Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 1 of 13 PageID #:
`18946
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`
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`Plaintiffs,
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`Defendant and Counterclaim
`Plaintiff.
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`
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`v.
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`AMGEN INC.,
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`
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` Case No. 1:17-cv-01407-CFC (Consol.)
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`v.
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`AMGEN INC.,
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`
`
`
`
` Case No. 1:18-cv-00924-CFC
`
`Defendant and Counterclaim
`Plaintiff.
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`

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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 2 of 13 PageID #:
`18947
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`AMGEN INC.’S MOTION FOR PARTIAL REARGUMENT
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`Defendant Amgen Inc. (“Amgen”) moves for reargument pursuant to D. Del. LR 7.1.5,
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`regarding certain portions of the Court’s Orders in CA No. 17-1407-CFC (Consol.) (“the Avastin
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`case”) (D.N. 407)1 and CA No. 17-924-CFC (“the Herceptin case”) (D.I. 259).
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`I.
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`FACTS AND PROCEDURAL HISTORY
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`To comply with deadlines set out in each case (March 29, 2019 for Avastin and June 10,
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`2019 for Herceptin), Amgen provided notice that, should its senior management decide to launch
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`either biosimilar product (something that has not occurred), Amgen intends to proffer its senior
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`management’s reliance on the advice of opinion counsel2 as a defense to any allegation that those
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`future launch activities—if undertaken—constitute willful infringement. (D.I. 196; D.N. 201.) In
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`neither instance did Amgen assert that it would (or indeed could) proffer such reliance on advice
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`of counsel to defend against allegations that any of its past activities constituted willful
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`infringement.3
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`On June 13, 2019 Plaintiffs Genentech, Inc. and City of Hope (collectively, “Plaintiffs”)
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`moved to compel production of documents and witnesses for deposition stemming from Amgen’s
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`indication of its intent to assert reliance on the advice of counsel defense against any future
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`assertion of willful patent infringement based on product launch. (D.N. 393and 395; D.I. 253,
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`254.) Amgen filed its responsive briefs on June 14, 2019. (D.N 398-399; D.I. 255.)
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`This Court heard a joint argument on June 18, 2019 as part of a discovery conference that
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`1 For clarity, docket entries in the Avastin case will be cited as “D.N.” and docket entries in the
`Herceptin case will be cited as “D.I.”
`2 Amgen produced Opinion Letters for the Kao and Baughman patents in the Herceptin case and
`for the Kao, Gawlitzek, Carvalhal, and Fyfe patents in the Avastin case.
`3 Plaintiffs have asserted in the Avastin case, but not the Herceptin case, that certain past activities
`are safe harbor violations. As explained at the hearing, Amgen will rely on its safe harbor, non-
`infringement, and invalidity defenses, and will not rely on any opinions of counsel, for those
`allegations of past willful infringement. (See Tr. 31:15-32:5.)
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 3 of 13 PageID #:
`18948
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`had been scheduled in the Avastin case, in view of overlapping arguments in the two cases with
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`respect to the disputed scope of waiver. During the argument, the Court asked counsel for Amgen
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`for caselaw supporting the proposition that the work product of in-house counsel that “is not
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`communicated to the decision-maker through the reliance of counsel” should not be produced.
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`(June 18, 2019 Hearing Transcript (“Tr.”) at 44:4-8; 46:23-47:2.) In addition to citing to In re
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`EchoStar Communications Corp., 448 F.3d 1294 (Fed. Cir. 2006), Amgen’s counsel cited
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`Convolve, Inc. v. Compaq Computer Corp., 2007 WL 4205868 (S.D.N.Y. Nov. 26, 2007), which
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`interpreted EchoStar to hold that in-house counsel’s privileged work product that was not
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`communicated to the decision makers was not waived where the accused infringer relied on the
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`advice of counsel as a defense to allegations of ongoing infringement. Convolve, 2007 WL
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`4205868, at *5. Near the conclusion of argument on the issue, the Court asked Genentech’s
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`counsel for its preference as to whether to provide further briefing to aid decision on the issue or
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`accept the Court’s ruling from the bench. (Tr. at 82:3-15.) The Court did not provide Amgen the
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`same option for further briefing.
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`The Court on June 20, 2019 issued written Orders citing the reasons stated during the June
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`18, 2019 hearing. (D.I. 259, D.N. 407.) While the Court recognized that communications with
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`outside trial counsel and uncommunicated work product of outside trial counsel were not subject
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`to waiver (Tr. at 40:3-14; 41:6-11; 45:22-46:1), the Court stated, “I did not see [EchoStar] define
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`a decision-maker as confined to one person or as not including in-house counsel. So in my mind,
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`Amgen is the decision-maker and Amgen’s ultimate decisions are informed by the knowledge of
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`[] a number of people within its organization. That includes in-house counsel.” (Tr. at 41:21-
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`42:1.) Accordingly, the Court found that Amgen’s production of the Opinion Letters “has effected
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`a subject matter waiver of Amgen’s attorney-client privilege” concerning validity and/or
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`-2-
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 4 of 13 PageID #:
`18949
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`infringement of the patents at issue in the Opinion Letters. (D.I. 259, D.N. 407.) The Court’s
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`Orders provide that “[t]he waiver extends to communications pre-dating the Opinion Letters and
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`extends to Amgen’s in-house counsel,” including work product that was not communicated to
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`decision-makers concerning the subject matter addressed in the opinions. (Id.; D.N. 407; Tr. at
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`41:6-11.) The Orders also required completion of production by July 2, 2019. (D.I. 259; D.N.
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`407.)
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`II.
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`ARGUMENT
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`Amgen respectfully moves for reargument pursuant to D. Del. LR 7.1.5. Reargument may
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`be appropriate in three circumstances: “a) where the Court has patently misunderstood a party, b)
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`where the Court has made a decision outside the adversarial issues presented to the Court by the
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`parties, or c) where the Court has made an error not of reasoning but of apprehension ….” Schering
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`Corp. v. Amgen, Inc., 25 F. Supp. 2d 293, 295 (D. Del. 1998) (internal quotations and citations
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`omitted). The Court should exercise its discretion to reconsider an order where there has been a
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`clear error of law or fact and to prevent manifest injustice. Pac. Biosciences of CA., Inc. v. Oxford
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`Nanopore Techs., Inc., C.A. No. 17-275-LPS, 2019 WL 2453780, at *1 (D. Del. June 12, 2019)
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`(citing Max’s Seafood Café by Lou-Ann, Inc. v. Quinteros, 176 F. 3d 669, 667 (3d Cir. 1999)).
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`Here, there are three errors of apprehension that will result in manifest injustice: First, the
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`scope of waiver of attorney-client communications should apply only to communications between
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`in-house counsel and the relevant decision-makers; second, Amgen in-house counsel are not de
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`facto clients or decision-makers; and third, EchoStar and subsequent cases establish that in-house
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`counsel’s work product not communicated to decision makers is not subject to waiver.
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`A.
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`The scope of waiver involving an advice-of-counsel defense to willful
`infringement depends on the relevant decision and the actual decision-maker
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`The U.S. Supreme Court has recognized that willfulness is not a general inquiry into any
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 5 of 13 PageID #:
`18950
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`decision made at any time by a company, but instead that willfulness is focused on “the knowledge
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`of the actor at the time of the challenged conduct.” Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S.
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`Ct. 1923, 1933 (2016) (emphases added).
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`Here, there is no “challenged conduct” that has yet occurred that forms the basis of a
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`willfulness allegation against which Amgen is proffering reliance on opinion of counsel. Indeed,
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`the potential “challenged conduct” in these cases will not even occur unless Amgen acts on a
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`decision to launch its biosimilar products prior to the expiration of the Plaintiffs’ asserted patents.
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`Thus, although Amgen has indeed made earlier decisions to establish its manufacturing methods
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`and obtain regulatory approval for its biosimilar products, the only decision it will attempt to
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`defend by reliance on advice of counsel is the decision to engage in product launch activities.
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`Similarly, responsibility for the decision to engage in future challenged conduct—should
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`it occur—is not borne by everyone in the company, but by those having the authority to direct the
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`company to engage in the challenged conduct. Indeed, other courts have recognized that “the
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`actor” within a corporation is the individual or individuals who have authority to and who make
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`the decision, and not the corporation as a whole. See, e.g., Collaboration Props., Inc. v. Polycom,
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`Inc., 224 F.R.D. 473, 476-77 (N.D. Cal. 2004) (“Even if documents informing Polycom’s state of
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`mind were deemed waived by virtue of assertion of reliance on advice of counsel, the problem
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`here is that CPI has not provided any evidence that the state of mind of the engineers who authored
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`or received the documents can be imputed to Polycom. CPI has not, for example, offered any
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`evidence indicating that the engineers are high-level officers whose statements may be imputed to
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`Polycom.”); see also Convolve, Inc., 2007 WL 4205868, at *5 (in-house counsel work product not
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`discoverable if not shared with relevant decision makers or opinion counsel); see also Medtronic
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`Inc., 2013 WL 12149252, at *10.
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 6 of 13 PageID #:
`18951
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`The Supreme Court’s focus on the knowledge of (i) the actor (ii) at the time of the
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`challenged conduct is significant. While the Supreme Court’s standard accounts for cumulative
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`information known to the actor, regardless of when the information was learned, it excludes
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`information that was never communicated to the actor. In contrast, this Court’s ruling expands the
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`willfulness analysis to cover the uncommunicated knowledge of legal advisers who may not even
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`be employed at Amgen at the time of a potential launch decision (“the challenged conduct”). But
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`according to the willfulness inquiry set forth in Halo, a former in-house employee’s
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`uncommunicated mental impressions would be irrelevant given that the former employee could
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`not possibly be considered “the actor” and will not even be at the company “at the time the
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`challenged conduct” is performed.
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`If Amgen launches its products prior to expiration of the asserted patents, senior executives
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`who will decide whether or not to place each product into the market are the actors who will
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`authorize the conduct that Plaintiffs will allege is willfully infringing. They are thus the relevant
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`decision-makers, and information and communications that informed their state of mind are the
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`salient materials to which waiver should apply.
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`B.
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`Amgen’s in-house counsel should not be presumed to be de facto decision-
`makers at all, much less the decision-makers having authority for launch
`decisions
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`Treating in-house attorneys as de facto decision-makers would eviscerate the work product
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`privilege entirely for in-house counsel. The core concept of the work product privilege is that it
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`protects the legal theories, mental impressions, strategy, and thoughts of an attorney performing
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`her “legal duties.” Hickman v. Taylor, 329 U.S. 495, 510-11 (1947) (“[I]t is essential that a lawyer
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`work with a certain degree of privacy, free from unnecessary intrusion by opposing parties and
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`their counsel.”) If in-house counsel were treated as solely performing a business function, then no
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`work product protection would ever apply to work performed by in-house counsel following
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 7 of 13 PageID #:
`18952
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`reliance on inside or outside opinions of counsel. The draconian result would strongly deter any
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`accused infringer from relying on opinions of counsel, lest their in-house counsel’s files be fair
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`game for their opponent. This disincentive to careful consideration of patents cannot be the law.
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`Across various contexts and scenarios, courts have consistently recognized that in-house
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`counsel’s activities are provided protection when that counsel is acting in a legal role as opposed
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`to a business role. See, e.g., In re Ford Motor Co., 110 F.3d 954, 966 (3d Cir. 1997), abrogated
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`by Mohawk Indus., Inc. v. Carpenter, 110 F.3d 954 (2009); Faloney v. Wachovia Bank, N.A., 254
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`F.R.D. 204, 209-10 (E.D. Pa. 2008) (finding work product applied to documents created by in-
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`house counsel serving as legal adviser, while acknowledging that counsel could have a dual role).
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`Here, the Court effectively assumed that Amgen’s in-house counsel are de facto decision-makers,
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`despite Genentech having offered no facts in support of such a conclusion. Numerous decisions
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`recognize that merely having the role of in-house counsel is not enough to make an attorney a
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`decision-maker. See, e.g., TiVo Inc. v. Verizon Commc’ns, Inc., 2010 WL 9430466, at *2-3 (E.D.
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`Tex. June 15, 2010) (ruling that one of the accused infringer’s in-house counsel was a competitive
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`decision-maker, due to his participation on the board of directors of two affiliated companies of
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`the accused infringer, but that another in-house counsel who prosecuted patent applications was
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`not a competitive decision-maker); see also Amgen, Inc. v. Elanex Pharms., Inc., 160 F.R.D. 134,
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`139 (W.D. Wash. 1994) (finding various Amgen in-house attorneys not competitive decision-
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`makers).
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`Further—and critically—Genentech offered no facts that any of Amgen’s in-house
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`counsel—even if decision-makers in other contexts—could ever be considered “actors” having the
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`authority and discretion to decide whether Amgen would engage in product launch. By presuming
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`that all Amgen attorneys were decision-makers as to product launch, in the absence of any factual
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 8 of 13 PageID #:
`18953
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`record, the Court mis-apprehended the role of Amgen’s in-house counsel. Amgen respectfully
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`requests reargument as to all rulings that rely on the assumption that all of Amgen’s in-house
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`attorneys are decision-makers as to product launch.
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`C.
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`Amgen should not be found to have waived protection for in-house counsel
`work product that has not been communicated to the relevant decision-makers
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`The Court ruled that disclosure of the Opinions Letters resulted in waiver of in-house
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`counsel’s deliberations about the subject matter of the Opinion Letters, regardless of whether the
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`deliberations were communicated to any client/decision-makers at Amgen. (See Tr. at 46:2-50:2.)
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`First, as discussed above, the Court’s ruling incorrectly found that in-house counsel always
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`acts as the client rather than as legal advisers to the client.
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`Second, this Court misapprehended the Federal Circuit’s reasoning in In re EchoStar
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`Communications Corp.. That court held there was no waiver of uncommunicated work product
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`from opinion counsel by explaining, “[w]ork-product waiver extends only so far as to inform the
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`court of the infringer’s state of mind. Counsel’s opinion is not important for its legal correctness.
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`. . . It is what the alleged infringer knew or believed, and by contradistinction not what other items
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`counsel may have prepared but did not communicate to the client, that informs the court of an
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`infringer’s willfulness.” 448 F.3d 1294, 1303 (Fed. Cir. 2006), cert. denied, 127 S. Ct. 846 (U.S.
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`2006) (emphasis added).
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`Other courts have embraced this reasoning to protect in-house counsel work product from
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`waiver following reliance on advice of counsel. In Medtronic Inc. v. Edwards Lifesciences Corp.,
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`Plaintiff moved to compel production of documents and deposition testimony of Defendant’s in-
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`house counsel (Kaiser). 2013 WL 12149252, at *10 (D. Minn. Nov. 8, 2013). In-house counsel
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`had worked with opinion counsel, analyzed the opinions of counsel and relayed the opinions to
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`decision-makers. Still, the Court protected the sanctity of in-house counsel’s work product: “[I]f
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 9 of 13 PageID #:
`18954
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`she possessed information that did not derive from [opinion counsel] or held opinions bearing on
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`validity (or invalidity), infringement (or noninfringement) or unenforceability and she did not
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`share that information or those opinions with the decisionmakers, then Medtronic is not entitled to
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`inquire into her personal knowledge or private opinions. In other words, just as Medtronic is not
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`entitled to ask outside opinion counsel to disclose information and opinions that outside counsel
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`never shared with the decisionmakers within Edwards, Medtronic is not entitled to query Kaiser
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`regarding information or opinions she may have harbored, which did not come from outside
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`counsel and which she did not share with these same decisionmakers.” Id. (emphasis added.)
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`Various other courts have recognized the sanctity of in-house counsel’s uncommunicated
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`work product. See, e.g., Convolve, Inc., 2007 WL 4205868, at *5 (denying further discovery from
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`in-house counsel because waiver “does not extend to work product that was not communicated to
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`the alleged infringer”) (internal quotation omitted)); see also Wis. Alumni Research Found. v.
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`Apple, Inc., 2015 WL 5009880, *1-2 (W.D. Wis. Aug. 20, 2015) (plaintiff was not entitled to
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`(i) information regarding why in-house counsel decided to discuss or not discuss certain topics
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`with opinion counsel, or (ii) in-house counsel’s communications with prosecution, IPR or litigation
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`counsel).
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`Courts have particularly recognized that uncommunicated work product is not probative of
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`the state of mind of the accused infringer. See Thorn Emi N. Am., Inc. v. Micron Tech., Inc., 837
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`F. Supp. 616, 622 (D. Del. 1993) (“The facts of consequence to the determination of a claim of
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`willful infringement relate to the infringer’s state of mind. Counsel’s mental impressions,
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`conclusions, opinions or legal theories are not probative of that state of mind unless they have been
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`communicated to that client.”); Steelcase Inc. v. Haworth, Inc., 954 F. Supp. 1195, 1198–99 (W.D.
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`Mich. 1997) (“The Federal Circuit has made it clear that the infringer’s intent, not that of counsel,
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`#: 18955
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`is the relevant issue. . . . [T]he scope of waiver of the attorney-client privilege must be broad
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`enough to illuminate the issues found relevant by the Federal Circuit, but no broader. . . . [T]he
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`scope of the waiver appears narrow, as it pertains to the attorney’s state of mind.”); In re Seagate
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`Tech., LLC, 497 F.3d 1360, 1369-70 (Fed. Cir. 2007) (discovery does not extend to work product
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`not communicated to an accused infringer), abrogated by Halo Elecs., Inc. v. Pulse Elecs., Inc.,
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`136 S. Ct. 1923 (2016). These cases compel protection of the work product of Amgen’s in-house
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`attorneys that has not been communicated to Amgen client/decision-makers.
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`D.
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`Amgen requests a separate schedule for willfulness discovery and a phased
`trial
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`Amgen further requests separating the willful infringement issues (and related discovery)
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`from the invalidity and infringement issues in this case, so as to provide the Court sufficient time
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`to consider these issues, while avoiding undue delay in the ongoing litigation. Quantum Corp. v.
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`Tandon Corp., 940 F.2d 642, 643-44 (Fed. Cir. 1991) (noting that trial courts “should give serious
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`consideration” to separating willfulness from other issues). To avoid disruption of upcoming case
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`deadlines, Amgen proposes that willfulness discovery and any related expert reports proceed on a
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`separate schedule from the liability issues in the case. 4 Following trial on liability issues,
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`willfulness would then be presented to the jury only if necessary. See Genentech, Inc. et al. v.
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`Amgen Inc., C.A. Nos. 17-1407 and 18-924, Tr. at 99:21-101:4 (D. Del. May 16, 2019). (“I have
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`real concerns that willfulness or inducement is used to prove infringement in front of a jury”);
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`Robert Bosch LLC v. Pylon Mfg. Corp., 2009 WL 2742750, at *1 n.3 (D. Del. Aug. 26, 2009)
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`(granting Defendant’s motion to bifurcate and noting that “[w]illfulness is an intrusive and
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`4 In the meantime, Amgen has offered to proceed with the depositions of any witnesses who are
`not solely related to willfulness, and to provide second depositions (if necessary) of any such
`witnesses after the Court issues a ruling on this motion. Genentech declined to proceed in this
`manner.
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 11 of 13 PageID
`#: 18956
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`inflammatory issue to discover and try.”) Amgen respectfully requests that the Court order the
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`parties to meet-and-confer and submit proposed schedules in each case.
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`E.
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`Amgen requests additional time to comply with the Court’s order
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`Amgen has been diligently collecting and reviewing documents and will begin its
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`production in short order. However, given the technical and time-intensive process of identifying,
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`collecting, reviewing, and producing the materials covered by the Court’s initial order, and given
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`that Amgen is shut down the week of July 1-5, Amgen is unable to complete production within the
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`time initially set by the Court. The scope of the Court’s present order involves more than
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`producing collected documents previously identified on a privilege log.5 Amgen has to perform
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`updated collections from custodians and counsel, process those documents for loading into a
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`review system, review the documents to identify the proper materials, and process them for
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`production. To the extent the Court grants Amgen’s request for reargument, Amgen respectfully
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`requests that the final compliance deadline be set for two weeks from the date of the order. In the
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`alternative, if the Court denies reargument, Amgen respectfully requests an additional three weeks
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`from the Court’s original deadline (i.e., to July 23, 2019) to comply with the Court’s order.
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`III. CONCLUSION
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`For the foregoing reasons, Amgen respectfully moves for reargument pursuant to D. Del.
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`LR 7.1.5. and requests the Court’s adoption of Amgen’s Proposed Order provided herewith.6
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`
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`
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`5 In both the Avastin and Herceptin cases, both sides have agreed that documents post-dating at
`least the filing of the complaint do not need to be logged. Accordingly, there was no obligation
`for Amgen to log a large majority of the material at issue here.
`6 Proposed orders and redlines against the relevant portions of the prior orders are submitted
`concurrently.
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`SMITH, KATZENSTEIN & JENKINS, LLP
`
`/s/ Neal C. Belgam
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attorneys for Defendant Amgen Inc.
`
`Dated: June 27, 2019
`
`Of Counsel:
`
`Michelle Rhyu
`Daniel Knauss
`Susan Krumplitsch
`Cooley LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`P (650) 843-5000
`rhyums@cooley.com
`dknauss@cooley.com
`skrumplitsch@cooley.com
`
`Orion Armon
`Cooley LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`P (720) 566-4000
`oarmon@cooley.com
`
`Eamonn Gardner
`Cooley LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`P (858) 550-6000
`egardner@cooley.com
`
`Lois Kwasigroch
`Nancy Gettel
`Amgen Inc.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P (805) 447-1000
`loisk@amgen.com
`ngettel@amgen.com
`
`-11-
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`Case 1:18-cv-00924-CFC-SRF Document 266 Filed 06/27/19 Page 13 of 13 PageID
`#: 18958
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`
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`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`
`
`
`/s/ James L. Higgins
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
`
`
`
`Attorneys for Amgen Inc.
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`
`
`
`
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`OF COUNSEL:
`
`Siegmund Y. Gutman
`PROSKAUER ROSE LLP
`2029 Century Park East, Suite 2400
`Los Angeles, CA 90067-3010
`(310) 557-2900
`
`Steven M. Bauer
`Kimberly A. Mottley
`Gourdin W. Sirles
`PROSKAUER ROSE LLP
`One International Place
`Boston, MA 02110
`(617) 526-9600
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`-12-
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