Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 1 of 95 PageID #: 12502
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 1 of 95 PageID #: 12502
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`EXHIBIT A
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`EXHIBIT A
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`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 1 of 95 PageID #: 12502
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`EXHIBIT A
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`EXHIBIT A
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`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 2 of 95 PageID #: 12503
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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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`)))))))))
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`DEFENDANT FOUNDATION MEDICINE, INC.’S
`AMENDED ANSWER AND COUNTERCLAIMS
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`Defendant Foundation Medicine, Inc. (“Foundation Medicine” or “FMI”) hereby
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`submits its amended answer and counterclaims to the Complaint filed by Plaintiff Guardant
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`Health, Inc. (“Guardant”) on November 23, 2020. Foundation Medicine denies any
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`allegation not specifically admitted herein.
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`INTRODUCTION
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`On November 9, 2017, nearly three years to the day before Guardant Health, Inc.
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`(“Guardant”) filed the present suit, Guardant sued Foundation Medicine, Inc. (“Foundation
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`Medicine” or “FMI”) accusing Foundation Medicine’s liquid biopsy assays of infringing
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`four patents (“Guardant I”).1 Guardant’s filing of this new case comes after a series of
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`setbacks suffered by Guardant and its co-founder and CEO, Dr. Helmy Eltoukhy (“Dr.
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`Eltoukhy”), in the Guardant I litigation. On the eve of the November 2020 trial for
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`1 Those four asserted patents were U.S. Patent Nos. 9,598,731 (the “’731 patent”),
`9,834,822 (the “’822 patent”), 9,840,743 (the “’743 patent”), and 9,902,992 (the “’992
`patent”).
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`1
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`GUARDANT HEALTH, INC.,
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`Plaintiff,
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`FOUNDATION MEDICINE, INC.,
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`v.
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`Defendant.
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`PUBLIC VERSION
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`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 3 of 95 PageID #: 12504
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`Guardant I, the Court postponed the trial specifically to allow for separate discovery and
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`evidentiary proceedings to address what it described as “very serious” allegations of
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`spoliation based on Dr. Eltoukhy’s intentional deletion of evidence on two separate
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`occasions after his deposition in Guardant I. Ex. 34 (Order on Spoliation Motion, D.I.
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`513), at 4-6. In the weeks leading up to that spoliation ruling, (i) the Court dismissed all
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`of Guardant’s claims alleging infringement of one patent (the ’731 patent); (ii) the Patent
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`Trial and Appeal Board (“PTAB”) found unpatentable in Inter Partes Review (“IPR”)
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`proceedings all but one dependent claim (not even asserted against Foundation Medicine)
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`of a second patent (the ’822 patent); (iii) the PTAB found unpatentable in IPR proceedings
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`half of Guardant’s claims of a third patent (the ’743 patent); and (iv) the Court denied two
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`attempts by Guardant to dismiss Foundation Medicine’s inequitable conduct counterclaim
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`directed to all four patents. Ex. 33 (Order on Summary Judgment, D.I. 4822), at 4, 6; Ex.
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`31 (Foundation Medicine, Inc. v. Guardant Health, Inc., IPR2019-00652, Paper 47), at 2;
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`Ex. 30 (Foundation Medicine, Inc. v. Guardant Health, Inc., IPR2019-00634, Paper 52),
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`at 2; Ex 27 (Order on Claim Construction and Motion to Dismiss, D.I. 404), at 5.
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`Discovery in Guardant I revealed that Guardant’s co-founders, Dr. Eltoukhy and
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`Dr. AmirAli Talasaz, conspired to intentionally conceal Dr. Eltoukhy’s material
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`contributions to Guardant’s alleged inventions from the United States Patent and
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`Trademark Office (“USPTO”) in a scheme to avoid Dr. Eltoukhy’s assignment and
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`confidentiality obligations to his then employer, Illumina, Inc. (“Illumina”), in order to
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`2 All D.I. cites herein refer to Guardant Health, Inc. v. Foundation Medicine, Inc., C.A.
`No. 17-01616-LPS-CJB, unless stated otherwise.
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`grant the patent rights to his new company, Guardant. When questioning and exhibits
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`marked at Dr. Eltoukhy’s deposition made it clear that this scheme would come to light --
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`and that Guardant’s carefully crafted reputation in the field of cancer diagnostics was in
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`jeopardy -- Dr. Eltoukhy deleted all of his Gmails from the relevant pre-2014 period shortly
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`after his deposition. He did this without consulting counsel and after serving as CEO to a
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`multi-billion dollar public company that has been part of numerous prior litigation matters,
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`where document preservation orders were well understood and in place. Then, months
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`later, he further deleted hundreds of other files only days before his laptop was to be
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`forensically imaged at Foundation Medicine’s request following the revelation of his first
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`round of deletions. Guardant now faces the prospect of an evidentiary hearing in May
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`2021, at which Dr. Eltoukhy has been ordered to appear so that the Court may hear his
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`testimony and make credibility findings regarding his intentional deletion of critical
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`evidence on at least two occasions.
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`Against
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`this backdrop, Guardant now files
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`this new
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`lawsuit accusing
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`FoundationOne® Liquid and FoundationOne® Liquid CDx of infringing seven related
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`patents (the “Patents-in-Suit”). Two of those patents are the same ’822 and ’743 patents
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`that Guardant asserted in Guardant I. Guardant also adds five “new” patents that are closely
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`related to the patents asserted in Guardant I and contain little that is new to the subject
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`matter of the Guardant I patents. Like the Guardant I patents, the Patents-in-Suit were
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`obtained through inequitable conduct on the USPTO. Additionally, Foundation Medicine
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`does not infringe any asserted claims of the Patents-in-Suit, and the asserted claims of the
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`Patents-in-Suit are invalid and/or unenforceable. Thus, this new lawsuit lacks merit.
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`Moreover, despite having never moved for a preliminary injunction in Guardant I
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`during the three years that action has been pending, Guardant now has taken the
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`extraordinary step of filing a motion for preliminary injunctive relief, by which it seeks to
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`preclude Foundation Medicine from offering its life-saving cancer diagnostic products to
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`the public, including (i) doctors who use the assays to develop personalized treatment plans
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`for cancer patients and (ii) biopharmaceutical companies who use the assays to develop
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`novel therapeutics to treat cancer patients. Guardant’s effort to obtain an expedited
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`preliminary injunction is likewise deeply flawed and more than merely troubling on the
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`merits. An injunction would dramatically reduce -- or in certain cases, eliminate --
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`diagnostic choices available to oncologists and cancer patients, many of whom have few
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`such choices remaining by the time liquid biopsies are used to assist treatment decisions.
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`FoundationOne® Liquid CDx (and Guardant’s 360 CDx) are the only two liquid biopsies
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`approved by the FDA for certain (different) targeted therapeutic drugs for non-small cell
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`lung cancer (NSCLC). FoundationOne® Liquid CDx is the only available FDA-approved
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`liquid companion diagnostic for prostate cancer, ovarian cancer, and breast cancer.
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`Guardant’s injunction would accordingly remove the only option for patients suffering
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`from these types of cancers and oncologists who wish to use a liquid companion diagnostic
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`to guide treatment decisions, and would eliminate treatment options for lung cancer
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`patients. See Ex. 14 (FDA Approves Blood Tests That Can Help Guide Cancer Treatment);
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`Ex. 15 (FoundationOne® Liquid CDx Technical Specifications).
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`These litigation tactics are thus without merit and pose a risk of detrimental and
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`irreparable harm to cancer patients and those in the industry who are working to improve
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`patient care. As such, they belie Drs. Eltoukhy’s and Talasaz’s previously professed
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`assertions that it was their concern for patients that drove them to found Guardant in the
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`first place. Regardless, such tactics do not immunize Guardant from Foundation
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`Medicine’s pending inequitable conduct claims based on the fraudulent scheme on which
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`Guardant was founded or the spoliation allegations based on its CEO’s attempts to destroy
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`evidence of that misconduct in Guardant I.
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`Accordingly, Foundation Medicine hereby submits its Answer and Counterclaims
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`to the Complaint filed by Guardant. Foundation Medicine denies any allegation not
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`specifically admitted herein.
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`Moreover,
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`NATURE OF THE ACTION3
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`1.
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`Foundation Medicine admits that the Complaint purports to state a cause of
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`action for patent infringement under Title 35 of the United States Code. Foundation
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`Medicine denies that it has infringed any valid and enforceable claim of the patents asserted
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`in the Complaint, and denies any remaining allegations of Paragraph 1 of the Complaint.
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`2.
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`Foundation Medicine admits that the Complaint purports to state a cause of
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`action under 35 U.S.C. § 1, et seq. Foundation Medicine further admits that copies of U.S.
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`Patent Nos. 10,501,810 (the “’810 patent), 10,704,085 (the “’085 patent”), 10,704,086 (the
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`“’086 patent”), 10,793,916 (the “’916 patent”), 10,801,063 (the “’063 patent”), 9,840,743
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`(the “’743 patent”), and 9,834,822 (the “’822 patent”) are attached to the Complaint as
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`Exhibits 1-7, respectively. Foundation Medicine denies the remaining allegations of
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`Paragraph 2 of the Complaint, and denies that it has infringed any valid and enforceable
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`claim of the ’810, ’085, ’086, ’916, ’063, ’743, and ’822 patents.
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`PARTIES
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`1.
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`Foundation Medicine is without information or knowledge sufficient to
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`form a belief as to the truth of the allegations of Paragraph 14 of the Complaint, and
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`therefore denies those allegations.
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`3 Headings from the Complaint are included for convenience, but are not allegations to
`which a response is required.
`4 Guardant’s Complaint contains two paragraphs numbered 1 and two paragraphs
`numbered 2. The paragraphs in this Answer and Counterclaims correspond to the
`numbered paragraphs beginning on p. 2 of the Complaint.
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`6
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`2.
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`Foundation Medicine is without information or knowledge sufficient to
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`form a belief as to the truth of the allegations of Paragraph 2 of the Complaint, and therefore
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`denies those allegations.
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`3.
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`Foundation Medicine is without information or knowledge sufficient to
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`form a belief as to the truth of the allegations of Paragraph 3 of the Complaint, and therefore
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`denies those allegations.
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`4.
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`Foundation Medicine is without information or knowledge sufficient to
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`form a belief as to the truth of the allegations of Paragraph 4 of the Complaint, and therefore
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`denies those allegations.
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`5.
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`Foundation Medicine admits that it is incorporated under the laws of the
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`State of Delaware, and that it maintains its principal place of business at 150 Second Street,
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`Cambridge, MA 02141. Foundation Medicine further admits that it markets and sells liquid
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`biopsy products known as FoundationOne® Liquid and FoundationOne® Liquid CDx.
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`Foundation Medicine admits
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`that
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`it performs FoundationOne® Liquid and
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`FoundationOne® Liquid CDx assays at its facility in Cambridge, MA.
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`JURISDICTION AND VENUE
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`6.
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`Paragraph 6 of the Complaint states a legal conclusion to which no response
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`is required. To the extent a response is required, Foundation Medicine admits that the
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`Complaint purports to assert an action under the patent laws of the United States, and that
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`the Court has subject matter jurisdiction over such actions provided that standing and other
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`requirements are met, but denies that the claim has any merit. Foundation Medicine denies
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`any remaining allegations of Paragraph 6 of the Complaint.
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`7.
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`Paragraph 7 of the Complaint states a legal conclusion to which no response
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`is required. To the extent a response is required, Foundation Medicine does not contest
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`that venue is proper for purposes of this action only.
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`8.
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`Foundation Medicine admits that it is incorporated under the laws of the
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`State of Delaware. The remainder of Paragraph 8 of the Complaint states a legal conclusion
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`to which no response is required. To the extent a response is required, Foundation
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`Medicine does not contest personal jurisdiction for purposes of this action only.
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`9.
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`Foundation Medicine admits that it used, offered for sale, and sold
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`FoundationOne® Liquid in this judicial district, and that it uses, offers for sale, and sells
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`FoundationOne® Liquid CDx in this judicial district. Foundation Medicine denies that it
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`uses FoundationOne® Liquid and FoundationOne® Liquid CDx throughout the United
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`States. The remainder of Paragraph 9 of the Complaint states a legal conclusion to which
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`no response is required. To the extent a response is required, Foundation Medicine does
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`not contest personal jurisdiction for purposes of this action only.
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`10.
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`Paragraph 10 of the Complaint states a legal conclusion to which no
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`response is required. To the extent a response is required, Foundation Medicine admits
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`that it sells FoundationOne® Liquid and FoundationOne® Liquid CDx in Delaware but
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`denies the remaining allegations of Paragraph 10.
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`11.
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`Paragraph 11 of the Complaint states a legal conclusion to which no
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`response is required. To the extent a response is required, Foundation Medicine does not
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`contest personal jurisdiction for purposes of this action only.
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`8
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`BACKGROUND
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`12.
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`Foundation Medicine repeats, re-alleges, and incorporates by reference the
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`foregoing paragraphs as if fully set forth herein.
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`13.
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`Foundation Medicine
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`admits
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`that
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`it
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`commercially
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`launched
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`FoundationACT® at least by mid-2016. Foundation Medicine further admits that Exhibit
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`8 to the Complaint purports to be a copy of a Foundation Medicine press release that
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`contains, inter alia, the language quoted in Paragraph 13.
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`14.
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`Foundation Medicine admits that Exhibit 9 to the Complaint purports to be
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`a copy of a poster entitled “Genomic profiling of circulating tumor DNA (ctDNA) from
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`patients with advanced cancers of the GI tract and anus.” Foundation Medicine admits that
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`this poster was presented at a conference by scientists affiliated with Foundation Medicine
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`in February 2017. Foundation Medicine also admits that Exhibit 10 purports to be a copy
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`of a paper titled “Analytical Validation of a Hybrid Capture-Based Next-Generation
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`Sequencing Clinical Assay for Genomic Profiling of Cell-Free Circulating Tumor DNA,”
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`which contains, inter alia, the figure in Paragraph 14 of the Complaint. Foundation
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`Medicine denies the remaining allegations of Paragraph 14 and any characterizations of
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`Exhibits 9 or 10 that are inconsistent with their plain language.
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`15.
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`Foundation Medicine admits that it released FoundationOne® Liquid at
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`least by 2018. Foundation Medicine further admits that Exhibit 11 to the Complaint
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`purports to be a copy of a Foundation Medicine press release that contains, inter alia, the
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`language quoted in Paragraph 15. Foundation Medicine denies the remaining allegations
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`of Paragraph 15.
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`9
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`16.
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`Foundation Medicine admits that FoundationOne® Liquid CDx received
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`FDA approval and was commercially available at least by 2020. Foundation Medicine
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`further admits that Exhibit 12 to the Complaint purports to be a copy of a Foundation
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`Medicine press release that contains, inter alia, the language quoted in Paragraph 16.
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`Foundation Medicine denies the remaining allegations of Paragraph 16 and any
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`characterization of the press release referenced therein that is inconsistent with its plain
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`language.
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`17.
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`Foundation Medicine admits that Exhibit 13 to the Complaint purports to
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`be a copy of a paper titled “Clinical and analytical validation of FoundationOne® Liquid
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`CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers
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`of solid tumor origin” that was published by Foundation Medicine on September 25, 2020.
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`Foundation Medicine admits that Exhibit 13 purports to contain a description of the
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`FoundationOne® Liquid CDx assay. Foundation Medicine denies the remaining
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`allegations of Paragraph 17 and any characterization of the paper referenced therein that is
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`inconsistent with its plain language.
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`18.
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`Foundation Medicine admits that FoundationACT®, FoundationOne®
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`Liquid, and FoundationOne® Liquid CDx are similar to the extent that each are liquid
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`biopsy products that were developed based on the FoundationOne® platform first used for
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`Foundation Medicine’s tissue test. Foundation Medicine further admits that each product
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`targets different numbers of genes. Foundation Medicine further admits that Exhibit 14
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`purports to be a copy of a label accompanying the FoundationOne® Liquid CDx FDA
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`10
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`submission, which contains, inter alia, the language quoted in Paragraph 18. Foundation
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`Medicine denies the remaining allegations of Paragraph 18 of the Complaint.
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`19.
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`Foundation Medicine denies the allegations of Paragraph 19 of the
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`Complaint.
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`20.
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`Foundation Medicine denies the allegations of Paragraph 20 of the
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`Complaint.
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`21.
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`Foundation Medicine denies the allegations of Paragraph 21 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 15 to the
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`Complaint.
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`22.
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`Foundation Medicine denies the allegations of Paragraph 22 of the
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`Complaint.
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`23.
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`Foundation Medicine denies the allegations of Paragraph 23 of the
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`Complaint.
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`24.
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`Foundation Medicine denies the allegations of Paragraph 24 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 16 to the
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`Complaint.
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`25.
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`Foundation Medicine denies the allegations of Paragraph 25 of the
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`Complaint.
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`26.
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`Foundation Medicine denies the allegations of Paragraph 26 of the
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`Complaint.
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`11
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`27.
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`Foundation Medicine denies the allegations of Paragraph 27 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 17 to the
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`Complaint.
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`28.
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`Foundation Medicine denies the allegations of Paragraph 28 of the
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`Complaint.
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`29.
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`Foundation Medicine denies the allegations of Paragraph 29 of the
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`Complaint.
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`30.
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`Foundation Medicine denies the allegations of Paragraph 30 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 18 to the
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`Complaint.
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`31.
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`Foundation Medicine denies the allegations of Paragraph 31 of the
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`Complaint.
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`32.
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`Foundation Medicine denies the allegations of Paragraph 32 of the
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`Complaint.
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`33.
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`Foundation Medicine denies the allegations of Paragraph 33 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 19 to the
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`Complaint.
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`34.
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`Foundation Medicine denies the allegations of Paragraph 34 of the
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`Complaint.
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`35.
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`Foundation Medicine denies the allegations of Paragraph 35 of the
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`Complaint.
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`12
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`36.
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`Foundation Medicine denies the allegations of Paragraph 36 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 20 to the
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`Complaint.
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`37.
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`Foundation Medicine admits that on February 1, 2019, it filed a Petition for
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`Inter Partes Review of claims 1-26 of the ’743 patent. Foundation Medicine admits that
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`on August 18, 2020, the PTAB found that claims 10-19 and 21 of the ’743 patent were not
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`unpatentable. The remainder of Paragraph 37 of the Complaint states a legal conclusion to
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`which no response is required. To the extent a response is required, Foundation Medicine
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`denies the remaining allegations of Paragraph 37.
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`38.
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`Foundation Medicine denies the allegations of Paragraph 38 of the
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`Complaint.
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`39.
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`Foundation Medicine denies the allegations of Paragraph 39 of the
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`Complaint.
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`40.
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`Foundation Medicine denies the allegations of Paragraph 40 of the
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`Complaint, including to the extent those allegations are set forth in Exhibit 21 to the
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`Complaint.
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`41.
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`Foundation Medicine admits that on February 1, 2019, it filed a Petition for
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`Inter Partes Review of claims 1-13 and 17-20 of the ’822 patent. Foundation Medicine
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`admits that on August 18, 2020, the PTAB found that claim 12 of the ’822 patent was not
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`unpatentable. The remainder of Paragraph 41 of the Complaint states a legal conclusion to
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`which no response is required. To the extent a response is required, Foundation Medicine
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`denies the remaining allegations of Paragraph 41.
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`WILLFUL INFRINGEMENT
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`42.
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`Foundation Medicine repeats, re-alleges, and incorporates by reference the
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`foregoing paragraphs as if fully set forth herein.
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`43.
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`Paragraph 43 of the Complaint states a legal conclusion to which no
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`response is required. To the extent a response is required, Foundation Medicine admits
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`that the Patents-in-Suit and the applications resulting in the Patents-in-Suit are publicly
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`available. Foundation Medicine denies the remaining allegations of Paragraph 43 of the
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`Complaint, including any allegations of willful infringement.
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`44.
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`Foundation Medicine admits that on November 9, 2017, Guardant filed a
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`lawsuit alleging infringement of U.S. Patent No. 9,598,731. Foundation Medicine admits
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`that Exhibit 22 to the Complaint purports to be a copy of Guardant’s complaint filed in
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`Case No. 17-1616. Foundation Medicine admits that on February 5, 2018, Guardant
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`amended its complaint to add the ’822 and ’743 patents. Foundation Medicine admits that
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`it was aware of the existence of the ’822 and ’743 patents as of February 5, 2018, the date
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`of the filing of Guardant’s amended complaint. Foundation Medicine denies the remaining
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`allegations of Paragraph 44 of the Complaint, including that it has willfully infringed at
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`least the ’743 and ’822 patents.
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`45.
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`Foundation Medicine is without information or knowledge sufficient to
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`form a belief as to the truth of the allegations of Paragraph 45 of the Complaint regarding
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`the ownership of the ’810, ’085, ’086, ’916, and ’063 patents, and therefore denies those
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`allegations
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`. Foundation Medicine admits that the ’810 patent recites on its face an issue date
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`of December 10, 2019; that the ’085 patent recites on its face an issue date of July 7, 2020;
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`that the ’086 patent recites on its face an issue date of July 7, 2020; that the ’916 patent
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`recites on its face an issue date of October 6, 2020; and that the ’063 patent recites on its
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`face an issue date of October 13, 2020. Foundation Medicine denies the remaining
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`allegations of Paragraph 45 of the Complaint.
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`46.
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`Foundation Medicine admits that Foundation Medicine and Guardant each
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`market and sell products for cancer testing based on the use of cell-free DNA. Foundation
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`Medicine further admits that it filed a European opposition proceeding on November 5,
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`2020 directed to Guardant’s European Patent 3 378 952. Foundation Medicine denies the
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`remaining allegations of Paragraph 46 of the Complaint, including any allegations of
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`willful infringement.
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`COUNT I
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`47.
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`Foundation Medicine repeats, re-alleges, and incorporates by reference the
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`foregoing paragraphs as if fully set forth herein.
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`48.
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`Foundation Medicine admits that the ’810 patent is entitled “Systems and
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`methods to detect rare mutations and copy number variation,” and on its face recites an
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`issue date of December 10, 2019. Foundation Medicine denies that Guardant is without
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`information or knowledge sufficient to form a belief as to the truthowner of the remaining
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`allegations of Paragraph 48 of the Complaint, and therefore denies those allegations.all
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`rights, title to, and interest in the ’810 patent.
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`
`
`
`
`15
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 17 of 95 PageID #: 12518
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`
`
`
`
`
`
`49.
`
`Foundation Medicine denies the allegations of Paragraph 49 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 15 to the
`
`Complaint.
`
`50.
`
`Foundation Medicine denies the allegations of Paragraph 50 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 15 to the
`
`Complaint.
`
`COUNT II
`
`51.
`
` Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`52.
`
`Foundation Medicine admits that the ’085 patent is entitled “Systems and
`
`methods to detect rare mutations and copy number variation,” and on its face recites an
`
`issue date of July 7, 2020. Foundation Medicine denies that Guardant is without
`
`information or knowledge sufficient to form a belief as to the truthowner of the remaining
`
`allegations of Paragraph 52 of the Complaint, and therefore denies those allegations.all
`
`rights, title to, and interest in the ’085 patent.
`
`
`
`
`
`
`
`53.
`
`Foundation Medicine denies the allegations of Paragraph 53 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 16 to the
`
`Complaint.
`
`
`
`16
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 18 of 95 PageID #: 12519
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`
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`54.
`
`Foundation Medicine denies the allegations of Paragraph 54 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 16 to the
`
`Complaint.
`
`COUNT III
`
`55.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`56.
`
`Foundation Medicine admits that the ’086 patent is entitled “Systems and
`
`methods to detect rare mutations and copy number variation,” and on its face recites an
`
`issue date of July 7, 2020. Foundation Medicine denies that Guardant is without
`
`information or knowledge sufficient to form a belief as to the truthowner of the remaining
`
`allegations of Paragraph 56 of the Complaint, and therefore denies those allegations.all
`
`rights, title to, and interest in the ’086 patent.
`
`
`
`
`
`
`
`57.
`
`Foundation Medicine denies the allegations of Paragraph 57 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 17 to the
`
`Complaint.
`
`58.
`
`Foundation Medicine denies the allegations of Paragraph 58 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 17 to the
`
`Complaint.
`
`
`
`17
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 19 of 95 PageID #: 12520
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`
`
`COUNT IV
`
`59.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`60.
`
`Foundation Medicine admits that the ’916 patent is entitled “Systems and
`
`methods to detect rare mutations and copy number variation,” and on its face recites an
`
`issue date of October 6, 2020. Foundation Medicine denies that Guardant is without
`
`information or knowledge sufficient to form a belief as to the truthowner of the remaining
`
`allegations of Paragraph 60 of the Complaint, and therefore denies those allegations.all
`
`rights, title to, and interest in the ’916 patent.
`
`
`
`
`
`
`
`61.
`
`Foundation Medicine denies the allegations of Paragraph 61 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 18 to the
`
`Complaint.
`
`62.
`
`Foundation Medicine denies the allegations of Paragraph 62 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 18 to the
`
`Complaint.
`
`COUNT V
`
`63.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`64.
`
`Foundation Medicine admits that the ’063 patent is entitled “Methods and
`
`systems for detecting genetic variants,” and on its face recites an issue date of October 13,
`
`
`
`18
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 20 of 95 PageID #: 12521
`
`
`
`2020. Foundation Medicine denies that Guardant is without information or knowledge
`
`sufficient to form a belief as to the truthowner of the remaining allegations of Paragraph
`
`64 of the Complaint, and therefore denies those allegations.all rights, title to, and interest
`
`in the ’063 patent.
`
`
`
`
`
`
`
`
`
`65.
`
`Foundation Medicine denies the allegations of Paragraph 65 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 19 to the
`
`Complaint.
`
`66.
`
`Foundation Medicine denies the allegations of Paragraph 66 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 19 to the
`
`Complaint.
`
`COUNT VI
`
`67.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`68.
`
`Foundation Medicine admits that the ’743 patent is entitled “Systems and
`
`Methods to Detect Rare Mutations and Copy Number Variation,” and on its face recites an
`
`issue date of December 12, 2017. Foundation Medicine denies that Guardant is without
`
`information or knowledge sufficient to form a belief as to the truthowner of the remaining
`
`allegations of Paragraph 68 of the Complaint, and therefore denies those allegations.all
`
`rights, title to, and interest in the ’743 patent.
`
`
`
`
`
`19
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 21 of 95 PageID #: 12522
`
`
`
`
`
`
`
`69.
`
`Foundation Medicine denies the allegations of Paragraph 69 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 20 to the
`
`Complaint.
`
`70.
`
`Foundation Medicine denies the allegations of Paragraph 70 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 20 to the
`
`Complaint.
`
`COUNT VII
`
`71.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`72.
`
`Foundation Medicine admits that the ’822 patent is entitled “Systems and
`
`Methods to Detect Rare Mutations and Copy Number Variation,” and on its face recites an
`
`issue date of December 5, 2017. Foundation Medicine denies that Guardant is without
`
`information or knowledge sufficient to form a belief as to the truthowner of the remaining
`
`allegations of Paragraph 72 and therefore denies those allegations.all rights, title to, and
`
`interest in the ’822 patent.
`
`
`
`
`
`
`
`73.
`
`Foundation Medicine denies the allegations of Paragraph 73 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 21 to the
`
`Complaint.
`
`
`
`20
`
`
`
`Case 1:20-cv-01580-LPS Document 68-1 Filed 05/05/21 Page 22 of 95 PageID #: 12523
`
`
`
`74.
`
`Foundation Medicine denies the allegations of Paragraph 74 of the
`
`Complaint, including to the extent those allegations are set forth in Exhibit 21 to the
`
`Complaint.
`
`JURY DEMAND
`
`75.
`
`The Complaint sets forth a demand for a trial by jury. Pursuant to Fed. R.
`
`Civ. P. 38, Foundation Medicine likewise demands a trial by jury on all issues so triable.
`
`PRAYER FOR RELIEF
`
`1.
`
`Foundation Medicine denies that Guardant is entitled to any of its requested
`
`relief, including that sought in paragraphs A – F of Guardant’s Prayer for Relief or any
`
`other type of recovery from Foundation Medicine. Guardant’s prayer should, therefore, be
`
`denied in its entirety and with prejudice.
`
`2.
`
`Foundation Medicine asks that the Complaint be dismissed and that
`
`judgment be entered for Foundation Medicine.
`
`3.
`
`Foundation Medicine asks that the Court determine that this is an
`
`exceptional case under 35 U.S.C. § 285 and award attorneys’ fees, costs, and other
`
`expenses to Foundation Medicine in this action.
`
`4.
`
`Foundation Medicine denies any allegation in the Complaint not
`
`specifically admitted.
`
`AFFIRMATIVE/ADDITIONAL DEFENSES
`
`Withou
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