Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 1 of 17
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`Case No. 1:18-cv-12029-ADB
`
`LEAVE TO FILE REPLY
`GRANTED 10/28/21
`(ECF NO. 213)
`
`FILED UNDER SEAL
`GRANTED 11/4/21
`(ECF NO. 220)
`
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`))
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`TEVA PHARMACEUTICALS
`
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS USA, INC.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`
`
`REPLY MEMORANDUM OF LAW IN SUPPORT OF DEFENDANT ELI LILLY AND
`COMPANY’S MOTION FOR LEAVE TO AMEND ANSWER
`
`

`

`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 2 of 17
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ............................................................................................................................... 1
`
`II. ARGUMENT ....................................................................................................................................... 2
`
`A. Lilly Was Diligent ........................................................................................................................... 2
`B. The Proposed Amendment Is Not Futile ....................................................................................... 4
`III. CONCLUSION ................................................................................................................................. 10
`
`ii
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`

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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 3 of 17
`
`TABLE OF AUTHORITIES
`
`Federal Cases
`
`Adams Respiratory Therapeutics, Inc. v. Perrigo Co.,
`255 F.R.D. 443 (W.D. Mich. 2009) ...........................................................................................7
`
`Adorno v. Crowley Towing & Transp. Co.,
`443 F.3d 122 (1st Cir. 2006) ......................................................................................................4
`
`Agfa Corp. v. Creo Prods. Inc.,
`451 F.3d 1366 (Fed. Cir. 2006)..................................................................................................9
`
`Bd. of Tr. of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc.,
`No. 05-cv-04158, 2008 WL 624771 (N.D. Cal. Mar. 4, 2008) .................................................2
`
`eSpeed, Inc. v. Brokertec USA, L.L.C.,
`417 F. Supp. 2d 580 (D. Del. 2006), aff’d, 480 F.3d 1129 (Fed. Cir. 2007) .............................9
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009)..........................................................................................4, 5, 6
`
`Fiskars, Inc. v. Hunt Mfg. Co.,
`221 F.3d 1318 (Fed. Cir. 2000)..................................................................................................9
`
`JBF Interlude 2009 Ltd. v. Quibi Holdings LLC,
`Nos. 2:20-CV-02299, 2:20-CV-02250, 2021 WL 1390365 (C.D. Cal. Apr. 12,
`2021) ..........................................................................................................................................5
`
`O’Connell v. Hyatt Hotels of Puerto Rico,
`357 F.3d 152 (1st Cir. 2004) ......................................................................................................4
`
`PetEdge, Inc. v. Yahee Techs. Corp.,
`C.A. No. 15-cv-113171-ADB, 2017 WL 1702276 (D. Mass. May 2, 2017) ............................6
`
`Rosario-Diaz v. Gonzalez,
`140 F.3d 312 (1st Cir. 1998) ......................................................................................................4
`
`Sig Sauer, Inc. v. Freed Designs, Inc.,
`No. 14-cv-461-SM, 2017 WL 4119046 (D.N.H. Mar. 17, 2017) ..............................................4
`
`Symbol Techs., Inc. v. Aruba Networks, Inc.,
`609 F. Supp. 2d 353 (D. Del. 2009) ...........................................................................................9
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011)..................................................................................................5
`
`iii
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`

`

`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 4 of 17
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`Rules and Regulations
`
`Fed. R. Civ. P. 9(b) ............................................................................................................... passim
`
`Fed. R. Civ. P. 10(c) .......................................................................................................................7
`
`Fed. R. Civ. P. 12(b)(6) ...................................................................................................................4
`
`Fed. R. Civ. P. 16(b) ...................................................................................................................2, 4
`
`Fed. R. Civ. P. 30(b)(6) ...................................................................................................................3
`
`iv
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`

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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 5 of 17
`
`TABLE OF ABBREVIATIONS
`
`IPR
`Lilly
`Mot.
`
`Abbreviation Description
`’045 patent
`U.S. Patent No. 8,586,045
`’907 patent
`U.S. Patent No. 9,884,907
`’908 patent
`U.S. Patent No. 9,884,908
`Ex. __
`Exhibits to the Declaration of Emily R. Gabranski in Support of Defendant’s
`Motion for Leave to Amend Answer (ECF No. 194) (Exs. 1-17) or to the
`accompanying Declaration of Emily R. Gabranski in Support of Defendant’s
`Reply on its Motion for Leave to Amend Answer (Exs. 18-37)
`Inter Partes Review
`Eli Lilly and Company
`Memorandum of Law in Support of Defendant Eli Lilly and Company’s Motion
`for Leave to Amend Answer (ECF No. 193)
`Exhibits to Memorandum of Law in Support of Defendant Eli Lilly and
`Company’s Motion for Leave to Amend Answer (ECF No. 193) (Exs. A-C)1
`Plaintiffs Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals
`USA, Inc.’s Opposition to Motion for Leave to Amend Answer (ECF No. 207)
`Patents-in-Suit U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908
`Pfizer
`Pfizer Inc.
`PTO
`United States Patent and Trademark Office
`Teva
`Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals USA, Inc.
`
`Mot. Ex. __
`
`Opp.
`
`1 All citations to Mot. Ex. A (clean version of Lilly’s proposed amended answer) and Mot. Ex. B
`(redline version) herein are to the Counterclaims section of each.
`v
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`

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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 6 of 17
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`I.
`
`INTRODUCTION
`
`Lilly’s proposed amended pleading is predicated on the fact that the inventors of the
`
`patents-in-suit sought broad, dominating genus claims, impacting research and development in the
`
`CGRP antibody space, based on the development of a single species falling within the scope of
`
`that genus. Teva’s inventors argued to the PTO that antibodies binding to any portion of CGRP
`
`would be functional, in order to secure allowance of those first dominating claims. The inventors
`
`knew those arguments were false, or at the very least, misleading, based on known prior art
`
`
`
` which they concealed from the PTO. But for the
`
`nondisclosure of this evidence, such broad claims would never have issued. The materiality of this
`
`information is reinforced by the fact that
`
`
`
`
`
`. (Mot. Ex. A at ¶¶ 187-99, 205-77.)
`
`Equally troubling, the inventors (and Teva) argued to the PTO that their invention was
`
`premised on the discovery that a full-length antibody could treat migraine. However,
`
`
`
`
`
`But for the fact that this information was concealed from the PTO, the patents-in-suit would not
`
`have issued. Further, the concealment of this information (and that discussed above) foreclosed
`
`full and fair consideration by the PTO of the validity issues now before the Court, including during
`
`recent IPR proceedings. Indeed, the materiality of this information is reinforced by the contentions
`
`of both Dr. Pons and Teva in the IPRs regarding the state of the art. (Mot. Ex. A at ¶¶ 187-89, 200-
`
`12, 278-307.)
`
`Teva’s Opposition fails to prove any lack of diligence on the part of Lilly. Teva seeks to
`
`reframe its own failure to provide discovery that its inventors clearly had an obligation to provide
`
`as Lilly’s lack of diligence. And Teva’s Opposition fails to cite even a single case where leave to
`
`

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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 7 of 17
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`amend was denied for lack of good cause for a pleading subject to Fed. R. Civ. P. 9(b). As for the
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`“futility” prong of the Rule 16(b) inquiry, Teva improperly seeks to litigate now whether the
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`evidence—yet to be adduced at trial—will be sufficient to prove Lilly’s allegations of inequitable
`
`conduct. That is not the proper inquiry at this stage. Rather, the issue for the Court is whether the
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`allegations now fairly set forth circumstances which, if true and proven, support a finding of
`
`unenforceability. Lilly respectfully submits that its proposed amended pleading exceeds that bar.
`
`II.
`
`ARGUMENT
`
`A.
`
`Lilly Was Diligent
`
`Despite Teva having on multiple occasions represented to this Court that Lilly was
`
`“working diligently through fact discovery,” including after Lilly served its subpoenas on
`
`
`
`and the named inventors in May 2021 (ECF No. 128 at 1; ECF No. 113 at 2; see also ECF No.
`
`126 at 1), Teva now contends that Lilly was not diligent in seeking the discovery underlying its
`
`proposed amended pleading. This argument fails.
`
`Teva’s own lack of diligence in discovery does not transfer to Lilly. Although ignored by
`
`Teva, Lilly’s proposed amended pleading relies extensively on deposition testimony of certain
`
`named inventors of the patents-in-suit that Lilly could not have reasonably obtained earlier. (Mot.
`
`Ex. A at ¶¶ 192, 218, 220, 222-23, 227-28, 241-43, 261-62, 267, 285, 287, 295.) The case law
`
`cited in Lilly’s motion, which Teva also ignores, recognizes that it is “appropriate,” “reasonable,”
`
`and “perhaps necessary” for a party to obtain corroborating deposition testimony before asserting
`
`inequitable conduct. Marical Inc. v. Cooke Aquaculture Inc., C.A. No. 1:14-cv-00366-JDL, 2017
`
`WL 3254693, at *6 (D. Me. July 31, 2017); Bd. of Tr. of Leland Stanford Junior Univ. v. Roche
`
`Molecular Sys., Inc., No. 05-cv-04158, 2008 WL 624771, at *7, n.7 (N.D. Cal. Mar. 4, 2008). No
`
`fact depositions occurred before the March 22, 2021, deadline for the parties to amend their
`
`pleadings—nor could they have. Indeed, as of March 25, 2021, the parties were “still in the process
`
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 8 of 17
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`of supplementing their document productions and written discovery responses and need[ed]
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`additional time to review those materials before fact depositions [we]re conducted and completed.”
`
`(ECF No. 113 at 2.) And even though Lilly served its Rule 30(b)(6) notice on March 8, 2021,
`
`before the March 22 deadline, Teva did not make inventor Jaume Pons, its Rule 30(b)(6)
`
`representative on the inventors’ work, available for deposition until August 20, 2021—more than
`
`five months later. Thus, Lilly could not have reasonably obtained the deposition testimony cited
`
`in its proposed amended pleading before the deadline to amend the pleadings.
`
`Teva also fails to establish that Lilly lacked diligence in seeking the remaining discovery
`
`underlying its proposed amended pleading. Teva’s suggestion that Lilly should have acted earlier
`
`in subpoenaing Teva’s predecessors in interest
`
` and the named inventors) overlooks that
`
`Lilly’s subpoenas were directed to documents regarding inventor activity that should have been
`
`produced by Teva and were narrowly tailored, accounting for and relying on the discovery that
`
`Teva had provided to date. For example, one of the four requests in the
`
` subpoena (Ex. 18 at
`
`6 (Request No. 4))2 sought additional documents relating to
`
`,
`
`
`
`
`
`
`
`
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`Even if Lilly had subpoenaed
`
` earlier, there is no reason to think that Lilly would
`
`have obtained the relevant document discovery in sufficient time to amend its pleadings before the
`
`deadline. Despite Teva’s asserted
`
`, which was disclosed to Lilly by
`
`December 2020 (Ex. 19 at 2), it took Teva until February 2021 to obtain “authority” from
`
`
`
`to produce 16 early development documents it had collected from
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` no later than May 2020.
`
`2 Exs. 18-37 are attached to the Reply Declaration of Emily R. Gabranski, filed concurrently.
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 9 of 17
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`(Ex. 14 at 2; Ex. 13 at 1, n. 2.) Lilly later learned that Teva’s collection from
`
` had been
`
`grossly inadequate, as
`
` independent collection of documents in response to Lilly’s
`
`subpoenas of the named inventors yielded “approximately (and possibly more than) 100,000
`
`documents.” (Ex. 16.) On these facts, Lilly was diligent in pursuing discovery from Teva and its
`
`predecessors in interest, particularly given Teva’s own representations and reassurances.
`
`None of the case law cited in Teva’s Opposition is relevant to the issue of diligence under
`
`this procedural posture. Indeed, Teva fails to cite any case in which a Rule 16(b) motion for leave
`
`to amend a pleading to add inequitable conduct allegations (or other allegations subject to the
`
`heightened Rule 9(b) pleading standard) was denied for lack of diligence. This is unsurprising, as
`
`courts within this Circuit have consistently found movants diligent even with months of alleged
`
`“delay” due to the nature of these allegations. See, e.g., Sig Sauer, Inc. v. Freed Designs, Inc., No.
`
`14-cv-461-SM, 2017 WL 4119046, at *3 (D.N.H. Mar. 17, 2017) (delay not unreasonable in view
`
`of “the gravity of such an assertion, and the strict pleading requirements involved”). Teva’s two
`
`cited cases, Rosario-Diaz, dealing with summary judgment motions on police qualified immunity,
`
`and O’Connell, a non-Rule 9(b) case where delay was due to attorney error, do not hold otherwise.
`
`B.
`
`The Proposed Amendment Is Not Futile
`
`Teva misapprehends the applicable standard. The “futility” inquiry under Rule 16(b) asks
`
`whether an amended pleading would survive a motion to dismiss under Fed. R. Civ. P. 12(b)(6).
`
`Adorno v. Crowley Towing & Transp. Co., 443 F.3d 122, 126 (1st Cir. 2006). Accordingly, the
`
`Court “must accept as true all well-pleaded facts and draw all reasonable inferences” in favor of
`
`Lilly to determine whether Lilly’s proposed amended pleading states a plausible claim. Marical,
`
`2017 WL 3254693, at *5. In addition, the Court must confirm that Lilly’s amended pleading
`
`complies with Rule 9(b) by identifying “the specific who, what, when, where, and how of the
`
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 10 of 17
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`material misrepresentation or omission committed before the PTO.” Exergen Corp. v. Wal-Mart
`
`Stores, Inc., 575 F.3d 1312, 1327 (Fed. Cir. 2009).
`
`Teva’s Opposition departs from this standard and invites the Court to try the merits of
`
`Lilly’s new inequitable conduct claim rather than the sufficiency of Lilly’s pleading. Specifically,
`
`Teva purports to examine the sufficiency of Lilly’s proposed pleading by measuring it against the
`
`Federal Circuit’s test in Therasense. (See, e.g., Opp. at 5-6.) But that test sets forth the elements
`
`required “[t]o prevail on a claim of inequitable conduct,” not to plead a claim of inequitable
`
`conduct. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011)
`
`(emphases added). Whereas Teva asserts that these elements must be “establish[ed]” (Opp. at 6,
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`10), Lilly’s proposed pleading need only “include sufficient allegations of underlying facts from
`
`which a court may reasonably infer” their presence. Exergen, 575 F.3d at 1328 (emphasis added).
`
`Additionally, contrary to Teva’s arguments (Opp. at 17), whether an intent to deceive the PTO will
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`ultimately be found to be the “single most” reasonable inference is not at issue at the pleading
`
`stage. See, e.g., JBF Interlude 2009 Ltd. v. Quibi Holdings LLC, Nos. 2:20-CV-02299, 2:20-CV-
`
`02250, 2021 WL 1390365, at *7 (C.D. Cal. Apr. 12, 2021) (“[T]he ‘single most reasonable
`
`inference’ standard governs what needs to be shown to prevail [on the merits of] an inequitable
`
`conduct claim, not what is needed to survive a Rule 12 motion.”) (emphasis in original). Lilly’s
`
`proposed pleading states a plausible claim that satisfies Rule 9(b), and thus would not be futile.
`
`Teva improperly asks the Court to simply “disregard” large portions of the pleading. First,
`
`Teva suggests that all allegations referring to “the Applicants” should be “disregard[ed],” pointing
`
`to the definition of “Applicants” provided in a separate counterclaim in Lilly’s original answer.
`
`(Opp. at 8-9 (citing Mot. Ex. B at ¶ 141).) But Lilly’s allegations in proposed Counterclaim XXI
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`were intended to be self-contained, with “Applicants” referring to the named inventors (see Mot.
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 11 of 17
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`Ex. A at ¶ 246)—not a “range of unspecified individuals from a range of different companies and
`
`law firms”—and separate detailed allegations as to the prosecuting agent (see, e.g., id. at ¶¶ 252,
`
`260). The scope of Counterclaim XIX (a counterclaim based on an unrelated inequitable conduct
`
`theory) and that of proposed Counterclaim XXI are simply different; Counterclaim XIX addresses
`
`nine patents, while Counterclaim XXI addresses only three of those patents. Further, the cases
`
`Teva cites—Exergen and PetEdge—did not “disregard” allegations on facts even close to those
`
`present here. E.g., PetEdge, Inc. v. Yahee Techs. Corp., C.A. No. 15-cv-113171-ADB, 2017 WL
`
`1702276 (D. Mass. May 2, 2017) (striking single-paragraph affirmative defense that appeared to
`
`allege inequitable conduct for failure “to identify a specific individual” where none was named);
`
`Exergen, 575 F.3d at 1325-26 (no individual named in seven-paragraph counterclaim). Here,
`
`specific individuals are named. (See, e.g., Mot Ex. A at ¶¶ 213-22, 243, 252, 260, 278.)
`
`Teva also improperly asks the Court to “disregard” allegations that rest on “information
`
`and belief.” (Opp. at 10.) But such allegations are permitted under Rule 9(b) when “essential
`
`information lies uniquely within another party’s control” as long as “the pleading sets for the
`
`specific facts upon which the belief is reasonably based.” Exergen, 575 F.3d at 1330. Teva points
`
`to a paragraph in Lilly’s proposed amended pleading alleging “on information and belief” that
`
` Lilly’s proposed pleading sets forth in detail the factual basis for its
`
`
`
`understanding that
`
`
`
`
`
`
`
`
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` Thus,
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`Lilly’s allegation at this paragraph and elsewhere are permissible on “information and belief”
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 12 of 17
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`under Rule 9(b). Indeed, for all allegations made on “information and belief,” the evidence
`
`supporting Lilly’s “belief” is identified in Lilly’s proposed pleading, often in the very paragraph
`
`containing the allegation. (See, e.g., Mot. Ex. A at ¶¶ 219, 223, 224, 227, 250, 251.)
`
`Teva also improperly contends Lilly’s proposed pleading lacks sufficient allegations to
`
`“establish that any specific individual made a deliberate decision to withhold material information
`
`or ma[de] a false representation with the intent to deceive the PTO.” (Opp. at 10.) But, as noted
`
`above, such “establish[ment]” is not the standard. As Teva acknowledges, Lilly’s proposed
`
`pleading names three specific individuals:
`
`
`
`
`
`. (See, e.g., Mot. Ex. A at ¶¶ 243-52; Opp. at 11
`
`(acknowledging that Lilly’s allegations as to these individuals are detailed “across more than thirty
`
`pages of [Lilly’s] proposed pleading”), 14.) Lilly’s proposed pleading also identifies
`
`
`
` on “information and belief” on the basis that each (1) had knowledge of the
`
` and (2) had a duty to disclose that information to the PTO, but did
`
`not. Lilly’s allegations are supported not only by the text of the proposed pleading, but also by the
`
`74 exhibits cited therein. See Fed. R. Civ. P. 10(c) (“A copy of a written instrument that is an
`
`exhibit to a pleading is part of the pleading for all purposes.”); Adams Respiratory Therapeutics,
`
`Inc. v. Perrigo Co., 255 F.R.D. 443, 446 (W.D. Mich. 2009) (“all purposes” includes satisfaction
`
`of Rule 9(b)); see also Exs. 20-37 (exemplary exhibits cited in Lilly’s proposed amendment).
`
` Lilly pleads that
`
` each knew of (1)
`
`
`
`
`
`
`
` Lilly also
`
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 13 of 17
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`pleads that
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` knew of
`
` but failed to disclose it during prosecution of the ’045 patent.
`
`(Id. at ¶¶ 228-31.) Lilly also provides sufficient factual allegations to establish that the withheld
`
`information was material (Mot. Ex. A at ¶¶ 194-204, 232-40, 256-76, 278, 285-306) and to permit
`
`the reasonable inference that
`
` understood this. For example,
`
`
`
`
`
`
`
`While Teva invites the Court to conclude that the related discussion
`
` concerned patents other than those at issue (Opp. at 19), the only patent
`
`application filed by
`
` during this time frame (2004-2005) relating to anti-CGRP antagonist
`
`antibodies was the provisional application that led to the patents-in-suit. (See, e.g., Mot. Ex. A at
`
`¶ 206.) Further, it is reasonable to infer that
`
` knew that
`
`was material based on the allegations and evidence in Lilly’s proposed pleading, including
`
`
`
`
`
` sworn statement that “Key Opinion Leaders” in the field “frequently expressed skepticism
`
`that an antibody like fremanezumab would be able to treat migraine because it could not cross the
`
`[blood brain barrier].” (Id. at ¶ 278 (citing Ex. G); Ex. 5 (cited document).)
`
`It is also reasonable to infer that the ’045 patent would not have issued “but for” these
`
`material omissions.
`
` disproves the very argument made to the PTO that secured allowance of
`
`the ’045 patent (discussed below), and
`
` illustrate its fallacy. (Mot. Ex. A at ¶¶ 259-63.) Further,
`
`
`
` if
`
`disclosed, would have undermined the asserted therapeutic utility of the claimed anti-CGRP
`
`antagonist antibodies, warranting rejection. (Id. at ¶¶ 278, 291-92, 305.) Lilly’s allegations permit
`
`the reasonable inference that
`
` possessed the requisite deceptive intent. Each
`
`was involved in drafting the non-provisional priority application, the claims of which did not
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 14 of 17
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`specify where in CGRP the antibody must bind.3 (Id. at ¶¶ 220, 240, 243.) Each affirmed they had
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`“reviewed and understand the contents” of that application “including the claims,” and
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`acknowledged their duty to disclose material information. (Id. at ¶¶ 246-47.) Each was aware of
`
`
`
`
`
`
`
`, and
`
` was further aware of
`
` and its teachings that were
`
`inconsistent with the argument advanced for broad patentability (id. at ¶¶ 227-29).
`
`
`
` were each also aware of
`
` and its materiality. (Id.
`
`at ¶¶ 278, 285-306.) Yet, neither disclosed any of this information to the PTO at any point before
`
`the ’045 patent issued. (Id. at ¶¶ 218-220, 230, 235-37, 239-40, 278, 287, 299, 304.) It is reasonable
`
`to infer this was deliberately done with an intent to deceive the PTO.
`
`Finally, the later disclosure of
`
` during prosecution of the ’907 and ’908 patents does
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`not cut against scienter. There is no evidence that
`
` had any role in that
`
`disclosure. (Opp. at 20.) Even if they had,
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` addressed in Lilly’s proposed
`
`pleading were never disclosed. Nor was the material misrepresentation by
`
` (on behalf
`
`of the inventors) ever pointed out to the PTO to allow it to revisit the patentability of the parent
`
`’045 patent on a factually accurate record. As such, the inequitable conduct during prosecution of
`
`the ’045 patent was not cured and may plausibly render the ’907 and ’908 patents unenforceable.4
`
`3 Contrary to Teva’s argument, drafting and reviewing a patent application necessarily involves
`deciding what data and references should be disclosed to the PTO and, itself, is a task “typically
`handled by lawyers.” (Opp. at 17.)
`4 It is well-established that inequitable conduct “early in the prosecution may render unenforceable
`all claims which eventually issue from the same or a related applications.” Agfa Corp. v. Creo
`Prods. Inc., 451 F.3d 1366, 1379 (Fed. Cir. 2006) (affirming unenforceability of child patent based
`on inequitable conduct during prosecution of parent patent); see also eSpeed, Inc. v. Brokertec
`USA, L.L.C., 417 F. Supp. 2d 580, 596-97 (D. Del. 2006), aff’d, 480 F.3d 1129 (Fed. Cir. 2007)
`(discussing the limited circumstances under which inequitable conduct may be cured). The Fiskars
`and Symbol Techs. cases cited by Teva are inapposite as each examined the sufficiency of the
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`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 15 of 17
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` Lilly alleges that
`
` (on behalf of the inventors) made the following
`
`false or misleading statement to the PTO: “[A]ny antibody that effectively binds CGRP may
`
`reasonably be expected to have the claimed effect.” (Mot. Ex. A at ¶ 260.) Lilly further explains
`
`that the ’045 patent issued as a direct result, permitting a reasonable inference of “but for”
`
`materiality. (Id. at ¶¶ 261-63.) Teva contends that Lilly does not adequately allege that
`
`
`
`knew the statement was false or possessed the requisite intent to deceive. (Opp. at 12-13.) To the
`
`contrary,
`
`aware of
`
` scienter can reasonably be inferred in two ways: (1) if
`
`, or (2) if
`
` failed to discuss
`
` was
`
` with the
`
`inventors, which constitutes recklessness. (Mot. Ex. A at ¶ 252; Mot. at 12.) Accordingly, Teva
`
`should not be permitted to assert
`
` alleged lack of recollection as a complete defense
`
`to inequitable conduct by and through this false or misleading statement. (Opp. at 13.)
`
`Finally, Teva improperly offers numerous alternative explanations for the factual
`
`allegations in Lilly’s proposed pleading, postulating things the inventors or counsel “might have”
`
`or “could have” been thinking, as allegedly “more plausible inference[s].” (Opp. at 13-14, 18-20.)
`
`Each of these arguments amounts to a request that the Court draw inferences in Teva’s favor5—a
`
`request plainly contrary to the legal standard for assessing “futility.” (See supra at 4.) If anything,
`
`these arguments concede that the facts also “might” or “could” infer inequitable conduct, which
`
`makes Lilly’s proposed counterclaim anything but futile.
`
`III.
`
`CONCLUSION
`
`For the foregoing reasons and the reasons of record, Lilly respectfully requests that it be
`
`granted leave to amend its Answer.
`
`manner of an otherwise timely disclosure of material evidence during prosecution of an original
`application, not the impact of non-disclosure of such evidence on continuation applications.
`5 Teva’s assertions regarding the alleged involvement of
` should be
`disregarded at this stage for the same reasons. (See, e.g., Opp. at 13, n.5.)
`10
`HIGHLY CONFIDENTIAL  OUTSIDE COUNSEL ONLY
`
`

`

`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 16 of 17
`
`Dated: November 4, 2021
`
`William B. Raich
`Danielle A. Duszczyszyn
`Denise Main
`Pier D. DeRoo
`Daniel F. Roland
`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
`Daniel.Roland@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
`
`11
`HIGHLY CONFIDENTIAL  OUTSIDE COUNSEL ONLY
`
`

`

`Case 1:18-cv-12029-ADB Document 233 Filed 11/18/21 Page 17 of 17
`
`CERTIFICATE OF SERVICE
`
`I, Andrea L. Martin, hereby certify that on November 4, 2021, a copy of the foregoing
`document was served on all outside counsel of record via email.
`
`/s/Andrea L. Martin
`Andrea L. Martin
`
`