Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 1 of 10 PageID #: 25247
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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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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`Defendant.
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`Civ. No. 18-924-CFC
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`Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington,
`Delaware; William F. Lee, Lisa J. Pirozzolo, Emily R. Whelan, Kevin S. Prussia,
`Andrew J. Danford, WILMER CUTLER PICKERING HALE AND DORR LLP,
`Boston, Massachusetts; Robert J. Gunther Jr., WILMER CUTLER PICKERING
`HALE AND DORR LLP, New York, New York; Daralyn J. Durie, Adam R. Brausa,
`DURIE TANGRI LLP, San Francisco, California. Counsel for PlaintifJGenentech,
`Inc.
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`Neal C. Belgam, Eve H. Ormerod, SMITH KATZENSTEIN & JENKINS LLP,
`Wilmington, Delaware; Michelle Rhyu, Susan Krumplitsch, Daniel Knauss,
`COOLEY LLP, Palo Alto, California; Orion Armon, COOLEY LLP, Broomfield,
`Colorado; Eamonn Gardner, COOLEY LLP, San Diego, California. Counsel for
`Defendant Amgen Inc.
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`MEMORANDUM OPINION
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`July 18, 2019
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 2 of 10 PageID #: 25248
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`CONNOLLY, UNITEDSATES DISTRICT JUDGE
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`This action arises under the Biologics Price Competition and Innovation Act
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`of 2009 (BPCIA), Pub. L. No. 111-148, §§ 7001-7003, 124 Stat. 119, 804-21
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`(2010) (codified as amended at 42 U.S.C. § 262, 35 U.S.C. § 271(e), 28 U.S.C. §
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`220l(b), 21 U.S.C. § 355 et seq.). Plaintiffs Genentech, Inc. and City of Hope
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`have sued Defendant Amgen Inc. based on Amgen' s submission of a Biologics
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`License Application (BLA) for approval to market Kanjinti, a biosimilar of
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`Genentech' s drug product Herceptin.
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`On May 15, 2018, Amgen served Genentech a Notice of Commercial
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`Marketing pursuant to § 262(/)(8)(A) of the BPCIA. Kanjinti was approved by the
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`FDA on June 13, 2019. Four weeks later, on July 10, 2019, Genentech moved for
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`a temporary restraining order and preliminary injunction to prevent Amgen from
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`commercially launching, marketing, or selling Kanjinti until the Court renders a
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`decision on the merits of Genentech' s patent infringement claims following trial,
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`and until the Court of Appeals for the Federal Circuit has adjudicated any appeal of
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`that decision. D.I. 273; D.I. 274. That same day, I arranged an emergency
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`teleconference with the parties and orally ordered a standstill until I received
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`Amgen's response to Genentech's motions and had an opportunity to consider
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 3 of 10 PageID #: 25249
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`fully the issues and rule on the merits. For the foregoing reasons, I will deny
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`Genentech' s motions for a temporary restraining order and preliminary injunction.
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`I. BACKGROUND
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`The non-proprietary names for Herceptin and Kanjinti are respectively
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`trastuzumab and trastuzumab-anns. 1 For purposes of a trial scheduled for
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`December 2019, the parties are litigating ten patents which cover: (i) the
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`trastuzumab antibody itself (the Composition Patent)2; (ii) techniques for
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`identifying patients who might benefit from trastuzumab therapy (the HER2
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`Diagnostic Patents )3; (2) various aspects of cell culture, purification, and antibody
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`manufacturing purification (the Manufacturing Patents)4; and (3) methods of
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`administration (the Dosing Patents). D.I. 44; D.I. 60 at 2-3; D.I. 75. Genentech's
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`motions seek relief based on claims in the three Dosing Patents: U.S. Patent Nos.
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`6,627,196 (the "#196 patent"), 7,371,379 (the "#379 patent") and 10,160,811 (the
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`"#811 patent"). All three patents relate to methods of treating cancer with a
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`1 The FDA employs a "naming convention" pursuant to which it gives a "core name"
`to the reference product (in this case, trastuzumab) and adds for each biosimilar a
`"distinguishing suffix that is devoid of meaning and composed of four lowercase
`letters ... attached with a hyphen to the core name" (in this case, "-anns").
`2 U.S. Patent No. 6,407,213 claims the trastuzumab antibody.
`3 The HER2 Diagnostic Patents at issue are U.S. Patent Nos. 7,993,834 and
`8,076,066.
`4 The Manufacturing Patents at issue are U.S. Patent Nos. 6,620,918; 8,512,983;
`8,574,869; and 9,714,293.
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`2
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 4 of 10 PageID #: 25250
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`specific dosage regimen: intravenous ("IV") administration of an initial 8 mg/kg
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`dose followed by one or more 6 mg/kg doses separated by three weeks. D.I. 279-1,
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`Ex. 1, CL 11; Ex. 2, CL 11; Ex. 3, CL 6. The #379 patent further recites
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`coadministration with a chemotherapy agent. Id., Ex. 2, CL 6. The #811 patent
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`further recites treatment of breast cancer. Id., Ex. 3, CL 11.
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`IT. LEGALSTANDARDS
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`A preliminary injunction is "a drastic and extraordinary remedy that is not to
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`be routinely granted." Intel Corp. v. ULSI Sys. Tech., Inc., 995 F.2d 1566, 1568
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`(Fed. Cir. 1993). To obtain such extraordinary relief, the moving party must prove
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`that: ( 1) it has a reasonable likelihood of success on the merits; (2) it would suffer
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`irreparable harm in the absence of an injunction; (3) the balance of hardships tips
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`in its favor; and ( 4) an injunction would have a favorable impact on the public
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`interest. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350
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`(Fed. Cir. 2001). "These factors, taken individually, are not dispositive; rather, the
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`district court must weigh and measure each factor against the other factors and
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`against the form and magnitude of the relief requested." Hybritech Inc. v. Abbott
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`Lab., 849 F.2d 1446, 1451 (Fed. Cir. 1988). The grant or denial of a preliminary
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`injunction is within the sound discretion of the district court. Polymer Tech., Inc.
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`v. Bridwell, 103 F.3d 970, 973 (Fed. Cir. 1996).
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`3
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`The standards for a preliminary injunction also apply to a motion for a
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`temporary restraining order when, as here, the opposing party has notice of the
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`motion. See Takeda Pharm. USA, Inc. v. W.-Ward Pharm. Corp., 2014 WL
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`5088690, at* 1 (D. Del. Oct. 9, 2014). Accordingly, Genentech's motion for a
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`temporary restraining order rises and falls with its motion for a preliminary
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`injunction.
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`III. DISCUSSION
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`"Central to the movant' s burden are the likelihood of success and irreparable
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`harm factors." Sofamor Danek Grp., Inc. v. DePuy-Motech, Inc., 74 F.3d 1216,
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`1219 (Fed. Cir. 1996). "A court may decline to issue a preliminary injunction if
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`the movant does not prove either of these factors." Jeneric/Pentron, Inc. v. Dillon
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`Co., 205 F.3d 1377, 1380 (Fed. Cir. 2000). Here, I am denying the motion for
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`preliminary injunction, because Genentech has failed to establish irreparable harm.
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`A patentee's undue delay in seeking a preliminary injunction "negates the
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`idea of irreparability." Pfizer, Inc. v. Teva Pharm., USA, Inc., 429 F.3d 1364, 1382
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`(Fed. Cir. 2005); Polymer Tech., 103 F.3d at 974 (same). Genentech has known of
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`Amgen's intent to market Kanjinti since Amgen served its 180-day Notice of
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`Commercial Marketing on May 15, 2018. In addition, Genentech received
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`information through discovery that made clear Amgen' s plan to launch its
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`4
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 6 of 10 PageID #: 25252
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`marketing ofKanjinti in July 2019. Specifically, in February 2019, Amgen
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`produced to Genentech documents showing that it filed a "resubmission" to the
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`FDA in December 2018.5 Given the known six-month regulatory timeline for the
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`FDA to consider the resubmission (see D.I. 289-1, Ex. 11 at 4), Genentech would
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`have understood at the time that the FDA would act on the resubmission by the end
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`of June 2019. In April 2019, Amgen produced documents with its launch plan
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`redactions removed, thus enabling Genentech to see that Amgen planned to launch
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`in July 2019. Id. at Ex. 12. From late April through mid-June, five Amgen
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`witnesses testified during depositions that Amgen was preparing to be ready to
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`launch Kanjinti in July 2019. D.I. 289-1, Ex. 14 at 66:12-67:3, 83 :9-12; Ex. 15 at
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`40:20-23; Ex. 16 at 79:6-10, 81 :3-6; Ex. 17 at 18:5-1 0; and Ex. 18 at 32: 11-33: 18.
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`The FDA approved Kanjinti on June 13, 2019. But Genentech did not file
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`its motion for a preliminary injunction until July 10, 2019-fourteen months after
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`receiving the Notice of Commercial Marketing, three months after receiving a
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`fairly specific launch date, and almost one month after Amgen had FDA approval
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`to launch Kanjinti.
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`5 A resubmission is "a submission by the biologics license applicant or supplement
`applicant of all materials needed to fully address all deficiencies identified in the
`complete response letter." 21 C.F.R. § 600.3.
`5
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 7 of 10 PageID #: 25253
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`Genentech' s actions are also contrary to the spirit and purpose of the
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`BPCIA. As the Federal Circuit explained, the 180-day period triggered by the
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`notice of commercial marketing "gives the parties and the district court the time for
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`adjudicating such matters without the reliability-reducing rush that would attend
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`requests for relief against immediate market entry that could cause irreparable
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`injury." Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 1063 (Fed. Cir. 2016), cert.
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`denied, 137 S. Ct. 591 (2016). Thus, the 180-day period is designed to prevent
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`exactly the circumstances that Genentech has engineered in this case-a "race to
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`court for immediate relief to avoid irreparable harm from market entry, and ... the
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`hurried motion practice that (8)(A) is designed to replace."6 Id. at 1065.
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`Genentech's undue delay in requesting a preliminary injunction, particularly
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`in light of relevant provisions under the BPCIA, should be sufficient by itself to
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`deny the motion. Nevertheless, a finding of no irreparable harm is also supported
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`by the fact that Genentech has engaged in a pattern and practice of licensing the
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`Dosage Patents.
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`6 Notably, Genentech demonstrated its ability to avoid hurried motion practice in a
`related case involving the same patents and the same reference product but a
`different defendant. With Amgen, however, Genentech represented to the Court as
`recently as May 16, 2019 that it was not seeking a preliminary injunction. See D.I.
`289-1, Ex. 19 at 26:1-4.
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`6
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 8 of 10 PageID #: 25254
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`An injunction is a form of equitable relief and, therefore, available only
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`when there is no adequate remedy at law. See N. Cal. Power Agency v. Grace
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`Geothermal Corp., 105 S.Ct. 459,459 (1984) ("A party seeking an injunction from
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`a federal court must invariably show that it does not have an adequate remedy at
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`law."); Coca-Cola Bottling Co. of Shreveport, Inc. v. Coca-Cola Co., 769 F. Supp.
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`671, 713 (D. Del. 1991) ("The Court may only invoke its equity powers when there
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`is no adequate remedy at law."). Thus, to establish irreparable harm, the movant
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`must "clearly establish[] that monetary damages could not suffice." Abbott Labs. v.
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`Andrx Pharm., Inc., 452 F.3d 1331, 1348 (Fed. Cir. 2006). The fact that "movants
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`have engaged in a pattern of granting licenses under the patent" makes it
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`"reasonable to expect that invasion of the patent right can be recompensed with a
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`royalty rather than with an injunction." Polymer Tech., 103 F.3d at 974; see also
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`High Tech Med. Instrumentation, Inc. v. New Image Indus., Inc., 49 F.3d 1551,
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`1557 (Fed. Cir. 1995) (offering to license the patent "suggests that any injury
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`suffered by [the patentee] would be compensable in damages"). Here, Genentech
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`granted
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` licenses for the Dosing Patents to Mylan, Celltrion, and Pfizer
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`that allow a biosimilar to enter the market in
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` D.I. 291-1, Exs. 37-39. In other words, Genentech has been
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`able to place a value on the patents and has approved competitors entering the
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`7
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 9 of 10 PageID #: 25255
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`market
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`. Under these facts, any potential damages for sales
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`in the next four months should be quantifiable. See King Pharm., Inc. v. Sandoz,
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`Inc., 2010 WL 1957640, at *6 (D.N.J. May 17, 2010) (denying a preliminary
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`injunction where any changes to the market from the non-movant's entry should be
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`easy to calculate given the short period time).
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`The "absence of irreparable harm ... ma[kes] unnecessary a consideration of
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`... [the] likelihood of success in proving infringement." Ill. Tool Works, Inc. v.
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`Grip-Pak, Inc., 906 F.2d 679, 682 n.3 (Fed. Cir. 1990); Polymer Tech., 103 F.3d at
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`97 4 ("[T]he district court did not err by focusing its analysis solely on irreparable
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`harm in denying [the movant's] motion."). Due to the hurried nature of this
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`particular motion practice, I will not take additional time to set forth my analysis
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`with respect to other preliminary injunction factors. 7 Genentech has failed to
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`7 I will briefly make note of considerations under the fourth factor that also weigh
`in favor of denying the motion for a preliminary injunction. "[A]lthough there
`exists a public interest in protecting rights secured by valid patents, the focus of the
`district court's public interest analysis should be whether there exists some critical
`public interest that would be injured by the grant of preliminary relief." Hybritech
`Inc., 849 F.2d at 1458. For pharmaceutical drugs that prolong and save lives, there
`is a critical public interest in affordable access to those drugs. Genentech itself
`acknowledges this public interest by stating that it is "committed to ensuring
`patient access by providing Herceptin free of charge to patients who are uninsured
`or cannot afford treatment." D.I. 275 at 18. In that context, I note that
`Genentech' s exclusivity based on the Composition Patent expired on June 18,
`2019, and only two of the four indications on the Kanjinti label allegedly infringe
`the Dosing Patents, meaning there are two recited methods of using Kanjinti that
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`Case 1:18-cv-00924-CFC Document 315 Filed 07/22/19 Page 10 of 10 PageID #: 25256
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`establish irreparable harm and therefore its motions for preliminary and temporary
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`injunctive relief must be denied.
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`IV. CONCLUSION
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`For the foregoing reasons, I will deny Genentech' s motions for a temporary
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`restraining order and preliminary injunction (D.I. 273; D.I. 274). The standstill
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`ordered on July 10, 2019 is lifted.
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`The Court will issue an Order consistent with this Memorandum Opinion.
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`are free of any allegations of infringement. "[T]he prospect that an injunction
`would have the effect of depriving the public of access to a large number of non(cid:173)
`infringing features," weighs against granting an injunction. Apple Inc. v. Samsung
`Elecs. Co. Ltd., 735 F.3d 1352, 1372-73 (Fed. Cir. 2013).
`9
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