane
`Boston, MA 02210-2001
`Emily.Gabranski@finnegan.com
`Marta.Garcia@finnegan.com
`Lulu.Wang@finnegan.com
`
`Attorneys for Defendant
`Eli Lilly and Company
`
`16
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`
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 311 Filed 03/28/22 Page 21 of 21
`
`CERTIFICATE OF SERVICE
`
`I, Andrea L. Martin, hereby certify that this document filed through the ECF system will
`be sent electronically to the registered participants as identified on the Notice of Electronic Filing
`(NEF) and paper copies will be sent to those indicated as non-registered participants on March
`28, 2022. The unredacted version of this document will be served on all outside counsel of
`record via email.
`
`/s/Andrea L. Martin, Esq.
`Andrea L. Martin, Esq.
`
`