Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 1 of 7 PageID #: 13475
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 20-1580 (LPS)
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`GUARDANT HEALTH, INC.,
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`Plaintiff,
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`v.
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`FOUNDATION MEDICINE, INC.,
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`Defendant.
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`FOUNDATION MEDICINE, INC.’S SUR-REPLY IN OPPOSITION TO
`PLAINTIFF GUARDANT HEALTH, INC.’S MOTION
`FOR PRELIMINARY INJUNCTION
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`OF COUNSEL:
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`Eric J. Marandett
`G. Mark Edgarton
`Sophie F. Wang
`Diane C. Seol
`CHOATE HALL & STEWART LLP
`Two International Place
`Boston, MA 02110
`(617) 248-5000
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Karen Jacobs (#2881)
`Jeremy A. Tigan (#5239)
`Sarah E. Simonetti (#6698)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`kjacobs@morrisnichols.com
`jtigan@morrisnichols.com
`ssimonetti@morrisnichols.com
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`Attorneys for Defendant
`Foundation Medicine, Inc.
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`PUBLIC VERSION
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`Confidential Version Filed: May 4, 2021
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`Public Version Filed: May 24, 2021
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 2 of 7 PageID #: 13476
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`I.
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`GUARDANT FAILS TO SHOW FMI’S DEFENSES LACK SUBSTANTIAL MERIT
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`Guardant’s consistent reliance on attorney argument, not evidence, fails to prove that
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`FMI’s defenses lack “substantial merit.” This alone warrants denial of its motion. See Kyphon,
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`Inc. v. Disc-O-Tech. Med. Techs. Ltd., 2004 WL 2898064, at *3 (D. Del. Dec. 10, 2004) (denying
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`injunction where patentee “has not presented any expert testimony, but rather relies on attorney
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`argument, to refute” prior art defenses). See also Johnston v. IVAC Corp., 885 F.2d 1574, 1581
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`(Fed. Cir. 1989) (“Attorney[] argument is no substitute for evidence.”).1
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`Obviousness: FMI’s evidence of obviousness in view of Schmitt and other references is
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`entirely unrebutted.2 Guardant’s two-page, unsupported argument in response merely asserts that
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`(i) the ’992 IPR non-institution decision somehow undermines FMI’s invalidity defenses, and (ii)
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`Dr. Gabriel did not list specific ligation conditions or perform an experiment to show reasonable
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`expectation of success. D.I. 46, 3-5. The first challenge is a red herring. Guardant does not—and
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`cannot—explain how the PTAB’s preliminary decision is material, let alone dispositive, given that
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`the patent, legal standard, prior art, and, critically, factual record before the Court sharply differ
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`from that before the PTAB. Guardant’s selective3 reliance on the ’992 IPR is thus improper.
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`As to Guardant’s second argument, Dr. Gabriel’s unrebutted opinions detail how the prior
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`art indisputably discloses the claimed “at least 20%” ligation efficiency. See, e.g., D.I. 31, ¶¶139-
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`67. For example, Schmitt discloses efficiencies “comparable to those seen with standard library
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`preparation methods,” which common textbooks described as being at least 20%. D.I. 31, ¶¶141
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`1 Guardant’s imposition of a “clear and convincing evidence” standard on FMI at the PI stage (D.I.
`8, 16; D.I. 46, 3), rather than on Guardant, is incorrect. See Nat’l Steel Car, Ltd. v. Canadian Pac.
`Ty. Ltd., 357 F.3d 1319, 1335 (Fed. Cir. 2004) (“[V]ulnerability is the issue at the preliminary
`injunction stage,” and requires “less proof than the clear and convincing showing.”).
`2 Dr. Cooper offered no rebuttal opinions and admitted he “didn’t do that analysis” as to prior art
`or whether a POSA could achieve ≥20% ligation efficiency. Ex. 134, 102:20-103:6, 106:10-14.
`3 See HSM Portfolio LLC v. Elpida Memory Inc., 160 F. Supp. 3d 708, 731 (D. Del. 2016)
`(rejecting attempt to “have it both ways” with contradictory obviousness and infringement
`arguments). Compare D.I. 8, 1, 16, with D.I. 46, 10 (arguing importance of ’992 patent both ways).
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 3 of 7 PageID #: 13477
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`(citing Ex. 93, 22:53-56)4, 144 (citing Ex. 53, at A0779), 162; Ex. 149, 53:12-20, 68:16-24.
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`Hendricks and the NEB Manual, neither of which were considered by the PTAB, further disclose
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`specific ligation efficiencies of ≥95% (Ex. 72, ¶[0076]; Ex. 61, 24), and show that “a variety of
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`routine optimization techniques” were known in the art.5 That Dr. Gabriel did not perform an
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`experiment herself is of no moment. First, obviousness does not require enablement of exact,
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`unclaimed conditions. See Amgen Inc. v. Hoechst Marion Roussel, 314 F.3d 1313, 1357 (Fed. Cir.
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`2003); see also, e.g., Ex. 149, 72:5-12. Second, Guardant’s own scientists
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` See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
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`1367-68 (Fed. Cir. 2007); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985) (argument that
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`compound “must be tested” to determine if it will work “does not overcome [prior art’s] teaching”
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`that such compounds “will work”). Notably, Dr. Cooper admitted that POSAs knew how to
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`routinely get ≥20% (even 90%) efficiency, by, e.g., adjusting variables per “molecular biology
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`textbooks” like “Sambrook.” Ex. 134, 136:15-137:4, 124:19-125:4, 142:21-143:7.
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`Indefiniteness/Written Description: Guardant also fails to rebut FMI’s substantial § 112
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`defenses,6 particularly its own expert’s fatal concession that “start and stop is sort of in the eye of
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`the beholder.” Ex. 134, 294:16-295:10. Guardant relies on a contrived ruler analogy and rewriting
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`its grouping limitation to recite “the start” and “the stop” position on “two ends,” rather than “a
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`4 All emphasis is added, and exhibit numbers refer to Appendix Vols. 1-5, unless noted otherwise.
`5 See Ex. 149, 160:25-161:15, 164:12-18, 139:23-140:11; D.I. 26, 6-9. Guardant does not dispute
`(i) the high level of ordinary skill in the art; and (ii) the evidence establishing motivation to
`combine. See, e.g., D.I. 31, ¶¶251-52, 258-59, 365-67; see generally Ex. 134.
`6 While Guardant argues about “the number of cfDNA molecules that map to each mappable base
`position,” (D.I. 46, 9), its broad claims recite “a number,” which is concededly not defined. See
`D.I. 10, ¶161; Ex. 134, 60:7-61:21, 68:2-11, 63:14-64:3, 70:12-20, 78:21-79:12. And for “a set,”
`Guardant itself relies on a hypothetical “set” (“~1.26 x 1030”) of barcodes for written description.
`D.I. 46, 7; Ingevity Corp. v. BASF Corp., 2019 WL 2356978, at *4 (D. Del. June 4, 2019).
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 4 of 7 PageID #: 13478
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`start” and “a stop.” D.I. 46, 5-6; D.I. 49, ¶¶24-25.7 “Courts do not rewrite the claims to narrow
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`them for the patentee to cover only the valid portion.” Alcon Research, LTD v. Apotex Inc., 687
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`F.3d 1362, 1368 (Fed. Cir. 2012). And, because “the patent provides no guidance” regarding the
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`claimed grouping method at all, the terms are indefinite and lack written description.8 Saso Golf,
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`Inc. v. Nike, Inc., 843 Fed. App’x 291, at *13 (Fed. Cir. Feb. 10, 2021). See D.I. 26, 9-14.
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`Non-infringement: Guardant’s infringement9 arguments lack evidentiary support, notably
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`any analysis of FMI’s source code, and ignore the claim language. First, Guardant does not
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`meaningfully dispute
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`that FMI’s source code
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`hypothetical situation
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`its claim that
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`. Yet, Guardant speculates that FMI might literally infringe in a
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` Guardant cites no evidence for this scenario, or for
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`7 Guardant failed to raise such a construction in its opening brief. See Align Tech., Inc. v. 3Shape
`A/S, 2020 WL 5979353, at *3 n.5 (D. Del. Oct. 8, 2020) (arguments not raised in opening brief are
`“untimely and waived.”). Guardant’s contrived analogies also fail because Dr. Cooper admitted
`that “start” and “stop” positions of reads are not precisely identifiable, spatially linear, or limited
`to a single meaning. See Ex. 134, 279:7-20, 293:18-296:3; D.I. 49, ¶24. Dr. Benson similarly
`explained that “start and stop could mean many things.” See Ex. 150, 127:18-22.
`8 Dr. Cooper’s cursory written description opinions do not even address the specification passages
`that Guardant cites as purportedly describing the grouping limitation. See D.I. 49, ¶¶23, 26.
`Indeed, those passages discuss only “sequence information” and “tagging parent molecules” that
`happen to have the “same start and stop positions” with a large number of barcodes, which the
`patent itself disparages as “cumbersome and expensive.” D.I. 46, 6-7; ’086 Patent, 41:1-13.
`9 Guardant argues only literal infringement in its Motion and therefore has waived any argument
`under the doctrine of equivalents. See Align Tech., 2020 WL 5979353, at *3 n.5.
`10 Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005).
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 5 of 7 PageID #: 13479
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`; Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006)
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`(“[C]laims are interpreted with an eye toward giving effect to all terms in the claim.”).
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`Unenforceability: Guardant’s entire rebuttal on unenforceability is centered on its shifting
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`priority claims before the USPTO and in litigation. D.I. 46, 9-11. The Asserted Patents are
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`continuations of the ’992 patent, which on its face claims priority to the infected ’734 Provisional.
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`D.I. 26, 16-17. Moreover, Guardant’s removal of Dr. Eltoukhy as an inventor on the Asserted
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`Patents despite the clear incorporation of his “communication theory” into the claims does not
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`cure—and indeed is further evidence of—the Founders’ inequitable conduct and unclean hands.
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`See Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998). See also 1616
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`Action, D.I. 331-33, Exs. 2, 25, 43, 45, 48-50, 59, 65, 70-71, 79, 83.
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`II.
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`GUARDANT FAILS TO PROVE THE REMAINING PRELIMINARY INJUNCTION FACTORS
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`Irreparable Harm and Balance of Harms: Guardant’s reply arguments lack merit. For
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`example, Guardant asserts that its multi-year delay in seeking an injunction does not preclude
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`irreparable harm because it “is not the law,” yet cites no law. In fact, courts have rejected finding
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`irreparable harm due to a plaintiff’s delay in nearly identical situations. See, e.g., Genentech, Inc.
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`v. Amgen, Inc., 2019 WL 3290167, at *2-3 (D. Del. July 18, 2019) (no irreparable harm where
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`plaintiff knew of launch plan well before seeking injunction); Ex. 133, 54:11-55:9 (Guardant knew
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`11 In any event, Dr. Cooper’s unsupported hypothetical scenario supposes that
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 6 of 7 PageID #: 13480
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`“at least as of Q3 2018” that FMI was seeking CDx approval); Ex. 95. Similarly, Guardant cannot
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`avoid that its prior money damages claim neutralizes its assertion of irreparable harm. D.I. 46, 12.
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`See Integra Lifesciences Corp. v. HyperBranch Med. Tech., Inc., 2016 WL 4770244, at *8 (D.
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`Del. Aug. 12, 2016) (harm that “no damages payment…could address”).
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`Finally, Guardant’s definition of the “status quo” as “the period before August 2020,” (i.e.,
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`before F1LCDx received FDA-approval), rather than November 2020 when this suit was filed and
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`F1LCDx was already on the market, ignores the law. D.I. 46, 13. See Litton Sys. v. Sundstrand
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`Corp., 750 F. 2d 952, 961 (Fed. Cir. 1984) (“status quo” is “that state of affairs existing
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`immediately before the filing of the litigation, the last uncontested status which preceded the
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`pending controversy”); Kos Pharms., Inc. v. Andrx Corp., 369 F.3d 700, 729 (3d Cir. 2004).
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`Public Interest: Through the self-serving declaration of its own executive, Guardant
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`downplays the significance that FMI provides the only FDA-approved CDx for multiple cancer
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`therapies. D.I. 46, 13-15. Dr. Odegaard admitted, however,
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` and because
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`there are physicians “who view FDA approval of novel diagnostic areas like liquid biopsy as
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`necessary before they’re really comfortable using these new modalities.” Ex. 152, 25:3-8, 188:11-
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`189:3. See id. at 118:15-22, 189:16-190:14, 195:13-196:7. Dr. Odegaard also “spoke to no
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`physicians in order to prepare statements for [his] declaration.” Id. at 139:15-140:10.12 Guardant
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`thus cannot credibly argue that no harm would befall the public interest.
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`CONCLUSION
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`In view of the record, Guardant’s motion for a preliminary injunction should be denied.
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`12 In contrast, FMI submitted unrebutted testimony from two independent physicians and one
`biopharmaceutical customer explaining the importance of FDA approval and the negative impact
`of an injunction. See, e.g., D.I. 34-36; Ex. 151, 17:6-11; D.I. 34, ¶¶8, 11. See also Waters Corp.
`v. Agilent Techs., Inc., 410 F. Supp. 3d 702, 718 (D. Del. 2019) (“the public benefits from having
`the continued presence of a product already validated for use in biologic drug development and
`FDA submission is a significant countervailing factor weighing against” an injunction).
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`Case 1:20-cv-01580-LPS Document 73 Filed 05/24/21 Page 7 of 7 PageID #: 13481
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`OF COUNSEL:
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`Eric J. Marandett
`G. Mark Edgarton
`Sophie F. Wang
`Diane C. Seol
`CHOATE HALL & STEWART LLP
`Two International Place
`Boston, MA 02110
`(617) 248-5000
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`May 4, 2021
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Jeremy A. Tigan
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`Karen Jacobs (#2881)
`Jeremy A. Tigan (#5239)
`Sarah E. Simonetti (#6698)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`kjacobs@morrisnichols.com
`jtigan@morrisnichols.com
`ssimonetti@morrisnichols.com
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`Attorneys for Defendant
`Foundation Medicine, Inc.
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