Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 1 of 47 PageID #: 33366
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC.,
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`AMGEN INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`C.A. No. 18-924-CFC
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`REPLY BRIEF IN SUPPORT OF GENENTECH’S MOTION TO
`STRIKE AMGEN’S ELEVENTH AND TWELFTH AFFIRMATIVE
`DEFENSES (AND DISMISS, OR ALTERNATIVELY, STRIKE
`ASSOCIATED COUNTERCLAIMS)
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`PUBLIC VERSION FILED:
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`December 2, 2019
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 2 of 47 PageID #: 33367
`Case 1:18—cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 2 of 47 PageID #: 33367
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS
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`INTRODUCTION _____________________________________________________________________________________________________ l
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`ARGUIvIENT ............................................................................................................ 3
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`I.
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`Amgen Was Required To Seek Leave To Add New Defenses ______________________ 3
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`A.
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`B.
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`The Court‘s Scheduling Drder Required Amgen To Seek Leave To
`Include Its Defenses .............................................................................. 4
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`The Majoritj,r View Is To Require Amgen To Seek Leave To Add
`Defenses That Exceed The Breadth [3f Genentech‘ s Amendments _____ 6
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`II.
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`The Court Should Deny Amgen Leave To Inject An Improper Inventorship
`Dr Derivation Defense Into This Case At This Late Stage ............................. 9
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`A.
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`B.
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`Amgen Cannot Establish Good Cause Under Rule 16(b)(4) ________________ 9
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`Amgen Also Fails To Meet The Rule 15(a) Standard ........................ 12
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`1-
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`2-
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`3-
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`Amgen Undulv Delayed ___________________________________________________________ 12
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`Amgen‘ 3 Amendment Would Burden The Court And Unfajrlv
`Prejudice Genentech ................................................................. 13
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`Amgen‘ 3 Proposed Amendment Is Futile ________________________________ 15
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`Ill
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`The Court Should Den}; Amgen Leave To Inject Ari Improper Inequitahle
`Conduct Defense Into This Case At This Late Stage ___________________________________ 15
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`A.
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`B.
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`Amgen Cannot Establish Good Cause Under Rule 16(b){4) ______________ 15
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`Amgen Also Fails To Meet The Rule 15(a) Standard ........................ 1?
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`1-
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`3-
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`3-
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`Amgen Undulv Delayed ___________________________________________________________ 17"
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`Amgen: 3 Amendment Would Burden The Court And Unfajrlv
`Prejudice Genentech _________________________________________________________________ IS
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`Amgen: 3 Proposed Amendment Is Futile ________________________________ 19
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`CONCLUSION ....................................................................................................... 19
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`TABLE OF AUTHORITIES
`
`Am. Axle & Mfg., Inc. v. Neapco Holdings LLC,
`No. CV 15-1168-LPS, 2017 WL 3888228 (D. Del. Sept. 6, 2017) ................... 13
`Cobra Int’l, Inc. v. BCNY Int’l, Inc,
`702 F. App’x 994 (Fed. Cir. 2017) ..................................................................... 13
`
`Compagnie Des Grands Hôtels d’Afrique S.A. v. Starwood Capital
`Group Global I LLC,
`No. CV 18-654-RGA, 2019 WL 4740083 (D. Del. Sept. 27, 2019) .................. 16
`Coppola v. Smith,
`2015 WL 2127965 (E.D. Cal. May 6, 2015) ........................................................ 7
`In re Frescati Shipping Co.,
`886 F.3d 291 (3d Cir. 2018), cert. granted sub nom. CITGO
`Asphalt Ref. Co. v. Frescati Shipping Co., 139 S. Ct. 1599 (2019) ............. 11, 12
`Johnson v. Mammoth Recreations, Inc.,
`975 F.2d 604 (9th Cir. 1992) ................................................................................ 6
`Magsil Corp. v. Seagate Tech.,
`No. CV 08-940-HB, 2010 WL 2710472 (D. Del. July 7, 2010) ........................ 16
`Patel v. Pandya,
`2016 WL 3129615 (D.N.J. June 2, 2016) ............................................................. 7
`Robinson v. Johnson,
`313 F.3d 128 (3d Cir. 2002) ................................................................................. 4
`Sirona Dental Sys., Inc. v. Dental Imaging Techs. Corp.,
`No. CV 10-288-GMS, 2012 WL 3929949 (D. Del. Sept. 10, 2012) ............ 4, 7, 8
`Slim CD, Inc. v. Heartland Payment Sys., Inc.,
`2007 WL 2459349 (D.N.J. Aug. 24, 2007) .......................................................... 6
`Teva Pharm. USA, Inc. v. Forest Labs., Inc.,
`No. 13-cv-02002-GMS, 2016 WL 7325511 (D. Del. June 16,
`2016) ......................................................................................................... 4, 5, 7, 8
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ............................................................................ 7
`ii
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`Virginia Innovation Scis., Inc. v. Samsung Elecs. Co.,
`11 F. Supp. 3d 622 (E.D. Va. 2014) ..................................................................... 8
`Rules
`Fed. R. Civ. P. 8 ....................................................................................................... 11
`Fed. R. Civ. P. 15 ..............................................................................................passim
`Fed. R. Civ. P. 16(b) ........................................................................................ 7, 9, 15
`Other Authorities
`3 James Wm. Moore et al., Moore’s Federal Practice § 15.17[6] (3d
`ed. 2012) ............................................................................................................... 5
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`INTRODUCTION
`Amgen’s new defenses should be stricken because Amgen could have
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`pursued discovery into the facts underlying those defenses well before the deadline
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`for amended pleadings and the close of fact discovery.
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`Amgen essentially seeks to relitigate this Court’s prior ruling rejecting
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`Amgen’s effort to pursue that discovery. D.I. 395 at 1, 412 at 1. In denying those
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`requests, the Court rightly noted that the individual Amgen contends was an
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`inventor—Dr. Brian Leyland-Jones—was “in [Amgen’s] employ. [Amgen] could
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`have issued … a litany of subpoenas to depose everybody that he said he had
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`conversations with and worked on in connection with his role in the inventorship
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`but [Amgen] didn’t do it. So the application [for discovery] is untimely and
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`therefore, it’s denied.” See Ex. 1 (Oct. 16, 2019 Hearing Tr.) at 207:4-9. The
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`Court likewise rejected Amgen’s reliance on an email authored by one of the
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`named inventors—Dr. Sharon Baughman—which Amgen argued suggested Dr.
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`Leyland-Jones conceived of the invention. Compare D.I. 412 at 1; Ex. 1 at
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`204:18-205:2 (“[Genentech’s Counsel:] She didn’t say he was the inventor. . . THE
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`COURT: I agree with you.”) with D.I. 456 at 15. Nor did the Court credit
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`Amgen’s assertion that it could not have investigated its defenses until it learned of
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`Dr. Baughman’s email or took the deposition of one of Genentech’s experts, Dr.
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`Karen Gelmon. Compare D.I. 412 at 1-2 with D.I. 456 at 17, 19. The Court
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`1
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`therefore rejected all of Amgen’s excuses for why it did not assert its derivation
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`and inventorship defenses in a timely fashion. Amgen’s arguments on its proposed
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`inequitable conduct defense should be rejected for the same reasons.
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`Amgen makes two new arguments for why it should nevertheless be
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`permitted to assert these defenses now.
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`First, Amgen argues that it was permitted as a matter of right to add these
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`new defenses without leave of Court. In essence, Amgen is arguing that this Court
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`lacks the authority to enforce its own Scheduling Order or to strike Amgen’s new
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`defenses and counterclaims, even though those defenses are untimely and their
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`assertion would derail the case schedule and radically change the contours of this
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`case. That argument is unsupported by the federal rules, the relevant case law, and
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`common sense.
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`Second, Amgen argues that Genentech will not be prejudiced by the
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`untimely defenses because the trial has moved from December 2019 to April 2020.
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`As a threshold matter, the Court should reject Amgen’s effort to engage in self-
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`help, given that the rescheduled trial date was the result of Amgen’s refusal to
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`stipulate that Kanjinti will have been prescribed according to the infringing
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`regimen by December—something two of Amgen’s own experts have since
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`2
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`admitted.1 But, more fundamentally, the existing schedule is compressed and gives
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`the parties only a few short months to complete discovery related to Amgen’s July
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`launch and prepare for trial, not to allow Amgen to chase new defenses and force
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`Genentech to develop rebuttal evidence in response. Amgen’s new defenses would
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`require reopening fact and expert discovery on the merits, a gambit that the Court
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`has already rejected. At a minimum, Genentech would need to take depositions of
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`other participants in meetings to corroborate that Genentech scientists had already
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`come up with the extended dosing regimen prior to any involvement of Dr.
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`Leyland-Jones. And Amgen’s new inequitable conduct defense would require
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`depositions of third parties who were involved in the prosecution of the ʼ869 patent
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`and Amgen scientists who cited to the inventors’ publication.
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`This Court already has rejected Amgen’s effort to reopen discovery as
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`untimely. The Court’s analysis remains correct, and those defenses (and associated
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`counterclaims) should be stricken.
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`I.
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`ARGUMENT
`Amgen Was Required To Seek Leave To Add New Defenses
`Amgen’s primary argument is that Rule 15(a) immunizes Amgen from
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`judicial scrutiny because, in Amgen’s view, it was responding to Genentech’s
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`1 Ex. 1 at 218:24-219:6; Ex. 2 (Belgram Letter to Judge Connolly (Oct. 21, 2019))
`(electing to extend trial); Ex. 3 (Slamon Dep. Tr. (Oct. 23, 2019)) at 151:2-11; Ex.
`4 (Glaspy Dep. Tr. (Oct. 31, 2019)) at 39:16-22.
`3
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`Third Amended Complaint (“TAC”). That argument fails for two independent
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`reasons. First, Rule 15(a) does not prohibit this Court from enforcing its
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`Scheduling Order including the April 2019 deadline to amend the pleadings.
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`Second, even setting the Scheduling Order to one side, most courts follow the so-
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`called “moderate approach” to responsive pleadings under Rule 15(a), whereby
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`leave of Court is required to make changes in the amended response that are not
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`commensurate with the changes in the amended complaint.2 Amgen was thus not
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`entitled to amend its answer as a matter of right and instead must establish “good
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`cause” and also satisfy the Rule 15(a) standard for amended pleadings.
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`A. The Court’s Scheduling Order Required Amgen To Seek Leave
`To Include Its Defenses
`The Scheduling Order set an April 2019 deadline to amend the pleadings.
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`D.I. 44 at 11; Robinson v. Johnson, 313 F.3d 128, 137 (3d Cir. 2002) (“Affirmative
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`defenses must be raised as early as practicable, not only to avoid prejudice, but
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`2 Here, the Court granted Genentech leave to file its TAC because Amgen
`announced its intention to launch its biosimilar, which is a “new event that led to
`the amendment” under Rule 15(d). See Teva Pharm. USA, Inc. v. Forest Labs.,
`Inc., No. 13-cv-02002-GMS, 2016 WL 7325511, at *1 n.1 (D. Del. June 16, 2016);
`Fed. R. Civ. P. 15(d) (amendment to account for “transaction, occurrence, or event
`that happened after the date of the pleading to be supplemented”). Thus, the same
`analysis applies if the Court concludes Genentech’s TAC was filed pursuant to
`Rule 15(d) rather than Rule 15(a). See, e.g., Sirona Dental Sys., Inc. v. Dental
`Imaging Techs. Corp., No. CV 10-288-GMS, 2012 WL 3929949, at *3 (D. Del.
`Sept. 10, 2012) (“If the Answer should be characterized as a response to a
`supplemental pleading [pursuant to Rule 15(d)], it is therefore within this court’s
`discretion to permit or disallow DITC's unclean hands defense.”).
`4
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`also to promote judicial economy.”). This Court has already found that Amgen
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`should have developed its derivation and inventorship defenses months ago. Ex. 1
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`at 207:4-19. Having missed the relevant deadline in the Scheduling Order, Amgen
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`must seek leave of Court—and establish “good cause”—to include those defenses
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`now. Cf. 3 James Wm. Moore et al., Moore’s Federal Practice § 15.17[6] (3d ed.
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`2012) (“Service of an amended pleading does not automatically re-open the time
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`for asserting matters that should have been asserted in response to the original
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`pleading.”).
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`Amgen’s argument that this Court cannot enforce its own Scheduling Order
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`has already been rejected in this district. In Teva, the parties disputed whether “an
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`answer in response to an amended pleading requires leave from the court if it
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`addresses issues outside of the scope of the amended complaint.” Teva, 2016 WL
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`7325511, at *1 n.1. The court viewed the amended response as an “amended
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`pleading” under Rule 15(a) and found that it violated the court’s scheduling order
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`because the defendants “did not obtain leave from the court prior to filing its
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`answer and thereby failed to satisfy the consent requirement.” Id. In rejecting the
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`defendants’ argument that they “were permitted to amend . . . as a matter of
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`course” notwithstanding the scheduling order, id., the Teva court echoed the
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`reasoning of other courts that “[d]isregard of the [scheduling] order would
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`undermine the court’s ability to control its docket, disrupt the agreed-upon course
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`5
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`of the litigation, and reward the indolent and the cavalier.” Johnson v. Mammoth
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`Recreations, Inc., 975 F.2d 604, 610 (9th Cir. 1992).
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`Accordingly, Amgen needed to seek the Court’s permission—and establish
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`“good cause”—to include a defense that it knew or should have known about at the
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`time of the April 2019 deadline.
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`B.
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`The Majority View Is To Require Amgen To Seek Leave To Add
`Defenses That Exceed The Breadth Of Genentech’s Amendments
`Even setting aside the Scheduling Order and the April 2019 deadline for
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`amended pleadings, Rule 15(a) itself independently required Amgen to seek leave
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`of Court to add new defenses and counterclaims. Amgen is simply wrong on the
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`law when it suggests that it “was not required to seek leave to add these affirmative
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`defenses and counterclaims” under Rule 15(a). D.I. 456 at 2.
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`Rule 15(a) permits a party to file “any required response to an amended
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`pleading . . . .” Most courts do not interpret Rule 15(a) as authorizing new
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`allegations that do not qualify as “required response[s]” to the amended complaint.
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`Instead, they interpret Rule 15(a) as permitting amendments without leave of Court
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`only when “the amended complaint changes the theory or scope of the case, and
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`then, the breadth of the changes in the amended response must reflect the breadth
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`of the changes in the amended complaint.” Slim CD, Inc. v. Heartland Payment
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`Sys., Inc., 2007 WL 2459349, at *6 (D.N.J. Aug. 24, 2007). If the changes in an
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`amended response exceed the breadth of the changes in an amended complaint, the
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`party proposing the amended response must seek leave of court pursuant to the
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`Rule 16(b) and/or 15(a) standards before filing. See id.
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`This interpretation of Rule 15(a), which courts characterize as a “moderate
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`approach” to the scope of permitted amendments, is the “majority” view and is
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`“favored by commentators as well.” Patel v. Pandya, 2016 WL 3129615, at *2
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`(D.N.J. June 2, 2016) (explaining “the moderate approach”). The Federal Circuit
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`has approved of the moderate approach to reject efforts “to expand the breadth of
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`[] affirmative defenses or counterclaims.” Unigene Labs., Inc. v. Apotex, Inc., 655
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`F.3d 1352, 1359-60 (Fed. Cir. 2011) (applying Second Circuit law). And the two
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`most recent decisions in this District have also endorsed the “moderate approach,”
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`recognized that it is supported “by the weight of authority, from both judges and
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`commentators,” and also described it as the “most sensible view” given that a
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`contrary interpretation would “throw the door open to entirely new claims and
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`defenses each time a ministerial amendment was made to a pleading.” Teva, 2016
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`WL 7325511, at *1 n.1; see also Sirona, 2012 WL 3929949, at *2 n.3.
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`Amgen suggests that the 2007 amendment to Rule 15(a) forecloses this
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`moderate approach, but courts, including courts in this district, have expressly
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`rejected that view. See, e.g., Teva, 2016 WL 7325511, at *1 n.1; Patel, 2016 WL
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`3129615, at *2 (noting that “the substitution of Rule 15(a) does not affect the
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`viability of…the moderate approach.”); see also Coppola v. Smith, 2015 WL
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`2127965, at *3 (E.D. Cal. May 6, 2015); Virginia Innovation Scis., Inc. v. Samsung
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`Elecs. Co., 11 F. Supp. 3d 622, 631 (E.D. Va. 2014). Rule 15(a) only permits
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`“required responses” without leave. As one district court explained, the purpose of
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`the amendment “to Rule 15 appears to have been only to make ‘changes in the time
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`allowed to make one amendment as a matter of course,’ [such that] the ‘plead in
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`response’ language” that was stricken from the rule “is arguably still pertinent to
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`the allowable scope of a response to an amended pleading.” Virginia Innovation
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`Scis., 11 F. Supp. 3d at 632.
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`Amgen also overstates its argument by suggesting that “[t]he weight of the
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`authority in this District” cuts against the moderate approach. Genentech has been
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`able to find only five cases in Delaware squarely addressing this issue. The only
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`two Delaware cases decided in the last decade, Teva, 2016 WL 7325511, and
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`Sirona, 2012 WL 3929949, both favored the moderate approach. The three cases
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`that adopted a more “permissive approach” were all decided more than twenty
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`years ago, and none of them appeared to address the impact of a missed deadline in
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`a scheduling order, much less the situation where—as in this case—the amended
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`response includes defenses that could have been pursued prior to that deadline.
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`Here, the Court allowed Genentech to file its TAC for the limited purpose of
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`addressing Amgen’s July 2019 launch of a Herceptin biosimilar product. D.I. 346.
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`Amgen therefore was required to seek leave for its new defenses, because those
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`defenses have nothing to do with Genentech’s amendments and inject wholly new
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`factual and legal theories into the case months after the deadline to amend
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`pleadings has passed.
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`II. The Court Should Deny Amgen Leave To Inject An Improper
`Inventorship Or Derivation Defense Into This Case At This Late Stage
`Because Amgen’s new defenses and counterclaims are not responsive to
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`Genentech’s amendments, under Rule 16(b) they should be stricken unless Amgen
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`can show “good cause” for its delay in asserting them. As the Court has already
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`determined in response to Amgen’s requests for untimely discovery related to this
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`claim, no such good cause exits. Ex. 1 at 207:4-208:3.
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`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4)
`Amgen’s opposition rehashes its discovery grievances. D.I. 456 at 12-16.
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`In doing so, Amgen mischaracterizes interactions between the parties in an effort
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`to blame Genentech for Amgen’s own failure to diligently pursue these claims.3
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`Amgen’s contention that Genentech “obstructed Amgen’s [discovery] efforts at
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`every turn,” is belied by the sheer volume of information that Genentech provided
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`in response to Amgen’s requests relating to the inventorship of the Dosing Patents
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`3 For example, Amgen asserts that after providing Amgen with the TAC on August
`2, 2019, “Genentech waited an additional two weeks to follow up,” and then
`Amgen gave its consent “six business days later, on August 26, 2019.” D.I. 456 at
`n.3. In fact, Amgen failed to respond at all from August 2 through August 26.
`Amgen also contends that it diligently pursued discovery from Roche. D.I. 456 at
`23-24. The Court rejected this argument when it found Amgen’s request for Roche
`documents untimely. Ex. 1 at 207:21-208:3.
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`and Dr. Leyland-Jones’s involvement in the related clinical trial. See D.I. 442 at 5-
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`7.
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`But the Court need not revisit these discovery squabbles because Amgen’s
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`justification for its untimely amendment boils down to (1) the July 23rd production
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`of Dr. Baughman’s email; and (2) the expert report and testimony of Genentech’s
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`expert, Dr. Gelmon—both of which this Court previously considered and rejected
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`as a basis for proceeding with Dr. Leyland-Jones’s untimely deposition.4 The
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`Court reviewed the full, unredacted Baughman email and agreed that the redacted
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`portions were properly subject to attorney-client privilege, Ex. 1 at 205:6-7, and
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`rejected the unprivileged portions as a basis for re-opening liability fact discovery.
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`The Court also evaluated Dr. Gelmon’s testimony and rejected it as a justification
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`for conducting untimely discovery. Ex. 1 at 206:19-207:9.
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`Nothing has changed. It remains true that Amgen knew of (indeed,
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`employed) Dr. Leyland-Jones and “could have issued … a litany of subpoenas to
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`depose everybody that he said he had conversations with and worked on in
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`4 As discussed in detail in Genentech’s Opening Brief, neither of these items add
`anything new to the ample evidence Amgen had about Dr. Leyland-Jones’s
`participation before the close of fact discovery. See D.I. 442 at 7-13.
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`connection with his role in the inventorship but [Amgen] didn’t do it.” See id. at
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`207:4-8.5
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`Amgen argues that the Court should reach a different result because Amgen
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`could not have pleaded its derivation defense until it could corroborate Dr.
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`Leyland-Jones’s role in the design of the dosing regimen. D.I. 456 at 20-21. That
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`argument fundamentally misses the point. To the extent Amgen believed
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`“corroboration” was necessary, it was required to pursue that “corroboration” long
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`before the deadline for amended pleadings. See Ex. 1 at 207:4-19 (this Court
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`denying Amgen’s discovery requests as untimely).
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`In any event, Amgen does not cite, and Genentech is not aware of, any case
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`holding that a party pleading a derivation or incorrect inventorship defense must
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`plead the specific evidence it would ultimately proffer in support of that defense,
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`including the existence of corroborating evidence, as opposed to providing the
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`short and plain statement of facts—that Dr. Leyland-Jones was purportedly the
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`correct inventor—that Rule 8 requires at the pleading stage. Cf. In re Frescati
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`Shipping Co., 886 F.3d 291, 313 (3d Cir. 2018) (“In general, ‘[a]n affirmative
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`5 Amgen suggests that Genentech obstructed its efforts to take the Leyland-Jones
`deposition. DI 456 at 14. In fact, Genentech noted its understanding, in view of the
`fact that Samsung, not Amgen, had subpoenaed Dr. Leyland-Jones, “that this
`deposition will not proceed. If you have a different understanding, please let us
`know immediately.” DI 456 at Ex. 16. Amgen responded, “your understanding is
`correct.” Id.
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`defense ... ‘need not be articulated with any rigorous degree of specificity, and is
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`sufficiently raised for purposes of [Fed. R. Civ. P. 8] by its bare assertion.’’”)
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`(alterations in original), cert. granted sub nom. CITGO Asphalt Ref. Co. v. Frescati
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`Shipping Co., 139 S. Ct. 1599 (2019).
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`And even if Amgen were prohibited from pleading the defense until it had
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`uncovered corroborating evidence (as opposed to pleading the defense and
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`developing such evidence in discovery), at the time Amgen amended its Answer, it
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`did not have the Gelmon testimony (and it did not cite to the Gelmon report) so the
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`only piece of allegedly “corroborating” evidence to which Amgen could be
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`referring is the Baughman email. The Court already found that the Baughman
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`email does not justify Amgen’s untimely discovery requests and rejected Amgen’s
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`efforts to change the contours of the case based on the production of this email.
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`Ex. 1 at 204:18-205:2.
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`B. Amgen Also Fails To Meet The Rule 15(a) Standard
`1.
`Amgen Unduly Delayed.
`As explained above, this Court has already concluded that the Baughman
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`email and the Gelmon testimony cannot excuse Amgen’s untimely and unduly
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`delayed pursuit of evidence supporting its derivation defense. Ex. 1 at 207:4-19.
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`Amgen also delayed in filing its amendment after it received the Baughman email
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`that it claims it needed to plead that defense. D.I. 456 at 13-18. Thus, even if, as
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`Amgen contends, it could not plead its derivation defense until it received the
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 17 of 47 PageID #: 33382
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`Baughman email on July 23rd, it still waited an additional two months, which the
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`Federal Circuit has held is not diligent. Cobra Int'l, Inc. v. BCNY Int'l, Inc, 702 F.
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`App'x 994, 995 (Fed. Cir. 2017); see also iCeutica Pty Ltd, 2019 WL 4604029, at
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`n.3 (D. Del. Sept. 23, 2019). Amgen makes no attempt to distinguish two of the
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`cases Genentech cited finding similar delays reflected a lack of diligence. D.I. 456
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`at 25-26 (failing to address Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, No.
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`CV 15-1168-LPS, 2017 WL 3888228, at *4 (D. Del. Sept. 6, 2017) (finding no due
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`diligence where party received documents after deadline for amended pleadings,
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`but waited four months); iCeutica, 2019 WL 4604029, at n.3 (noting with
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`disapproval that “despite making its intent to amend known at the Markman
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`hearing, [d]efendant still waited an additional eight (8) weeks”).
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`2.
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`Amgen’s Amendment Would Burden The Court And
`Unfairly Prejudice Genentech.
`The trial was moved from December to April in order to allow Genentech to
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`pursue additional discovery that it needs to respond to Amgen’s July launch, after
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`Amgen refused to stipulate to or provide discovery relating to uses of Kanjinti
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`pursuant to the claimed dosing regimen. Ex. 1 at 218:24-219:6. The April trial
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`will also encompass damages. Ex. 5 (Sept. 25, 2019 Teleconference Tr.) at 9:1-4;
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`Ex. 1 at 218:24-219:6. In the few months left until trial, the parties must undertake
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`additional damages-related document collections and productions, expert reports,
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`and fact and expert depositions. Far from “eliminating any purported time
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 18 of 47 PageID #: 33383
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`constraints” (D.I. 456 at 26-27) as Amgen claims, the parties are facing a
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`compressed time schedule to conduct this discovery and prepare for trial in a few
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`short months. The addition of Amgen’s untimely defenses would only add to this
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`burden and force Genentech to further divert resources away from trial preparation.
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`Amgen tries to minimize this prejudice by arguing that the information
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`relating to inventorship is within Genentech’s control. Not so. Genentech would
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`need to identify and interview potential witnesses with knowledge relevant to Dr.
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`Leyland-Jones’s purported involvement in the Dosing Patents, including third
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`parties involved in the clinical trial and other meetings. Genentech would then
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`have to collect and review any additional documents that those witnesses identify
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`as potentially relevant. Genentech would then need to conduct depositions of these
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`individuals. And Genentech would have to supplement its expert reports to
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`respond to any newly discovered evidence. Even for the information within
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`Genentech’s control, it would have to go through the same process of witness
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`interviews, document collections, depositions, and expert report supplementation.
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`Those tasks are particularly daunting given that the relevant events occurred 20
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`years ago. And all of that time would further take away from Genentech’s ability
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`to prepare for trial in the short amount of time it has remaining.
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 19 of 47 PageID #: 33384
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`3.
`Amgen’s Proposed Amendment Is Futile
`Amgen’s Opposition Brief cites only to Dr. Baughman’s email and Dr.
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`Gelmon’s testimony to support its argument that the allegations in its Amended
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`Answer are sufficient. D.I. 456 at 29-30. Both of these items were before the
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`Court in connection with Amgen’s untimely discovery request, and the Court
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`rejected them as a basis for allowing Amgen to pursue its new defenses. As
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`explained in detail in Genentech’s Opening Brief, neither of these items suggest
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`that Dr. Leyland-Jones should be considered an inventor. D.I. 442 at 15-17; see
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`Ex. 1 at 204:18-205:2 ([Genentech’s Counsel]: She didn’t say he was the inventor.
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`Her testimony bears that out…. The Court: I agree with you). And the Court’s
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`denial of Amgen’s four untimely requests means that Amgen has essentially no
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`evidence to support its new defenses. Ex. 1 at 207:10-208:3; see D.I. 395 (Amgen
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`describing requests as “highly relevant” to derivation defense). Without any
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`factual content to support the elements of an improper inventorship or derivation
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`claim, Amgen’s amendment would be futile.
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`III. The Court Should Deny Amgen Leave To Inject An Improper
`Inequitable Conduct Defense Into This Case At This Late Stage
`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4)
`Amgen admits that, by January 2019, it had received three internal
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`presentations and a journal article that it alleges suggest “that Dr. Trexler-Schmidt
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`may have known” that data was omitted from the patent. D.I. 456 at 32. Yet
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 20 of 47 PageID #: 33385
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`Amgen waited months, until after the deadline to amend the pleadings, without
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`taking a single deposition related to the issue. And two of the depositions it now
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`claims are relevant were only taken in a related case after the close of fact
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`discovery in this case. Amgen’s choice to delay these depositions cannot justify its
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`untimely amendments. See, e.g., Compagnie Des Grands Hôtels d'Afrique S.A. v.
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`Starwood Capital Group Global I LLC, No. CV 18-654-RGA, 2019 WL 4740083,
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`at *3 (D. Del. Sept. 27, 2019) (cannot rely on “time pressures of [] own making” to
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`justify extending deadline); Magsil Corp. v. Seagate Tech., No. CV 08-940-HB,
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`2010 WL 2710472, at *2 (D. Del. July 7, 2010) (“decision to wait until little more
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`than one month before the close of fact discovery to depose such a major witness is
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`not an adequate justification for subjecting plaintiffs to [] undue delay and
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`prejudice”).
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`Regardless, as discussed in Genentech’s Opening Brief, the testimony adds
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`nothing to the documentary evidence that Amgen had months before the deadline
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`to amend the pleadings. D.I. 442 at 19-20. Amgen does not directly address this
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`point. It merely repeats the factual allegations contained in its Amended Answer
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`and asserts without explanation that it was unable to satisfy the pleading
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`requirements until after it took these depositions. D.I. 456 at 30-34, 37-38. That
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`Case 1:18-cv-00924-CFC-SRF Document 466 Filed 12/02/19 Page 21 of 47 PageID #: 33386
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`assertion is untrue,6 but even if Amgen could somehow use these depositions to
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`justify its delay, it still waited over two months from the time it had the last
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`deposition transcript to amend its Answer. Such a delay is not dilig