Case 1:18-cv-00924-CFC-SRF Document 479 Filed 01/14/20 Page 1 of 5 PageID #: 33808
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`v.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C. A. No.: 17-1407-CFC-SRF
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` (CONSOLIDATED)
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`C.A. No.: 18-924-CFC-SRF
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`LETTER RESPONSE BY THIRD PARTIES PFIZER, MYLAN, CELLTRION, AND
`TEVA REGARDING AMGEN’S REQUEST FOR CONFIDENTIAL DOCUMENTS
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`AMGEN INC.,
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`GENENTECH, INC.,
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`v.
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`AMGEN INC.,
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`Defendant.
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`Plaintiff,
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`Defendant.
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`OF COUNSEL:
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
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`January 14, 2020
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`
`Dominick T. Gattuso
`HEYMAN ENERIO GATTUSO & HIRZEL LLP
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`dgattuso@hegh.law
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`Attorneys for Third Party Pfizer Inc.
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`Case 1:18-cv-00924-CFC-SRF Document 479 Filed 01/14/20 Page 2 of 5 PageID #: 33809
`Magistrate Judge Sherry R. Fallon
`January 14, 2020
`Page 1
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`Dear Magistrate Judge Fallon:
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`We write as counsel for third-party Pfizer and with the input and consent of third parties
`Mylan, Celltrion, and Teva (collectively, “Third Parties”) and Plaintiffs Genentech, Inc. and F.
`Hoffmann-La Roche Ltd. (collectively, “Genentech”)1 in response to Amgen Inc.’s (“Amgen”)
`motion to compel the production of fully unredacted versions of the confidential settlement
`agreements (collectively, “Third Parties’ Agreements”) reached separately by each third party
`with Genentech, concerning the patents Genentech claims cover Herceptin (trastuzumab) and
`separately the patents Genentech claims cover Avastin (bevacizumab).2 Amgen is also
`requesting that its in-house counsel have complete access to the fully unredacted Third-Party
`Agreements. Amgen is seeking production of these agreements in the above-captioned cases:
`C.A. Nos. 17-1407-CFC (“the Avastin case”) and 18-924-CFC (“the Herceptin case”).
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`Amgen’s request has already been heard—and denied—by this Court. During the
`October 16, 2019 hearing held in these cases, Judge Connolly denied Amgen’s request for
`production of fully unredacted versions of Pfizer’s settlement agreements. Ex. A, October 16,
`Hearing at 293:9-13, 294:4-12, 295:2-12. Instead, Judge Connolly permitted Pfizer to redact
`launch dates from its agreements (id. at 298:18-299:6), and restricted access to the redacted
`documents to only Amgen’s outside counsel. Id. at 296:16-297:14. Judge Connolly’s order was
`limited to Pfizer3, but since that order, Celltrion and Teva have communicated to Amgen that
`they are willing to produce their respective settlement agreements under the conditions that
`Judge Connolly ordered for Pfizer’s settlement agreements, and Mylan is willing to do the
`same.4 The Third Parties now request that Your Honor deny Amgen’s current request to the
`extent it seeks production beyond what Judge Connolly ordered with respect to Pfizer’s
`settlement agreements―i.e., production only to outside counsel and with confidential launch
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`1 As explained below, Genentech takes no position on Amgen’s motion.
`2 Mylan, Pfizer, Celltrion, and Teva are each parties to settlement agreements concerning the
`patents Genentech claims cover Herceptin (trastuzumab). Pfizer is a party to a settlement
`agreement concerning the patents Genentech claims cover Avastin (bevacizumab). Each of
`Mylan, Pfizer, Celltrion and Teva plan to participate in the January 17, 2020 hearing addressing
`this matter.
`3 Id. at 293:9-13, 294:7-12. Pfizer was the only Third Party that had briefed the discovery
`dispute at the time of the hearing. Genentech has produced the Pfizer settlement agreements
`with only non-public launch dates redacted.
`4 Amgen’s representation of the “conditions” attached to production of the agreements consistent
`with the Court’s October 16 order regarding Pfizer’s license (Amgen Ltr. at 2) is
`exaggerated. First, in connection with the preliminary injunction proceedings in the Herceptin
`case, Genentech produced an unredacted version of Celltrion and Teva’s agreement on an
`outside counsel only basis. Second, in offering to agree to production of the agreement in the
`Avastin case under the conditions in Judge Connolly’s October 16 order, Celltrion and Teva
`sought assurance that this nearly year-long debate over production of their agreements in these
`cases would end. There was no intention of limiting discovery in future litigation—it is clear
`now that Amgen misunderstood Celltrion and Teva’s request, but it did not seek clarification at
`the time.
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`Case 1:18-cv-00924-CFC-SRF Document 479 Filed 01/14/20 Page 3 of 5 PageID #: 33810
`Magistrate Judge Sherry R. Fallon
`January 14, 2020
`Page 2
`dates redacted. Amgen’s request is just as overbroad, unnecessary, and highly prejudicial to the
`Third Parties’ business interests as it was when it was previously denied, and Amgen identifies
`no changed circumstances that warrant a different outcome now.
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`As an initial matter, Judge Connolly denied Amgen’s request after Amgen’s product
`launches and Genentech’s request for preliminary injunctions, so these are not new
`circumstances.5 Amgen’s assertion that there is no longer business sensitivity concerning the
`Third Parties’ confidential launch dates and other confidential settlement terms because Amgen
`has already launched its trastuzumab and bevacizumab biosimilar products in the U.S. is plainly
`incorrect. Indeed, Amgen can still settle the pending litigations with Genentech to reduce its
`liability, despite the fact that it has already launched its products. Also, Amgen’s counsel
`admitted during the December 19, 2019 meet and confer that Amgen still has upcoming launches
`in other countries. Knowledge of the confidential terms, including launch dates, of the Third
`Parties’ Agreements would give Amgen an unfair competitive business advantage with respect to
`its upcoming foreign launches as well as in any settlement negotiations with Genentech, to the
`detriment of the Third Parties.
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`Further, Amgen’s argument that Judge Connolly permitted redactions of the launch dates
`in Pfizer’s settlement agreements based on a suggestion by Pfizer that other information in the
`agreements would reveal the launch delay is a blatant mischaracterization of the October 16
`hearing. First, Pfizer did not suggest that other terms would reveal launch delay. Rather, Pfizer
`requested that its launch accelerator provisions should also be redacted. See Ex. A, October 16,
`Hearing at 299:8-300:6. Further, as is plainly discernable from the transcript of the hearing,
`Judge Connolly permitted redaction of launch dates before there was any discussion of
`accelerator provisions (see id. at 298:18-299:6), and the ensuing discussion of whether to redact
`accelerator provisions, in addition to launch dates, did not impact the Court’s decision on actual
`launch dates in any way. See id. at 299:8-300:6.
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`Even if Your Honor were inclined to grant Amgen’s outside counsel access to fully
`unredacted versions of the Third Parties’ Agreements, Your Honor should nonetheless deny
`access to Amgen’s in-house counsel. As a first matter, Judge Connolly did not reserve ruling on
`whether the agreements could be disclosed to in-house counsel under the Protective Order, as
`Amgen claims. Judge Connolly’s ruling was very clear. Id. at 296:19-297:1(“The answer is no.
`I’m only ruling with regard to outside counsel. I’m basically granting Amgen’s application in
`part and I’m saying that the Pfizer agreement will be shared with outside counsel. That does not
`include in-house counsel and that does not include somebody who is in-house and yet files an
`appearance and wants to be considered outside counsel. That’s not outside counsel.”). Judge
`Connolly explained that Amgen could revisit the issue (id. at 297:7-14), but no circumstances
`have changed since October to warrant production to in-house counsel now.
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`Further, production of confidential launch information and sensitive business information
`to in-house counsel raises a significant risk that Amgen will gain an unfair competitive
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`5 Amgen’s allegation that Genentech’s production of redacted Third-Party Agreements violated
`Judge Connolly’s May 16, 2018 Order is wrong. Amgen neither sought relief from the Court
`regarding the alleged violation, nor displayed any urgency in seeking the redacted information.
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`Case 1:18-cv-00924-CFC-SRF Document 479 Filed 01/14/20 Page 4 of 5 PageID #: 33811
`Magistrate Judge Sherry R. Fallon
`January 14, 2020
`Page 3
`advantage (intentionally or unintentionally) over the Third Parties (and Genentech). See, e.g.,
`Letter Order at 5, Jazz Pharm., Inc. v. Amneal Pharm. LLC, No. 13-391 (ES) (JAD) (D.N.J. Dec.
`6, 2017), ECF No. 411 (limiting access of the settlement agreements to counsel not involved in
`any settlement discussions to “strike an appropriate balance” between any purported relevance of
`the agreements and any competitive disadvantage to the producing parties) (Ex. B); AbbVie Inc.
`v. B.I. Int’l GmbH, No. 17-cv-7065-MSG-RL, 2019 WL 1571666, at *4 (D. Del. Apr. 11, 2019)
`(restricting access to the settlement agreements to outside counsel only); Allergan, Inc. v. Teva
`Pharm. USA, Inc., No. 2:15-CV-1455-WCB, 2017 WL 132265, at *4 (E.D. Tex. Jan. 12, 2017)
`(agreeing to condition production of settlement agreements only to movant’s outside counsel and
`on an Attorneys’ Eyes Only basis). Knowing when, and under what circumstances, the Third
`Parties are authorized to launch their bevacizumab and trastuzumab biosimilar products would
`give Amgen an unwarranted “leg up” in making crucial, competitive decisions such as whether
`and on what terms to seek a settlement and as to the timing of any future foreign launches.
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`Amgen has indicated that its in-house counsel contribute to both litigation strategy and
`settlement negotiations. For example, Amgen explained that the involvement of its in-house
`counsel in litigation is part of Amgen’s “unique business structure” and that not allowing in-
`house counsel access to settlement agreements would “be forcing us to create in-house lawyers
`that are settlement only and in-house lawyers that are litigation only,” thus admitting that its in-
`house counsel serve both roles. See Ex. C, May 16 Hearing at 52:9-12. When asked again
`during the December 19, 2019 meet and confer about Amgen’s in-house counsel’s participation
`in settlement strategy and negotiations and launch decisions, Amgen’s counsel affirmed that at
`least one designated in-house counsel will participate in any settlement discussions. Therefore,
`the risk of commercial injury to the Third Parties is extremely high. Indeed, the Third Parties
`should not be forced to divulge their most sensitive business information, such as launch dates,
`because of Amgen’s chosen “unique business structure.”
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`Amgen tries to justify its request by arguing that its outside and designated in-house
`counsel are bound by the terms of the Protective Order, limiting use of the information in the
`Third Parties’ Agreements for litigation purposes only. But courts have recognized that
`individuals cannot compartmentalize knowledge in such a way and have routinely restricted
`access to in house counsel involved in strategic business decisions. PhishMe, Inc. v. Wombat
`Sec. Technologies, Inc., 16-cv-403-LPS-CJB, 2017 WL 4138961, at *2 n.6 (D. Del. Sept. 8,
`2017) (“The primary concern, as it is in all such cases, is the extent to which the human mind is
`such that it becomes very difficult – once one learns of a competitor’s confidential information—
`to completely insulate that information from the thought process involved in providing one’s
`client advice on competition-related issues.”). Here, it is nearly impossible to imagine that
`Amgen’s counsel could separate their knowledge of the terms of the Third-Parties’ Agreements
`from their decision-making concerning settlement strategy and negotiating and providing legal
`advice regarding Amgen’s launch dates. Further, Amgen has failed to articulate any credible
`rationale for why it is necessary for its in-house counsel to have access to such sensitive
`commercial information or why its outside counsel are not capable of representing Amgen’s
`litigation interests with respect to the Third Parties’ Agreements.
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`Lastly, the cases that Amgen cites in support of its request for access by in-house counsel
`are not instructive here because they all address general disputes related to proposed protective
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`Case 1:18-cv-00924-CFC-SRF Document 479 Filed 01/14/20 Page 5 of 5 PageID #: 33812
`Magistrate Judge Sherry R. Fallon
`January 14, 2020
`Page 4
`orders, and do not concern in-house counsel access to settlement agreements containing third
`party confidential information and, in particular, specific launch dates of direct competitors.
`Nor are protective orders from unrelated litigations instructive here for the same reason.
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`For these reasons, the Third-Parties respectfully request that Your Honor deny Amgen’s
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`request for production of fully unredacted copies of the Third Party Agreements to its outside
`and in-house counsel.
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`Genentech takes no position on Amgen’s motion, and this issue is a dispute between
`Amgen and the Third Parties. However, Genentech writes separately to address Amgen’s
`assertion that Genentech “should be precluded from arguing that the deferred launch dates confer
`any value to the patents-in-suit, and from contesting Amgen’s contention that Genentech is
`willing to license the patents-in-suit to a competitor for no value” (Amgen Ltr. at 2) if Amgen
`does not obtain in-house counsel access or unredaction of the ex-U.S. launch dates in these
`agreements. Genentech has produced to Amgen all information in these settlement agreements
`pertaining to the patents-in-suit, and Amgen is fully able to determine the value of the patents-in-
`suit based upon the information that it already has. Moreover, when it comes to Amgen’s own
`agreements with third parties, Amgen has insisted on limiting its production to outside counsel
`only and only to the agreements covering the United States. See Ex. D. Amgen cannot claim
`that it is prejudiced if its access to the terms of Genentech’s agreements with these Third Parties
`is limited in the same manner.
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`DATE: January 14, 2020
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` Respectfully submitted,
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`OF COUNSEL:
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
`
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`/s/_Dominick T. Gattuso__
`Dominick T. Gattuso (No. 3630)
`HEYMAN ENERIO GATTUSO & HIRZEL LLP
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`dgattuso@hegh.law
`
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`Attorneys for Third Party Pfizer Inc.
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