`34333
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC.,
`
`Plaintiff,
`
`v.
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`C.A. No. 18-924-CFC-SRF
`Original Version Filed: Feb. 20, 2020
`Public Version Filed: Feb. 27, 2020
`
`AMGEN’S OPENING LETTER IN ADVANCE OF FEBRUARY 25, 2020 DISCOVERY
`TELECONFERENCE
`
`SMITH, KATZENSTEIN & JENKINS, LLP
`
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`10000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attorneys for Defendant Amgen Inc.
`
`Of Counsel:
`
`Michelle Rhyu
`Daniel Knauss
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`650-843-5287
`mrhyu@cooley.com
`dknauss@cooley.com
`
`Orion Armon
`Eamonn Gardner
`COOLEY LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`egardner@cooley.com
`
`Dated: February 20, 2020
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 516 Filed 02/27/20 Page 2 of 5 PageID #:
`34334
`
`Dear Magistrate Judge Fallon:
`
`
`Amgen respectfully requests that the Court compel Genentech to produce a witness to
`testify on Topics 50 and 51 in Amgen’s Second Notice of 30(b)(6) Deposition. These topics seek
`testimony concerning Genentech’s past admissions to the Patent Office that other patents than
`those scheduled to be litigated at the upcoming trial in this case drive sales of the branded drug at
`issue, Herceptin. This has significant implications for Genentech’s damages claims because
`Genentech can only recover the value attributable to the asserted patents, and no more. Not
`surprisingly, Genentech has stymied Amgen’s efforts to obtain this discovery. At first, Genentech
`refused to provide a witness, claiming that its written statements “speak for themselves.” Later,
`after several rounds of correspondence, Genentech attempted to retroactively designate a witness
`after she testified, even though she provided no testimony about Genentech’s admissions, and
`counsel for Amgen was not given any prior notice. The Court should not endorse Genentech’s
`tactics to sidestep its discovery obligations.
`
`Relevant Factual Background
`
`I.
`
`Here, Genentech claims that Amgen’s manufacture and sale of its biosimilar drug, Kanjinti,
`infringes Genentech’s asserted method patents. After Kanjinti was launched in the market,
`Genentech amended its complaint to seek money damages, including lost profits from lost sales of
`its drug Herceptin. Damages discovery is ongoing and trial is set for April 20, 2020.
`
`On November 27, 2019, Amgen timely propounded 30(b)(6) deposition Topics 50 and 51,
`which sought a corporate representative to testify about Genentech’s admissions in other court and
`administrative agency proceedings that Genentech patents other than the presently asserted
`patents-in-suit drove consumer demand for, and the commercial success of, Genentech’s drug
`Herceptin. (Ex. A [Nov. 27, 2019 Amgen Inc.’s Second Notice of Deposition, at 1, and Topics
`50-51].) Topics 50 and 51 are set forth below:
`
`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.
`
`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.
`
`
`The testimony that Amgen seeks is highly relevant to the appropriate measure of
`Genentech’s damages, which must be tied to the incremental value provided by the alleged
`inventions of Genentech’s patents-in-suit. As described in more detail below, Amgen narrowed
`these Topics during the meet-and-confer process to focus on Genentech’s statements in other
`district court and Patent Office proceedings that three other patent families—and not the presently
`asserted patents—were the primary drivers of the commercial success of Genentech’s drug
`Herceptin. Genentech made those arguments to preserve the validity of those patents. This
`includes, for example, Genentech’s ’213 Patent and ’441 Patent:
`
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`1
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`Case 1:18-cv-00924-CFC-SRF Document 516 Filed 02/27/20 Page 3 of 5 PageID #:
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` “Some of Genentech’s most successful antibodies embody the ’213 claims, including
`Herceptin… together generating billions of dollars in revenue annually. … This commercial
`success confirms the non-obviousness of the challenged claims.” (Ex. B [Celltrion, Inc. v.
`Genentech, Inc. IPR2017-01373, Patent Owner’s Response, Paper No. 38 at 66 (P.T.A.B.
`Mar. 8, 2018)]);
`
` “[T]he ’441 invention has been an enormous commercial success. Herceptin® is the
`commercial embodiment of the ’441 invention and one of the most successful drugs of all
`time. There is a direct nexus between Herceptin®’s commercial success and the ’441
`invention. From 1998 until 2006, the only approved first-line use of Herceptin® was in
`combination with a taxoid, as claimed in the ’441 patent. … Following its launch,
`Herceptin® was quickly adopted, resulting in hundreds of millions of dollars in sales in those
`years immediately following its approval.” (Ex. C [Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00731, Patent Owner’s Response, Paper No. 50 at 60 (P.T.A.B. Dec. 22, 2017)].)
`
`Despite the relevance of the discovery that Amgen sought through Topics 50-51,
`Genentech refused to designate a witness to testify regarding either topic:
`
` On December 20, 2019, Genentech served Responses and Objections to Amgen’s Second
`30(b)(6) Notice, refusing to designate a witness to testify on Topics 50 and 51. (Ex. D
`[Genentech’s Responses and Objections, dated Dec. 20, 2019] at 90-91.)
`
` On January 8, 2020, Amgen narrowed its request and explained in detail that Genentech
`should designate a corporate witness to testify regarding facts and data underlying
`Genentech’s statements in various district court proceedings and inter partes reviews
`(including those cited above), because of the relevance of those statements to Genentech’s
`claims for lost profits damages for lost sales of Herceptin.
`
` On January 20, 2020, Genentech served Amended Responses and Objections to Amgen’s
`Second 30(b)(6) Notice, refusing again to designate a witness for Topics 50 and 51. (Ex. E
`[Genentech’s Amended Responses and Objections, dated Jan. 20, 2020] at 90-91.)
`
` On January 22, 2020, Genentech informed Amgen that it maintained its objections. (See Ex.
`F [Jan. 22, 2020 Ltr from Wiener to Armon] at 3.) The next day, on January 23, 2020, Amgen
`deposed Melissa Abreu, Genentech’s corporate witness designated on various other topics,
`but not Topics 50 and 51. At no point before or during Ms. Abreu’s deposition did Genentech
`inform Amgen that they intended to designate Ms. Abreu to testify regarding Topics 50 and
`51.
`
` On January 23, 2020, Amgen again demanded a corporate witness to testify on Topics 50
`and 51, given that the Topics “are directly relevant to calculation of money damages based
`on alleged infringement of the patents-in-suit (including but not limited to lost profits and/or
`apportionment).” (Ex. G [Jan. 23, 2020 Ltr from Armon to Wiener] at 2-3.)
`
` On January 28, 2020—five days after Ms. Abreu’s deposition—Genentech stated that Ms.
`Abreu had been prepared to answer questions regarding Topics 50-51, and claimed that
`
`
`
`2
`
`
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`Case 1:18-cv-00924-CFC-SRF Document 516 Filed 02/27/20 Page 4 of 5 PageID #:
`34336
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`Amgen could have asked Ms. Abreu about them. (Ex. H [Jan. 28, 2020 Ltr from Wiener to
`Armon] at 2.)
`
` On January 29, 2020, Amgen again set forth with specificity the scope of the requested
`testimony and sought to confer. (See Ex. I [Jan. 29, 2020 Ltr from Armon to Wiener] at 3.)
`The parties held final meet-and-confer teleconferences regarding Topics 50-51 on January
`29 and 31, 2020, and reached an impasse.
`
`II.
`
`The Court Should Compel Genentech To Produce a Witness to Testify Regarding
`Topics 50 & 51
`
`Amgen seeks facts that are highly relevant to the calculation of money damages in this
`case. Indeed, Genentech has never disputed the relevance of the information sought. It is well-
`established that, where multiple patents cover a product (or methods of making or using the
`product), damages may only be awarded for the apportioned value of each patent found to be
`infringed. Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Sys., LLC, 350
`F.3d 1327, 1346 (Fed. Cir. 2003) (vacating and remanding lost profits award for the entire value
`of the device where the court failed to apportion damages to account for the infringing and non-
`infringing features driving customer demand); see also Riles v. Shell Exploration and Prod. Co.,
`298 F.3d 1302, 1311–12 (Fed. Cir. 2002) (vacating reasonable royalty award for damage because
`patentee’s evidence of a reasonable royalty based on the entire value of the product failed to
`associate the proposed royalty with the value of the patented method); Ericsson, Inc. v. D–Link
`Sys., Inc., 773 F.3d 1201, 1233 (Fed. Cir. 2014) (“[T]he patent holder should only be compensated
`for the approximate incremental benefit derived from his invention.”). Genentech’s refusal to
`provide a witness to testify on Topics 50 and 51 improperly prevents Amgen from obtaining
`discovery that could substantially reduce the amount of any damages awarded in this case.
`
`Genentech’s initial refusal to designate a Rule 30(b)(6) witness regarding its own
`statements in proceedings before the U.S. Patent Office was baseless, claiming that these
`statements “speak for themselves.” (Ex. D at 90-91.) Amgen is entitled to discover through
`deposition testimony the facts, data and background information underlying Genentech’s
`admissions. In Ethypharm S.A. France v. Abbott Laboratories, this Court rejected similar
`arguments that a party’s production of documents is sufficient to obviate a Rule 30(b)(6)
`deposition, and granted a motion to compel production of a 30(b)(6) witness. 271 F.R.D. 82, 94
`n.89 (D. Del. 2010); see also In re Vitamins Antitrust Litig., 217 F.R.D. 229, 233 (D.D.C. 2002)
`(rejecting the argument that the Rule 30(b)(6) deposition “would serve no useful purpose” because
`documents related to the topic had already been produced). Indeed, both parties to this lawsuit
`have designated Rule 30(b)(6) witnesses to testify about many other documents that contain party
`statements (for example, annual reports, contracts, and press releases).
`
`Genentech’s later claim, that Amgen could have and should have examined Ms. Abreu on
`Topics 50 and 51, is also baseless. Ms. Abreu was never designated for those topics, and she
`provided no testimony about Genentech’s statements to the Patent Office. Designating a witness
`“after the fact is not an acceptable substitute for such designation being made prior to the
`deposition.” Hasbro, Inc. v. MGA Entm’t, Inc., CA 06-262 S, 2006 WL 8456970, at *4 (D.R.I.
`Sept. 1, 2006) (rejecting attempt to retroactively designate a Rule 30(b)(6) witness and ordering
`production of a corporate witness). Amgen is entitled to know in advance what topics a witness
`
`
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`3
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`Case 1:18-cv-00924-CFC-SRF Document 516 Filed 02/27/20 Page 5 of 5 PageID #:
`34337
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`is prepared to offer testimony on behalf of Genentech, as it naturally affects the “questions which
`the witness may be asked and which s/he may be required to answer.” See id. To ensure an orderly
`discovery process, Rule 30(b)(6) requires the noticing party to “describe with reasonable
`particularity the matters for examination,” and the responding party to “set out the matters on
`which each person designated will testify.” Fed. R. Civ. P. 30(b)(6). If Ms. Abreu was prepared
`to answer questions regarding Topics 50 and 51, Genentech should have designated her for those
`Topics and apprised Amgen of those designations within a reasonable time before the deposition
`of Ms. Abreu, but it did not.
`
`Amgen seeks highly relevant testimony through Topics 50-51. Genentech has no
`legitimate basis to refuse to designate a corporate witness to testify regarding these Topics. Amgen
`thus respectfully requests that this Court compel Genentech to do so.
`
`Respectfully submitted,
`
`/s/ Eve H. Ormerod
`
`Eve H. Ormerod (No. 5369)
`
`Enclosures
`
`Cc:
`
`
`
`Clerk of Court (via hand delivery)
`All Counsel of Record (via email)
`
`
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`4
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