Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 1 of 6 PageID #:
`18059
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`Public Version Filed: May 21, 2019
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`Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 2 of 6 PageID #:
`18060
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`OF COUNSEL:
`William A. Rakoczy
`Lara E. FitzSimmons
`Eric R. Hunt
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 222-6301
`
`
`
`
`
`
`OF COUNSEL:
`Robert V. Cerwinski
`Linnea P. Cipriano
`GOODWIN PROCTOR LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018
`(212) 459-7258
`
`
`Dated: May 14, 2019
`
`James M. Lennon
`DEVLIN LAW FIRM LLC
`1306 N. Broom St., Suite 1
`Wilmington, DE 19806
`(302) 449-7676
`jlennon@devlinlawfirm.com
`
`
`Attorneys for Third Parties
`Mylan N.V., Mylan GmbH, Mylan Inc.,
`Mylan Institutional LLC and
`Mylan Pharmaceuticals, Inc.
`
`Karen E. Keller
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market St., 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`kkeller@shawkeller.com
`
`
`Attorneys for Third Parties Celltrion Inc.,
`Celltrion Healthcare Co., Ltd., Teva
`Pharmaceuticals USA, Inc., and Teva
`Pharmaceuticals International GmbH
`
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 3 of 6 PageID #:
`18061
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`Dear Judge Connolly:
`
`
`We write as counsel for Pfizer, Mylan and Celltrion in response to Amgen Inc.’s
`(“Amgen”) motion to compel the production of the confidential settlement agreements reached
`separately by each Third Party group and Genentech, Inc. and F. Hoffmann-La Roche Ltd.
`(collectively, “Genentech”), concerning the patents Genentech claims cover Herceptin
`(trastuzumab). Amgen is requesting production of these settlement agreements in two cases:
`C.A. Nos. 17-1407-CFC (“the Avastin case”) and 18-924-CFC (“the Herceptin case”).
`
`Disclosure of the Herceptin settlement agreements, which contain the Third Parties’
`highly confidential business information, to Amgen would materially prejudice the Third Parties,
`and this prejudice is disproportional to Amgen’s need for this information in its litigations. The
`Third Parties and Genentech have made every effort to protect the confidentiality of that highly
`sensitive information. This is particularly critical here, where Amgen is a direct competitor of
`(1) the Third Parties on a biosimilar for Herceptin (trastuzumab), and (2) Pfizer on a biosimilar
`for Avastin (bevacizumab). Thus, disclosure of the settlement agreements would confer a
`significant competitive business advantage on Amgen as to not one but two products.
`
`I. Amgen’s Request for the Production of the Settlement Agreements Should Be Denied
`
`The discoverability of these documents is governed by Fed. R. Civ. P. 26(b)(1) and
`hinges on relevance and proportionality, both of which counsel against production here.
`
`Avastin Case: The settlement agreements are irrelevant to any damages analysis in the
`Avastin case. They involve biosimilars to Herceptin, which is an entirely different drug with a
`different degree of commercial success; different patent portfolios; and different biosimilars.
`Moreover, the agreements have no relationship to a reasonable royalty analysis in the Avastin
`case because: (1) they do not concern a bevacizumab biosimilar at issue here and (2) they address
`a variety of other Herceptin disputes in several national and international forums. The
`complicated nature of these settlements, in particular the aggregation of claims concerning
`unrelated products, patents, and disputes, means that they are not useful to determine the arms-
`length value of a royalty for any single patent or the commercial success of any single patent.
`
`Amgen’s allegations that the settlement agreements are relevant to the calculation of a
`reasonable royalty in the Avastin case are misguided and unsupportable. Federal Circuit law
`requires that a license be proven comparable to the hypothetical negotiation for it to be used in a
`reasonable royalty damages analysis. See, e.g., Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d
`1301, 1325-26 (Fed. Cir. 2009); LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51, 77-
`78 (Fed. Cir. 2012) (holding that a settlement agreement executed before trial in an active
`litigation lacked probative value and thus was not admissible). Licenses that are “tainted by the
`coercive environment of patent litigation are unsuitable to prove a reasonable royalty” because
`there is no “voluntary agreement . . . reached between a willing licensor and a willing licensee,
`with validity and infringement of the patent not being disputed.” LaserDynamics, 694 F.3d at
`77. The cases Amgen cites in its letter do not alter this analysis and are distinguishable from the
`facts presently before the court.
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`

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`Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 4 of 6 PageID #:
`18062
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`Hon. Colm F. Connolly, U.S.D.J.
`May 14, 2019
`Page 2
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`Courts have denied discovery of agreements, like the settlement agreements at issue, for
`lack of relevance to the reasonable royalty analysis because such licenses are radically different
`from those that would be reached in a hypothetical negotiation. See e.g., Multimedia Patent
`Trust v. Apple Inc., No. 10-CV-2618-H-KSC, 2012 WL 12868261, *2 (S.D. Cal. Oct. 23, 2012)
`(denying motion to compel production of a worldwide license concerning forty patents resolving
`several lawsuits between direct competitors); Wi-Lan Inc. v. Research in Motion Corp., No. 10-
`CV-859-W-CAB, 2010 WL 2998850, at *4-*5 (S.D. Cal. July 28, 2010) (denying a motion to
`compel because there was “extremely little, if any relevance” of agreements concerning global
`patents); Affinity Labs of Texas v. Apple, Inc., No. 09-CV-4436-CW-JL, 2011 WL 1753982, at
`*12 (N.D. Cal. May 9, 2011) (finding that “[c]ontrolling Federal Circuit law confirms that [a
`settlement resolving five lawsuits between significant competitors and hundreds of patents] is not
`relevant” to damages where there is no discernible link between the patents and the settlement).
`
`Here, in particular, the Third Parties understand that Genentech is seeking damages for
`Amgen’s past activities that fall outside of the Section 271(e) safe harbor. Those infringing
`activities, which establish the date of hypothetical negotiations, would have occurred prior to the
`execution of the settlement agreements, at least with regards to the settlement agreements
`concerning Pfizer and Celltrion. These agreements, therefore, cannot be relevant to this analysis.
`
`Second, Plaintiffs have not moved for a preliminary injunction to enjoin Amgen, making
`any relevance claims regarding the issue of irreparable harm speculative at best. Amgen’s
`boundless request for the settlement agreements is, therefore, not proportional to the needs of the
`case, especially at this time, and Amgen’s request appears to be a classic fishing expedition.
`
`Herceptin Case: The settlement agreements are also irrelevant to the Herceptin case
`where there is no issue before the Court warranting their discovery. As an initial matter, Amgen
`does not have an approved trastuzumab biosimilar with which to enter the market. Moreover,
`there is no claim for past damages, so there will be no reasonable royalty analysis.
`
`Additionally, the Third Parties understand that Plaintiffs have not moved for a
`preliminary injunction to enjoin Amgen from entering the market, and the question of whether
`Plaintiffs will suffer irreparable harm will only be an issue if Amgen decides to launch “at risk”
`or if Genentech is successful on the merits of its infringement case. To date, there is no
`indication that Amgen will do so. The relevance of settlement agreements is strictly tied to the
`specific issues raised in each case, which is critical to the analysis here. For example, in AbbVie
`Inc. v. Boehringer Ingelheim (“B.I.”), the enforceability of the patents due to unclean hands was
`at issue, and the Court found settlement agreements discoverable based in large part on B.I.’s
`argument that AbbVie had a “‘patent thicket’ of ‘overlapping and non-inventive patents’” that
`delayed competition. AbbVie Inc. v. B.I. Int’l GmbH, No. 17-CV-01065, 2019 WL 1571666, at
`*3-4 (D. Del. April 11, 2019) (citations omitted). Furthermore, key facts about the AbbVie
`agreements, including launch dates and the obligation to pay royalties, were already public. See
`AbbVie Inc. v. B.I., D.I. 145 at 5 (Aug. 6, 2018). Even then, however, the Court restricted the
`production of the settlement agreements “subject to the protective order . . . and to review by
`outside counsel only.” AbbVie Inc. v. B.I., 2019 WL 1571666, at *4.
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 5 of 6 PageID #:
`18063
`
`Hon. Colm F. Connolly, U.S.D.J.
`May 14, 2019
`Page 3
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`Despite the differences between the Herceptin and Avastin cases, one aspect is the same:
`Amgen’s request is wholly disproportionate to the needs of each case. Amgen seeks access to
`highly confidential business information of its direct competitors (Pfizer, Mylan, and Celltrion),
`apparently for its settlement negotiations. (See Amgen Ltr. at 3.) Knowing when, and under
`what circumstances, the Third Parties are authorized to launch their biosimilar Herceptin product
`would give Amgen and its counsel an unwarranted “leg up” in making crucial competitive
`decisions such as whether and when to launch “at risk,” and whether and on what terms to seek a
`settlement of the Herceptin case. In fact, Amgen’s letter suggests that it wants access for this
`exact purpose and that if this access were denied, Amgen may not continue to use its “resources
`on settlement negotiations.” It is well-settled that production of settlement agreements for the
`purpose of assessing Amgen’s settlement position is improper. See, e.g., Centillion Data Sys.,
`Inc. v. Ameritech Corp., 193 F.R.D. 550, 553 (S.D. Ind. 1999) (denying production of a
`settlement agreement because Defendants’ “interest in evaluating settlement strategies” did not
`overcome the confidentiality of agreement). The Third Parties and Genentech have agreed to
`strict confidentiality terms to protect the settlement agreements because their disclosure—such as
`that requested by Amgen—can irreparably injure the Third Parties’ proprietary business
`interests.
`
`II. If the Settlement Agreements Were Deemed Relevant, Access Should Be Extremely Limited
`
`If the Court were to require production of the settlement agreements, the Third Parties
`respectfully request that any such production be made subject to the Protective Orders and to the
`following additional restrictions, each of which are supported by good cause:
`
`First, information concerning the specific dates on which the Third Parties can begin
`activities related to the commercial launch of the each Third Party’s trastuzumab product in the
`U.S. and related provisions concerning those dates and all irrelevant information, including
`information about ex-U.S. jurisdictions and information identifying the party to the agreement,
`should be redacted. See e.g., Wi-Lan Inc., 2010 WL 2998850, at *5.
`
`Second, the settlement agreements should be accessed only by outside counsel of record
`for Amgen who will not participate in or advise on settlement negotiations in either the
`Herceptin or Avastin cases. There is a significant risk that Amgen will gain an unfair
`competitive advantage (intentionally or unintentionally) over the Third Parties even with
`redacted versions, especially in the Herceptin case. See e.g., Letter Order at 5, Jazz Pharm., Inc.
`v. Amneal Pharm. LLC, et al., No. 13-391 (ES) (JAD) (D.N.J. Dec. 6, 2017) (limiting access of
`the settlement agreements to counsel not involved in any settlement discussions to “strike an
`appropriate balance” between any purported relevance agreements and any competitive
`disadvantage to the producing parties) (Ex. A); AbbVie Inc. v. B.I. Int’l GmbH, 2019 WL
`1571666, at *4 (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). The risk of commercial injury
`to the Third Parties (and Genentech) is extremely high without such limitations.
`
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`

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`Case 1:18-cv-00924-CFC-SRF Document 214 Filed 05/21/19 Page 6 of 6 PageID #:
`18064
`
`Hon. Colm F. Connolly, U.S.D.J.
`May 14, 2019
`Page 4
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`DATE: May 14, 2019
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` Respectfully submitted,
`
`
`OF COUNSEL:
`Thomas J. Meloro
`Michael W. Johnson
`Diana G. Santos
`WILLKIE FARR & GALLAGHER LLP
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
`
`
`
`
`OF COUNSEL:
`William A. Rakoczy
`Lara E. FitzSimmons
`Eric R. Hunt
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 222-6301
`
`
`
`
`
`
`OF COUNSEL:
`Robert V. Cerwinski
`Linnea P. Cipriano
`GOODWIN PROCTOR LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018
`(212) 459-7258
`
`
`
`/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
`
`
`
`
`Attorneys for Third Parties Pfizer, Inc.
`and Hospira, Inc.
`
`/s/_James M. Lennon ______________
`James M. Lennon (No. 4570)
`DEVLIN LAW FIRM LLC
`1306 N. Broom St., Suite 1
`Wilmington, DE 19806
`(302) 449-7676
`jlennon@devlinlawfirm.com
`
`
`Attorneys for Third Parties
`Mylan N.V., Mylan GmbH, Mylan Inc.,
`Mylan Institutional LLC and
`Mylan Pharmaceuticals, Inc.
`
`/s/_Karen E. Keller________________
`Karen E. Keller (No. 4489)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market St., 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`kkeller@shawkeller.com
`
`Attorneys for Third Parties Celltrion Inc.,
`Celltrion Healthcare Co., Ltd., Teva
`Pharmaceuticals USA, Inc., and Teva
`Pharmaceuticals International GmbH
`
`