Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 1 of 31 PageID #:
`32443
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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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`Plaintiff,
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`v.
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`AMGEN INC.,
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`Defendant.
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` Case No. 18-924-CFC
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`PLAINTIFF’S LETTER BRIEF IN SUPPORT OF ITS MOTION FOR A PROTECTIVE
`ORDER WITH RESPECT TO THE DEPOSITION OF DR. BRIAN LEYLAND-JONES,
`TO COMPEL THE PRODUCTION OF DOCUMENTS PURSUANT TO AMGEN’S
`PRIVILEGE WAIVER, AND TO MODIFY THE DISCOVERY LIMITS TO PROVIDE
`DEPOSITION TIME FOR DAMAGES WITNESSES
`
`
`
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Counsel for Plaintiff Genentech, Inc.
`
`Dated: October 4, 2019
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Stephanie Neely
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`
`
`ME1 31638679v.1
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`PUBLIC VERSION FILED: October 21, 2019
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 2 of 31 PageID #:
`32444
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`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Daralyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`ME1 31638679v.1
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`

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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 3 of 31 PageID #:
`32445
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`Dear Judge Connolly,
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`Genentech respectfully requests that the Court (i) enter a protective order preventing
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`Amgen from reopening discovery to take the deposition of Dr. Brian Leyland-Jones; (ii) compel
`Amgen to produce test results over which Amgen has waived privilege; and (iii) modify the
`discovery limits to provide deposition time for damages witnesses.
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`Protective Order Regarding Deposition of Dr. Brian Leyland-Jones
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`Fact discovery has been closed for months, expert discovery is in its very final stages,
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`and the parties are hard at work on their pretrial submissions. Yet, now—just two months from
`trial—Amgen seeks to depose Dr. Leyland-Jones, a third-party fact witness whose deposition
`Amgen previously declined to take.
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`This dispute stems from Amgen’s apparent intent to rely upon Dr. Leyland-Jones’s
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`testimony to support an entirely new and untimely invalidity theory that the asserted claims of
`U.S. Patent Nos. 6,627,196, 7,371,379, and 10,160,811 were allegedly invented by Dr. Leyland-
`Jones, not the Genentech scientists named as inventors on the patents. Amgen first disclosed this
`invalidity theory in an interrogatory response on September 3, 2019—nearly three months after
`the June 10, 2019 close of fact discovery and over five weeks after serving its invalidity expert
`reports.1 But Amgen had every opportunity to develop this defense—and take this deposition—
`during fact discovery, and it chose not to. It is simply too late to permit Amgen to pursue it now.
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`Because fact discovery is now closed, Amgen would need to show good cause to amend
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`the scheduling order to permit this discovery out of time. See Fed. R. Civ. P. 16(b)(4) (“[a]
`schedule may be modified only for good cause and with the judge’s consent”). To show “good
`cause,” the party seeking the discovery out of time must both explain why it needs more time and
`show that it was diligent in pursuing the discovery. Walker v. Centocor Ortho Biotech, Inc., 558
`F. App’x 216, 221-22 (3d Cir. 2014); Guilfoil v. Johnson, No. 15-cv-733-GMS, 2017 WL
`3473848, at *6 (D. Del. Aug. 11, 2017). Amgen has not even attempted to do so.
`
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`2017,
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`Amgen has long known of Dr. Leyland-Jones’s potential relevance to this case. In June
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`.2
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`If Amgen somehow did not learn of his potential relevance before, it certainly did once
`discovery began in this case. Dr. Leyland-Jones’s name was among the search terms used to
`identify documents to be produced in this case that Genentech disclosed to Amgen in November
`2018. Ex. 2. At that time, Genentech also produced documents relating to the Herceptin clinical
`trial (BO15935) that is the basis for Amgen’s assertion that Dr. Leyland-Jones invented the
`
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`1 On September 24, 2019, Amgen added this invalidity theory as an affirmative defense in its
`answer. D.I. 366 ¶¶ 97-161. Genentech intends to move to strike that defense as untimely.
`2
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`ME1 31638679v.1
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 4 of 31 PageID #:
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`dosing regimen claimed in Genentech’s patents. E.g., Ex. 3 at GNE-HER_000458584 (trial
`protocol showing dosing regimen). And during deposition discovery in May 2019, Amgen
`examined multiple witnesses about Dr. Leyland-Jones’s involvement in the development of the
`claimed dosing regimens, including Genentech’s Rule 30(b)(6) witness Dr. Robert Mass and
`named inventors Drs. Sharon Baughman and Steven Shak. E.g., Ex. 4, Mass Dep. at 353:6-8,
`355:1-362:6; Ex. 5 Baughman Dep. at 69:2-14, 71:2-25; Ex. 6, Shak Dep. at 158:17-159:17.
`Simply put, Amgen knew full well of Dr. Leyland-Jones’s potential relevance to this case.
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`Despite all that, Amgen never sought Dr. Leyland-Jones’s deposition during fact
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`discovery. Amgen even had the opportunity to depose Dr. Leyland-Jones shortly after the close
`of fact discovery when Samsung Bioepis scheduled his deposition in a related case. Amgen
`initially noticed that deposition in this case as well. D.I. 267. When the Samsung Bioepis case
`settled, however, Amgen confirmed that it would not proceed with the deposition. Ex. 7.
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`On July 30, 2019, Amgen reversed course and served a subpoena to take Dr. Leyland-
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`Jones’s deposition. D.I. 336. When Genentech objected to that as untimely, Amgen sought to
`justify taking his deposition out of time on the basis that Genentech had produced a redacted
`email on July 23, 2019 from Dr. Baughman (one of the inventors of Genentech’s patents) to
`Genentech’s outside counsel in this case. Ex. 8. That redacted email was produced at Amgen’s
`request following Dr. Baughman’s deposition, where she testified
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`Dr. Baughman’s email did not inject any new issue into this case.
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`If Amgen believed that those discussions made Dr. Leyland-Jones’s testimony important, it
`could have taken Dr. Leyland-Jones’s deposition following Dr. Baughman’s May 9 deposition.
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`Instead, Amgen waited three weeks after Dr. Baughman’s deposition before following up
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`on its request that Genentech produce the email. Ex. 9 at 2. On June 11, 2019, Genentech
`responded and explained why the email between Dr. Baughman and counsel was privileged. Ex.
`10 at 2. The Court then held a discovery conference on June 18, 2019. Amgen said nothing
`about the issue. After Amgen finally re-raised the issue on July 17, 2019 (after over a month of
`inaction), Genentech decided to avoid a discovery dispute by promptly producing the portion of
`the email disclosing the facts that Dr. Baughman reviewed before her deposition. In short,
`Amgen cannot use the timing of the production of this email as a basis to reopen discovery
`because Amgen simply was not diligent in pursuing it during fact discovery.
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`Although Amgen’s lack of diligence would be more than enough reason to issue a
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`protective order barring the late deposition of Dr. Leyland-Jones, the prejudice to Genentech of
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`ME1 31638679v.1
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 5 of 31 PageID #:
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`having this deposition proceed now further compels that result. This case is just two months
`away from trial, and Genentech’s efforts at this point should be devoted to getting ready for trial,
`not a deposition that Amgen elected not to take when it had the chance months ago. This is
`especially true because this is not just a single deposition of a few hours. Should Amgen depose
`Dr. Leyland-Jones and attempt to rely upon his testimony to pursue its belated new defense,
`Genentech would be entitled to follow-up discovery, including additional witness testimony to
`refute whatever Dr. Leyland-Jones might say.3 Genentech would also need supplemental expert
`discovery, since Genentech’s experts have had no opportunity to address Dr. Leyland-Jones’s
`testimony. There is simply not time for all of that while maintaining the December trial date.
`
`Compel Production of Test Results Pursuant to Privilege Waiver Order
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`Genentech seeks an order compelling Amgen to produce infringement-related test results
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`pursuant to the Court’s privilege waiver order. D.I. 259. Specifically, Amgen is withholding
`testing results performed by Amgen employees relevant to infringement of U.S. Patent No.
`8,574,869. Those tests performed by Amgen employees fall within the scope of the Court’s
`privilege waiver order, which requires production of “[a]ll documents relating to assessments of
`… infringement or validity of the ’869 patent” and “[a]ll documents relating to any
`experimentation, testing, or analysis to alter Amgen’s manufacturing process to avoid
`Genentech’s allegations of infringement of the ’869 patent.” D.I. 259 ¶¶ 1, 3. Amgen asserts
`that those test results are not within the scope of the Court’s privilege waiver order because those
`tests were purportedly performed at the request of Amgen’s outside trial counsel. That position
`is untenable. The testing and experimentation of Amgen’s employees is not information
`conveyed to them by outside trial counsel; they are facts that Amgen’s employees themselves
`generated and over which Amgen elected to waive privilege. Indeed, this material is exactly
`what this Court ordered produced. See D.I. 259 ¶¶ 1, 3. For example, Amgen engineer
`Benjamin Dionne was previously instructed at his deposition not to testify concerning these test
`results on the basis of work product protection. E.g., Ex. 11, Dionne Dep. at 65:8-23. The
`Court’s privilege waiver order specifically required Amgen to make Dr. Dionne available to
`available to testify on this subject. D.I. 259 ¶ 7. Amgen’s refusal to provide discovery
`concerning these test results is contrary to the Court’s prior order.
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`Modify Discovery Limits to Provide Deposition Time for Damages Witnesses
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`In April 2019, the parties stipulated to limit the total number of deposition hours for fact
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`witnesses. See D.I. 135 ¶ 3(a). Amgen has taken the position that those deposition limits should
`apply to damages witnesses too, even though damages were not at issue in this case when those
`prior limits were set. Given the changed circumstances, Genentech respectfully requests that the
`Court modify the deposition hours limits to provide separate time for damages depositions (e.g.,
`30 hours per side). Although damages have now been bifurcated (D.I. 370), Genentech raises
`this issue now so that the parties may appropriately manage their remaining deposition hours.
`
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`3 Those witnesses might include, for example, Dr. Susan Hellmann (whose Phase III clinical trial
`led Drs. Baughman and Shak to the claimed invention), Dr. Leyland-Jones’s eight co-authors on
`the publication resulting from the BO15935 clinical trial (Andrew Arnold, Karen Gelmon,
`Shailendra Verma, Jean-Pierre Ayoub, Andrew Seidman, Reg Dias, Julian Howell, and A.
`Rakhit), and Dr. Leyland-Jones’s other contacts at Roche (Della O’Neill and Cameron Szakacs).
`
`ME1 31638679v.1
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 6 of 31 PageID #:
`32448
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`MCCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Counsel for Plaintiff Genentech, Inc.
`
`Dated: October 4, 2019
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Stephanie Neely
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Daralyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`ME1 31638679v.1
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 21 of 31 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 23 of 31 PageID
`#: 32465
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 24 of 31 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 25 of 31 PageID
`#: 32467
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 26 of 31 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 27 of 31 PageID
`#: 32469
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`THIS DOCUMENT HAS
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`BEEN REDACTED IN ITS
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 28 of 31 PageID
`#: 32470
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 29 of 31 PageID
`#: 32471
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`THIS DOCUMENT HAS
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`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 30 of 31 PageID
`#: 32472
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`CERTIFICATE OF SERVICE
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`The undersigned counsel hereby certifies that true and correct copies of the foregoing
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`
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`document were caused to be served on October 4, 2019 on the following counsel in the manner
`
`indicated:
`
`
`VIA EMAIL:
`
`Neal C. Belgam
`Eve H. Ormerod
`Jennifer M. Rutter
`SMITH, KATZENSTEIN & JENKINS, LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`
`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
`
`Christopher B. Mead
`London & Mead
`1225 19th Street, NW, Ste. 320
`Washington, DC 20036
`(202) 331-3334
`cmead@londonandmead.com
`
`
`
`
`ME1 31626460v.1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 437 Filed 10/21/19 Page 31 of 31 PageID
`#: 32473
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`
`
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`Philip H. Mao
`Alexandra Leeper
`Lauren Krickl
`Benjamin S. Lin
`Alissa M. Wood
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`pmao@cooley.com
`aleeper@cooley.com
`lkrickl@cooley.com
`blin@cooley.com
`amwood@cooley.com
`
`Brian Kao
`Lois Kwasigroch
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`(805) 447-1000
`bkao@amgen.com
`loisk@amgen.com
`
`Attorneys for Defendant Amgen Inc.
`
`
`
`Dated: October 4, 2019
`
`
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`
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`
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`
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`ME1 31626460v.1
`
`2
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`