Case 1:18-cv-00924-CFC-SRF Document 445 Filed 10/24/19 Page 1 of 38 PageID #:
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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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`Defendant.
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`Plaintiff,
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`v.
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`C.A. No. 18-924-CFC
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`CORRECTED VERSION
`FILED: October 23, 2019
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`GENENTECH’S OPENING 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: October 24, 2019
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`TABLE OF CONTENTS
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`The Court Should Reject Amgen’s Effort To Inject An Improper
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`
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`II.
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`
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`NATURE AND STAGE OF PROCEEDINGS ....................................................... ii
`LEGAL STANDARD ............................................................................................ 3
`ARGUMENT......................................................................................................... 5
`I.
`Inventorship Or Derivation Defense Into This Case At This Late Stage. ...... 5
`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4). .............. 5
`B.
`Amgen Also Fails To Meet The Rule 15(a) Standard. .......................13
`1.
`Amgen Unduly Delayed..........................................................14
`2.
`Prejudice Genentech. ..............................................................14
`3.
`Amgen’s Amendment Is Futile. ...............................................15
`Inequitable Conduct Defense Into This Case Now. .....................................17
`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4). .............18
`Amgen Also Fails To Meet The Rule 15(a) Standard. .......................21
`B.
`Amgen Unduly Delayed..........................................................21
`1.
`2.
`Prejudice Genentech. ..............................................................22
`3.
`Amgen’s Proposed Amendment Is Futile. ...............................23
`CONCLUSION ....................................................................................................27
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`Amgen’s Amendment Would Burden The Court And Unfairly
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`The Court Should Also Reject Amgen’s Separate Effort To Inject An
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`Amgen’s Amendment Would Burden The Court And Unfairly
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`TABLE OF AUTHORITIES
`
`
`Federal Cases
`
`Page(s)
`
`Akzo N.V. v. ITC,
`808 F.2d 1471 (Fed. Cir. 1986) ........................................................................ 24
`
`Am. Axle & Mfg., Inc. v. Neapco Holdings LLC,
`No. CV 15-1168-LPS, 2017 WL 3888228 (D. Del. Sept. 6, 2017) ............. 11, 21
`
`Applied Mats., Inc. v. Adv. Semiconductor Mats. Am. Inc.,
`C.A. No. 92-20643-RMW, 1994 WL 270714 (N.D. Cal. Apr. 19,
`1994) ............................................................................................................... 27
`
`Asahi Glass Co., Ltd. v. Guardian Indus. Corp.,
`276 F.R.D. 417 (D. Del. 2011) ................................................................... 14, 21
`
`Bos. Sci. Corp. v. Edwards Lifesciences Corp.,
`No. CV 16-275-JFB-SRF, 2018 WL 5043754 (D. Del. Sept. 19,
`2018) ......................................................................................................... 13, 21
`
`Carrier Corp. v. Goodman Glob., Inc.,
`49 F. Supp. 3d 430 ........................................................................................... 18
`
`Compagnie Des Grands Hotels D’Afrique S.A. v. Starwood Capital
`Group Global I LLC, No. CV 18-654-RGA, 2019 WL 4740083 (D.
`Del. Sept. 27, 2019) ..................................................................................... 7, 19
`
`Cumberland Pharm. Inc. v. Mylan Institutional LLC,
`846 F.3d 1213 (Fed. Cir. 2017) ........................................................................ 15
`
`Cureton v. Nat’l Collegiate Athletic Ass’n,
`252 F.3d 267 (3d Cir. 2001) ............................................................................... 4
`
`Digital Control, Inc. v. Charles Mach. Works,
`437 F.3d 1309 (Fed. Cir. 2006) ........................................................................ 23
`
`E.E.O.C. v. Morgan Stanley & Co., Inc.,
`211 F.R.D. 225 (S.D.N.Y.2002) ......................................................................... 3
`
`
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`
`E. Minerals & Chems. Co. v. Mahan,
`225 F.3d 330 (3d Cir. 2000) ................................................................... 2, 13, 21
`
`Eaton Corp. v. Rockwell Intern. Corp.,
`323 F.3d 1344-45 (Fed. Cir. 2003) ................................................................... 15
`
`Elite Entm’t, Inc. v. Khela Bros. Entm’t,
`227 F.R.D. 444 (E.D.Va.2005) .......................................................................... 3
`
`Foman v. Davis,
`371 U.S. 178 (1962) ........................................................................................... 4
`
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) ........................................................................ 15
`
`iCeutica Pty Ltd v. Novitium Pharma LLC,
`No. CV 18-599-CFC, 2019 WL 4604029 (D. Del. Sept. 23, 2019) ............ 11, 21
`
`Innogenetics, N.V. v. Abbott Laboratories,
`512 F.3d 1363 (Fed. Cir. 2008) ........................................................................ 24
`
`Jo A. Yochum v. FJW Inv., Inc.,
`715 F. App’x 174 (3d Cir. 2017) ........................................................................ 4
`
`Koken v. GPC Int’l, Inc.,
`443 F. Supp. 2d 631 (D. Del. 2006) ................................................................... 4
`
`Monec Holding AG v. Motorola Mobility, Inc.,
`No. CV 11-798-LPS-SRF, 2013 WL 12218319 (D. Del. Nov. 5,
`2013) ................................................................................................................. 4
`
`Pfizer Inc. v. Teva Pharm. U.S.A., Inc.,
`882 F. Supp. 2d 643 (D. Del. 2012), aff’d sub nom. Pfizer Inc. v.
`Teva Pharm. USA, Inc., 555 F. App’x 961 (Fed. Cir. 2014) ............................. 15
`
`Pfizer Inc. v. Sandoz, Inc.,
`No. 12-654-GMS, 2013 WL 5934635 (D. Del. Nov. 4, 2013) .................... 14, 21
`
`Rothman v. Target Corp.,
`556 F.3d 1310 (Fed. Cir. 2009) ........................................................................ 24
`
`Scott v. Vantage Corp.,
`336 F. Supp. 3d 366 ................................................................................... 13, 21
`
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`Sepracor Inc. v. Teva Pharm. USA, Inc.,
`No. 09–cv–01302 (DMC)(MF), 2010 WL 2326262 (D.N.J. June 7,
`2010) ......................................................................................................... 24, 25
`
`Shane v. Fauver,
`213 F.3d 113 (3d Cir. 2000) ............................................................................... 5
`
`Sirona Dental Sys. Inc. v. Dental Imaging Techs. Corp.,
`No. 10-288-GMS, 2012 WL 3929949 (D. Del. Sept. 10, 2012) ..................... 3, 4
`
`Solomon v. Kimberly-Clark Corp.,
`216 F.3d 1372 (Fed. Cir. 2000) ........................................................................ 15
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) .................................................................. 23, 24
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007) ........................................................................ 24
`
`
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`NATURE AND STAGE OF PROCEEDINGS
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`The deadline to amend the pleadings in this case was April 5, 2019. Fact
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`discovery closed on June 10, 2019. D.I. 44, 196. Nearly six months after the
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`deadline for amended pleadings and three months after the close of fact discovery,
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`on September 24, 2019, Amgen added two new affirmative defenses under the
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`guise of its Answer to Genentech’s Third Amended Complaint, Affirmative
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`Defenses, and Counterclaims. The new and untimely defenses that Amgen is now
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`trying to chase are: (1) “improper inventorship/derivation of the ’196, ’379, and
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`’811 patents”; and (2) “unclean hands/inequitable conduct related to the ʼ869
`(showing changes made to Complaint); D.I. 346 (stipulation detailing nature of
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`patent.” D.I. 366 (Answer) at 23, 55. Neither of these defenses are related in any
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`way to the amendments Genentech made to its complaint. D.I. 344 Ex. B
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`changes). Nor had the parties agreed to such freewheeling amendments when they
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`stipulated to allow Genentech to file its Third Amended Complaint in order to
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`address Amgen’s July launch of a Herceptin biosimilar product.1 See D.I. 346. In
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`1 Genentech requested Amgen’s consent to its motion for leave to file an amended
`complaint on July 23, 2019. Ex. A at 3 (Danford email to Counsel (July 23,
`2019)). Following a meet and confer on the issue, Genentech sent Amgen a draft
`of the complaint on August 2, 2019. Id. at 2 (Danford email to Knauss (Aug. 2,
`2019)). Amgen did not respond, and Genentech followed up on August 16, 2019.
`Id. (Danford email to Knauss (Aug. 16, 2019)). The parties had an additional call
`on the issue, and Genentech again followed up seeking Amgen’s consent on August
`26, 2019. Id. at 1 (S. Lin email to Counsel (Aug. 26, 2019)). Finally, on August
`26, 2019, more than a month after Genentech’s first request, Amgen responded that
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`fact, during the month-long negotiation of this stipulation, which concluded weeks
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`after Amgen had received all of the evidence included in its Answer in support of
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`these new defenses, Amgen never once mentioned its intent to add these
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`affirmative defenses.
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`The Court should reject Amgen’s eleventh-hour effort to radically change
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`the contours of this case, less than nine weeks before trial. To justify such a last-
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`minute amendment Amgen must show “good cause” for the amendment and for
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`16(b)(4); E. Minerals & Chems. Co. v. Mahan, 225 F.3d 330, 340 (3d Cir. 2000).
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`why it failed to amend within the deadline set by the Court. Fed. R. Civ. P.
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`Amgen cannot show any cause, much less good cause, for its new defenses.
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`Amgen has known of the facts underlying its untimely defenses for months, if not
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`years. Allowing Amgen to chase its untimely “derivation” and “inequitable
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`conduct” defenses now would be unfairly prejudicial to Genentech. Genentech has
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`not been given any meaningful opportunity to develop its own rebuttal fact or
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`expert evidence, and it cannot reasonably do so in the weeks remaining before trial,
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`when the parties are deposing experts, preparing pretrial filings, and getting ready
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`for the trial.
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`it would not oppose Genentech’s filing of the third amended complaint. Id.
`(Krumplitsch email to S. Lin (Aug. 26, 2019)).
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`LEGAL STANDARD
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`Federal Rule of Civil Procedure 12(f) authorizes the Court to “strike from a
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`pleading an insufficient defense or any redundant, immaterial, impertinent, or
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`scandalous matter.” Although Amgen was required to file an Answer, at no point
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`a mere two months before trial. D.I. 346. Because Amgen’s Eleventh and Twelfth
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`did the parties discuss or agree that Amgen could insert new issues into this action
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`Affirmative defenses ‒ as well as its invalidity and unenforceability counterclaims
`to the extent they incorporate by reference these new defenses ‒ are unrelated to
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`the breadth of any amendment made by Genentech to its Third Amended
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`Complaint, their addition is subject to the “good cause” standard of Rule 16(b)(4)
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`and requires leave of Court. See, e.g., Elite Entm’t, Inc. v. Khela Bros. Entm’t, 227
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`F.R.D. 444, 446 & n.3, 4 (E.D.Va.2005) (noting that this approach is “predominant
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`in case law” and collecting cases); E.E.O.C. v. Morgan Stanley & Co., Inc., 211
`F.R.D. 225, 227 (S.D.N.Y.2002) (collecting cases); see also Sirona Dental Sys. Inc.
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`v. Dental Imaging Techs. Corp., No. 10-288-GMS, 2012 WL 3929949, at *2 n.3
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`(D. Del. Sept. 10, 2012).
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`Under Rule 16(b)(4), the Court should allow an untimely amendment only
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`when the party seeking it has shown “good cause.” Fed. R. Civ. Pro. 16(b)(4).
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`Good cause exists when the schedule cannot reasonably be met despite diligence of
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`the party seeking the extension. See, e.g., Sirona Dental Sys., 2012 WL 3929949 at
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`*4.
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`Even if good cause is established, a court may deny a party’s amendment if,
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`for example, the party opposing amendment shows “undue delay, bad faith or
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`dilatory motive on the part of the movant, repeated failure to cure deficiencies by
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`amendments previously allowed, undue prejudice to the opposing party by virtue
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`U.S. 178, 182 (1962); see also Jo A. Yochum v. FJW Inv., Inc., 715 F. App’x 174,
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`of allowance of the amendment, [or] futility of amendment.” Foman v. Davis, 371
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`177 (3d Cir. 2017). Delay is “undue” when it puts an unwarranted burden on the
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`court or prejudices the other party. Cureton v. Nat’l Collegiate Athletic Ass’n, 252
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`F.3d 267, 273 (3d Cir. 2001). “Undue prejudice occurs ‘when allowing the
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`amended pleading would (1) require the nonmoving party to expend significant
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`additional resources to conduct discovery and prepare for trial, (2) significantly
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`delay the resolution of the dispute, or (3) prevent [a party] from bringing a timely
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`action in another jurisdiction.’” Monec Holding AG v. Motorola Mobility, Inc., No.
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`CV 11-798-LPS-SRF, 2013 WL 12218319, at *2 (D. Del. Nov. 5, 2013) (quoting
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`Long v. Wilson, 393 F.3d 390, 400 (3d Cir. 2004)). “An amendment is futile if it is
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`frivolous, fails to state a claim upon which relief can be granted, or ‘advances a
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`claim or defense that is legally insufficient on its face.” Koken v. GPC Int’l, Inc.,
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`443 F. Supp. 2d 631, 634 (D. Del. 2006). The standard for analyzing futility of an
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`amendment under Rule 15(a) is the same standard of legal sufficiency applicable
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`under Rule 12(b)(6). Shane v. Fauver, 213 F.3d 113, 115 (3d Cir. 2000).
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`ARGUMENT
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`I. The Court Should Reject Amgen’s Effort To Inject An Improper
`Inventorship Or Derivation Defense Into This Case At This Late Stage.
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`Amgen’s Answer introduced, for the first time, an affirmative defense
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`alleging that “the Dosing Patents are invalid for failing to correctly name the
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`inventors and because the invention recited in the asserted claims was derived from
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`Dr. Brian Leyland-Jones.” D.I. 366 at ¶ 97. Amgen simply cannot show the
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`requisite good cause for amending the pleadings when the trial is less than two
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`months away.
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`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4).
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`Amgen had actual knowledge of Dr. Leyland-Jones’s involvement in the
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`early testing of the dosing regimen well before the deadline to amend the
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`pleadings. Amgen
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`. D.I. 397, Ex. 1 (Knauss Letter to Danford (May 3, 2019)). And,
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`according to Amgen,
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` Id. Moreover, as discussed
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` Genentech also
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`in more detail infra, Dr. Leyland-Jones was
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`produced numerous documents relevant to Dr. Leyland-Jones’s involvement. See,
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`e.g., D.I. 397, Ex. 3 (); Ex. D (
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`). Genentech even
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`included Dr. Leyland-Jones’s name as a search term for its production of
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`electronically stored information. See D.I. 397, Ex. 2 (Genentech’s Disclosure
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`Pursuant to Paragraph 6(b)(ii) of the ESI Order of Plaintiffs’ Non-Inventor
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`Custodians and Non-Custodial Data Sources, November 27, 2018).
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`Amgen certainly should have learned about Dr. Leyland-Jones’s
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`involvement in the genesis of the Dosing Patents (if any)
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`. At a minimum, one would have expected Amgen
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`. To the extent Amgen failed
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`and to follow up on the information it received in discovery, Amgen cannot use its
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`own lack of diligence to support a showing of good cause. Amgen then allowed
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`the deadline to amend the pleadings to pass without comment, without seeking to
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`schedule depositions with the inventors of the Dosing Patents. And Amgen chose
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`to wait 18 days after the close of fact discovery to notice its intent to attend the
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`deposition of Dr. Leyland-Jones that was then scheduled in the related Samsung
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`Bioepis case (18-cv-1363). D.I. 267. And then, when the Samsung Bioepis case
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`settled, Amgen chose not to proceed with the deposition. D.I. 397, Ex. 7 (Knauss
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`email to Passamaneck (July 1, 2019)). Amgen cannot possibly show good cause in
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`view of its lack of diligence in pursuing this discovery. See, e.g., Compagnie Des
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`Grands Hotels D’Afrique S.A. v. Starwood Capital Group Global I LLC, No. CV
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`18-654-RGA, 2019 WL 4740083, at *3 (D. Del. Sept. 27, 2019) (a party cannot
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`rely on “time pressures of its own making” to justify extending the deadline).
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`None of the purported evidence Amgen cites to support its allegations adds
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`anything new to the information Amgen knew or should have known at least by the
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`close of fact discovery, over three months before it filed its Answer. See D.I. 366
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`at ¶¶ 116-118, 136-138, 157-159.
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`First, Amgen cites to several presentations and articles authored by Dr.
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`Leyland-Jones. D.I. 366 at ¶¶ 116, 118, 136, 138, 157, 159. Amgen cited all but
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` Two of the items that
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`were not
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` The third article
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`Second, Amgen cites to documents produced by Dr. Leyland-Jones on
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`August 2, 2019 to support its allegation that Dr. Leyland-Jones was a “lead
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`investigator on the clinical trial to evaluate Herceptin dosing at the precise doses
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`recited by the asserted claims.” D.I. 366 at ¶¶ 117, 137, 158. That was hardly
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`news and surely must have come up
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` For example, Dr. Leyland-Jones was
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` Moreover, in May and early June, three Genentech witnesses
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`, and Dr. Robert Mass
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`testified to
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`397 Ex. 4 (Mass. Dep. Tr. 359:2-21 (May 30, 2019)); D.I. 397, Ex. 5 (Baughman
`Dep. Tr. at 69:2-14; 71:2-25 (May 9, 2019)); D.I. 397, Ex. 6 (Shak Dep. Tr. at
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` D.I.
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`158:17-159:17 (May 11, 2019)). Accordingly, the documents produced by Dr.
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`Leyland-Jones add nothing new to this evidence.
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`Third, Amgen cites to an email that Dr. Baughman, one of the inventors of
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`the Dosing Patents, wrote to Genentech’s outside counsel. In the email, Dr.
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`Baughman states
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` D.I. 397, Ex. 8 (GNE-BAUGHMAN_000001468-70).
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`This statement also adds nothing new to the case.
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`Dr. Baughman had already testified
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`D.I. 397, Ex. 4 at 359:2-21; D.I. 397, Ex. 5
`at 69:2-14; 71:2-25; D.I. 397, Ex. 6 at 158:17-159:17. For example, Dr.
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`Baughman testified
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` and therefore cannot serve as good cause to
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`justify its untimely amendment.
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`But even if somehow the production of a single paragraph in an email could
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`serve as an excuse for Amgen’s delay (which it cannot), Amgen still waited two
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`months after the receipt of this email to file an amended answer. Courts in this
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`district have found that this kind of delay is not diligent. See, e.g., Am. Axle &
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`Mfg., Inc. v. Neapco Holdings LLC, No. CV 15-1168-LPS, 2017 WL 3888228, at
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`*4 (D. Del. Sept. 6, 2017) (holding no due diligence where party received
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`when it received the documents and it moved to amend); iCeutica Pty Ltd v.
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`documents after deadline for amended pleadings, but waited four months between
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`Novitium Pharma LLC, No. CV 18-599-CFC, 2019 WL 4604029, at n.6 (D. Del.
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`Sept. 23, 2019) (declining to decide whether defendant acted diligently after
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`purportedly discovering plaintiffs claim construction at the Markman hearing,
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`which resulted in new indefiniteness defense, but noting with disapproval that
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`“despite making its intent to amend known at the Markman hearing, [d]efendant
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`still waited an additional eight (8) weeks to file the instant motion”).
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`In Amgen’s opposition to Genentech’s motion for a protective order, Amgen
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`cited one additional piece of information that, according to Amgen, supports its
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`derivation theory. D.I. 412 at 1. Changing tactics yet again, Amgen now appears
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`to be suggesting that it was not just Dr. Leyland-Jones who invented the Dosing
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`Patents but an entire “group of doctors including Dr. Leyland-Jones and two Roche
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`employees.” Id. at 1. To support the most recent incarnation of Amgen’s
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`derivation narrative, Amgen cites the deposition testimony of Dr. Karen Gelmon
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`(Genentech’s expert in this case). But Dr. Gelmon did not testify that
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` Ex. G (Gelmon
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`Dep. Tr. at 60:9-13, 104:25-105:22 (Oct. 7, 2019)). Dr. Gelmon did not
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`.2 Thus, Dr. Gelmon’s testimony regarding
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`Moreover, Dr. Gelmon’s new testimony is duplicative of information that
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`Amgen has had for months. For example, Dr. Gelmon’s new testimony was very
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`similar to the testimony she gave in a deposition in the inter partes review
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`2 Indeed, Dr. Gelmon’s testimony is entirely consistent with all of the evidence in
`the case - namely, that
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`See, e.g., Ex.s H - L (Genentech Supplemental Response to Interrogatory No. 2
`(citing
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`proceedings related to the dosing patent, a transcript of which was provided to
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`Amgen in January 2019.3 Ex. M (Gelmon Dep. Tr. (Mar. 1, 2018), GNE-
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`HER_001441055-1207) at 16:17-17:4, 36:11-37:1. Therefore, the new testimony
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`cannot justify Amgen’s untimely amendment.
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`The deadline to amend pleadings, as well as the close of fact discovery,
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`passed months ago. Yet Amgen now seeks to add an entirely new affirmative
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`defense to its case. Amgen has not provided any justification for this delay that
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`would rise to the level of good cause. Nor could it: Amgen had all the information
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`it needed to pursue this defense within the deadlines set by the Court’s Scheduling
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`Order but failed to do so. It cannot use an untimely amendment to remedy its own
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`lack of diligence.
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`B. Amgen Also Fails To Meet The Rule 15(a) Standard.
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`Because Amgen fails to meet the “good cause” standard, the Court need not
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`address the factors considered as part of the Rule 15(a) inquiry. See, e.g., Bos. Sci.
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`Corp. v. Edwards Lifesciences Corp., No. CV 16-275-JFB-SRF, 2018 WL
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`340); Scott v. Vantage Corp., 336 F. Supp. 3d 366, 378 (D. Del. 2018). But even
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`5043754, at *4 (D. Del. Sept. 19, 2018) (citing E. Minerals & Chems., 225 F.3d at
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`3 One difference between the two is that, in the inter partes review deposition, after
`stating that
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`testified that
`Ex. M at 15:5-
`16:16.
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`derivation defense where (1) Amgen unduly delayed; (2) the amendment would
`burden the court and prejudice Genentech; and (3) the amendment is futile.
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`under the more liberal Rule 15(a) inquiry, the Court should strike Amgen’s new
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`1.
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`Amgen Unduly Delayed.
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`As explained in detail supra, Amgen delayed unduly in amending its
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`Answer. Courts in this District have found undue delay in circumstances similar to
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`those presented here. See, e.g., Asahi Glass Co., Ltd. v. Guardian Indus. Corp.,
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`filed six months after the deadline to amend and after close of fact discovery);
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`276 F.R.D. 417, 420 (D. Del. 2011) (finding undue delay when the motion was
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`Pfizer Inc. v. Sandoz, No. 12-654-GMS, 2013 WL 5934635, at *3–4 (finding no
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`good cause when the motion was filed six months after the deadline to amend and
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`after close of fact discovery).
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`2.
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`Amgen’s Amendment Would Burden The Court And
`Unfairly Prejudice Genentech.
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`This case is just weeks away from trial. Forcing Genentech to divert
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`resources from its trial preparation to address a defense Amgen should have raised
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`months ago is inherently prejudicial. It is particularly problematic because, were
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`the new defense allowed, Genentech would have to press for a reopening of fact
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`and expert discovery to fully investigate it. At the very least, this would entail
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`additional fact witness testimony from others who were involved in the clinical
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`trial who could rebut any assertion that Dr. Leyland-Jones originated the idea of
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`three weekly dosing, as well as supplemental expert discovery to address new
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`facts. There is simply not enough time to fully investigate this wholly new defense
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`within the less than two months before trial is set to begin.
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`3.
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`Amgen’s Amendment Is Futile.
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`conception of the invention by another;” and (2) “communication of that
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`To succeed on a derivation defense, Amgen must establish: (1) “prior
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`conception to the patentee.” Pfizer Inc. v. Teva Pharm. U.S.A., Inc., 882 F. Supp.
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`2d 643, 705–06 (D. Del. 2012), aff’d sub nom. Pfizer Inc. v. Teva Pharm. USA,
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`Inc., 555 F. App’x 961 (Fed. Cir. 2014). These two elements must be proven by
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`LLC, 846 F.3d 1213, 1217-18 (Fed. Cir. 2017); Solomon v. Kimberly-Clark Corp.,
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`clear and convincing evidence. Cumberland Pharm. Inc. v. Mylan Institutional
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`216 F.3d 1372, 1381 (Fed. Cir. 2000). Critically, there must be evidence to show
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`that the alleged prior inventor disclosed the completed idea to the named
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`inventor(s) in sufficient detail to enable a person of ordinary skill in the art to
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`1344-45 (Fed. Cir. 2003); Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d
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`practice the claimed invention. Eaton Corp. v. Rockwell Intern. Corp., 323 F.3d
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`1573, 1577-78 (Fed. Cir. 1997) (reversing in part because the district court applied
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`the incorrect legal standard when it concluded the party asserting derivation “did
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`not need to prove communication of the entire conception, but rather only so much
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`of the invention ‘as would have made it obvious to one of ordinary skill in the
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`art’”).
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`Even taking Amgen’s accusations as true, it has failed to meet this standard.
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`Dr. Leyland-Jones’s authorship of publications, all but one of which were
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`published after the priority date of the patents, and his role as lead investigator on
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`clinical trials after the priority date, are not even probative of whether he
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`conceived of the invention before the priority date. The Patent Trial and Appeals
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`Board evaluated the only reference Amgen cites that was published before the
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`priority date and concluded that it did not even render the claim obvious, much less
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`demonstrate that the authors had completely conceived of the invention. See
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`Decision (Oct. 3, 2018); Celltrion Healthcare Co. v. Genentech, Inc., IPR2017-
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`Celltrion Healthcare Co. v. Genentech, Inc., IPR2017-01139, Final Written
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`01140, Final Written Decision (Oct. 3, 2018). Similarly, Dr. Leyland-Jones’s
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`involvement in the clinical trial, even as lead investigator, occurred after the
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`priority date, and does not demonstrate his involvement in conception. And Dr.
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`Baughman’s statement that
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`the invention; and (2) communicated it to Dr. Baughman. To the contrary, as Dr.
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`the idea of three weekly dosing, much less that he had: (1) completely conceived of
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` fails to show that Dr. Leyland-Jones originated
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`Baughman testified,
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` D.I. 397, Ex. 5 at 71:2-
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`25. Finally, to the extent Amgen now seeks to rely on the testimony of Dr.
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`Gelmon, as discussed in detail supra, that testimony is irrelevant to and unable to
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`support a claim of prior inventorship of the Dosing Patents. There is simply no
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`merit – as a matter of law – to Amgen’s untimely derivation defense.
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`II. The Court Should Also Reject Amgen’s Separate Effort To Inject An
`Inequitable Conduct Defense Into This Case Now.
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`Amgen’s Answer also introduced, for the first time, an affirmative defense
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`alleging that the ʼ869 patent is unenforceable due to Genentech’s alleged
`defense focuses on Example 8 and Figure 20 of the ʼ869 patent, which describes an
`application that resulted in the ʼ869 patent omitted data that, according to Amgen,
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`inequitable conduct. D.I. 366 at ¶ 11. Specifically, Amgen’s proposed new
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`experiment where the inventors used air sparging to prevent reduction of the
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`disulfide bonds that hold antibodies together. Amgen contends that the patent
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`disproves the inventors’ claim to have discovered a method to prevent disulfide
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`bond reduction.
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`Amgen again failed to ask the Court for leave to make this untimely
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`amendment, and to present any reason to justify it. Amgen should not be permitted
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`include a second, entirely new defense where it has failed to show good cause for
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`not doing so within the deadlines set by the Court’s Scheduling Order, particularly
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`where the amendment was unduly delayed, would burden the court and unduly
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`prejudice Genentech, and would ultimately prove futile.
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`A. Amgen Cannot Establish Good Cause Under Rule 16(b)(4).
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`Amgen fails to identify any facts that it did not know, or should not have
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`known, before the deadline for amendment of the pleadings. The overwhelming
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`majority of the material that Amgen cites in support of this defense was in its
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`possession long before the deadline to amend the pleadings. D.I. 366 at ¶ 28.
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`First, Amgen has had the 2010 Trexler Schmidt article since
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` see Carrier
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`Corp. v. Goodman Glob., Inc., 49 F. Supp. 3d 430, 433 (D. Del. 2014) (finding no
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`good cause where allegation “rest[ed] on a document produced nearly seven
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`months prior to the filing of the motion for leave . . . as well as upon publicly
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`available documents.”). This article was also submitted to, and considered by the
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`patent examiner during prosecution, and so appears in the patent’s file history,
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`which was produced to Amgen in October 2018. Ex. O (GNE-
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`HER924_000134369-78). The article was also produced by Genentech as a
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`standalone document in January 2019. Ex. P (GNE-HER_002466470-79).
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`Second, the three internal Genentech presentations to which Amgen cites
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`were all produced to Amgen in November and December 2018. Ex. Q (GNE-
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