Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 1 of 18 PageID #: 13358
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`RAVGEN, INC.,
`
`
`
`
`
`v.
`
`ARIOSA DIAGNOSTICS, INC.,
`ROCHE SEQUENCING SOLUTIONS, INC.,
`ROCHE MOLECULAR SYSTEMS, INC., and
`FOUNDATION MEDICINE, INC.,
`
`
`
`RAVGEN, INC.,
`
`
`
`
`
`v.
`
`MYRIAD GENETICS, INC., and
`MYRIAD WOMEN’S HEALTH, INC.,
`
`
`
`RAVGEN, INC.,
`
`
`
`
`
`v.
`
`BIORA THERAPEUTICS, INC.,
`
`
`
`
`
`Plaintiff,
`
`Defendants.
`
`Plaintiff,
`
`Defendants.
`
`Plaintiff,
`
`Defendant.
`
`
`
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`
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`
`
`
`
`
`
`
`
`
`
`C.A. No. 20-cv-1646-RGA-JLH
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`JURY TRIAL DEMANDED
`
`
`
`
`
`
`
`
`
`C.A. No. 20-cv-1730-RGA-JLH
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`C.A. No. 20-cv-1734-RGA-JLH
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`JURY TRIAL DEMANDED
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`
`
`PLAINTIFF’S OPPOSITION TO DEFENDANTS’ MOTION
`TO SET AN EARLY INEQUITABLE CONDUCT TRIAL
`
`
`Dated: August 14, 2023
`
`
`
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`FARNAN LLP
`919 N. Market St., 12th Floor
`Wilmington, DE 19801
`Telephone: (302) 777-0300
`Facsimile: (302) 777-0301
`
`John M. Desmarais (pro hac vice)
`Kerri-Ann Limbeek (pro hac vice)
`
`
`
`

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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 2 of 18 PageID #: 13359
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`Brian D. Matty (pro hac vice)
`Jamie L. Kringstein (pro hac vice)
`Kyle G. Petrie (pro hac vice)
`Joze Welsh (pro hac vice)
`Jun Tong (pro hac vice)
`Deborah J. Mariottini (pro hac vice)
`Peter Zhu (pro hac vice)
`Benjamin N. Luehrs (pro hac vice)
`Frederick J. Ding (pro hac vice)
`Julianne M. Thomsen (pro hac vice)
`William Benjamin Nichols (pro hac vice)
`DESMARAIS LLP
`230 Park Avenue New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
`jdesmarais@desmaraisllp.com
`klimbeek@desmaraisllp.com
`bmatty@desmaraisllp.com
`jkringstein@desmaraisllp.com
`kpetrie@desmaraisllp.com
`jwelsh@desmaraisllp.com
`jtong@desmaraisllp.com
`dmariottini@desmaraisllp.com
`pzhu@desmaraisllp.com
`bluehrs@desmaraisllp.com
`fding@desmaraisllp.com
`jthomsen@desmaraisllp.com
`wnichols@desmaraisllp.com
`Attorneys for Plaintiff Ravgen, Inc.
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 3 of 18 PageID #: 13360
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`
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`I. 
`
`II. 
`
`TABLE OF CONTENTS
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`Page
`
`INTRODUCTION ...............................................................................................................1 
`
`RELEVANT FACTUAL BACKGROUND ........................................................................2 
`
`A. 
`
`B. 
`
`C. 
`
`Defendants Convinced The Court To Halt These Cases For A Year To Let
`The PTAB Resolve Defendants’ Preferred Invalidity Defenses And
`Repeatedly Promised The Court Those Defenses Would End These Cases.
`..................................................................................................................................2 
`
`Roche Has Admitted In Other Litigations That The “Controversy” That
`Defendants Argue As The Basis For Inequitable Conduct Was Actually
`Resolved In Ravgen’s Favor. ...................................................................................3 
`
`Judge Klausner Did Not Consider PTAB Final Written Decisions Or
`Roche’s Contradictory Positions When He Decided Summary Judgment
`And Scheduled A Bench Trial. ................................................................................4 
`
`III. 
`
`ARGUMENT .......................................................................................................................5 
`
`A. 
`
`B. 
`
`C. 
`
`The Court Should Not Modify The Case Schedule For A Second Time To
`Give Another Defense Chosen By Defendants Priority Over Ravgen’s
`Claims. .....................................................................................................................6 
`
`Judicial Resources Will Not Be Conserved By An Early Bench Trial, And
`Resources Will Instead Be Wasted If Defendants Fail To Produce
`Sufficient Evidence To Warrant Any Trial On Inequitable Conduct. .....................7 
`
`Any Trial On Inequitable Conduct Should Occur At The Same Time As
`A Jury Trial For Efficient Resolution Of All Claims. ...........................................11 
`
`IV. 
`
`CONCLUSION ..................................................................................................................13 
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 4 of 18 PageID #: 13361
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`
`
`Cases 
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`AAMP of Fla., Inc v. Auto. Data Sols., Inc.,
`No. 8:13-CV-2019-T-35TGW, 2015 WL 12843845 (M.D. Fla. Oct. 8, 2015) ................ 10
`
`Armament Sys. & Procs., Inc. v. IQ Hong Kong, Ltd.,
`2007 WL 101230 (E.D. Wisc. Jan. 10, 2007) ................................................................... 12
`
`Aventis Pharma S.A. v. Hospira, Inc.,
`675 F.3d 1324 (Fed. Cir. 2012)......................................................................................... 10
`
`California Inst. of Tech. v. Broadcom Ltd.,
`No. CV 16-3714-GW (AGRX), 2019 WL 8807748 (C.D. Cal. July 1, 2019), aff’d,
`25 F.4th 976 (Fed. Cir. 2022) ........................................................................................... 10
`
`Gomez v. Trustees of Harvard Univ.,
`676 F.Supp. 13 (D.D.C. 1987) ............................................................................................ 7
`
`Hoffman v. Jacobi,
`No. 4:14-CV-00012-SEB, 2014 WL 5488430 (S.D. Ind. Oct. 29, 2014)........................... 7
`
`Koninklijke Philips N.V. v. Telit Wireless Sols., Inc.,
`No. 20-1708-CFC (D. Del. Feb. 22, 2023) ....................................................................... 12
`
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`No. CV 17-14-JFB-SRF, 2019 WL 365708 (D. Del. Jan. 30, 2019) ................................ 12
`
`Neology, Inc. v. Fed. Signal Corp.,
`No. CA 11-672-LPS-MPT, 2012 WL 4342070 (D. Del. Sept. 21, 2012) .......................... 6
`
`Robocast, Inc. v. Apple Inc.,
`39 F. Supp. 3d 552 (D. Del. 2014) .................................................................................... 13
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011)........................................................................................... 8
`
`Vaxcel Int’l Co. v. HeathCo LLC,
`No. CV 20-224-LPS, 2022 WL 611067 (D. Del. Feb. 3, 2022) ......................................... 6
`
`WebXchange Inc. v. Dell Inc.,
`No. CIV.A. 08-132-JJF, 2009 WL 5173485 (D. Del. Dec. 30, 2009) ................................ 7
`
`
`
`
`
`
`
`ii
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 5 of 18 PageID #: 13362
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`Ravgen opposes Defendants’ rehashed request to again change the case schedule to
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`prioritize Defendants’ new preferred defense (inequitable conduct) over Ravgen’s claims. If a
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`bench trial on inequitable conduct is ultimately needed in this case, it should be conducted at the
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`same time as any jury trial to resolve both sides’ claims concurrently when the Court, witnesses,
`
`and counsel are available for trial. That approach is routine whenever jury issues and bench issues
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`both need to be litigated, and Defendants provide no compelling reason for departing from that
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`standard approach to give their current favorite defense preferential treatment. The Court should
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`deny Defendants’ motion for an early bench trial (C.A. No. 20-1730, D.I. 157 (“Motion”)).
`
`I.
`
`INTRODUCTION
`
`Defendants are asking the Court for a third time to give priority to a defense of Defendants’
`
`choosing before litigating Ravgen’s infringement claims. Any defendant would prefer to take
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`multiple, serial chances at defenses before ever having to face a jury on a plaintiff’s claims. But
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`such an approach is the antithesis of judicial efficiency, and Defendants’ request should be denied
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`for that reason alone.
`
`Defendants again promise a defense that—according to Defendants—will eliminate these
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`cases and avoid up to four jury trials, but such promises from Defendants have fallen flat before.
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`Defendants’ best defense in this case was invalidity, and Defendants obtained a stay to allow IPRs
`
`challenging Ravgen’s patents to proceed first. Defendants repeatedly argued that the stay would
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`simplify the issues and eliminate these cases, just as they are arguing again now. But Defendants’
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`arguments proved incorrect. The stay did not simplify issues and did not eliminate any case (or
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`even any single Ravgen patent claim). And when these cases restarted after the stay, Defendants’
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`first action was to ask the Court to prioritize their next-favorite defense of inequitable conduct in
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`the post-stay case schedule. The Court correctly denied that request, and nothing has changed
`
`since. Yet Defendants continue unabashed, asking the Court now for the third time to give
`1
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`preferential treatment to a new defense that they promise will be case-dispositive. Defendants’ re-
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`run request is unprecedented and unjustified, and Defendants cannot show good cause to
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`reconfigure the case schedule to allow Defendants to serially try defenses of their choosing.
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`Defendants’ renewed promise that their next defense will carry the day does not justify
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`further modifying the schedule. And the interests of justice do not favor allowing Defendants serial
`
`chances to try their defenses before Ravgen ever gets its day in court. The Court should deny
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`Defendants’ Motion and leave the case schedule undisturbed.
`
`II.
`
`RELEVANT FACTUAL BACKGROUND
`A.
`
`Defendants Convinced The Court To Halt These Cases For A Year To Let The
`PTAB Resolve Defendants’ Preferred Invalidity Defenses And Repeatedly
`Promised The Court Those Defenses Would End These Cases.
`
`On November 29, 2021, Myriad moved for a stay pending IPR; the other Defendants later
`
`joined that motion. See C.A. No. 20-1730, D.I. 52; C.A. No. 20-1646, D.I. 100; C.A. No. 20-1734,
`
`D.I. 54. Defendants argued extensively that a stay would simplify issues and eliminate these cases.
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`C.A. No. 20-1730, D.I. 53 at 8 (“If the PTAB invalidates all of those claims, the case will likely
`
`be over[.]”); C.A. No. 20-1730, D.I. 58 at 1 (“Taken together, all five instituted IPRs make it likely
`
`that the PTAB will not just simplify the issues in this case, but dispose of the case in its entirety.”),
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`8 (“The IPRs will likely invalidate some or all of the asserted claims, making any time spent
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`addressing those claims a wasted effort.”); C.A. No. 20-1734, D.I. 54 at 2 (“Therefore, resolution
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`of the IPRs may dispose of two of these cases in their entirety, and the majority of the remaining
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`cases.”). Defendants maintained those positions throughout the stay, even as the IPRs were failing
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`to eliminate any claims. C.A. No. 20-1730, D.I. 78 at 8 (“[F]or FMI the case would be resolved
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`entirely if the challenged ’720 Patent claims are determined to be unpatentable in the upcoming
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`decisions.”); C.A. No. 20-1730, D.I. 80 (“There thus remains a good possibility that the Illumina
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`2
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 7 of 18 PageID #: 13364
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`IPRs will greatly simplify if not eliminate the cases before this Court[.]”). Then, after the IPRs
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`upheld all claims, the Court lifted the stay on February 13, 2023. C.A. No. 20-1730, D.I. 84.
`
`After the stay was lifted, Defendants immediately sought to prioritize their next favorite
`
`defense, asking for an early inequitable conduct trial ahead of summary judgment in the post-stay
`
`schedule. C.A. No. 20-1730, D.I. 87 at 10. In a letter to the Court regarding the schedule,
`
`Defendants put forth the same arguments they now repeat in their Motion. See C.A. 20-1730, D.I.
`
`87-1 at 3–4. The Court correctly denied Defendants’ request to expedite the inequitable conduct
`
`defense. Hearing Transcript of March 10, 2023 Scheduling Conference at 7:5–7.
`
`B.
`
`Roche Has Admitted In Other Litigations That The “Controversy” That
`Defendants Argue As The Basis For Inequitable Conduct Was Actually
`Resolved In Ravgen’s Favor.
`
`Defendants harp on repeated allegations that there was “controversy” about Ravgen’s
`
`experimental results, but even defendant Roche has previously argued that there was nothing to
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`the alleged “controversy.” In an opposition at the European Patent Office, Roche addressed the
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`same issues raised by the same papers Defendants argue about now (Chinnapapagari and Chung),
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`recounting that there had been “allegedly contradictory results of different research groups, some
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`reporting a stabilizing effect of formaldehyde (Dhallan et al. and Benachi et al.) while others
`
`reported no effect (Chinnapapagari et al. and Chung et al.).” Ex. 1 at 17.
`
`But while Defendants argue here that the “controversy” was so serious that the scientific
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`community allegedly “discredited” Dr. Dhallan’s invention (Motion at 8), Roche took the exact
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`opposite position in the EPO. Ex. 2 at 13–15. Specifically, Roche admitted that later papers,
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`including a 2008 study by Zhang et al.,1 “confirm[ed] the hypothesis proposed by Dhallan et al.,”
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`a finding that contradicted the very same Chinnapapagari and Chung papers that Defendants now
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`1 The Zhang study (attached hereto as Exhibit 3) is referred to as “D10” in the EPO papers.
`3
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 8 of 18 PageID #: 13365
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`extoll because those authors had deviated from Dr. Dhallan’s methods. Id. at 15. As Roche
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`admitted, “[Zhang] could indeed explain and rationalize the previously observed differences”
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`because “[t]he authors of [Zhang] noted differences in the sample processing times of the different
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`research groups.” Ex. 1 at 17.
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`And ultimately, as Roche admitted, “[a] protective effect of formaldehyde could indeed be
`
`detected if the whole blood sample was stored for a prolonged period of time before plasma
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`preparation,” validating Ravgen’s and Dr. Dhallan’s reported results. Id.; see also Ex. 2 at 15
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`(“[Zhang] resolved the controversy in the prior art and … confirmed that formaldehyde addition
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`preserves [cell-free fetal DNA] integrity and relative abundance in maternal plasma samples which
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`are to be stored for more than 24 hours.”).
`
`C.
`
`Judge Klausner Did Not Consider PTAB Final Written Decisions Or Roche’s
`Contradictory Positions When He Decided Summary Judgment And
`Scheduled A Bench Trial.
`
`Defendants rely heavily on Judge Klausner’s actions in the Quest case,2 which occurred in
`
`very different circumstances than those currently before this Court. In Quest, Judge Klausner
`
`issued an opinion (now vacated) denying the parties’ cross-motions for summary judgment on
`
`inequitable conduct. Quest, D.I. 449; D.I. 492. That opinion issued before the numerous PTAB
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`decisions repeatedly upholding Ravgen’s claims despite the Chinnapapagari and Chung papers
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`and did not even address materiality. The vacated opinion stated that “there are multiple inferences
`
`which could be drawn, not ‘a single most reasonable inference,’ as to why the [sic] Dr. Dhallan
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`and Dr. Cronin did not disclose the known publications to the PTO…. Having found a dispute as
`
`to the element of specific intent, the Court need not address whether the omitted references are
`
`material.” Quest, D.I. 449 at 13–14. Judge Klausner also noted that “Ravgen presented evidence
`
`
`2 Ravgen, Inc. v. Quest Diagnostics Inc. et al., No. 21-9011-GK-GJS (C.D. Cal.).
`4
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`that [Drs. Dhallan and Cronin] did not believe the [references] to be relevant comparisons” to the
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`patented methods, and that Ravgen also had not submitted third-party references to the PTO that
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`supported its results. Id. at 13. Trial was scheduled to begin on October 11, 2022. At the pretrial
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`conference, Judge Klausner noted he preferred to hold the bench trial first for ease of rescheduling
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`around his criminal docket, but could start the jury trial the very next day after the bench trial. Ex.
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`4 [Quest, D.I. 477] at 19:19–23:8 (“[Ravgen’s counsel:] All I’m saying is, we can start the trial on
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`the first day and do the PTO trial. We will be finished in one day. And the very next day pick the
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`jury. THE COURT: Yes. Okay.”). On October 7, 2022, as often happens on the eve of trial, the
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`parties settled. Quest, D.I. 492.
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`After the Quest case settled, the PTAB ruled on the instituted IPR petitions that these cases
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`were halted for, finding all claims patentable in every single final decision. In each of those IPRs,
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`the very references that were allegedly material to patentability of the patents-in-suit were before
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`the PTO, but the claims were nevertheless upheld. The PTAB found that all claims were
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`patentable over the references petitioners raised because there was no motivation to combine those
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`references or because the references failed to disclose all elements of the claims. IPR2021-01271,
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`Paper 45 at 43, 48–49; IPR2021-01272, Paper 50 at 56; IPR2021-01054, Paper 51 at 48; IPR2021-
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`00902, Paper 55 at 48; IPR2021-01026, Paper 51 at 38–40; IPR2021-01577, Paper 62 at 87.
`
`III. ARGUMENT
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`Defendants’ Motion should be denied for three reasons. First, Defendants have already
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`upended the case schedule once to try their best defense, and the Court already denied the same
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`request Defendants now re-raise to prioritize their next-best defense. Second, judicial economy
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`does not favor prioritizing inequitable conduct because Defendants’ burden is high and holding a
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`bench trial before dispositive motions would result in greater expenditure of judicial resources, not
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`5
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`less. Third, to the extent any trial on inequitable conduct is necessary at all in these cases, it should
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`occur at the same time as any jury trial to resolve all claims at the same time.
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`A.
`
`The Court Should Not Modify The Case Schedule For A Second Time To Give
`Another Defense Chosen By Defendants Priority Over Ravgen’s Claims.
`
`“A schedule may be modified only for good cause and with the judge’s consent.” Fed. R.
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`Civ. P. 16(b)(4). Defendants’ subjective belief in the strength of their defense is not a “good cause”
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`for which the Court should depart from the basic rules of case scheduling. See Vaxcel Int’l Co. v.
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`HeathCo LLC, No. CV 20-224-LPS, 2022 WL 611067, at *3 (D. Del. Feb. 3, 2022) (denying
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`motion for early summary judgment because although defendant “undoubtedly believe[d] that its
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`arguments are ‘compelling’ and will, once heard, end this case,” there was no reason to change the
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`schedule to “accord early priority to [defendant’s] case-dispositive motions”). Defendants should
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`not be given priority to take a shot at another defense before Ravgen has any chance to litigate its
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`own claims. Case schedules are made to allow both sides to develop their cases in parallel, not to
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`allow the side that promises it has a stronger case to go first. See Vaxcel, 2022 WL at *3; Neology,
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`Inc. v. Fed. Signal Corp., No. CA 11-672-LPS-MPT, 2012 WL 4342070, at *2 (D. Del. Sept. 21,
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`2012) (denying motion to file early summary judgment because “[t]he purpose of a scheduling
`
`order is to provide concrete deadlines on which the parties can rely in planning their respective
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`litigation strategies”). And given that Defendants have already had a chance to let their prior best
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`(and ultimately unsuccessful) invalidity defense go first, it would be manifestly unfair to prioritize
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`Defendants’ next-best defense ahead of Ravgen’s claims.
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`The sudden urgency in Defendants’ request to accelerate case deadlines for the inequitable
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`conduct defense to resolve it “early next year”—and before summary judgment—is belied by
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`certain Defendants’ failure to even plead the defense until just a few weeks ago. C.A. No. 20-1730,
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`D.I. 144 (Myriad amended pleading adding inequitable conduct issues on July 13, 2023). That
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`6
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`delay for a defense Defendants claim is so critical that it should be fast-tracked ahead of all other
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`issues in these cases is unexplainable considering Myriad was granted leave to add its inequitable
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`conduct defense over three months ago. C.A. No. 20-1730, D.I. 99. Defendants’ feigned urgency
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`is transparent, and the Court should see through it and leave the case schedule unchanged.
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`B.
`
`Judicial Resources Will Not Be Conserved By An Early Bench Trial, And
`Resources Will Instead Be Wasted If Defendants Fail To Produce Sufficient
`Evidence To Warrant Any Trial On Inequitable Conduct.
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`Defendants’ main argument for an early bench trial is that it could preserve judicial
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`resources. Motion at 9–10. But proving inequitable conduct is notoriously difficult. The Court
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`need not (and indeed could not) decide the merits of the inequitable conduct defense on the current
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`incomplete record. Until the record is fully developed and the Court has an opportunity to assess
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`Defendants’ inequitable conduct defense at the summary judgment stage, it is just as likely that
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`Defendants’ requested early trial would waste judicial resources rather than conserve them.
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`WebXchange Inc. v. Dell Inc., No. CIV.A. 08-132-JJF, 2009 WL 5173485, at *3 (D. Del. Dec. 30,
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`2009) (denying motion to bifurcate and hold early bench trial on inequitable conduct because
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`judicial economy argument was merely “based on the assumption that Defendants will succeed”
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`and there was a high burden to prevail).
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`Defendants not only ask the Court to schedule a bench trial on inequitable conduct before
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`any jury trials, but also ask the Court to schedule the bench trial before any summary judgment
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`motions. Motion at 10. Trying inequitable conduct prematurely, before the pressure-test of
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`summary judgment, will not serve the purposes of justice and judicial economy. Hoffman v.
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`Jacobi, No. 4:14-CV-00012-SEB, 2014 WL 5488430, at *3 (S.D. Ind. Oct. 29, 2014) (“The
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`purpose of pre-trial procedure is to serve the best interests of justice by eliminating unnecessary
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`proof and issues and weeding out unsupportable claims.”) (citing Gomez v. Trustees of Harvard
`
`Univ., 676 F.Supp. 13, 15 (D.D.C. 1987)). Even in the Quest case on which Defendants rely
`7
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`heavily, the Court scheduled a bench trial for inequitable conduct only after summary judgment
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`motions and also after the pre-trial conference, at the very end of the case.3 There is no reason to
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`take a drastically different approach here, and certainly no reason to simply assume a vacated
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`summary judgment decision based on a very different record in Quest necessarily guarantees
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`inequitable conduct defenses will survive summary judgment here. At the very least, the Court
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`should keep the current schedule and allow summary judgment to determine whether any trial on
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`this defense will even be necessary.
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`Defendants also argue that the vacated opinion in Quest indicates the “seriousness” of their
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`inequitable conduct allegations (Motion at 2), but that argument is misguided. For inequitable
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`conduct, Defendants must prove both (1) but-for materiality and (2) specific intent to deceive.
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`Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011). The Quest
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`opinion—in addition to being vacated—did not reach the issue of materiality at all, much less
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`conclude that the Chinnapapagari and Chung references were material. Quest, D.I. 449 at 13–14.
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`And ample evidence will show that these references are not material: they are third-party
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`publications that—as Roche has admitted in its EPO opposition proceedings—merely purport to
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`have failed to reproduce the results in Dr. Dhallan’s publication, as often happens in the regular
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`course of scientific experimentation and discovery. See Ex. 1 at 17–18; Ex. 2 at 13–15. And the
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`Chinnapapagari and Chung references do not show that Dr. Dhallan’s work was “discredited by
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`the scientific community,” as Defendants argue (Motion at 8)—rather, other publications
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`supported Dr. Dhallan’s work, which has been adopted by nearly every major industry player in
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`3 Defendants insinuate that Judge Klausner scheduled the bench trial first because of his belief in
`the merits of their defense. But when that determination was made, Judge Klausner made clear
`that his concern was ability to reschedule any trial around his criminal docket, which was easier
`for a bench trial. Ex. 4 [Quest, D.I. 477] at 19:19–23:8.
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 13 of 18 PageID #: 13370
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`the non-invasive prenatal testing space. See Ex. 3 (Zhang study “confirm[ing] the hypothesis
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`proposed by Dhallan et al.”), Ex. 5 (Benachi study “conclud[ing] that formaldehyde increases the
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`percentage of free fetal DNA in maternal plasma or serum by inhibiting maternal cell lysis”).
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`Defendants (including Roche) asking to hasten their inequitable conduct defense is
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`particularly indefensible in view of Roche’s directly contrary arguments in other proceedings.
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`Roche itself admitted that there was nothing to the “controversy” surrounding the Chinnapapagari
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`and Chung references—with the scientific community accepting Dr. Dhallan’s discovery.
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`Defendants cannot credibly claim that Dr. Dhallan’s experiments were so faulty as to warrant
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`inequitable conduct when Roche publicly endorsed Dr. Dhallan’s results over
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`the
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`Chinnapapagari and Chung critics and unequivocally admitted that any “controversy” spurred
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`by their papers was “resolved” in Dr. Dhallan’s favor. See Ex. 2 at 15. Indeed, Roche maintained
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`that position in multiple filings, all the way through its appeal brief in the EPO, admitting that
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`“[Zhang] clearly demonstrates that formaldehyde treatment increased … the percentage of cell-
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`free fetal DNA during long-term storage by stabilizing cells.” Ex. 6 at 13. Now that it is facing
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`Ravgen’s infringement claims, however, Roche switches sides—without disclosing its prior
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`position to the Court and without even mentioning the prior arguments or the EPO opposition in
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`the Motion—to claim that the Chinnapapagari and Chung papers definitively disprove Ravgen’s
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`reported results. When Roche has previously agreed that the Chinnapapagari and Chung articles
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`were immaterial because others soon proved Ravgen was right all along, it is hard to fathom how
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`Defendants will be able to prove the materiality of those references.
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`Furthermore, after the Quest decision was issued and vacated, the PTO upheld Ravgen’s
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`patent claims, despite being provided with the allegedly-material references. Defendants’
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`inequitable conduct allegations rely entirely on evidence that did not change a thing when it was
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 14 of 18 PageID #: 13371
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`actually provided to the PTO. Defendants argue in a footnote that this Court should disregard the
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`fact that the Chinnapapagari and Chung references were before the PTO in the IPRs because the
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`PTO did not expressly rely on those references (Motion at 9, fn. 4), but that is exactly the point.
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`For a reference to be but-for material to patentability, it must lead to invalidation of the claims by
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`the PTO. The PTO concluded the opposite, finding that the claims were patentable despite any
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`alleged “controversy” espoused by the Chinnapapagari and Chung references. In the wake of the
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`PTO’s decision, “[t]here is simply no space for speculation regarding what the PTO would have
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`done had it known of the [] references…. What the PTO would have done is known[.]”4 See AAMP
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`of Fla., Inc v. Auto. Data Sols., Inc., No. 8:13-CV-2019-T-35TGW, 2015 WL 12843845, at *29
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`(M.D. Fla. Oct. 8, 2015).
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`To the extent Defendants argue that Chinnapapagari and Chung would have led to a
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`conclusion from the patent examiner that differed from the PTAB’s result, Defendants ignore the
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`fundamental similarity of the prior art before the examiner and the art in the IPRs. Across the IPRs,
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`the petitioners argued obviousness based on combining references for analyzing cell-free DNA
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`with references for using formaldehyde to fix cells—the very arguments underlying the examiner’s
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`original rejections. The PTAB’s reasoning applies equally to the original art considered by the
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`examiner to the art raised during IPR and similarly confirms the immateriality of the references.
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`California Inst. of Tech. v. Broadcom Ltd., No. CV 16-3714-GW (AGRX), 2019 WL 8807748, at
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`*6 (C.D. Cal. July 1, 2019), aff’d, 25 F.4th 976 (Fed. Cir. 2022) (granting summary judgment of
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`no inequitable conduct and noting that “[t]he fact that the PTAB considered and rejected
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`4 While a reference may still be material even if a district court did not find that reference
`invalidating, that is because different standards of proof apply in the PTO and district court,
`whereas an IPR uses the PTO’s evidentiary standard. See Aventis Pharma S.A. v. Hospira, Inc.,
`675 F.3d 1324, 1334 (Fed. Cir. 2012) (explaining that a district court’s failure to invalidate a patent
`was not necessarily dispositive of materiality due to the different standard of proof).
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 15 of 18 PageID #: 13372
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`obviousness combinations where [certain prior art references] were offered for the same concept
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`that Defendants also would offer [a different reference] similarly supports the conclusion that [the
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`different reference] is not but-for material to the patentability of the asserted claims”).
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`Defendants’ current attempt to manufacture deceptive intent from Ravgen’s reported
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`experimental results in the patent specifications likewise falls flat. See Motion at 5–6, fn. 3.
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`Defendants’ only purported evidence of “manipulat[ion]” is Ravgen’s use of the word “represent”
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`in connection with the experimental results, but all scientific observations must be “represented”
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`in some manner. Defendants do not even allege that Ravgen deliberately designed its reporting of
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`its experimental results to mislead the examiner (particularly considering Ravgen’s patents explain
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`exactly how the reported data was obtained and calculated), much less that that the examiner was
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`materially misled about those results.5
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`C.
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`Any Trial On Inequitable Conduct Should Occur At The Same Time As A
`Jury Trial For Efficient Resolution Of All Claims.
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`To the extent the Court decides that the defendants’ allegations of inequitable conduct are
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`sufficient to survive summary judgment and warrant a bench trial, any such bench trial should
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`occur at the same time as a jury trial, as courts routinely do when there are equitable issues to be
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`tried. Indeed, in the Quest case upon which Defendants rely, the Court scheduled a bench trial for
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`inequitable conduct after the pre-trial conference and right before the jury trial. Taking the same
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`approach here would set a bench trial almost concurrently with any jury trial—i.e., after the
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`October 18, 2024 pre-trial conference and before the October 28, 2024 trial date—which is a
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`sensible approach if the Court determines such a bench trial is ultimately warranted.
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`5 Indeed, the patents also include a summary table of the reported experimental results that clearly
`sets forth the interpretation of the results as meaning the samples contained >50% fetal DNA. See
`Table XXII, ’277 Patent at col. 226; ’720 Patent at col. 216. See also ’277 Patent at 222:55–57,
`’720 Patent at 213:31–33 (describing samples as having “fifty percent or greater” fetal DNA in
`maternal blood).
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`Case 1:20-cv-01730-RGA-JLH Document 186 Filed 08/14/23 Page 16 of 18 PageID #: 13373
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`The current case schedule would allow an inequitable conduct bench trial, if necessary, to
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`occur concurrently with any jury trial, consistent with routine precedent. In fact, it is “standard
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`practice” to hold trials on inequitable conduct after jury trials. Liqwd, Inc. v. L’Oreal USA, Inc.,
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`No. CV 17-14-JFB-SRF, 2019 WL 365708, at *2 (D. Del. Jan. 30, 2019). Factual issues of
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`materiality and validity might overlap, and at least one witness, the inve