Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 1 of 20
`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 1 of 20
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Vv.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`NueeBS
`
`Case No. 1:18-cv-12029-ADB
`
`Leave to File Under Seal Granted on
`May6, 2022 (ECF No. 341)
`
`DEFENDANT ELI LILLY AND COMPANY’S MEMORANDUMIN OPPOSITION
`TO PLAINTIFFS’ MOTION TO EXCLUDE
`CERTAIN OPINIONS OF JAMES M. MCDONNELL,PH.D.
`
`

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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 2 of 20
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`TABLE OF CONTENTS
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`Introduction ......................................................................................................................... 1
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`Legal Standard .................................................................................................................... 3
`
`I.
`
`II.
`
`III.
`
`Argument ............................................................................................................................ 3
`
`A.
`
`Teva’s Motion to Exclude Dr. McDonnell’s Opinions Regarding
`Materiality Should Be Denied Because It Contradicts Relevant Law and
`Fails to Consider Dr. McDonnell’s Opinions as a Whole ...................................... 3
`
`1.
`
`2.
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`3.
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`The Information Withheld from the USPTO Is Highly Material ............... 3
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`Dr. McDonnell Properly Refrained from Speculating Whether the
`Withheld Information Is “But-for” Material ............................................... 6
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`Dr. McDonnell Properly Assessed and Determined that the
`Withheld Information Was Not Cumulative ............................................... 8
`
`B.
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`Teva Omits Critical Facts That Compel Denying Its Motion to Exclude
`Dr. McDonnell’s Opinions Regarding Literal Infringement ................................ 10
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`IV.
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`Conclusion ........................................................................................................................ 13
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`i
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 3 of 20
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
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`Federal Cases
`
`Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc.,
`2014 WL 7330777 (D. Mass. Dec. 19, 2014) ........................................................................2, 7
`
`In re Biogen ’755 Patent Litig.,
`2018 WL 3613162 (D.N.J. Jul. 26, 2018) ..................................................................................7
`
`Canrig Drilling Tech. Ltd. v. Trinidad Drilling L.P.,
`2016 WL 7188657 (S.D. Tex. Dec. 12, 2016) ...........................................................................7
`
`Daubert v. Merrell Dow Pharms., Inc.,
`509 U.S. 579 (1993) ...................................................................................................................3
`
`U.S. ex rel. Dyer v. Raytheon Co.,
`2013 WL 5348571 (D. Mass. Sep. 23, 2013) ..........................................................................13
`
`Hebert v. Lisle Corp.,
`99 F.3d 1109 (Fed. Cir. 1996)..................................................................................................12
`
`J&M Indus., Inc. v. Raven Indus., Inc.,
`457 F. Supp. 3d. 1022 (D. Kan. 2020) .......................................................................................7
`
`Levin v. Dalva Bros.,
`459 F.3d 68 (1st Cir. 2006) ........................................................................................................3
`
`Medicines Co. v. Mylan Inc.,
`2014 WL 1516599 (N.D. Ill. Apr. 17, 2014) .........................................................................6, 7
`
`Medtronic, Inc. v. Mirowski Family Ventures, LLC,
`571 U.S. 191 (2014) .................................................................................................................13
`
`Niazi Licensing Corp. v. St. Jude Med. S.C., Inc.,
`2020 WL 5512507 (D. Minn. Sep. 14, 2020) ..........................................................................12
`
`Regeneron Pharms., Inc. v. Merus B.V.,
`144 F. Supp. 3d 530 (S.D.N.Y. 2015), aff’d 864 F.3d 1343 (Fed. Cir. 2017) ...........................6
`
`Regeneron Pharms., Inc. v. Merus N.V.,
`864 F.3d 1343 (Fed. Cir. 2017)..................................................................................................9
`
`Smith v. Jenkins,
`732 F.3d 51 (1st Cir. 2013) ........................................................................................................3
`
`ii
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 4 of 20
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`Summit 6, LLC v. Samsung Elec. Co.,
`802 F.3d 1283 (Fed. Cir. 2015)..................................................................................................9
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) (en banc)..................................................................................6
`
`United States v. Corey,
`207 F.3d 84 (1st Cir. 2000) ........................................................................................................2
`
`WNS Holdings, LLC v. United Parcel Serv., Inc.,
`2009 WL 2136961 (W.D. Wis. Jul 14, 2009), aff’d, 368 F. App’x 144 (Fed.
`Cir. 2010) .................................................................................................................................13
`
`Rules
`
`Fed. R. Evid. 702 ...................................................................................................................2, 3, 10
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`
`
`
`
`iii
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 5 of 20
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`Abbreviation
`’045 Patent
`Br.
`
`CGRP
`Ex. __1
`Lilly
`Patents-in-Suit
`Shaw
`Tan 1995
`Teva
`
`USPTO
`
`TABLE OF ABBREVIATIONS
`
`
`Description
`U.S. Patent No. 8,586,045
`ECF No. 323 (Plaintiffs’ Memorandum in Support of the Motion to
`Exclude Certain Opinions of Defendant’s Expert James M. McDonnell,
`Ph.D.)
`calcitonin gene-related peptide
`Exhibit No. __
`Eli Lilly and Company
`U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908
`Shaw et al., Br. J. Pharmacol. (1992) 106:196-98
`Tan et al., Clinical Sci. (Lond) (1995) 89:565-73
`Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals
`USA, Inc.
`The United States Patent and Trademark Office
`
`
`1 Refers to Exhibits to the accompanying Declaration of Emily Gabranski In Support of Defendant
`Eli Lilly and Company’s Opposition to Plaintiffs’ Motion to Exclude Certain Opinions of James
`M. McDonnell, Ph.D., unless otherwise indicated.
`iv
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 6 of 20
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`I.
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`Introduction
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`Lilly’s expert James M. McDonnell, Ph.D., who has over 20 years of experience as an
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`antibody engineer, intends to testify on the antibody topics in this case. Teva seeks to exclude two
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`aspects of his testimony: (1) that certain information withheld from the USPTO by Teva’s named
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`inventors was material to patentability; and (2) in its infringement analysis, Teva failed to satisfy
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`its burden of showing that galcanezumab is a “humanized” antibody. Teva’s motion should be
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`denied because Dr. McDonnell’s opinions are supported and consistent with controlling law.
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`Teva seeks to exclude Dr. McDonnell’s testimony regarding materiality because allowing
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`such testimony could have potentially dire consequences for Teva—its Patents-in-Suit ultimately
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`being held unenforceable for inequitable conduct. By way of background, Teva’s asserted claims
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`cover the use of any and all human and/or humanized antagonist antibodies that bind anywhere on
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`CGRP.
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` also
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`failed to disclose prior art revealing that the only reported antibody that bound to the mid-region
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`of CGRP enhanced, rather than antagonized, CGRP activity.
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`Dr. McDonnell opined that this withheld information is material to the patentability of the
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`asserted claims because it confirms lack of possession for Teva’s overbroad claims. He further
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`opined that the withheld information conflicted with representations made to the USPTO to secure
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`allowance of one of the Patents-in-Suit, the ’045 patent. Teva argues that this testimony should
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`be excluded for two reasons.
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`First, Teva alleges that Dr. McDonnell committed legal error by not opining as to what the
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`USPTO examiner would have done, hypothetically speaking, had
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` disclosed
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`the withheld information. But there is no obligation for a technical expert to speculate on what the
`1
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 7 of 20
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`USPTO examiner would have done. Indeed, courts in this district and elsewhere have repeatedly
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`warned against doing so. E.g., Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc., 2014
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`WL 7330777, at *8 (D. Mass. Dec. 19, 2014) (an expert “may not speculate as to what the examiner
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`did or did not think, or how different information would have impacted the examiner’s opinions
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`or thoughts”).
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`Second, Teva argues that Dr. McDonnell’s opinion should be excluded because he
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`allegedly did not conduct a side-by-side analysis to evaluate whether the undisclosed information
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`was duplicative of information in Teva’s Patents-in-Suit or otherwise disclosed to the USPTO.
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`But Dr. McDonnell testified that, in fact, he did “compare” the undisclosed and disclosed
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`information, and moreover the extensive analyses in his reports confirm that the undisclosed
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`failures and prior art are not cumulative to the limited patent disclosure and the disclosed prior art.
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`Teva’s desire to view certain of Dr. McDonnell’s opinions in a vacuum is improper. See United
`
`States v. Corey, 207 F.3d 84, 88 n.5 (1st Cir. 2000) (“under Rule 702 the only inquiry is whether
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`the expert opinion, taken as a whole, may assist the jury in resolving an ultimate issue of fact”).
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`Teva’s attempt to exclude Dr. McDonnell’s infringement analysis fares no better. To
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`establish literal infringement, Teva must prove, by a preponderance of the evidence, that Lilly’s
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`galcanezumab antibody contains “minimal” non-human sequence. To do so, Teva’s expert used
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`software that compared the sequences of galcanezumab and Teva’s fremanezumab with those in a
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`database. As Dr. McDonnell observed, however, Teva’s expert used different software settings
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`for each. With galcanezumab, Teva’s expert deviated from the software’s default settings, electing
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`to compare galcanezumab’s sequences against only human sequences, whereas for fremanezumab
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`he used the software’s default settings. Teva’s expert provided no basis for treating the antibodies
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`differently. Dr. McDonnell’s testimony would help explain the significance of this deliberate
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`2
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 8 of 20
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`change in software settings to the jury—which skewed the analysis for galcanezumab such that it
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`appears more human (i.e., contains minimal non-human sequence). In essence, Teva seeks to
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`exclude Dr. McDonnell’s testimony because it exposes the unreliable methods of its own expert.
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`Teva may not want the jury to hear how its infringement case was built on misleading data, but
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`that is no basis for exclusion.
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`Excluding expert testimony is disfavored. Teva’s baseless motion should be denied, and
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`the Court should allow the jury to hear Dr. McDonnell’s highly relevant testimony.
`
`II.
`
`Legal Standard
`
`Fed. R. Evid. 702, which codifies the standard set forth in Daubert v. Merrell Dow
`
`Pharmaceuticals, Inc., 509 U.S. 579 (1993), permits expert testimony if “the expert’s scientific,
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`technical, or other specialized knowledge will help the trier of fact to understand the evidence or
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`to determine a fact in issue.” To be admissible, the testimony must: (1) be based on sufficient facts
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`or data, (2) be the product of reliable principles and methods, and (3) reliably apply the principles
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`and methods to the facts of the case. Smith v. Jenkins, 732 F.3d 51, 64 (1st Cir. 2013) (citing Fed.
`
`R. Evid. 702 and Daubert, 509 U.S. at 592-94).
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`“Rule 702 has been interpreted liberally in favor of the admission of expert testimony.”
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`Levin v. Dalva Bros., 459 F.3d 68, 78 (1st Cir. 2006) (citing Daubert, 509 U.S. at 588).
`
`III. Argument
`A.
`
`Teva’s Motion to Exclude Dr. McDonnell’s Opinions Regarding
`Materiality Should Be Denied Because It Contradicts Relevant Law
`and Fails to Consider Dr. McDonnell’s Opinions as a Whole
`1.
`
`The Information Withheld from the USPTO Is Highly Material
`
`The antibodies tested in the Patents-in-Suit bind to one discrete region of CGRP, its C-
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`terminal end. Ex. A at ¶ 188. But the claims of the Patents-in-Suit encompass the use of any
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`human and/or humanized antagonist antibody, regardless of where it binds to CGRP. Id.
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`3
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 9 of 20
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`These
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` were not disclosed in the patent applications leading to the Patents-in-Suit.
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`Ex. J at 193:2-14; Ex. K at 191:16-192:7. Nor were they disclosed to the USPTO during
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`prosecution of the Patents-in-Suit. See ECF No. 279 at 82.
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 10 of 20
`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 10 of 20
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`Po Shawis not mentioned in the Patents-in-Suit and was not submitted
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`to the USPTO during prosecution of the ’045 patent. See ECF No. 279 at 81.
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`Dr. McDonnell opined that these undisclosed materials were material to patentability.
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`Ex. C at § 153. For example, he explained thatP| are material because they confirm that
`the named inventors did not possess the full scope of the claimed subject matteri
`Is. . 265198: Fx. a0 4 154, He fries
`explained thatPe Shaw are material because they are
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`inconsistent with arguments made to the USPTO during prosecution of the ’045 patent,
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`in
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`particular, the representation that “any antibody that effectively binds CGRP may reasonably be
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`expected to have the claimed effect” regardless of where it binds within CGRP. Ex. P at
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`TEVAFREM000030998 (emphasis added); Ex. A at §§ 199-201; Ex. C at §§ 155-167.
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`Teva seeks to exclude Dr. McDonnell’s opinions on the materiality of the withheld
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`information, even though the Court previously stated that this “withheld information (|
`fF the Shaw reference .
`. .) were plainly material.” ECF No. 236 at 24.” Tevaidentifies
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`two reasons that allegedly justify exclusion: Dr. McDonnell purportedly (1) did not analyze “but-
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`for” materiality and (2) did not consider the cumulativeness of the withheld information. Br. at 9-
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`12. As discussed below, neither warrants exclusion.
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`2 The Court further stated as follows: “Evidence
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`relating to anti-CGRP antibodies. Thus, if this information had been disclosed to the PTO, a
`reasonable examiner would have considered it important when deciding whether to issue the
`patent.” ECF No. 236 at 24; id. at 25 (“a reasonable examiner would have found it important to
`knowif the .
`.
`. statement [made during prosecution of the ’045 patent] were true or false”).
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`5
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 11 of 20
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`2.
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`Dr. McDonnell Properly Refrained from Speculating Whether
`the Withheld Information Is “But-for” Material
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`Teva incorrectly argues that Dr. McDonnell’s opinions on the materiality of the withheld
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`information should be excluded because he did not consider whether that information is “but-for”
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`material. Br. at 9-11. The “but-for” materiality standard requires “the Court [to] determine
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`whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.”
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`Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1291-92 (Fed. Cir. 2011) (en banc).
`
`But there is no requirement that technical experts opine on what the USPTO examiner would or
`
`would not have done if the undisclosed information had been disclosed. Indeed, many courts,
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`including in this district, have expressly held that technical experts should not do so.
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`By contrast, when, as here, information withheld from the USPTO is technical in nature,
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`courts evaluating “but-for” materiality often consider opinions from a technical expert who can
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`explain the relevance of the information to the patentability of the claims at issue. See, e.g.,
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`Regeneron Pharms., Inc. v. Merus B.V., 144 F. Supp. 3d 530, 571-77 (S.D.N.Y. 2015), aff’d 864
`
`F.3d 1343 (Fed. Cir. 2017) (consulting an expert’s testimony about the subject matter discussed in
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`references that were not disclosed to the USPTO in evaluating but-for materiality); Medicines Co.
`
`v. Mylan Inc., 2014 WL 1516599, at *5 (N.D. Ill. Apr. 17, 2014) (admitting an expert’s testimony
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`on “the potential materiality” of certain information based on the expert’s “extensive expertise” in
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`the “pharmaceutical industry”). This is exactly what Dr. McDonnell provided in this case. Based
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`on his extensive experience in antibody engineering (Ex. A at ¶¶ 4-7), Dr. McDonnell analyzed
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`the withheld information in detail (id. at ¶¶ 124-125, 189-197), explained its relevance to the
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`patentability of the claims (see supra § III.A.1), and reiterated its relevance in his deposition (Ex. Q
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`at 151:5-152:18).
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`6
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 12 of 20
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`Teva nevertheless seeks to exclude this highly relevant testimony because Dr. McDonnell,
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`an antibody engineer, did not opine on whether “the patent would not have issued had the allegedly
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`withheld information been disclosed.” Br. at 10-11. But Dr. McDonnell had no obligation to
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`opine on what the USPTO examiner would or would not have done had the named inventors
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`disclosed
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` the Shaw publication. Indeed, many courts, including courts
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`in this district, have warned against having technical experts opine on what the USPTO examiner
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`would have done had the withheld material been disclosed. E.g. Abbott, 2014 WL 7330777, at *8
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`(an expert “may not speculate as to what the examiner did or did not think, or how different
`
`information would have impacted the examiner’s opinions or thoughts”); In re Biogen ’755 Patent
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`Litig., 2018 WL 3613162, *12 (D.N.J. Jul. 26, 2018) (“experts may not testify as to a patent
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`examiner’s state of mind”); see also J&M Indus., Inc. v. Raven Indus., Inc., 457 F. Supp. 3d. 1022,
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`1046-47 (D. Kan. 2020) (allowing a technical expert to “offer opinions about technical aspects of
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`the claimed invention and the prior art and how, in her opinion, it affects the validity of the patent”
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`but excluding the same expert’s opinions on “what the patent examiner would have done had the
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`. . . prior art been disclosed”); Canrig Drilling Tech. Ltd. v. Trinidad Drilling L.P., 2016 WL
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`7188657, *7 (S.D. Tex. Dec. 12, 2016) (allowing a technical expert to testify whether “certain
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`relevant prior art was not before the PTO” but precluding testimony about “whether the PTO would
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`have reached a different result if all relevant prior art references were before it”); Medicines, 2014
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`WL 1516599, at *4-5 (precluding a technical expert “from opining on what the Patent Office
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`Examiner would have done or thought had she been given different information” but allowing
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`testimony “as to what [the expert] believes would have been material to the patent examiner”).
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`Dr. McDonnell testified in his deposition (see Br. at 11) that the withheld information
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`“could have been relevant” for evaluating claim 17 of the ’045 patent and other asserted claims.
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 13 of 20
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`Ex. Q at 151:5-17. He explained that he did not speculate whether that withheld information would
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`be “but-for” material because “[t]hat’s not [his] job.” Id. Teva’s efforts to exclude
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`Dr. McDonnell’s testimony on that basis is contrary to law and should be rejected.
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`3.
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`Dr. McDonnell Properly Assessed and Determined that the
`Withheld Information Was Not Cumulative
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`Teva’s other argument to exclude Dr. McDonnell’s materiality opinion is similarly flawed.
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`Citing Dr. McDonnell’s deposition testimony, Teva asserts that Dr. McDonnell “did not compare
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` Shaw, on one hand, with the information and
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`references that were disclosed to the Examiner, on the other.” Br. at 11-12.
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`Contrary to Teva’s assertion, Dr. McDonnell testified in his deposition that he did compare
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`the withheld information and the information in the Patents-in-Suit and that disclosed to the
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`Examiner.3 Ex. Q at 153:4-154:22 (Dr. McDonnell testifying: “I did compare them”).
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`Dr. McDonnell’s expert reports make clear that he assessed the noncumulative nature of the
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`withheld information. For instance, Dr. McDonnell opined that the antibodies tested in the Patents-
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`in-Suit bound to the C-terminal end of CGRP
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` Compare Ex. A
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`at ¶ 188 with id. at ¶ 192. Dr. McDonnell opined that the Patents-in-Suit and submitted prior art
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`disclose no antibodies directed to the mid-region of CGRP. In contrast, he opined that the withheld
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`Shaw publication reported that a mid-region binding antibody enhanced CGRP activity. Compare
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`Ex. C at ¶ 137 with id. at ¶¶ 137, 173. Dr. McDonnell opined that the prior art references submitted
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`to the USPTO disclosed at most one murine antibody that bound to the N-terminal end of CGRP
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`3 Dr. McDonnell further explained the challenges in these comparisons, noting that Teva’s patents
`and the prior art lacked critical information (such as amino acid sequence information for any
`murine antibody) to allow side-by-side comparisons. Ex. Q at 154:5-154:18.
`8
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 14 of 20
`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 14 of 20
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`and antagonized its activity, at least under certain conditions.‘
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`In contrast, the withheld Shaw
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`publication disclosed that N-terminal binding antibodies could antagonize or have no effect on
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`CGRP activity, and that this was not a function of howtightly the antibody bound. Compare Ex. A
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`at § 122-123 with id. at §§ 124-125 and Ex. C at § 172. Thus, Dr. McDonnell opined that the
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`withheld information was not cumulative to the limited information disclosed in the Patents-in-
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`Suit and submitted to the USPTO.
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`Teva dismisses this extensive testimony because the relevant discussions do not appear
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`side-by-side in Dr. McDonnell’s reports. Br. at 12. But Dr. McDonnell merely had to consider
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`whether the withheld information “teaches no more than what a reasonable examiner would
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`considerto be taught by the prior art already before the PTO,” not a side-by-side analysis as Teva
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`demands. Regeneron Pharms., Inc. v. Merus N.V., 864 F.3d 1343, 1350 (Fed. Cir. 2017); Ex. Q
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`at 153:4-154:22 (Teva’s counsel repeatedly asking abouta “side-by-side” analysis notwithstanding
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`Dr. McDonnell’s request for clarification). Here, Dr. McDonnell provided the requisite analyses
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`in his reports and in his deposition, and Teva fails to identify any reasonable basis for excluding
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`Dr. McDonnell’s testimony. See Summit 6, LLC v. Samsung Elec. Co., 802 F.3d 1283, 1296 (Fed.
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`Cir. 2015) (“where the methodology is reasonable andits data or evidence are sufficiently tied to
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`the facts of the case, the gatekeeping role of the court is satisfied”).
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`* That antibody, referred to as MAb C4.19, was reported in a journal article called Tan 1995
`(Ex. V). While Tan 1995 was submitted to the USPTO,it does not identify what region of CGRP
`is bound by MAb C4.19. Instead, that was reported in a doctoral thesis that
`did not submit to the USPTO. See Ex. W (7045
`patent) at
`page 2 (listing, inter alia, Tan 1995):
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 15 of 20
`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 15 of 20
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`In sum, Dr. McDonnell appropriately explained the relevance of the withheld information
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`to the patentability of the asserted claims. He refrained from speculating as to what the PTO
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`examiner would have done with this information—which was entirely appropriate. He also
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`explained the noncumulative nature of the withheld information. Teva’s meritless motion, which
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`finds no support in Fed. R. Evid. 702 and governing case law, should be denied.
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`B.
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`Teva Omits Critical Facts That Compel Denying Its Motion to Exclude
`Dr. McDonnell’s Opinions Regarding Literal Infringement
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`Teva also seeks to exclude Dr. McDonnell’s opinions that Teva, through its expert Dr.
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`Ravetch, failed to satisfy its burden of proving that galcanezumabliterally infringes the asserted
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`claims.
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`In particular, Teva seeks to exclude Dr. McDonnell’s opinions that Teva failed to prove
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`that galcanezumab is a “humanized antibody”as that term was construed by the Court. Br. at 4-
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`9. But Teva mischaracterizes Dr. McDonnell’s opinions and omitscritical facts.
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`The Court’s construction requires that a “humanized antibody” contain “minimal
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`sequence” derived from a non-human immunoglobulin.? ECF No. 101 at 16. To support Teva’s
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`infringement analysis, its expert Dr. Ravetch calculated the relative percentages of human and
`
`non-human sequencein Lilly’s galcanezumabantibody. Specifically, Dr. Ravetch calculated that
`
`galcanezumab contained 6.8% non-human sequenceusing a particular software tool and opined
`
`that galcanezumab was a “humanized”antibody becausethis constituted “minimal non-human
`
`immunoglobulin sequence.” Ex. D at §§ 111-112.
`
`there can be no dispute that
`> Teva summarily states that under the Court’s construction,
`galcanezumabis a “humanized” antibody. Br. at 6. Not so. The record showsthat the parties’
`experts dispute this very issue, providing competing views on how to evaluate whether
`
`alcanezumab contains “minimal” non-human sequence.
`
`
`Tellingly, Teva did not move for summary judgment on
` infringement.
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 16 of 20
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`But Dr. Ravetch fudged the numbers. As Dr. McDonnell explained, Dr. Ravetch changed
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`the software’s default settings, such that the species database used by the software contained
`
`exclusively human sequences. Ex. B at ¶ 183. As a result, only human sequences were compared
`
`against galcanezumab, “skewing the analysis such that the variable domain sequences of
`
`galcanezumab appear[ed] to be most similar to human.” Id. As Dr. McDonnell’s analyses
`
`revealed, had Dr. Ravetch used the default settings, he would have identified nearly all of
`
`galcanezumab variable domains as non-human (instead of just 6.8%). Id. at ¶¶ 181-182. Notably,
`
`and in stark contrast, when Dr. Ravetch analyzed Teva’s fremanezumab antibody, he used the
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`software’s default settings—i.e., he did not use a database of only human sequences. Id. at ¶ 184;
`
`Ex. D at Exhibit 3 at §§ II.B (heavy chain), II.C (light chain). Dr. Ravetch provided no explanation
`
`as to why he selected different software settings for different antibodies in assessing “minimal
`
`sequence.”6 Ex. B at ¶¶ 184-185.
`
`Instead of simply cross-examining Dr. McDonnell on the issue, Teva now seeks the
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`disfavored approach of having Dr. McDonnell’s “minimal sequence” opinions excluded, arguing
`
`that he (1) improperly relied on computer software in analyzing minimal sequence and (2)
`
`
`
` Br. at 4-9. Neither reason is sufficient.
`
`As explained above, Dr. McDonnell was directly responding to Dr. Ravetch’s sequence-based
`
`infringement analysis—an issue for which Teva bears the burden of proof. Ex. B at ¶¶ 179, 5.
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`While Teva faults Dr. McDonnell for allegedly “ignoring”
`
`
`
` (see, e.g., Br. at 1), Dr. McDonnell did not need to consult those
`
`
`6 In his reply report, Dr. Ravetch alleges that there is “no functional difference between” the two
`different settings that he used to analyze galcanezumab and fremanezumab. Ex. E at ¶ 16. Setting
`aside whether this self-serving assertion is correct, it does not explain why he changed the settings
`only when analyzing Lilly’s galcanezumab antibody.
`11
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 17 of 20
`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 17 of 20
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`documents to explain the deficiencies in Dr. Ravetch’s methodology. Further, these documents
`
`do not explain whether galcanezumabis a “humanized”antibody in the context of the Patents-in-
`
`Suit because they make no mention of “minimal” non-human sequence.Po
`
`PO As such,
`
`these documents cannot resolve the issue of whether
`
`galcanezumabcontains “minimal” non-human sequence.’
`
`The cases relied on by Teva are inapposite. For example, Teva cites Hebert v. Lisle Corp.
`
`to argue that Dr. McDonnell’s opinions should be excluded because they are allegedly based on a
`
`legally incorrect premise. Br. at 8. In Hebert, the testimony at issue involved incorrect statements
`
`of Jaw, provided by a witness who purported to be an expert in patent law. 99 F.3d 1109, 1115-
`
`17 (Fed. Cir. 1996). In contrast, Dr. McDonnell is a technical expert, responding to the technical
`
`analysis provided by Teva’s technical expert, Dr. Ravetch. While Teva argues that
`
`Dr. McDonnell’s opinion should be excluded because he purportedly did not know a
`a2 5)
`
`alleged deposition admission in no way undermines his technical critique of Dr. Ravetch’s
`
`infringement analysis. See, e.g., Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 2020 WL
`
`5512507, at *5 (D. Minn. Sep. 14, 2020) (denying a motion to exclude the opinions of an expert
`
`who did not understand the difference between direct and indirect infringement because “a
`
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`

`

`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 18 of 20
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`challenge to an infringement expert’s expertise in patent law may not undermine the expert’s
`
`qualifications and testimony in the area of expertise in which the expert is offered”) (emphasis in
`
`original); WNS Holdings, LLC v. United Parcel Serv., Inc., 2009 WL 2136961, at *3-4 (W.D. Wis.
`
`Jul 14, 2009), aff’d, 368 F. App’x 144 (Fed. Cir. 2010) (challenges to an expert’s “lack of expertise
`
`in patent law do not undermine [the expert’s] qualifications and testimony as an avionics expert”).
`
`It is “well established that the burden of proving infringement generally rests upon the
`
`patentee.” Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191, 198 (2014).
`
`Dr. McDonnell’s opinions shed light on Teva’s flawed infringement analysis and will assist the
`
`jury in determining the ultimate question of whether Teva has met its burden of proof. See U.S.
`
`ex rel. Dyer v. Raytheon Co., 2013 WL 5348571, at *9 (D. Mass. Sep. 23, 2013) (“The purpose of
`
`an expert is to assist the jury in resolving disputes of fact. It would be an unacceptable drain on,
`
`and a misuse of, judicial resources to allow a Daubert motion to become a mini-trial on the very
`
`facts the expert is intended to help the jury later resolve.”) Teva’s motion seeking to exclude that
`
`testimony should be denied.
`
`IV. Conclusion
`
`Lilly respectfully requests that the Court deny Teva’s motion to exclude certain opinions
`
`of Dr. James M. McDonnell.
`
`13
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`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 19 of 20
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`
`
`Dated: May 10, 2022
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`
`
`
`
`
`
`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
`
`14
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`

`Case 1:18-cv-12029-ADB Document 365 Filed 05/10/22 Page 20 of 20
`
`CERTIFICATE OF SERVICE
`
`I, Andrea 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 May 10,
`2022. The unredacted version of this document will be served on all outside counsel o