Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 1 of 26
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`Plaintiffs,
`
`
`v.
`
`ELI LILLY AND COMPANY,
`Defendant.
`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`
`
`
`
`
`
`
`
`
`
`PLAINTIFFS TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`AND TEVA PHARMACEUTICALS USA, INC.’S MEMORANDUM OF LAW
`IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT
`REGARDING INEQUITABLE CONDUCT AND UNCLEAN HANDS
`
`

`

`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 2 of 26
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`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................................................. 1
`BACKGROUND ............................................................................................................... 3
`A.
` (Count XXI) .............................................................. 3
` prior art discussing non-C-terminal binding antibodies ............. 3
`1.
` .......................................................................................... 4
`2.
`Unintentional delay filings (Count XIX) ............................................................... 5
`B.
`LEGAL STANDARDS ..................................................................................................... 5
`A.
`To survive summary judgment, Lilly must identify facts that would support
`a finding, by clear and convincing evidence, of inequitable conduct. ................... 5
`Inequitable conduct requires proof that a specific individual knowingly and
`deliberately withheld material information with the intent to deceive the
`PTO. ....................................................................................................................... 6
`ARGUMENT ..................................................................................................................... 7
`A.
`The record does not support a finding, by clear and convincing evidence,
`that
` committed inequitable conduct (Count XXI) ............. 7
`1.
`There is no genuine issue of material fact as to the materiality of the
`information. ................................................................................................ 7
`a.
`Materiality requires proof that a claim would not have issued
`but for the omitted information. ..................................................... 7
`The record contains no evidence of the but-for materiality of
`any of the alleged omissions. ......................................................... 9
`The record does not support a finding that either
`
` intended to deceive the Patent Office.............................................. 13
`Lilly must establish that the single most reasonable inference
`from the evidence is that a specific individual made a
`deliberate decision to withhold material information with the
`specific intent to deceive the Patent Office.................................. 13
`No reasonable factfinder could conclude, on this record, that
`the only reasonable inference is that
`
`withheld material information with the intent to deceive the
`PTO. ............................................................................................. 15
`The record does not support a finding of inequitable conduct based on the
`unintentional delay filings (Count XIX). ............................................................. 19
`CONCLUSION ................................................................................................................ 20
`
`b.
`
`2.
`
`a.
`
`b.
`
`I.
`II.
`
`III.
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`IV.
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`V.
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`B.
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`B.
`
`i
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 3 of 26
`
`TABLE OF AUTHORITIES
`
`
`
`
`
`Page(s)
`
`Cases
`
`1st Media, LLC v. Elec. Arts, Inc.,
`694 F.3d 1367 (Fed. Cir. 2012)....................................................................................14, 16, 19
`
`California Inst. of Tech. v. Broadcom Ltd.,
`25 F.4th 976 (Fed. Cir. 2022) ....................................................................................................8
`
`Crown Operations Int'l, Ltd. v. Solutia Inc.,
`289 F.3d 1367 (Fed. Cir. 2002)..................................................................................................5
`
`Exergen Corp. v. Kaz USA, Inc.,
`120 F. Supp. 3d 1 (D. Mass. 2015) .................................................................................. passim
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009)..................................................................................................6
`
`Fiskars, Inc. v. Hunt Mfg. Co.,
`221 F.3d 1318 (Fed. Cir. 2000)..........................................................................................11, 18
`
`Golden Blount, Inc. v. Robert H. Peterson Co.,
`438 F.3d 1354 (Fed. Cir. 2006)................................................................................................17
`
`Hospira, Inc. v. Sandoz Inc.,
`2012 WL 1587688 (D.N.J. May 4, 2012) ................................................................................14
`
`Impax Lab’ys, Inc. v. Aventis Pharms. Inc.,
`468 F.3d 1366 (Fed. Cir. 2006)................................................................................................13
`
`KFx Med., LLC v. Stryker Corp.,
`2019 WL 2012977 (S.D. Cal. May 7, 2019) ............................................................................18
`
`Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp.,
`383 F.3d 1337 (Fed. Cir. 2004) (en banc)................................................................................17
`
`Lexington Luminance LLC v. Osram Sylvania Inc.,
`972 F. Supp. 2d 88 (D. Mass. 2013) ................................................................................ passim
`
`Metris U.S.A., Inc. v. Faro Techs., Inc.,
`882 F. Supp. 2d 160 (D. Mass. 2011) .............................................................................. passim
`
`Navico Inc. v. Garmin Int’l, Inc.,
`2017 WL 3701189 (E.D. Tex. Aug. 7, 2017) ....................................................................15, 17
`
`ii
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`

`

`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 4 of 26
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`
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`Semiconductor Energy Lab’y Co. v. Samsung Elecs. Co.,
`749 F. Supp. 2d 892 (W.D. Wis. 2010) ...................................................................................18
`
`Signify N. Am. Corp. v. Reggiani Lighting USA, Inc.,
`2020 WL 1331919 (S.D.N.Y. Mar. 23, 2020) .................................................................8, 9, 10
`
`Symbol Techs., Inc. v. Aruba Networks, Inc.,
`609 F. Supp. 2d 353 (D. Del. 2009) ...................................................................................12, 18
`
`Therasense, Inc. v. Benton, Dickinson & Co.,
`649 F.3d 1279 (Fed. Cir. 2011) (en banc)........................................................................ passim
`
`Virginia Innovation Sciences, Inc. v. Samsung Elecs. Co., Ltd.,
`11 F. Supp. 3d 622 (E.D. Va. 2014) ........................................................................................14
`
`Statutes
`
`35 U.S.C. § 120 ............................................................................................................................3, 5
`
`Other Authorities
`
`Fed. R. Civ. P. 56(a) ........................................................................................................................5
`
`MPEP § 609.05(b) .........................................................................................................................12
`
`Nicole Murphy, Inequitable-Conduct Doctrine Reform: Is the Death Penalty for
`Patents Still Appropriate?, 93 Minn. L. Rev. 2274 (2009) .......................................................6
`
`Robert D. Swanson, The Exergen & Therasense Effects, 66 Stan. L. Rev. 695
`(2014) .........................................................................................................................................1
`
`
`
`iii
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 5 of 26
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`
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`I.
`
`INTRODUCTION
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`Federal Circuit precedent has significantly limited the doctrine of inequitable conduct,
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`ensuring that the “‘atomic bomb’ of patent law” can only be used in truly “egregious
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`circumstances.” Therasense, Inc. v. Benton, Dickinson & Co., 649 F.3d 1279, 1288 (Fed. Cir.
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`2011) (en banc); Lexington Luminance LLC v. Osram Sylvania Inc., 972 F. Supp. 2d 88, 91 (D.
`
`Mass. 2013). Under this “dramatic[ally] constrict[ed]” version of the doctrine, a patent infringer
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`can only avoid the consequences of its wrongful conduct if it can identify clear and convincing
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`evidence that satisfies heightened versions of both the doctrine’s materiality and intent elements.
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`Metris U.S.A., Inc. v. Faro Techs., Inc., 882 F. Supp. 2d 160, 166 (D. Mass. 2011). Making those
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`showings has proven exceptionally difficult: In just the three years following Therasense, the
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`Federal Circuit precedent limiting the doctrine more than halved the percentage of adequately-
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`pleaded inequitable conduct claims that ultimately succeed—from nearly a quarter to under ten
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`percent. Robert D. Swanson, The Exergen & Therasense Effects, 66 Stan. L. Rev. 695, 696 (2014).
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`Lilly has failed to adduce evidence sufficient to permit a finding, by clear and convincing
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`evidence, that Lilly satisfied either the materiality or the intent element—let alone both. Lilly’s
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`primary inequitable conduct claim is that
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` of the patents-in-suit
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`(Plaintiffs’ Statement of Undisputed Material Facts (“SUMF”) ¶¶ 1–7)—
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`—should have but did not disclose to the PTO one prior art reference (“Shaw”)
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`
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`
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`. Second Supplemental Amended Answer, Dkt. No. 277
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`(“SSAA”), Count XXI; SUMF ¶¶ 13-14. But there is no evidence that this information was even
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`material, let alone that
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` affirmatively withheld it from the PTO with the intent
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`to deceive. As to materiality, Lilly offers no testimony that the evidence was material under the
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`Therasense standard, which requires a showing that the PTO “would not have allowed a claim”
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`had the information been disclosed, and therefore there is no dispute of fact as to this element. 649
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`1
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 6 of 26
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`
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`F.3d at 1291. Lilly disclosed no expert on PTO practice or procedure. SUMF ¶ 23. And while
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`two of its technical experts wrote in their reports that the art
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` would have been “material,”
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`those experts admitted during depositions that they did not use the word “material” in the relevant
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`legal sense—all they meant was that the information “could have been relevant” to the examiner
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`or was “germane” to the issues being considered. Id. ¶¶ 24, 39.
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`
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`
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` Indeed, the inventors indisputably did disclose the Shaw reference in
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`prosecuting two out of the three patents-in-suit, the examiner indicated that he considered Shaw,
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`and those patents issued anyway.
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`Lilly’s position on intent to deceive is even weaker. To prevail, Lilly must show that intent
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`to deceive is the “single most reasonable inference able to be drawn from the evidence.”
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`Therasense, 649 F.3d at 1290. But, as this Court recognized, Lilly’s claim reduces merely to its
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`allegations that
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`knew of the Shaw reference
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`, knew these were
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`important, and did not submit them. Dkt. No. 236 (“Order”) at 25. Even if Lilly could establish
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`materiality, which it cannot, “the Federal Circuit has emphatically rejected” a finding of specific
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`intent to deceive based only on knowledge of the materiality of supposedly omitted information—
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`this is even the case where such knowledge and materiality has been proven. Exergen Corp. v.
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`Kaz USA, Inc., 120 F. Supp. 3d 1, 7 (D. Mass. 2015). Here, the record establishes reasonable
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`inferences other than intent to deceive, precluding Lilly’s claim as a matter of law. Id.
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`Lilly also advances an unrelated inequitable conduct theory, alleging that some unspecified
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`attorney committed inequitable conduct relating to the filing of three Petitions to Accept an
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`2
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 7 of 26
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`
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`Unintentionally Delayed Priority Claim Under 35 U.S.C. § 120. SSAA, Count XIX; SUMF ¶ 12.
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`Lilly claims that the delay was actually intentional, but no evidence supports this assertion.
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`II.
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`BACKGROUND
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`The patent claims at issue in this case are directed, at a high level, to treating migraines by
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`using antibodies that bind to the calcitonin gene-related peptide (“CGRP”) and inhibit its function.
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`E.g., SUMF ¶¶ 8–9. Lilly’s amended counterclaims assert two counts of inequitable conduct.1 Id.
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`¶¶ 11–15. With fact and expert discovery now closed, however, record evidence does not support
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`either of Lilly’s inequitable conduct theories; in fact, it refutes them both.
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`A.
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` (Count XXI)
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`Lilly’s primary inequitable conduct claim is based on its charge that certain information
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`should have been disclosed to the Patent Office. It claims that
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`
`
`, intentionally withheld that information, which Lilly argues is material, with the intent
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`to deceive the PTO. The information on which Lilly focuses is (1) a prior art reference
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`related to non-C-terminal binding antibodies, and (2)
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`
`
`
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`. Lilly’s evidence, however, fails to support its allegations.
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`1.
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` prior art discussing non-C-terminal binding antibodies
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`CGRP has three regions: an N-terminal region, a mid-region, and a C-terminal region.
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`SUMF ¶ 10. Lilly alleges that the patents only disclose CGRP-antagonist antibodies that bind to
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`the C-terminal region of CGRP, but nevertheless claim CGRP-antagonist antibodies that bind to
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`any region of CGRP. See SSAA ¶ 191. CGRP-antagonist antibodies are antibodies that do not
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`just bind to, but also inhibit the function of, CGRP. Lilly alleges that
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` was aware of a
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`1 Lilly also asserts one claim of unclean hands (SSAA, Count XX) which fails to allege any
`supporting facts beyond citing to the allegations for its inequitable conduct claim. Accordingly,
`for the same reasons that Count XIX of inequitable conduct is deficient, Count XX also fails.
`
`3
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 8 of 26
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`
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`prior art reference—Shaw et al., The effect of monoclonal antibodies to calcitonin gene-related
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`peptide (CGRP) on CGRP-induced vasodilatation in pig coronary artery rings, 106 Br. J.
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`Pharmacol. 196–98 (1992) (“Shaw”)—that included data on an antibody that bound to the mid-
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`region of CGRP, yet failed to antagonize or block the effects of CGRP. SSAA ¶ 192. Lilly claims
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` committed inequitable conduct by failing to disclose Shaw to the PTO in prosecuting
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`the ’045 patent. Lilly concedes, however, that
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` did disclose Shaw to the Patent Office
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`in prosecuting the other two patents-in-suit (the ’907 and ’908 patents), but Lilly alleges that Shaw
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`was “buried” in a list of other references. Id. ¶ 259. Lilly also asserts that
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`
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`. Id. ¶ 258. Lilly claims that, had
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` disclosed
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`Shaw
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`, the Patent Office would not have issued claims covering methods of
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`treating migraine using anti-CGRP antibodies that bind to regions other than the C-terminal.
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`Lilly failed to support these allegations with evidence. Thus, there is no material factual
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`dispute. Its experts disavowed any opinion that Shaw
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` are material in the relevant
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`sense. Shaw was disclosed and considered by the examiner in two of the three prosecutions at
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`issue—and those patents issued anyway. The record is devoid of any evidence that
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` were involved with the decision whether to disclose this information, let alone that
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`
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`
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`made a conscious decision not to disclose it with the specific intent to deceive the PTO. In fact,
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`the record conflicts with any suggestion of materiality or intent to deceive. See, pp. 9–19, infra.
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`2.
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`Separately, Lilly asserts that
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`4
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 9 of 26
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`B.
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`Unintentional delay filings (Count XIX)
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`.
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`Lilly’s second count of inequitable conduct asserts that unspecified Wilson Sonsini counsel
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`made false statements in three Petitions to Accept an Unintentionally Delayed Priority Claim
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`Under 35 U.S.C. § 120. See SSAA ¶¶ 152–54, 162–64, 170–72. Those filings state that the “entire
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`delay” at issue was unintentional, but Lilly alleges that this was deceptive because the delay was,
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`in fact, intentional. The record, however, lacks even a shred of evidence that the delay was
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`intentional, and certainly does not support a finding that anyone intended to deceive the PTO.
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`III. LEGAL STANDARDS
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`A.
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`To survive summary judgment, Lilly must identify facts that would support a
`finding, by clear and convincing evidence, of inequitable conduct.
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`Summary judgment is appropriate when “there is no genuine issue as to any material fact
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`and the moving party is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Because
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`a patent “enjoys a presumption of validity . . . which can be overcome only through clear and
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`convincing evidence,” summary judgment on a defense is appropriate where “the nonmoving
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`party, who bears the burden of proof at trial, failed to produce clear and convincing evidence on
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`an essential element of a defense upon which a reasonable jury could invalidate the patent.” Crown
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`Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1378 (Fed. Cir. 2002).
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`5
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`

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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 10 of 26
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`B.
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`Inequitable conduct requires proof that a specific individual knowingly and
`deliberately withheld material information with the intent to deceive the PTO.
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`Inequitable conduct “is an equitable defense that prevents enforcement of a patent obtained
`
`through fraud.” Lexington Luminance, 972 F. Supp. 2d at 91. To establish inequitable conduct,
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`an infringer must establish, by clear and convincing evidence, that “a specific individual (1) knew
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`of the withheld material information or of the falsity of the material misrepresentation, and
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`(2) withheld or misrepresented this information with a specific intent to deceive the PTO.”
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`Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328–29 & n.5 (Fed. Cir. 2009). Because
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`a finding of inequitable conduct has “far-reaching consequences” for a patentee, the Federal
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`Circuit has described it as the “‘atomic bomb’ of patent law.” Therasense, 649 F.3d at 1288–89.
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`For many years, the Federal Circuit applied “low” and “broad” standards for establishing
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`inequitable conduct’s key materiality and intent elements. Therasense, 649 F.3d at 1287–88. This
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`low standard, combined with the explosive impact of an inequitable-conduct finding, made the
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`defense irresistible to patent infringers, such that overuse of the doctrine became an “absolute
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`plague” on the patent system. Id. at 1289; see also Nicole Murphy, Inequitable-Conduct Doctrine
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`Reform: Is the Death Penalty for Patents Still Appropriate?, 93 Minn. L. Rev. 2274, 2274–75
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`(2009) (criticizing prior standard for “imposing the death penalty for relatively minor acts of
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`misconduct,” leading to a “windfall” for infringers).
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`That all changed with a set of Federal Circuit cases that culminated in the court’s 2011
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`decision in Therasense. In that case, the court granted rehearing en banc to address “the problems
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`created by the expansion and overuse of the inequitable conduct doctrine.” 649 F.3d at 1285. The
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`court severely restricted the doctrine, “tighten[ing] the standards for finding both intent and
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`materiality.” Id. at 1290. The result, as courts in this district have recognized, is that inequitable
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`conduct is now exceptionally difficult to prove. E.g., Metris, 882 F. Supp. 2d at 166 (Therasense
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`6
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 11 of 26
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`“dramatic[ally] constrict[s]” the doctrine); Lexington Luminance, 972 F. Supp. 3d at 91 (doctrine
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`is limited to “egregious circumstances”); Exergen, 120 F. Supp. 3d at 3 (“The burden of proof is
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`indeed weighty.”).
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`As discussed in more detail below, Therasense “signaled a dramatic constriction of the
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`inequitable conduct doctrine” in two specific ways. Metris, 882 F. Supp. 2d at 166. First, the
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`court held that materiality requires an alleged infringer to show by clear and convincing evidence
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`that the patent would not have issued but for the asserted misconduct. Therasense, 649 F.3d at
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`1291. Second, the court held that an intent to deceive the patent office must be the single most
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`reasonable inference from the facts and must be shown by clear and convincing evidence. Id. at
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`1290. Hence, “when there are multiple reasonable inferences that may be drawn,” including “gross
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`negligence,” then “intent to deceive cannot be found.” Id. at 1290–91.
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`IV. ARGUMENT
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`A.
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`The record does not support a finding, by clear and convincing evidence, that
` committed inequitable conduct (Count XXI)
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`Lilly has not adduced evidence that could support a finding either that the undisclosed
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`information to which it points was determinative as to the issuance of the patents-in-suit or that
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` acted with specific intent to deceive the PTO.
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`1.
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`There is no genuine issue of material fact as to the materiality of the
`information.
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`a.
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`Materiality requires proof that a claim would not have issued
`but for the omitted information.
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`Prior to 2011, the Federal Circuit took a “broad view of materiality,” requiring only a
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`“likelihood” that an examiner would have considered the information “important.” Therasense,
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`649 F.3d at 1288. In Therasense, however, the Federal Circuit tightened the materiality standard
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`to combat overuse of the inequitable conduct defense. Id. at 1291. In particular, the Court rejected
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`7
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 12 of 26
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`an “importance” standard and held that “the materiality required to establish inequitable conduct
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`is but-for materiality. When an applicant fails to disclose prior art to the PTO, that prior art is only
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`but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed
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`prior art.” Id. (emphasis added); see also California Inst. of Tech. v. Broadcom Ltd., 25 F.4th 976,
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`991 (Fed. Cir. 2022) (“CalTech”) (“Prior art is but-for material if the PTO would have denied a
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`claim had it known of the undisclosed prior art.”).2 This constituted a “sea-change” in the law and
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`a “dramatic constriction” of the materiality standard. Metris, 882 F. Supp. 2d at 166. Indeed, one
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`court in this district concluded, in a case in which it had found inequitable conduct pre-Therasense,
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`that its “findings of materiality . . . have been cast to dust” by Therasense. Id. at 167.
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`One key aspect of the materiality inquiry is that undisclosed information “is not but-for
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`material if it is merely cumulative.” CalTech, 25 F.4th at 991. Because the party asserting
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`inequitable conduct bears the burden of proof, that party must “specify why or how” the allegedly
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`omitted information “was not cumulative of cited prior art.” Lexington Luminance, 972 F. Supp.
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`2d at 93; see also Signify N. Am. Corp. v. Reggiani Lighting USA, Inc., 2020 WL 1331919, at *5
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`(S.D.N.Y. Mar. 23, 2020) (party asserting inequitable conduct “ma[de] no attempt to distinguish
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`the [omitted] publication from the disclosed publications”).
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`This Court, in allowing Lilly to add new inequitable conduct allegations to its pleading,
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`cited the materiality standard from Signify, writing that information “is material if there is a
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`substantial likelihood that a reasonable examiner would consider it important in deciding whether
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`to allow the application to issue as a patent,” or if the information “falls within the standards set
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`forth in PTO Rule 56.” Order at 24 (quotation marks omitted). The court in Signify erroneously
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`2 The standard is different in the case of “affirmative egregious conduct,” Therasense, 649 F.3d at
`1292, but that is not at issue here.
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`8
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 13 of 26
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`applied pre-Therasense law. The Federal Circuit in Therasense rejected this lower materiality
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`standard, and required a showing that “the PTO would not have allowed a claim had it been aware
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`of the undisclosed prior art.” 649 F.3d at 1291. The court also rejected PTO Rule 56 as
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`establishing the materiality standard for inequitable conduct because the court’s earlier precedent
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`incorporating the “low bar” in that rule had “resulted in the very problems this court sought to
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`address by taking this case en banc.” Id. at 1294; see also Metris, 882 F. Supp. 2d at 168.3
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`b.
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`The record contains no evidence of the but-for materiality of any
`of the alleged omissions.
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`The record does not contain evidence from which a factfinder could conclude, and certainly
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`not by clear and convincing evidence, that any claim would not have issued had Shaw
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` been disclosed to the PTO.
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`Binding
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` art. Lilly has adduced no evidence to support its charge that
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`consideration of Shaw
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`reject any patent claim that it issued.
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` would have led the PTO to
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`3 The court’s error in Signify did not impact the outcome in that case because the court found that
`the undisclosed reference was cumulative and hence immaterial. Signify, 2020 WL 1331919, at
`*5.
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`9
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 14 of 26
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` disclosed to the PTO that not all antibodies that bind CGRP also
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`antagonize it, regardless of where the antibody binds. SUMF ¶ 51. This is most clear from Tables
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`2 and 3, which show C-terminal antibodies that bind, but do not antagonize, CGRP. Id. ¶¶ 10, 22.
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`While Shaw discusses that some non-C-terminal antibodies bind, but do not antagonize, CGRP, it
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`also shows that some non-C-terminal binding antibodies do antagonize CGRP. Id. ¶¶ 32–34. The
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` Id. ¶ 40.
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`examiner would put particularly little weight on this
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` an
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`antibodies that bind, but did not antagonize, CGRP, disclosing more information that
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` Thus, given that the patent disclosed C-terminal
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 15 of 26
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` is highly unlikely to have changed the examiner’s view of patentability. As Dr. Hale
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`put it, if the examiner were “so inclined, the examiner would require neither
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` nor Shaw 1992 to reach the conclusion that a certain level of binding affinity is necessary but
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`not sufficient for an anti-CGRP antibody to be an antagonist.” Id. ¶ 43.
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`Lilly’s materiality theory suffers from an additional flaw:
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` Shaw
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`were “duplicative of disclosures in the specification and prior art non-antagonist anti-CGRP
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`antibodies with a variety of different epitopes”—i.e., antibodies that bound to different regions of
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`CGRP. Id. ¶¶ 37–38. As discussed, the data in the patent makes clear that not all antibodies that
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`bind CGRP also antagonize it. In addition, a disclosed prior art reference, Tan 1994, similarly
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`explained that not all anti-CGRP antibodies are antagonists. Id. ¶ 47. Tan also cites Shaw for one
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`of its key teachings: “The binding of an antibody to a peptide does not always result in blockade
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`of biological activity.” Id. ¶ 48. It thus was clear to the examiner, even without Shaw
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`, that not all antibodies that bind to CGRP also antagonize it.
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`Dr. Hale’s opinion is supported by the undisputed fact that Shaw was disclosed in the
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`prosecution of both the ’907 and ’908 patents, the examiner considered Shaw, and yet those patents
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`issued anyway. Id. ¶¶ 29–31, 35–36. Though Lilly accuses the inventors of “burying” Shaw, the
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`Federal Circuit has explicitly rejected the theory that the failure to call sufficient attention to a
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`disclosed reference can constitute inequitable conduct. Fiskars, Inc. v. Hunt Mfg. Co., 221 F.3d
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 16 of 26
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`1318, 1327 (Fed. Cir. 2000); see also Symbol Techs., Inc. v. Aruba Networks, Inc., 609 F. Supp.
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`2d 353, 358 (D. Del. 2009) (rejecting inequitable conduct claim based on purported “burying” of
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`a reference). And, regardless, such a theory is inapplicable here given that the examiner did not
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`strikethrough Shaw, which means that he considered it. SUMF ¶¶ 29–31.; see also MPEP
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`§ 609.05(b) (if an examiner does not “strikethrough” a citation, it means it has “been considered”).
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`. Lilly’s evidence concerning the materiality
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` is even
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`weaker.
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` Even if a factfinder could agree that
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` were “germane” to the
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`issues before the examiner, under Therasense that is not sufficient to establish materiality.
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 17 of 26
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`No factfinder could conclude that
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` would have led the examiner to reject the claims for lack of utility
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`or written description. Indeed, even before Therasense, the Federal Circuit rejected a finding of
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`inequitable conduct when
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` and applicants “never
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`suggested that [the data they submitted] was the only testing data” they had. Impax Lab’ys, Inc.
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`v. Aventis Pharms. Inc., 468 F.3d 1366, 1377 (Fed. Cir. 2006).
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`2.
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`The record does not support a finding that either
`intended to deceive the Patent Office.
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`a.
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`Lilly must establish that the single most reasonable inference
`from the evidence is that a specific individual made a deliberate
`decision to withhold material information with the specific
`intent to deceive the Patent Office.
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`When tightening the standard for intent in Therasense, the court held that “the accused
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`infringer must prove by clear and convincing evidence that the applicant knew of the reference,
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`knew that it was material, and made a deliberate decision to withhold it.” 649 F.3d at 1290.
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 18 of 26
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`Showing that an applicant’s failure to disclose information “amounts to gross negligence or
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`negligence under a ‘should have known’ standard does not satisfy this intent requirement.” Id.;
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`see also, e.g., Hospira, Inc. v. Sandoz Inc., 2012 WL 1587688, at *32 (D.N.J. May 4, 2012) (“Gross
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`negligence in failing to submit data is not adequate.”). Nor does “[p]roving that the applicant knew
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`of a reference, should have known of its materiality, and decided not to submit it to the PTO.”
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`Therasense, 649 F.3d at 1290.
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`The Federal Circuit strictly limited the circumstances when inferences can establish a
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`specific intent to deceive. Id. Specifically, the court held that, “to meet the clear and convincing
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`evidence standard, the specific intent to deceive must be the single most reasonable inference able
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`to be drawn from the evidence” and “when there are multiple reasonable inferences that may be
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`drawn, intent to deceive cannot be found.” Id. at 1290–91 (quotation marks omitted; emphasis
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`added). Moreover, as the burden of proof by clear and convincing evidence lies with the alleged
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`infringer, the patentee “need not offer any good faith explanation unless the accused infringer first
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`proves a threshold level of intent to deceive by clear and convincing evidence.” Id. at 1291
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`(alterations and quotation marks omitted); see also 1st Media, LLC v. Elec. Arts, Inc., 694 F.3d
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`1367, 1372–73 (Fed. Cir. 2012) (“A court can no longer infer intent to deceive from non-disclosure
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`of a reference solely because that reference was known and material. Moreover, a patentee need
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`not offer any good faith explanation for his conduct unless and until an accused infringer has met
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`his burden to prove an intent to deceive by clear and convincing evidence.” (citation omitted)).
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`These principles apply at summary judgment. Indeed, courts have recognized this and
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`granted summary judgment where the record does not support a finding that intent to deceive is
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`the “single most reasonable inference.” E.g., Exergen Corp., 120 F. Supp. 3d at 7; Virginia
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`Innovation Scis., Inc. v. Samsung Elecs. Co., Ltd., 11 F. Supp. 3d 622, 641–42 (E.D. Va. 2014);
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`Case 1:18-cv-12029-ADB Document 418 Filed 07/27/22 Page 19 of 26
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`Navico Inc. v. Garmin Int’l, Inc., 2017 WL 3701189, at *2 (E.D. Tex. Aug. 7, 2017), adopted,
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`2017 WL 3676787 (E.D. Tex. Aug. 25, 2017) (granting summary