throbber
Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 1 of 76 PageID #:
`34370
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GENENTECH, INC.,
`
`Plaintiff,
`
`v.
`
`AMGEN INC.,
`
`Defendant.
`
`
`
`
`
` Case No. 18-924-CFC
`
`
`
`
`
`
`
`
`
`PLAINTIFF’S LETTER BRIEF IN OPPOSITION TO
`DEFENDANT’S FEBRUARY 20, 2020 DISCOVERY DISPUTE LETTER
`
`
`
`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: February 21, 2020
`
`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
`
`
`
`
`
`PUBLIC VERSION FILED:
`FEBRUARY 28, 2020
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 2 of 76 PageID #:
`34371
`
`Daralyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 3 of 76 PageID #:
`34372
`
`Magistrate Judge Sherry Fallon
`February 21, 2020
`Page 1
`
`Dear Judge Fallon,
`Amgen’s motion to compel Rule 30(b)(6) deposition testimony should be denied because
`Amgen’s requests are impermissibly vague, overbroad and burdensome and because Genentech
`provided corporate testimony on effectively identical subject matter.
`I.
`Background Facts Relevant to this Dispute
`In this and other litigations, Genentech has pursued infringement of several patents relating
`to Herceptin. Among those patents are the “Dosing Patents,” the “Cabilly Patents,” the “Carter
`Patent,” and the “Combination Chemotherapy Patents.” (D.I. 79 ¶¶ 44, 47, 49.) These patents
`have been asserted or challenged in dozens of district court suits and inter partes review (“IPR”)
`proceedings. In this litigation, Genentech also alleges that Amgen’s Kanjinti manufacturing
`process infringes an additional Genentech patent, the “’869 Kao Patent.” (D.I. 79 ¶ 68.) The
`Cabilly Patents and the Carter Patent have expired; the asserted claims of the Combination
`Chemotherapy Patents were invalidated in IPR proceedings (decisions that Genentech is currently
`challenging on appeal). The asserted claims of the Dosing Patents—which remain at issue in this
`case—recite methods of treatment of HER2-overxpressing cancer through extended dosing
`regimens for the therapeutic antibody trastuzumab used in Genentech’s Herceptin and in Amgen’s
`biosimilar Kanjinti. The ’869 Kao Patent also remains at issue in this case.
`Fact discovery closed on June 10, 2019. (D.I. 196.) Amgen launched Kanjinti “at risk”—
`i.e., before the expiration of the Dosing Patents and the ’869 Kao Patent—on July 18, 2019. On
`September 4, 2019, Genentech filed an amended complaint seeking money damages. (D.I. 347.)
`On November 21, 2019, the Court entered the parties’ stipulated request for a period of discovery
`directed to Genentech’s claim for money damages. (D.I. 462.) Among other things, that schedule
`provided that (1) the parties would serve Rule 30(b)(6) deposition notices on November 27, 2019;
`(2) the parties would serve written objections and responses to their respective Rule 30(b)(6)
`deposition notices on December 20, 2019; and (3) the discovery period directed to Genentech’s
`claim for money damages would close January 31, 2020. (D.I. 462.)
`Pursuant to the agreed-upon schedule, the parties served Rule 30(b)(6) deposition notices
`directed to Genentech’s claim for money damages on November 27, 2019. Several of Amgen’s
`81 topics were directed in whole or in part to drivers of consumer demand for Herceptin. For
`example, (1) Topic 49 was directed to “[a]ll drivers of consumer demand for Herceptin,” (2) Topics
`54, 59, and 63 were directed to the dosing regimens of the asserted claims of the Dosing Patents
`as drivers of demand for Herceptin; and (3) Topic 55 was directed to “[f]acts and data in
`[Genentech’s] possession regarding the significance of a patient’s HER2 positive/overexpressing
`status as a driver of demand for Herceptin”; and (4) Topics 56-58 were directed to “[f]acts and
`data in [Genentech’s] possession regarding the significance of the inventions claimed in the”
`Carter Patent, Cabilly Patent, and Combination Chemotherapy Patents, respectively, “as drivers of
`demand for Herceptin.” (Ex. A.) Topics 50-51, at issue here, were directed to the same substantive
`subject matter, seeking testimony regarding Genentech’s “statements in any filing in any
`governmental regulatory agency, court, or administrative agency proceeding, including in any inter
`partes review proceedings, regarding the drivers of consumer demand for [and commercial success
`of] Herceptin.” (D.I. 510 at 1.)
`In its December 20, 2019 written objections and responses, Genentech stated that it would
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 4 of 76 PageID #:
`34373
`
`Magistrate Judge Sherry Fallon
`February 21, 2020
`Page 2
`
`“designate one or more witnesses to testify” in relation to Topics 49, 54-59, and 63 “regarding
`Genentech’s general knowledge regarding drivers of demand for trastuzumab, including market
`research Genentech has produced relating to drivers of demand for Herceptin.” (Ex. B at 88-89,
`96-107, 114-115.) However, Genentech objected to the two topics at issue here, Topics 50-51,
`because, among other things, the topics “fail[] to describe with reasonable particularity the matters
`on which examination is requested,” because the topics are “unduly burdensome and overly
`broad,” and because “any such filings speak for themselves; accordingly, the information sought
`by [these Topics] is more appropriately obtained through other means of discovery.” (Ex. B at 90-
`91.) On December 23, 2019 and January 8, 2020, the parties met and conferred regarding their
`respective Rule 30(b)(6) positions. Counsel for Genentech maintained its position that Topics 50-
`51 are improper in view of the burden involved in attempting to prepare a witness regarding
`unspecified statements in unspecified filings and submissions and because any such statements
`would, in any event, speak for themselves. Accordingly, we requested that Amgen describe the
`testimony it sought more specifically. In response, counsel for Amgen stated that Amgen is
`entitled to testimony regarding whether Genentech “stands by” its prior statements in IPR
`proceedings and litigation; Amgen did not then—or since then—narrow Topics 50-51 to any
`specific set of statements or even any defined universe of such proceedings.
`On January 15, 2020, Genentech informed Amgen that it would designate Genentech
`employee Melissa Abreu to testify regarding certain topics. Ms. Abreu’s areas of knowledge were
`well-known to counsel for Amgen; during the liability discovery phase of the case, Ms. Abreu had
`testified as Genentech’s corporate designee regarding, among other things, Herceptin marketing,
`market research, and commercial success. (Ex. C at 23, 49-54, 56, 58, 59-63, 80-82.) In its January
`19, 2020 amended objections and responses to Amgen’s Rule 30(b)(6) notice, Genentech formally
`designated Ms. Abreu to testify regarding Topics 49, 54-59, and 63, a set of topics that included,
`among other things, “[a]ll drivers of demand for Herceptin” as well as “[f]acts and data in
`[Genentech’s] possession regarding the significance of the inventions claimed in the” Carter
`Patent, Cabilly Patent, Combination Chemotherapy Patents, and Dosing Patents. (Ex. D at 88-89,
`96-107, 114-115.)
`Although Amgen now suggests that it had “narrowed” Topics 50-51 during the parties’
`January 8 discussion (D.I. 510 at 2), its correspondence demonstrates otherwise; on January 20,
`2020, Amgen stated that it “is entitled to discover the facts and data in Genentech’s possession
`that support the statements referenced in [Topics 50-51],” which encompass “statements in any
`filing in any governmental regulatory agency . . . or administrative agency proceeding” as well as
`litigation and IPRs. (Ex. E at 3.) On January 22, 2020, Genentech reiterated that it was “willing
`to further consider the propriety of these topics if Amgen identifies the specific statements about
`which it seeks testimony.” (D.I. 510 Ex. F at 3-4.)
`Amgen took Ms. Abreu’s Rule 30(b)(6) deposition on January 23, 2020. On January 29,
`2020, Amgen reasserted that it was “entitled to discover the facts and data in Genentech’s
`possession that support the statements referenced in [Topics 50-51], and in particular, the bases
`for Genentech’s and its experts’ statements in IPRs regarding the Cabilly, Carter, or . . .
`Combination Chemotherapy and Dosing Patents . . . related to drivers of consumer demand or
`commercial success of Herceptin.” (D.I. 510 Ex. I at 3.) Even to the extent that formulation
`constituted any narrowing of Amgen’s request—a debatable proposition, since Amgen did not
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 5 of 76 PageID #:
`34374
`
`Magistrate Judge Sherry Fallon
`February 21, 2020
`Page 3
`
`identify any specific statements—it came over a month after Genentech objected that Topics 50-
`51 “fail[] to describe with reasonable particularity the matters on which examination is requested,”
`a full three weeks after Genentech requested that Amgen identify specific statements of interest,
`and just two days before the close of the damages fact discovery period. Genentech responded the
`following day, explaining that in light of Amgen’s continued failure to provide the requested
`specificity and Genentech’s prior objections, Genentech would decline to designate a witness to
`testify regarding Topics 50-51. (Ex. F at 3.) The parties met and conferred again the following
`day and maintained their positions.
`II.
`Topics 50-51 Are Impermissibly Vague, Overbroad, and Burdensome
`As Genentech noted in its original written objections and responses—and further explained
`when the parties met and conferred—Topics 50-51 fail to provide Genentech with sufficient
`information to prepare a witness to testify on its behalf. Herceptin has been the subject of multiple
`lawsuits over many years, and the patents at issue have been asserted in many of those suits and
`have been challenged in numerous IPR proceedings. In particular, the Carter Patent has been
`asserted or challenged in over a dozen district court and IPR cases, the Cabilly Patents have been
`asserted or challenged in over two dozen district court and IPR cases dating back to 2003, the
`Combination Chemotherapy Patents have been challenged in eight IPRs, and the Dosing Patents
`have been challenged in six IPRs. It would thus be unduly burdensome for Genentech to comb
`the files of all these proceedings, and separately to prepare a witness to testify regarding all of
`Genentech’s statements regarding Herceptin, even assuming Amgen’s January 29, 2020 letter
`narrowed the scope of this dispute, but Topics 50-51 are actually even far broader. They
`encompass not only litigation and IPRs but “any filing in any governmental regulatory agency”—
`sweeping in Genentech’s nearly three-decade FDA history relating to Herceptin—as well as any
`other “administrative agency proceeding” (not just IPRs) (D.I. 510 at 1.)
`Genentech attempted to avoid this dispute, requesting when the parties first met and
`conferred that Amgen identify the specific statements of interest. Amgen failed to do so then, or
`at any time prior to the deposition of Ms. Abreu, Genentech’s designated witness regarding the
`subject matter at issue; i.e., drivers of demand for Herceptin (including the extent to which the
`Carter Patent, Cabilly Patents, Combination Therapy Patents, and Dosing Patents drive such
`demand). Indeed, even now Amgen has not identified the specific statements about which it seeks
`testimony, instead requesting that the Court order Genentech provide testimony regarding the full
`scope of Topics 50-51. Amgen’s failure to obtain the desired testimony is a problem of its own
`making. See Novartis Pharm. Corp. v. Abbott Labs., 203 F.R.D. 159, 162 (D. Del. 2001) (denying
`motion to compel because the moving party “had ample opportunity to obtain the discovery it now
`moves to compel within the discovery deadline”).
`III. Topics 50-51 Are Cumulative
`Amgen cannot credibly contend that it was unable to obtain testimony regarding the drivers
`of demand for Herceptin.1
`
`
`1 Amgen’s suggestion that the discovery at issue here “could substantially reduce the amount of
`any damages awarded in this case” is likewise meritless, as the only two examples Amgen
`provides demonstrate. The statements quoted in Amgen’s brief are directed to the nexus
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 6 of 76 PageID #:
`34375
`
`Magistrate Judge Sherry Fallon
`February 21, 2020
`Page 4
`
`
`First, Topics 50-51 are among at least ten topics in Amgen’s Rule 30(b)(6) notice directed
`to some aspect of that subject matter. Topic 49, for example, sought testimony regarding “[a]ll
`drivers of demand for Herceptin,” while Topics 56-59 sought testimony regarding “[f]acts and data
`in [Genentech’s] possession regarding the significance of the inventions claimed in the” Carter
`Patent, Cabilly Patent, Combination Chemotherapy Patents, and Dosing Patents. And as explained
`above, Genentech designated Ms. Abreu to testify regarding Topics 49 and 56-59, among others.
`Ms. Abreu was prepared to and did testify regarding those topics. For example, she
`answered questions regarding (1) “whether . . . the most important consideration is whether the
`patient has HER2-overexpressing breast cancer”; (2) whether “the primary driver or market
`demand for Herceptin as a drug is the antibody molecule itself”; (3) “facts and data in
`[Genentech’s] possession relating to market demand for the 8/6/3 dosing regimen” claimed in the
`Dosing Patents; (4) “information in [Genentech’s] possession regarding the significance of the
`inventions described as being covered by the combination chemotherapy patents”; and (5)
`“information in [Genentech’s] possession concerning the importance of the Cabilly patent
`inventions to the commercial value of Herceptin.” (Ex. G at 24-25, 29, 37.)
`Amgen’s argument regarding Ms. Abreu’s testimony misapprehends Genentech’s position.
`Genentech did not attempt to designate her “after the fact” or “state[] that [she] had been prepared
`to answer questions regarding Topics 50-51 (D.I. 510 at 2-3); rather, Genentech pointed out that
`Amgen had ample opportunity to question a Genentech corporate designee about drivers of
`demand for Herceptin. (D.I. 510 Ex. H at 2.) That was true then, and is true now; Amgen has
`never (even now) complained about the scope of Ms. Abreu’s preparation or knowledge.
`Second, Topics 50-51 do not seek “facts, data and background information” as Amgen now
`claims it is entitled to. (D.I. 510 at 2.) Rather, they seek only testimony regarding “statements.”
`(D.I. 510 at 1.) Amgen separately sought testimony regarding “facts and data” relating to demand
`for Herceptin through separate topics—i.e., Topics 49, 54-59, and 63—on each of which Amgen
`already had the opportunity to obtain Genentech’s testimony.
`Third, Amgen’s own correspondence and letter brief demonstrate that Amgen is already
`aware of the statements it considers relevant; indeed, that is the point of Genentech’s objection
`that its statements “speak for themselves.” If Amgen contends Genentech’s past statements
`constitute party admissions, and to the extent they satisfy other evidentiary requirements, Amgen
`can seek to use them with or without Genentech’s testimony regarding Topics 50-51.
`Because Genentech has fulfilled its discovery obligations, Amgen’s request should be
`denied. Novartis, 203 F.R.D. at 163 (denying motion to compel Rule 30(b)(6) testimony in part
`because “another deposition . . . would be cumulative to the testimony already procured”).
`
`between the commercial success of Herceptin and Genentech’s challenged patents, but the extent
`of damages to which Genentech is entitled depends on the incremental value of the Dosing
`Patents to Amgen’s product. And it is undisputed that Amgen made the decision that it could not
`launch Kanjinti without including the claimed dosing regimen, which itself proves that
`incremental value. (D.I. 275 at 8-9.) Whether other patents contribute value to Herceptin is
`orthogonal to the issues in this case. Regardless, as explained above, Genentech has not
`withheld any discovery regarding demand for Herceptin.
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 7 of 76 PageID #:
`34376
`
`Magistrate Judge Sherry Fallon
`February 21, 2020
`Page 5
`
`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: February 21, 2020
`
`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
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 8 of 76 PageID #:
`34377
`
`
`
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`
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`
`
`
`EXHIBIT A
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 9 of 76 PageID #:
`34378
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No. 18-00924-CFC
`
`GENENTECH, INC.,
`
`
`Plaintiff and Counterclaim Defendant,
`
`v.
`
`AMGEN INC.,
`
`Defendant and Counterclaim Plaintiff.
`
`
`DEFENDANT AMGEN INC.’S SECOND NOTICE OF DEPOSITION OF PLAINTIFFS
`PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6)
`
`
`
`
`PLEASE TAKE NOTICE that, pursuant to Rule 30(b)(6) of the Federal Rules of Civil
`
`Procedure, counsel for Defendant Amgen Inc. (“Defendant” or “Amgen”) will take the deposition
`
`by oral examination of Plaintiff Genentech, Inc. (“Genentech”) on the topics set forth in the
`
`attached Schedule A, through one or more officers, directors, agents, or other persons designated
`
`by Plaintiff to testify on its behalf.
`
`The deposition will take place before an officer duly authorized by law to administer oaths,
`
`at the office of Cooley LLP, 3175 Hanover St, Palo Alto, CA 94304, on a date or dates to be
`
`determined as mutually convenient for both parties. The testimony will be recorded
`
`stenographically and by videotape. The deposition will be taken for the purposes of discovery and
`
`all other purposes permitted by the Federal Rules of Civil Procedure.
`
`
`
`
`
`
`
`
`
`1
`
`DEFENDANT AMGEN’S SECOND
`NOITICE OF DEPOSITION 30(B)(6)
`18-00924
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 10 of 76 PageID
`#: 34379
`
`
`47.
`
`Facts and data in Your possession regarding the business and financial terms on
`
`which You have granted a license to Amgen to any patent.
`
`48.
`
`Facts and data in Your possession regarding analyses You have performed
`
`regarding the business and financial terms on which You have considered authorizing any third-
`
`party to manufacture or sell an authorized biosimilar of any product of Yours.
`
`49.
`
`50.
`
`All drivers of consumer demand for Herceptin.
`
`Your statements in any filing in any governmental regulatory agency, court, or
`
`administrative agency proceeding, including in any inter partes review proceedings, regarding the
`
`drivers of consumer demand for Herceptin.
`
`51.
`
`Your statements in any filing in any governmental regulatory agency, court, or
`
`administrative agency proceeding, including in any inter partes review proceedings, regarding the
`
`drivers of commercial success of Herceptin.
`
`
`
`52.
`
`The commercial value to Genentech You ascribe to each of the inventions claimed
`
`in each asserted claim of each Patent-in-Suit.
`
`53.
`
`Facts and data in Your possession concerning market demand for the use of air
`
`sparging to prevent the reduction of disulfide bonds as claimed in the asserted claims of the ’869
`
`patent.
`
`54.
`
`Facts and data in Your possession relating to or reflecting market demand for the
`
`dosing regimens claimed in the asserted claims of the ’196, ’379, and ’811 patents.
`
`55.
`
`Facts and data in Your possession regarding the significance of a patient’s HER2
`
`positive/overexpressing status as a driver of demand for Herceptin.
`
`56.
`
`Facts and data in Your possession regarding the significance of the inventions
`
`claimed in the Carter patent as drivers of demand for Herceptin.
`
`57.
`
`Facts and data in Your possession regarding the significance of the inventions
`
`claimed in the Cabilly Patents as drivers of demand for Herceptin.
`
`58.
`
`Facts and data in Your possession regarding the significance of the inventions
`
`claimed in the Combination Chemotherapy patents as drivers of demand for Herceptin.
`
`
`
`
`
`12
`
`DEFENDANT AMGEN’S SECOND
`NOTICE OF DEPOSITION 30(B)(6)
`18-00924
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 11 of 76 PageID
`#: 34380
`
`
`59.
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`Facts and data in Your possession regarding the significance of the inventions
`
`claimed in the Dosing Patents as drivers of demand for Herceptin.
`
`60.
`
`Facts and data in Your possession regarding revenues (if any) that You attribute to
`
`the Dosing Patents asserted in this lawsuit.
`
`61.
`
`Facts and evidence in Your possession regarding pricing analyses for any extended
`
`dosing regimen for Herceptin involving dosing less frequently than weekly.
`
`62.
`
`Facts and evidence in Your possession regarding reimbursement analyses for any
`
`extended dosing regimen for Herceptin involving dosing less frequently than weekly.
`
`63.
`
`Facts and evidence in Your possession regarding patient demand for extended
`
`dosing regimens for Herceptin.
`
`64.
`
`Facts and data in Genentech’s possession concerning non-infringing alternatives
`
`known to Genentech to any of the Patents-in-Suit.
`
`
`
`65.
`
`Facts and data in Genentech’s possession concerning the market acceptability of
`
`non-infringing alternatives known to Genentech for any of the Patents-in-Suit.
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`66.
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`Facts and data in Genentech’s possession concerning the cost of implementing non-
`
`infringing alternatives known to Genentech for any of the Patents-in-Suit.
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`67.
`
`The costs incurred by Genentech to research and develop (including any clinical
`
`trials) each invention claimed in each asserted claim of each Patent-in-Suit.
`
`68.
`
`Facts and evidence concerning comparative analyses You have performed of
`
`weekly dosing of Herceptin to any extended dosing regimen.
`
`69.
`
`Facts and evidence in Your possession regarding the unacceptability to patients,
`
`doctors and/or payers of dosing Herceptin on a weekly dosing regimen.
`
`70. Market research or customer research that You have performed or commissioned
`
`concerning the acceptability of treating early breast cancer patients with trastuzumab on any dosing
`
`regimen that is not allegedly covered by the Dosing Patents.
`
`71.
`
`Facts and data in Your possession regarding manufacture outside the United States
`
`of Herceptin finished drug product, drug product or drug substance that is sold in the United States,
`
`
`
`
`
`13
`
`DEFENDANT AMGEN’S SECOND
`NOTICE OF DEPOSITION 30(B)(6)
`18-00924
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 12 of 76 PageID
`#: 34381
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`
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`EXHIBIT B
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 13 of 76 PageID
`#: 34382
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Plaintiff,
`
`
`
`v.
`
`
`
`GENENTECH, INC.,
`
`
`
`
`
`AMGEN INC.,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. 1:18-cv-00924-CFC
`
`
`
`
`Defendant and Counterclaim
`Plaintiff.
`
`PLAINTIFF GENENTECH, INC’S RESPONSES AND OBJECTIONS TO
`DEFENDANT AMGEN, INC.’S SECOND RULE 30(b)(6) DEPOSITION NOTICE
`
`Pursuant to Rules 26 and 30 of the Federal Rules of Civil Procedure and the Local Civil
`
`Rules of the United States District Court for the District of Delaware, Plaintiff Genentech, Inc.
`
`(“Genentech”) hereby objects and responds to the Second Notice of Deposition Pursuant to Rule
`
`30(b)(6) dated November 27, 2019 (the “Notice”) served by Defendant Amgen, Inc. (“Amgen”).
`
`GENERAL OBJECTIONS
`
`Plaintiff incorporates each of the following General Objections into its responses to each of
`
`the Topics for Examination (“Topics”), whether or not each such General Objection is expressly
`
`referred to in a response to a specific Topic.
`
`1.
`
`Genentech objects to the Notice, and to the Definitions and Topics contained
`
`therein, to the extent they seek to impose a burden on Genentech greater than or inconsistent with
`
`that required by the Federal Rules of Civil Procedure, including Rule 30(b)(6), the Local Rules, or
`
`any other relevant rule, statute, regulation, or precedent.
`
`2.
`
`Genentech objects to Amgen’s definitions of “Plaintiff,” “You,” and “Your” as
`
`overbroad, unduly burdensome, and vague to the extent they purport to place the burden on
`
`– 1 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 14 of 76 PageID
`#: 34383
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`TOPIC 49:
`
`All drivers of consumer demand for Herceptin.
`
`RESPONSE TO TOPIC 49:
`
`
`
`Genentech objects to this Topic to the extent that it fails to describe with reasonable
`
`particularity the matters on which examination is requested, and is unduly burdensome and overly
`
`broad. Genentech objects to this Topic to the extent that it seeks information that is not relevant to
`
`the claims or defenses of any party to this litigation, not reasonably calculated to lead to the
`
`discovery of admissible evidence, or seeks discovery that is not proportional to the needs of the
`
`case.
`
`Genentech further objects to this Topic to the extent that it seeks information protected
`
`from disclosure by the attorney-client privilege, the work-product doctrine, or any other applicable
`
`privilege or immunity.
`
`Genentech further objects to this Topic as seeking information outside its possession,
`
`custody, or control.
`
`Genentech further objects to this Topic as premature to the extent that it seeks expert
`
`discovery in a manner inconsistent with the Federal Rules of Civil Procedure and the Court’s
`
`November 21, 2019 Order regarding Damages and Third-Party Subpoena Discovery (D.I. 462).
`
`Genentech further objects to this Topic as improperly seeking party contentions through
`
`deposition. See, e.g., Intellectual Ventures II LLC v. Symantec Corp., C.A. 13-440-LPS (D. Del.
`
`June 12, 2015) (Stark, J.), Tr. at 37-38; Sanofi-Aventis, U.S. LLC v. Eli Lilly and Company, C.A.
`
`14-113-RGA-MPT (D. Del. Feb. 26, 2015) (Thynge, J.), Tr. at 87; Axiohm IPS Inc. v. Epson Am.,
`
`Inc., C.A. No. 00-420-SLR (D. Del. Mar. 28, 2001) (Robinson, J.), Tr. at 4; Int’l Bus. Machines
`
`Corp. v. The Priceline Grp. Inc, No. CV 15-137-LPS, 2016 WL 6305981, at *2 (D. Del. Sept. 29,
`
`– 88 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 15 of 76 PageID
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`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`2016) (denying request to compel party to put forward a witness to testify on “de facto contention
`
`deposition categories” that are “more properly the subject of expert testimony”).
`
`Subject to and without waiving the foregoing General and Specific Objections, Genentech
`
`will designate one or more witnesses to testify regarding Genentech’s general knowledge
`
`regarding drivers of demand for trastuzumab, including market research Genentech has produced
`
`relating to drivers of demand for Herceptin.
`
`
`
`
`
`– 89 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 16 of 76 PageID
`#: 34385
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`TOPIC 50:
`
`Your statements in any filing in any governmental regulatory agency, court,
`or administrative agency proceeding, including in any inter partes review
`proceedings, regarding the drivers of consumer demand for Herceptin.
`
`RESPONSE TO TOPIC 50:
`
`
`
`Genentech objects to this Topic to the extent that it fails to describe with reasonable
`
`particularity the matters on which examination is requested, and is unduly burdensome and overly
`
`broad. Genentech objects to this Topic to the extent that it seeks information that is not relevant to
`
`the claims or defenses of any party to this litigation, not reasonably calculated to lead to the
`
`discovery of admissible evidence, or seeks discovery that is not proportional to the needs of the
`
`case.
`
`Genentech further objects to this Topic because any such filings speak for themselves;
`
`accordingly, the information sought by this Topic is more appropriately obtained through other
`
`means of discovery.
`
`Based on the foregoing General and Specific Objections, Genentech will not designate a
`
`witness to testify regarding this Topic.
`
`
`
`
`
`– 90 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 17 of 76 PageID
`#: 34386
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`TOPIC 51:
`
`Your statements in any filing in any governmental regulatory agency, court,
`or administrative agency proceeding, including in any inter partes review
`proceedings, regarding the drivers of commercial success of Herceptin.
`
`RESPONSE TO TOPIC 51:
`
`
`
`Genentech objects to this Topic to the extent that it fails to describe with reasonable
`
`particularity the matters on which examination is requested, and is unduly burdensome and overly
`
`broad. Genentech objects to this Topic to the extent that it seeks information that is not relevant to
`
`the claims or defenses of any party to this litigation, not reasonably calculated to lead to the
`
`discovery of admissible evidence, or seeks discovery that is not proportional to the needs of the
`
`case.
`
`Genentech further objects to this Topic because any such filings speak for themselves;
`
`accordingly, the information sought by this Topic is more appropriately obtained through other
`
`means of discovery.
`
`Based on the foregoing General and Specific Objections, Genentech will not designate a
`
`witness to testify regarding this Topic.
`
`
`
`
`
`– 91 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 518 Filed 02/28/20 Page 18 of 76 PageID
`#: 34387
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`TOPIC 54:
`
`Facts and data in Your possession relating to or reflecting market demand
`for the dosing regimens claimed in the asserted claims of the ’196, ’379, and
`’811 patents.
`
`RESPONSE TO TOPIC 54:
`
`
`
`Genentech objects to this Topic to the extent that it fails to describe with reasonable
`
`particularity the matters on which examination is requested, and is unduly burdensome and overly
`
`broad. Genentech objects to this Topic to the extent that it seeks information that is not relevant to
`
`the claims or defenses of any party to this litigation, not reasonably calculated to lead to the
`
`discovery of admissible evidence, or seeks discovery that is not proportional to the needs of the
`
`case.
`
`Genentech further objects to this Topic to the extent that it seeks information protected
`
`from disclosure by the attorney-client privilege, the work-product doctrine, or any other applicable
`
`privilege or immunity.
`
`Genentech further objects to this Topic as premature to the extent that it seeks expert
`
`discovery in a manner inconsistent with the Federal Rules of Civil Procedure and the Court’s
`
`November 21, 2019 Order regarding Damages and Third-Party Subpoena Discovery (D.I. 462).
`
`Genentech further objects to this Topic to the extent that it seeks testimony on information
`
`that is subject to confidentiality obligations to thi

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