Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 1 of 18
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`
`Civil Action No.
`1:18-cv-12029-ADB
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`
`
`
`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
`
`
`Defendant.
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`
`PLAINTIFFS’ MEMORANDUM IN SUPPORT OF THE MOTION TO EXCLUDE
`CERTAIN OPINIONS OF DEFENDANT’S EXPERT JAMES M. MCDONNELL, PH.D.
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 2 of 18
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`TABLE OF CONTENTS
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`INTRODUCTION ................................................................................................................... 1
`I.
`LEGAL STANDARDS ....................................................................................................... 3
`II.
`III. ARGUMENT ....................................................................................................................... 4
`A.
`Dr. McDonnell Should Be Precluded from Testifying That Lilly’s Emgality® Product
`Does Not Literally Infringe the Asserted Claims Because Galcanezumab Is Not a “Humanized
`Antibody.” ................................................................................................................................... 4
`B.
`Dr. McDonnell Should Be Precluded from Testifying That Information Allegedly
`Withheld from the USPTO Is “Material.” ................................................................................... 9
`IV. CONCLUSION .................................................................................................................. 12
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`i
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 3 of 18
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`TABLE OF AUTHORITIES
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`
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`Page(s)
`
`Cases
`
`Am. Med. Sys. v. Laser Peripherals, LLC,
`712 F. Supp. 2d 885 (D. Minn. 2010) ........................................................................................3
`
`Bruno v. Bozzuto's, Inc.,
`311 F.R.D. 124 (M.D. Pa. 2015) ............................................................................................4, 8
`
`Chemipal Ltd. v. Slim-Fast Nutritional Foods Int'l, Inc.,
`350 F. Supp. 2d 582 (D. Del. 2004) ...........................................................................................3
`
`Daubert v. Merrell Dow Pharm., Inc.,
`509 U.S. 579 (1993) ...................................................................................................................3
`
`Eli Lilly & Co. v. Apotex, Inc.,
`837 F. App'x 780 (Fed. Cir. 2020) .............................................................................................8
`
`Eli Lilly & Co. v. Hospira, Inc.,
`933 F.3d 1320 (Fed. Cir. 2019)..................................................................................................8
`
`Foradori v. Harris,
`523 F.3d 477 (5th Cir. 2008) .....................................................................................................3
`
`Hebert v. Lisle Corp.,
`99 F.3d 1109 (Fed. Cir. 1996)................................................................................................3, 8
`
`Maguire v. Nat'l R.R. Passenger Corp.,
`No. 99 C 3240, 2002 WL 472275 (N.D. Ill. Mar. 28, 2002) .....................................................4
`
`Martinez v. Porta,
`601 F. Supp. 2d 865 (N.D. Tex. 2009) ......................................................................................3
`
`Micro Chem, Inc. v. Lextron, Inc.,
`317 F.3d 1387 (Fed. Cir. 2003)..................................................................................................3
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`711 F.3d 1348 (Fed. Cir. 2013)..................................................................................................3
`
`Regeneron Pharms., Inc. v. Merus N.V.,
`864 F.3d 1343 (Fed. Cir. 2017)..........................................................................................10, 11
`
`Sheffield v. Int'l Paper Co.,
`No. 2018-CV-02701-JPM-CGC, 2020 WL 1882906 (W.D. Tenn. Feb. 26,
`2020) ..........................................................................................................................................4
`
`ii
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 4 of 18
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`Shire LLC v. Abhai, LLC,
`298 F. Supp. 3d 303 (D. Mass. 2018) ........................................................................................8
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`Smith & Nephew, Inc. v. Interlace Med., Inc.,
`955 F. Supp. 2d 69 (D. Mass. 2013) ....................................................................................2, 10
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`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011)..................................................................................2, 9, 10, 11
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`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)....................................................................................................5
`
`In re Welding Fume Prods. Liab. Litig.,
`2010 WL 7699456 (N.D. Ohio June 4, 2010)............................................................................3
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`Other Authorities
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`Fed. R. Evid. 702 .........................................................................................................................3, 4
`
`Local Rule 16.6(d) ...........................................................................................................................7
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`iii
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 5 of 18
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`I.
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`INTRODUCTION
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`James M. McDonnell, Ph.D., an expert witness for defendant Eli Lilly and Company
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`(“Lilly”), has proffered opinions in his expert reports in support of Lilly’s written description,
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`enablement, and inequitable conduct defenses. He has also given opinions in support of Lilly’s
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`argument that use of its Emgality® product does not infringe the asserted claims. The Court should
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`exercise its gatekeeping function to exclude two aspects of Dr. McDonnell’s testimony.1
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`First, Dr. McDonnell’s opinion that the use of Lilly’s Emgality® product does not literally
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`infringe the asserted claims is based on an incorrect understanding of the law. The question of
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`infringement requires an expert (and ultimately the fact finder) to compare the properties and
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`characteristics of the accused product (here, Lilly’s Emgality®) to the limitations of the asserted
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`claims. Dr. McDonnell opined that Lilly does not infringe the asserted claims because
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`galcanezumab, the active ingredient in Emgality®, is not a “humanized antibody” as that term has
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`been construed by the Court. To reach this conclusion, Dr. McDonnell ignored available evidence
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`that speaks directly to the characteristics of Emgality®—
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` The flaw in Dr. McDonnell’s infringement analysis is apparent:
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`without any basis in law or science, he ignored
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`. When confronted
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`, Dr. McDonnell admitted that, had he applied
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`the correct standard
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`, he would have reached a
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`different conclusion. Opinions that are based on a misunderstanding of the law and that ignore
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`1 Below, Teva identifies several paragraphs in Dr. McDonnell’s reports that contain these improper
`opinions. To the extent such opinions appear elsewhere in Dr. McDonnell’s report, those opinions
`should be excluded for the same reasons.
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`1
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`relevant evidence are unreliable and should be excluded, especially where, as here, the expert has
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`conceded that his opinion would have been different had he considered all available evidence and
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`applied the proper legal standard.
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`Second, the Court should also exclude Dr. McDonnell’s opinion, relevant to Lilly’s
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`inequitable conduct defense, that information allegedly withheld from the USPTO during
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`prosecution of the ʼ045 patent was “material” to patentability of the claims of the ’045 patent. That
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`opinion, too, is based on an incorrect understanding of the law. When it comes to inequitable
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`conduct allegations, “materiality” has a very specific meaning; the Federal Circuit has held that
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`withheld information is “material” only if the claims would not have issued had that information
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`been disclosed during prosecution. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276,
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`1291 (Fed. Cir. 2011) (“This court holds that, as a general matter, the materiality required to
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`establish inequitable conduct is but-for materiality. When an applicant fails to disclose prior art
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`to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been
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`aware of the undisclosed prior art.”). Dr. McDonnell admitted in his deposition, however, that he
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`based his opinions on the wrong test for materiality; he testified that he understood information to
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`be “material” if it is merely “relevant to” patentability. In addition, “[i]t is well-established . . .
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`that information is not material if it is cumulative of other information already disclosed to the
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`PTO.” Smith & Nephew, Inc. v. Interlace Med., Inc., 955 F. Supp. 2d 69, 75 (D. Mass. 2013)
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`((quoting Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1367 (Fed. Cir. 2008)).
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`Accordingly, a conclusion of materiality requires an assessment of the other prior art submitted to
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`the PTO during prosecution of the ’045 patent. Dr. McDonnell admitted that he did not do that
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`analysis and that he has no opinions on whether the information allegedly withheld was cumulative
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`2
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`over the information the USPTO did receive and review. For these reasons, his opinion that the
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`allegedly withheld information was “material” is unreliable and should be excluded.
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`II. LEGAL STANDARDS
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`Under the standards established by Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579,
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`592-595 (1993), “[d]istrict courts, as gatekeepers, must . . . ensure that all expert testimony is
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`rooted in firm scientific or technical ground. To that end, . . . an expert’s testimony [must] be the
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`product of reliable principles and methods applied to sufficient facts or data.” Power Integrations,
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`Inc. v. Fairchild Semiconductor Int’l, Inc., 711 F.3d 1348, 1373 (Fed. Cir. 2013). To be
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`admissible, the expert testimony must be, among other things, based on sufficient facts or data and
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`the product of reliable principles and methods. Fed. R. Evid. 702. “The party offering the expert
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`testimony has the burden of proving admissibility.” Chemipal Ltd. v. Slim-Fast Nutritional Foods
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`Int'l, Inc., 350 F. Supp. 2d 582, 588 (D. Del. 2004) (citing Daubert, 509 U.S. at 592, n. 10).2
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`Courts routinely exclude expert testimony where, as here, the expert premises his or her opinions
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`on a faulty application of law. See, e.g., Hebert v. Lisle Corp., 99 F.3d 1109, 1117 (Fed. Cir. 1996)
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`(“Incorrect statements of law are no more admissible through ‘experts’ than are falsifiable
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`scientific theories.”); see also Foradori v. Harris, 523 F.3d 477, 515 n.46 (5th Cir. 2008) (“[T]he
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`report of Captain D’s economic expert, Dr. Gerald Lee, may be faulted for relying on an incorrect
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`premise.”); Am. Med. Sys. v. Laser Peripherals, LLC, 712 F. Supp. 2d 885, 901 (D. Minn. 2010)
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`(finding “opinions inadmissible because they are based on incorrect legal standards.”); In re
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`Welding Fume Prods. Liab. Litig., 2010 WL 7699456, at *24-25 (N.D. Ohio June 4, 2010) (same);
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`Martinez v. Porta, 601 F. Supp. 2d 865, 866 (N.D. Tex. 2009) (same, because “such an opinion
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`2 The admissibility of expert testimony is not unique to patent law and is reviewed under the law
`of the regional circuit. Micro Chem, Inc. v. Lextron, Inc., 317 F.3d 1387, 1390–91 (Fed. Cir.
`2003).
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`3
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 8 of 18
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`cannot be based on an erroneous legal premise.”). Courts similarly exclude expert testimony for
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`failure to consider relevant data and evidence, especially when that material is contrary to the
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`expert’s conclusion. See, e.g., Bruno v. Bozzuto’s, Inc., 311 F.R.D. 124, 142 (M.D. Pa. 2015)
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`(excluding expert opinion that only considered data values most helpful to Plaintiff “regardless of
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`their disjunction with reality”); Maguire v. Nat’l R.R. Passenger Corp., No. 99 C 3240, 2002 WL
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`472275, at *5 (N.D. Ill. Mar. 28, 2002) (holding that expert’s opinion did “not meet Rule 702
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`standards of reliability” because, inter alia, he “did not review all of the factual evidence available
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`to him before reaching his conclusions.”); Sheffield v. Int’l Paper Co., No. 2018-CV-02701-JPM-
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`CGC, 2020 WL 1882906, at *2 (W.D. Tenn. Feb. 26, 2020) (“The Court is not required to accept
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`an economist's projections where they demonstrate cherry-picking an isolated and self-serving data
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`point rather than responding to the reality of the case.”).
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`III. ARGUMENT
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`A. Dr. McDonnell Should Be Precluded from Testifying That Lilly’s Emgality®
`Product Does Not Literally Infringe the Asserted Claims Because Galcanezumab Is
`Not a “Humanized Antibody.”
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`All of the asserted claims in this case require a “humanized antibody.” Lilly argues that its
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`product Emgality® does not literally infringe the asserted claims because the active ingredient in
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`its drug, galcanezumab, is not a humanized antibody, and it seeks to support that argument with
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`testimony from Dr. McDonnell.3 This testimony should be excluded because it is based on Dr.
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`McDonnell’s incorrect belief that he could not consider available,
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`that term. Not only is Dr. McDonnell’s decision to disregard this information improper, it is a
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` as this Court has construed
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`3 Emgality® is the brand name for the final drug product; galcanezumab is the generic name for
`the active ingredient in Emgality®, namely, the anti-CGRP antagonist antibody.
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`4
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`necessary component of his opinion, which, by his own admission, does not hold if all relevant
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`information is considered.4
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`“A literal patent infringement analysis involves two steps: the proper construction of the
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`asserted claim and a determination as to whether the accused . . . product infringes the asserted
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`claim as properly construed.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581–82 (Fed.
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`Cir. 1996). The Court already construed the term “humanized antibody” to mean “a form of non-
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`human (e.g. murine) antibodies that are specific chimeric immunoglobulins . . . that contain
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`minimal sequence derived from non-human immunoglobulin.” Dkt. No. 101 at 16; see also Ex. 1
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`(U.S. Pat. No. 8,586,045) at 12:61–13:25 (defining “humanized antibodies”). The specification
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`further explains that “[f]or the most part, humanized antibodies are human immunoglobulins
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`(recipient antibody) in which residues from a complementarity determining region (CDR) of the
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`recipient are replaced by residues from a CDR of a non-human species (donor antibody) such as
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`mouse, rat, or rabbit having the desired specificity, affinity, and biological activity.” Ex. 1 at
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`12:66–13:5; see also Dkt. No. 101 at 16 (holding that the examples of humanized antibodies
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`provided in the specification are relevant to further explain the term to the jury). In other words,
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`humanized antibodies are typically antibodies in which the discrete portions of the antibody that
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`bind to the target (i.e., the antibody’s “complementarity determining regions” or “CDRs”) are
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`derived from a non-human animal while the rest of the antibody is derived from the human
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`“germline” (i.e., the repertoire of possible immunoglobulin genes in humans). This means that the
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`underlying amino acid sequence of the resulting humanized antibody will be primarily human.
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`4 Dr. McDonnell’s improper opinions regarding galcanezumab’s status as a “humanized antibody”
`are located at ¶¶ 177–87 of his rebuttal report. Ex. 3 (Oct. 28, 2021 Rebuttal Expert Report of
`James M. McDonnell, Ph.D.).
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`5
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`Under the Court’s construction, there can be no dispute that galcanezumab is a humanized
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`antibody.
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`5Notably, Dr. McDonnell did not contend that the galcanezumab sequences were actually derived
`from monkey, rather than human, immunoglobulin sequences. Id.
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`At his deposition, Dr. McDonnell confirmed the extent to which his non-infringement
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`opinion
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` Thus, even according to
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`Dr. McDonnell, the viability of his opinion rises and falls based on what information he is
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`permitted to consider.
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`There is no basis in the law for Dr. McDonnell’s approach of ignoring available evidence
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`that describes an accused product
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` Infringement analysis is based on
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`the actual characteristics of an accused product or process, not merely what can be discerned based
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`on public information. This perhaps is best exemplified in Local Rule 16.6(d) of this Court, which
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`requires accused infringers to disclose “documents sufficient to show the composition, operation,
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`construction, and performance of the accused components, elements, or functionality” early in the
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`discovery process without regard for whether that information is confidential. L.R. 16.6(d)(4)(A).
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`Indeed, many of the documents exemplified in this Rule—“source code, specifications,
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`schematics, flow charts, artwork, and formulas”—would be expected to be confidential, and the
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`Rule accordingly provides for a “Default Protective Order” to cover such disclosures. Id.; L.R.
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`16.6(d)(6). This Rule reflects the reality that accused infringers—including those in the
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`pharmaceutical industry—often hold characteristics of their products and methods as trade secrets,
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`and that confidential information regarding accused products obtained in discovery is routinely
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`used to prove infringement. See, e.g., Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320 (Fed. Cir.
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`2019) (finding infringement based on confidential regulatory filings for accused drug product); Eli
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`Lilly & Co. v. Apotex, Inc., 837 F. App'x 780, 783 (Fed. Cir. 2020) (same); Shire LLC v. Abhai,
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`LLC, 298 F. Supp. 3d 303, 318 (D. Mass. 2018) (same). Because Dr. McDonnell’s opinions are
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`based on a legally incorrect premise and have a high likelihood of confusing the jury, they should
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`be excluded. See Hebert, 99 F.3d at 1117.
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`Moreover, by applying the wrong legal standard, Dr. McDonnell ignored evidence that
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`directly contradicted his opinion that galcanezumab is not a humanized antibody. As discussed
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`above,
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` Simply put,
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`Dr. McDonnell’s opinion that a POSA “might” reach a conclusion based on a set of information
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`6
` Dr. McDonnell also ignored
` public documents in which Lilly and its scientists repeatedly referred to
`a myriad of
`galcanezumab as a “humanized” antibody (e.g.,
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`, in the drug label, to doctors in
`advertising materials, etc.).
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 13 of 18
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`that is admittedly incomplete and excludes contrary data is not reliable evidence of whether
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`galcanezumab is, in fact, humanized. See Bruno, 311 F.R.D. at 142.
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`In sum, Dr. McDonnell’s opinion that galcanezumab is not a “humanized antibody” and
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`that the use of galcanezumab does not literally infringe any of the asserted claims on that basis is
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`based on an incorrect understanding of the law,
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`.
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` But
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`this information is available, and there is no basis to exclude it or disregard it. Dr. McDonnell’s
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`opinion concerning what a POSA would think without this information are therefore irrelevant,
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`and permitting him to testify about these opinions would be likely to confuse a jury. The Court
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`should exclude this opinion.
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`B. Dr. McDonnell Should Be Precluded from Testifying That Information Allegedly
`Withheld from the USPTO Is “Material.”
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`Lilly argues that the patents-in-suit are unenforceable for inequitable conduct, because
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` allegedly failed to disclose certain information to the USPTO
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`during prosecution of the ’045 patent. See Dkt. No. 261 at ¶¶ 188–287. To succeed on this
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`argument Lilly must prove, among other things, that this information was material to patentability.
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`Therasense, 649 F.3d at 1290 (Fed. Cir. 2011). To make this argument, Lilly offers the testimony
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`of Dr. McDonnell, who opined that
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`McDonnell’s opinions focus on two pieces of information: (1) a prior art reference authored by
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`Shaw, et al. and (2)
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`. Dr. McDonnell’s opinion that this
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`information is “material” should be excluded because it relies on the wrong legal standard.7
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`The law is clear that “the materiality required to establish inequitable conduct is but-for
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`materiality,” which means a withheld reference is material only if “the PTO would not have
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`allowed a claim had it been aware of the undisclosed” reference. Therasense, 649 F.3d at 1291
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`(emphasis added). Moreover, undisclosed information is not material if it is “merely cumulative,”
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`i.e., it “teaches no more than what a reasonable examiner would consider to be taught by the”
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`references and information already before the PTO. Regeneron Pharms., Inc. v. Merus N.V., 864
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`F.3d 1343, 1350 (Fed. Cir. 2017) (citation omitted); see also Smith & Nephew, 955 F. Supp. 2d at
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`75 (“It is well-established . . . that information is not material if it is cumulative of other
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`information already disclosed to the PTO.” (quoting Star Sci., Inc, 537 F.3d at 1367)). Dr.
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`McDonnell’s opinions are deficient with respect to both but-for materiality and cumulativeness.8
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`First, Dr. McDonnell applied the wrong definition of “materiality.” As discussed above,
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`Federal Circuit precedent requires Lilly (and Dr. McDonnell) to establish but-for materiality—that
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`the PTO would not have allowed claim 17 of the ’045 patent had the purportedly withheld
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`information been disclosed. See Therasense, 649 F.3d at 1291. But Dr. McDonnell stated that the
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`allegedly withheld information would have been “material” to the USPTO’s decision to issue a
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`7 Dr. McDonnell’s improper materiality opinions are contained in ¶¶ 198–201 of his opening
`report (Ex. 5) and ¶¶ 153–167 of his reply report (Ex. 6).
`8 Dr. McDonnell’s opinions and Lilly’s arguments about inequitable conduct are deficient in many
`ways; Teva addresses all these deficiencies in its motion for summary judgment regarding Lilly’s
`inequitable conduct counterclaims, which Teva files concurrently with this motion. This motion
`focuses only on Dr. McDonnell’s incorrect standard for materiality.
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`patent in this case because it would have been “relevant to th[e] assessment” of whether claim 17
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`of the ’045 patent is patentable. See Ex. 4 at 151:5–17 (emphasis added). Therasense makes clear
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`that mere “relevance” is not sufficient. In that case, the Federal Circuit expressly rejected a
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`standard based on mere relevance—or even whether a reasonable examiner would consider
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`information “important”—instead holding that a party alleging inequitable conduct must show that
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`the patent would not have issued had the allegedly withheld information been disclosed. 649 F.3d
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`at 1294–95.
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`More than stating the wrong standard (“relevance”),
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`Second, Dr. McDonnell failed to evaluate cumulativeness. The Federal Circuit has held
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`that information is not “material” for purposes of inequitable conduct if that material is cumulative
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`of other information already before the patent examiner. See Regeneron Pharms., 864 F.3d at
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`11
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`1350. Thus, for an expert to reach a conclusion about the “materiality” of undisclosed information,
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`he must compare the information that was not disclosed and the information that was disclosed, to
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`determine whether the former would have been cumulative of the latter. Dr. McDonnell did no
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`such thing.
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`Because Dr. McDonnell applied the wrong standard for materiality and did not assess
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`whether the allegedly withheld information was merely cumulative over information that the
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`Examiner received, his opinion that the allegedly withheld information is “material” is unreliable
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`and must be excluded at trial.
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`IV. CONCLUSION
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`For the foregoing reasons, Teva respectfully requests that the Court strike Dr. McDonnell’s
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`testimony that: (1) Lilly does not infringe the asserted claims because galcanezumab is not a
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`“humanized antibody” as construed by the Court; and (2) certain prior art references and
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` are “material” to the patentability of the ’045 patent.
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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 17 of 18
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`Respectfully Submitted,
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`/s/ Elaine Herrmann Blais
`Douglas J. Kline (BBO# 556680)
`Elaine Herrmann Blais (BBO# 656142)
`Robert Frederickson III (BBO# 670111)
`Joshua S. Weinger (BBO# 690814)
`Alexandra Lu (BBO# 691114)
`Eric T. Romeo (BBO# 691591)
`Kathleen A. McGuinness (BBO# 693760)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`dkline@goodwinlaw.com
`eblais@goodwinlaw.com
`rfrederickson@goodwinlaw.com
`jweinger@goodwinlaw.com
`alu@goodwinlaw.com
`eromeo@goodwinlaw.com
`kmcguinness@goodwinlaw.com
`
`I. Neel Chatterjee (pro hac vice)
`GOODWIN PROCTER LLP
`601 Marshall St.
`Redwood City, CA 94063
`Tel.: (650) 752-3100
`Fax: (650) 853-1038
`nchatterjee@goodwinlaw.com
`
`Natasha E. Daughtrey (pro hac vice)
`GOODWIN PROCTER LLP
`601 S. Figueroa St.
`Los Angeles, CA 90017
`Tel.: (213) 426-2500
`Fax: (213) 623-1673
`ndaughtrey@goodwinlaw.com
`
`Attorneys for Plaintiffs
`
`
`
`
`Dated: March 28, 2022
`
`
`
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`13
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`

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`Case 1:18-cv-12029-ADB Document 432 Filed 07/27/22 Page 18 of 18
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`CERTIFICATE OF SERVICE
`
`I, Elaine Hermann Blais, 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 July 27, 2022.
`
`/s/ Elaine Herrmann Blais
`Elaine Herrmann Blais (BBO# 656142)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`eblais@goodwinlaw.com
`
`