Case 1:17-cv-01407-CFC Document 318 Filed 03/26/19 Page 1 of 5 PageID #: 26957
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`Plaintiffs,
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`Consol. Civ. No. 17-1407-CFC
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`GENENTECH, INC. and CITY OF )
`HOPE,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`AMGEN INC.
`
`Defendant,
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`MEMORANDUM ORDER
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`Pending before the Court is a motion by Plaintiffs Genentech, Inc. and City
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`of Hope (collectively, "Genentech") to amend the Protective Order entered on
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`November 5, 2018. (D.I. 291). Genentech argues that the amendment it seeks is
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`necessary so that it can use discovery obtained in this patent infringement action to
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`initiate a new patent infringement action against Defendant Amgen Inc. ("Amgen").
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`(Id.). For the following reasons, the motion is DENIED.
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`1.
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`In November 2016, Amgen filed Biologics License Application No.
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`761028 (the "BLA") seeking approval of ABP 215 (trademark name "Mvasi").
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`Mvasi is a biosimilar to Genentech' s drug product A vastin. On September 14, 2017,
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`the Food and Drug Administration (the "FDA") approved Amgen's BLA. It is
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`1
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`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`Plaintiffs,
`
`Consol. Civ. No. 17-1407-CFC
`
`GENENTECH, INC. and CITY OF )
`HOPE,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`AMGEN INC.
`
`Defendant,
`
`MEMORANDUM ORDER
`
`Pending before the Court is a motion by Plaintiffs Genentech, Inc. and City
`
`of Hope (collectively, "Genentech") to amend the Protective Order entered on
`
`November 5, 2018. (D.I. 291). Genentech argues that the amendment it seeks is
`
`necessary so that it can use discovery obtained in this patent infringement action to
`
`initiate a new patent infringement action against Defendant Amgen Inc. ("Amgen").
`
`(Id.). For the following reasons, the motion is DENIED.
`
`1.
`
`In November 2016, Amgen filed Biologics License Application No.
`
`761028 (the "BLA") seeking approval of ABP 215 (trademark name "Mvasi").
`
`Mvasi is a biosimilar to Genentech' s drug product A vastin. On September 14, 2017,
`
`the Food and Drug Administration (the "FDA") approved Amgen's BLA. It is
`
`1
`
`
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`Case 1:17-cv-01407-CFC Document 318 Filed 03/26/19 Page 2 of 5 PageID #: 26958
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`undisputed that the manufacturing facility identified in the BLA is located in
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`Thousand Oaks, California.
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`2.
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`3.
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`Genentech filed the current patent infringement action in October 2017.
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`In August 2018, Amgen filed Supplemental Biologics License
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`Application No. 761028-003 (the "sBLA"), seeking approval to manufacture Mvasi
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`at a Rhode Island facility. (D.1. 291-1, Ex. 2 at ,r 2).
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`4.
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`Genentech asserts that amendment of the Protective Order is required
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`so that Genentech can use discovery obtained in this litigation to initiate a new patent
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`infringement action against Amgen.
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`(D.I. 291 at 1). Genentech's proposed
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`complaint for the new patent infringement action alleges 26 counts of patent
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`infringement. (D.I. 291-1, Ex. 2). All but one of the counts in the proposed
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`complaint allege that the manufacture ofMvasi at the Rhode Island facility infringes
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`14 different patents held by Genentech (the "Mvasi Claims"). (See Id. at 1il 23-232,
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`243-88). The one non-Mvasi claim alleges that Amgen's manufacture in Rhode
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`Island of the drug product Repatha infringes U.S. Patent No. 9,493,744 (the
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`"Repatha Claim"). (Id. at ,r,r 233-42).
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`5.
`
`The Court finds that the Protective Order it entered on November 5,
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`2018 (D.1. 291) does not preclude Genentech from using information obtained in
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`this action to file the Mvasi Claims in a new patent infringement action. Paragraph
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`28 of the Protective Order states: "Confidential Discovery Material produced by a
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`2
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`
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`Case 1:17-cv-01407-CFC Document 318 Filed 03/26/19 Page 3 of 5 PageID #: 26959
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`Party . . . may be used by a Receiving. Party only for purposes of this Litigation or
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`future United States patent infringement litigation between the Parties arising from
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`Defendant's filing of Biologics License Application No. 761028." (D.I. 209 at ,r 28
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`( emphasis added)). The proposed complaint is for a future United States patent
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`infringement litigation between the parties; and the Mvasi Claims set forth in that
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`proposed complaint arise from Amgen' s filing of the Biologics License Application
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`No. 761028.
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`6.
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`Genentech ties all the Mvasi Claims to Amgen' s filing of Supplemental
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`Biologics License f\pplication No. 761028-003. (D.I. 291-1, Ex. 2). The applicable
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`FDA regulations define a "supplement" as "a request to approve a change in an
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`approved license application." 21 C.F .R. § 600 .3(gg); see also 21 C.F .R. § 601.12
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`(requiring applicants to file a supplement when there are changes to the "product,
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`production process, quality controls, equipment, facilities, responsible personnel, or
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`labeling established in the approved license application" (emphasis added)).
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`Because the Mvasi Claims are based on Amgen's filing of the sBLA, and the sBLA
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`is a request to approve a change in the BLA, the Mvasi Claims arise from Amgen's
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`BLA. There is, therefore, no need to amend the Protective Order for Genentech to
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`use discovery obtained in this litigation to pursue the Mvasi Claims.
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`7. With respect to the Repatha Claim, Genentech bears the burden of
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`demonstrating that the Protective Order should be modified. Phillips Petroleum Co.
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`3
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`Case 1:17-cv-01407-CFC Document 318 Filed 03/26/19 Page 4 of 5 PageID #: 26960
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`v. Rexene Prods. Co., 158 F.R.D. 43, 46 (D. Del. 1994). Courts have discretion to
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`modify the terms of a protective order if the moving party demonstrates "good
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`cause." Pansy v. Borough of Stroudsburg, 23 F.3d 772, 786 (3d Cir. 1994). In
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`Pansy, the Third Circuit identified eight factors that may be considered in evaluating
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`whether good cause exists: ( 1) whether disclosure will violate any privacy interests;
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`(2) whether the information is being sought for a legitimate purpose; (3) whether
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`disclosure will cause embarrassment to a party; ( 4) whether the information to be
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`disclosed is important to public health and safety; ( 5) whether sharing the
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`information among litigants will promote fairness and efficiency; ( 6) whether the
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`party benefitting from the order is a public entity or official; (7) whether the case
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`involves issues important to the public; and (8) the parties' reliance on the order.
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`Invista North Am. S.a.r.l. v. M & GUSA Corp., 2014 WL 1908286, at *9 n. 14 (D.
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`Del. Apr. 25, 2014) (citing Pansy, 23 F.3d at 787-91).
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`8.
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`Applying the Pansy factors, I find that Genentech has failed to establish
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`good cause to amend the Protective Order. In making its motion, Genentech focused
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`exclusively on the Mvasi Claims. (See D.I. 291 at 1-2). But as noted above, the
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`Protective Order does not prohibit Genentech from bringing the Mvasi Claims in a
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`new patent infringement case. Genentech made no attempt to apply any Pansy factor
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`to the Repatha Claim.
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`4
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`Case 1:17-cv-01407-CFC Document 318 Filed 03/26/19 Page 5 of 5 PageID #: 26961
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`9.
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`Against Genentech's weak, if not non-existent, showing of good cause,
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`the Court balances Amgen' s interest in protecting the confidentiality of the material
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`in question. For discovery in this action, Amgen was expected to produce
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`confidential business
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`information
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`related
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`to
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`the design, development,
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`manufacturing, and sale of a drug that is likely to generate billions of dollars in
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`revenue. (D.I. 161-1, Ex. 1 at 38). In order to facilitate this discovery, the parties
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`crafted a Protective Order that all believed would protect the confidentiality of the
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`documents produced. The Court reviewed and signed the Protective Order and
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`understood that the parties would rely on the terms of the Order. "[T]he ability to
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`rely on the Protective Order is essential in cases involving the disclosure of highly
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`confidential business information." In re Intel Corp. Microprocessor Antitrust
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`Litig., 2008 WL 4861544, at* 19 (D. Del. Nov. 7, 2008). Under these circumstances,
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`Amgen' s reliance on the Protective Order outweighs Genentech' s interest in using
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`discovery from this litigation to pursue the Repatha Claim. Thus, Genentech has
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`failed to demonstrate good cause to modify the Protective Order.
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`NOW, THEREFORE, at Wilmington this 26th day of March, 2019, it is
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`HEREBY ORDERED that Genentech's motion to amend the Protective Order (D.I.
`
`291) is DENIED ..
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`5
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