Case 1:20-cv-01580-LPS Document 22 Filed 01/14/21 Page 1 of 73 PageID #: 2816
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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 ANSWER AND COUNTERCLAIMS
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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 four
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`patents (“Guardant I”).1 Guardant’s filing of this new case comes after a series of setbacks suffered
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`by Guardant and its co-founder and CEO, Dr. Helmy Eltoukhy (“Dr. Eltoukhy”), in the Guardant
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`I litigation. On the eve of the November 2020 trial for Guardant I, the Court postponed the trial
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`specifically to allow for separate discovery and evidentiary proceedings to address what it
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`described as “very serious” allegations of spoliation based on Dr. Eltoukhy’s intentional deletion
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`of evidence on two separate occasions after his deposition in Guardant I. Ex. 34 (Order on
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`Spoliation Motion, D.I. 513), at 4-6. In the weeks leading up to that spoliation ruling, (i) the Court
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`dismissed all of Guardant’s claims alleging infringement of one patent (the ’731 patent); (ii) the
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`Patent 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) of a
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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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`GUARDANT HEALTH, INC.,
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`Plaintiff,
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`v.
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`FOUNDATION MEDICINE, INC.,
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`Defendant.
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`second patent (the ’822 patent); (iii) the PTAB found unpatentable in IPR proceedings half of
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`Guardant’s claims of a third patent (the ’743 patent); and (iv) the Court denied two attempts by
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`Guardant to dismiss Foundation Medicine’s inequitable conduct counterclaim directed to all four
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`patents. Ex. 33 (Order on Summary Judgment, D.I. 4822), at 4, 6; Ex. 31 (Foundation Medicine,
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`Inc. v. Guardant Health, Inc., IPR2019-00652, Paper 47), at 2; Ex. 30 (Foundation Medicine, Inc.
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`v. Guardant Health, Inc., IPR2019-00634, Paper 52), at 2; Ex 27 (Order on Claim Construction
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`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 Dr.
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`AmirAli Talasaz, conspired to intentionally conceal Dr. Eltoukhy’s material contributions to
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`Guardant’s alleged inventions from the United States Patent and Trademark Office (“USPTO”) in
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`a scheme to avoid Dr. Eltoukhy’s assignment and confidentiality obligations to his then employer,
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`Illumina, Inc. (“Illumina”), in order to grant the patent rights to his new company, Guardant. When
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`questioning and exhibits marked at Dr. Eltoukhy’s deposition made it clear that this scheme would
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`come to light -- and that Guardant’s carefully crafted reputation in the field of cancer diagnostics
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`was in 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 multi-
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`billion dollar public company that has been part of numerous prior litigation matters, where
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`document preservation orders were well understood and in place. Then, months later, he further
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`deleted hundreds of other files only days before his laptop was to be forensically imaged at
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`Foundation Medicine’s request following the revelation of his first round of deletions. Guardant
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`now faces the prospect of an evidentiary hearing in May 2021, at which Dr. Eltoukhy has been
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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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`ordered to appear so that the Court may hear his testimony and make credibility findings regarding
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`his intentional deletion of critical evidence on at least two occasions.
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`Against this backdrop, Guardant now files this new lawsuit accusing FoundationOne®
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`Liquid and FoundationOne® Liquid CDx of infringing seven related patents (the “Patents-in-
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`Suit”). Two of those patents are the same ’822 and ’743 patents that Guardant asserted in Guardant
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`I. Guardant also adds five “new” patents that are closely related to the patents asserted in Guardant
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`I and contain little that is new to the subject matter of the Guardant I patents. Like the Guardant I
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`patents, the Patents-in-Suit were obtained through inequitable conduct on the USPTO.
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`Additionally, Foundation Medicine does not infringe any asserted claims of the Patents-in-Suit,
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`and the asserted claims of the Patents-in-Suit are invalid and/or unenforceable. Thus, this new
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`lawsuit lacks merit.
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`Moreover, despite having never moved for a preliminary injunction in Guardant I during
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`the three years that action has been pending, Guardant now has taken the extraordinary step of
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`filing a motion for preliminary injunctive relief, by which it seeks to preclude Foundation Medicine
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`from offering its life-saving cancer diagnostic products to the public, including (i) doctors who use
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`the assays to develop personalized treatment plans for cancer patients and (ii) biopharmaceutical
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`companies who use the assays to develop novel therapeutics to treat cancer patients. Guardant’s
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`effort to obtain an expedited preliminary injunction is likewise deeply flawed and more than
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`merely troubling on the merits. An injunction would dramatically reduce -- or in certain cases,
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`eliminate -- diagnostic choices available to oncologists and cancer patients, many of whom have
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`few 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 approved
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`by the FDA for certain (different) targeted therapeutic drugs for non-small cell lung cancer
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`(NSCLC). FoundationOne® Liquid CDx is the only available FDA-approved liquid companion
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`diagnostic for prostate cancer, ovarian cancer, and breast cancer. Guardant’s injunction would
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`accordingly remove the only option for patients suffering from these types of cancers and
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`oncologists who wish to use a liquid companion diagnostic to guide treatment decisions, and would
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`eliminate treatment options for lung cancer patients. See Ex. 14 (FDA Approves Blood Tests That
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`Can Help Guide Cancer Treatment); Ex. 15 (FoundationOne® Liquid CDx Technical
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`Specifications).
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`These litigation tactics are thus without merit and pose a risk of detrimental and irreparable
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`harm to cancer patients and those in the industry who are working to improve patient care. As
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`such, they belie Drs. Eltoukhy’s and Talasaz’s previously professed assertions that it was their
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`concern for patients that drove them to found Guardant in the first place. Regardless, such tactics
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`do not immunize Guardant from Foundation Medicine’s pending inequitable conduct claims based
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`on the fraudulent scheme on which Guardant was founded or the spoliation allegations based on
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`its CEO’s attempts to destroy evidence of that misconduct in Guardant I.
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`Accordingly, Foundation Medicine hereby submits its Answer and Counterclaims to the
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`Complaint filed by Guardant. Foundation Medicine denies any allegation not specifically admitted
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`herein.
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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 action
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`for patent infringement under Title 35 of the United States Code. Foundation Medicine denies that
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`it has infringed any valid and enforceable claim of the patents asserted in the Complaint, and denies
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`any remaining allegations of Paragraph 1 of the Complaint.
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`3 Headings from the Complaint are included for convenience, but are not allegations to which a
`response is required.
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`2.
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`Foundation Medicine admits that the Complaint purports to state a cause of action
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`under 35 U.S.C. § 1, et seq. Foundation Medicine further admits that copies of U.S. Patent Nos.
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`10,501,810 (the “’810 patent), 10,704,085 (the “’085 patent”), 10,704,086 (the “’086 patent”),
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`10,793,916 (the “’916 patent”), 10,801,063 (the “’063 patent”), 9,840,743 (the “’743 patent”), and
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`9,834,822 (the “’822 patent”) are attached to the Complaint as Exhibits 1-7, respectively.
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`Foundation Medicine denies the remaining allegations of Paragraph 2 of the Complaint, and denies
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`that it has infringed any valid and enforceable claim of the ’810, ’085, ’086, ’916, ’063, ’743, and
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`’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 form a
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`belief as to the truth of the allegations of Paragraph 14 of the Complaint, and therefore denies those
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`allegations.
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`2.
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`Foundation Medicine is without information or knowledge sufficient to form a
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`belief as to the truth of the allegations of Paragraph 2 of the Complaint, and therefore denies those
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`allegations.
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`3.
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`Foundation Medicine is without information or knowledge sufficient to form a
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`belief as to the truth of the allegations of Paragraph 3 of the Complaint, and therefore denies those
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`allegations.
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`4.
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`Foundation Medicine is without information or knowledge sufficient to form a
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`belief as to the truth of the allegations of Paragraph 4 of the Complaint, and therefore denies those
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`allegations.
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`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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`5.
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`Foundation Medicine admits that it is incorporated under the laws of the State of
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`Delaware, and that it maintains its principal place of business at 150 Second Street, Cambridge,
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`MA 02141. Foundation Medicine further admits that it markets and sells liquid biopsy products
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`known as FoundationOne® Liquid and FoundationOne® Liquid CDx. Foundation Medicine
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`admits that it performs FoundationOne® Liquid and FoundationOne® Liquid CDx assays at its
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`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 is
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`required. To the extent a response is required, Foundation Medicine admits that the Complaint
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`purports to assert an action under the patent laws of the United States, and that the Court has
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`subject matter jurisdiction over such actions provided that standing and other requirements are
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`met, but denies that the claim has any merit. Foundation Medicine denies any remaining
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`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 is
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`required. To the extent a response is required, Foundation Medicine does not contest that venue
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`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 State of
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`Delaware. The remainder of Paragraph 8 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 contest
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`personal jurisdiction for purposes of this action only.
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`9.
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`Foundation Medicine admits
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`that
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`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 uses
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`FoundationOne® Liquid and FoundationOne® Liquid CDx throughout the United States. The
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`remainder of Paragraph 9 of the Complaint states a legal conclusion to which no response is
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`required. To the extent a response is required, Foundation Medicine does not contest personal
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`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 response is
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`required. To the extent a response is required, Foundation Medicine admits that it sells
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`FoundationOne® Liquid and FoundationOne® Liquid CDx in Delaware but denies the remaining
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`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 response is
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`required. To the extent a response is required, Foundation Medicine does not contest personal
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`jurisdiction for purposes of this action only.
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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 admits that it commercially launched FoundationACT® at
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`least by mid-2016. Foundation Medicine further admits that Exhibit 8 to the Complaint purports
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`to be a copy of a Foundation Medicine press release that contains, inter alia, the language quoted
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`in Paragraph 13.
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`14.
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`Foundation Medicine admits that Exhibit 9 to the Complaint purports to be a copy
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`of a poster entitled “Genomic profiling of circulating tumor DNA (ctDNA) from patients with
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`advanced cancers of the GI tract and anus.” Foundation Medicine admits that this poster was
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`presented at a conference by scientists affiliated with Foundation Medicine in February 2017.
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`Foundation Medicine also admits that Exhibit 10 purports to be a copy of a paper titled “Analytical
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`Validation of a Hybrid Capture-Based Next-Generation Sequencing Clinical Assay for Genomic
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`Profiling of Cell-Free Circulating Tumor DNA,” which contains, inter alia, the figure in Paragraph
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`14 of the Complaint. Foundation Medicine denies the remaining allegations of Paragraph 14 and
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`any characterizations of 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 least by
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`2018. Foundation Medicine further admits that Exhibit 11 to the Complaint purports to be a copy
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`of a Foundation Medicine press release that contains, inter alia, the language quoted in Paragraph
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`15. Foundation Medicine denies the remaining allegations of Paragraph 15.
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`16.
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`Foundation Medicine admits that FoundationOne® Liquid CDx received FDA
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`approval and was commercially available at least by 2020. Foundation Medicine further admits
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`that Exhibit 12 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 16. Foundation Medicine denies the
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`remaining allegations of Paragraph 16 and any characterization of the press release referenced
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`therein that is inconsistent with its plain language.
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`17.
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`Foundation Medicine admits that Exhibit 13 to the Complaint purports to be a copy
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`of a paper titled “Clinical and analytical validation of FoundationOne® Liquid CDx, a novel 324-
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`Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin” that
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`was published by Foundation Medicine on September 25, 2020. Foundation Medicine admits that
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`Exhibit 13 purports to contain a description of the FoundationOne® Liquid CDx assay.
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`Foundation Medicine denies the remaining allegations of Paragraph 17 and any characterization
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`of the paper referenced therein that is inconsistent with its plain language.
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`18.
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`Foundation Medicine admits that FoundationACT®, FoundationOne® Liquid, and
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`FoundationOne® Liquid CDx are similar to the extent that each are liquid biopsy products that
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`were developed based on the FoundationOne® platform first used for Foundation Medicine’s
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`tissue test. Foundation Medicine further admits that each product targets different numbers of
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`genes. Foundation Medicine further admits that Exhibit 14 purports to be a copy of a label
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`accompanying the FoundationOne® Liquid CDx FDA submission, which contains, inter alia, the
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`language quoted in Paragraph 18. Foundation Medicine denies the remaining allegations of
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`Paragraph 18 of the Complaint.
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`19.
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`20.
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`21.
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`Foundation Medicine denies the allegations of Paragraph 19 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 20 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 21 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 15 to the Complaint.
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`22.
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`23.
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`24.
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`Foundation Medicine denies the allegations of Paragraph 22 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 23 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 24 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 16 to the Complaint.
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`25.
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`26.
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`27.
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`Foundation Medicine denies the allegations of Paragraph 25 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 26 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 27 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 17 to the Complaint.
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`28.
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`29.
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`30.
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`Foundation Medicine denies the allegations of Paragraph 28 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 29 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 30 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 18 to the Complaint.
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`31.
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`32.
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`Foundation Medicine denies the allegations of Paragraph 31 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 32 of the Complaint.
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`33.
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`Foundation Medicine denies the allegations of Paragraph 33 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 19 to the Complaint.
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`34.
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`35.
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`36.
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`Foundation Medicine denies the allegations of Paragraph 34 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 35 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 36 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 20 to the Complaint.
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`37.
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`Foundation Medicine admits that on February 1, 2019, it filed a Petition for Inter
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`Partes Review of claims 1-26 of the ’743 patent. Foundation Medicine admits that on August 18,
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`2020, the PTAB found that claims 10-19 and 21 of the ’743 patent were not unpatentable. The
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`remainder of Paragraph 37 of the Complaint states a legal conclusion to which no response is
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`required. To the extent a response is required, Foundation Medicine denies the remaining
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`allegations of Paragraph 37.
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`38.
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`39.
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`40.
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`Foundation Medicine denies the allegations of Paragraph 38 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 39 of the Complaint.
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`Foundation Medicine denies the allegations of Paragraph 40 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 21 to the Complaint.
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`41.
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`Foundation Medicine admits that on February 1, 2019, it filed a Petition for Inter
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`Partes Review of claims 1-13 and 17-20 of the ’822 patent. Foundation Medicine admits that on
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`August 18, 2020, the PTAB found that claim 12 of the ’822 patent was not unpatentable. The
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`remainder of Paragraph 41 of the Complaint states a legal conclusion to which no response is
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`required. To the extent a response is required, Foundation Medicine denies the remaining
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`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 response is
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`required. To the extent a response is required, Foundation Medicine admits that the Patents-in-
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`Suit and the applications resulting in the Patents-in-Suit are publicly available. Foundation
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`Medicine denies the remaining allegations of Paragraph 43 of the Complaint, including any
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`allegations of willful infringement.
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`44.
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`Foundation Medicine admits that on November 9, 2017, Guardant filed a lawsuit
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`alleging infringement of U.S. Patent No. 9,598,731. Foundation Medicine admits that Exhibit 22
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`to the Complaint purports to be a copy of Guardant’s complaint filed in Case No. 17-1616.
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`Foundation Medicine admits that on February 5, 2018, Guardant amended its complaint to add the
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`’822 and ’743 patents. Foundation Medicine admits that it was aware of the existence of the ’822
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`and ’743 patents as of February 5, 2018, the date of the filing of Guardant’s amended complaint.
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`Foundation Medicine denies the remaining allegations of Paragraph 44 of the Complaint, including
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`that it has willfully infringed at least the ’743 and ’822 patents.
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`45.
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`Foundation Medicine is without information or knowledge sufficient to form a
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`belief as to the truth of the allegations of Paragraph 45 of the Complaint regarding the ownership
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`of the ’810, ’085, ’086, ’916, and ’063 patents, and therefore denies those allegations. Foundation
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`Medicine admits that the ’810 patent recites on its face an issue date of December 10, 2019; that
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`the ’085 patent recites on its face an issue date of July 7, 2020; that the ’086 patent recites on its
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`face an issue date of July 7, 2020; that the ’916 patent recites on its face an issue date of October
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`6, 2020; and that the ’063 patent recites on its face an issue date of October 13, 2020. Foundation
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`Medicine denies the remaining 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 market
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`and sell products for cancer testing based on the use of cell-free DNA. Foundation Medicine
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`further admits that it filed a European opposition proceeding on November 5, 2020 directed to
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`Guardant’s European Patent 3 378 952. Foundation Medicine denies the remaining allegations of
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`Paragraph 46 of the Complaint, including any allegations of 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 methods
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`to detect rare mutations and copy number variation,” and on its face recites an issue date of
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`December 10, 2019. Foundation Medicine is without information or knowledge sufficient to form
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`a belief as to the truth of the remaining allegations of Paragraph 48 of the Complaint, and therefore
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`denies those allegations.
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`49.
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`Foundation Medicine denies the allegations of Paragraph 49 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 15 to the Complaint.
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`50.
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`Foundation Medicine denies the allegations of Paragraph 50 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 15 to the Complaint.
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`COUNT II
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`51.
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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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`52.
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`Foundation Medicine admits that the ’085 patent is entitled “Systems and methods
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`to detect rare mutations and copy number variation,” and on its face recites an issue date of July
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`7, 2020. Foundation Medicine is without information or knowledge sufficient to form a belief as
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`to the truth of the remaining allegations of Paragraph 52 of the Complaint, and therefore denies
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`those allegations.
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`53.
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`Foundation Medicine denies the allegations of Paragraph 53 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 16 to the Complaint.
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`54.
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`Foundation Medicine denies the allegations of Paragraph 54 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 16 to the Complaint.
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`COUNT III
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`55.
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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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`56.
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`Foundation Medicine admits that the ’086 patent is entitled “Systems and methods
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`to detect rare mutations and copy number variation,” and on its face recites an issue date of July
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`7, 2020. Foundation Medicine is without information or knowledge sufficient to form a belief as
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`to the truth of the remaining allegations of Paragraph 56 of the Complaint, and therefore denies
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`those allegations.
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`57.
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`Foundation Medicine denies the allegations of Paragraph 57 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 17 to the Complaint.
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`58.
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`Foundation Medicine denies the allegations of Paragraph 58 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 17 to the Complaint.
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`COUNT IV
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`59.
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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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`60.
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`Foundation Medicine admits that the ’916 patent is entitled “Systems and methods
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`to detect rare mutations and copy number variation,” and on its face recites an issue date of October
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`6, 2020. Foundation Medicine is without information or knowledge sufficient to form a belief as
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`to the truth of the remaining allegations of Paragraph 60 of the Complaint, and therefore denies
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`those allegations.
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`61.
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`Foundation Medicine denies the allegations of Paragraph 61 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 18 to the Complaint.
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`62.
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`Foundation Medicine denies the allegations of Paragraph 62 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 18 to the Complaint.
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`COUNT V
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`63.
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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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`64.
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`Foundation Medicine admits that the ’063 patent is entitled “Methods and systems
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`for detecting genetic variants,” and on its face recites an issue date of October 13, 2020.
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`Foundation Medicine is without information or knowledge sufficient to form a belief as to the truth
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`of the remaining allegations of Paragraph 64 of the Complaint, and therefore denies those
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`allegations.
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`65.
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`Foundation Medicine denies the allegations of Paragraph 65 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 19 to the Complaint.
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`66.
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`Foundation Medicine denies the allegations of Paragraph 66 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 19 to the Complaint.
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`COUNT VI
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`67.
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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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`68.
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`Foundation Medicine admits that the ’743 patent is entitled “Systems and Methods
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`to Detect Rare Mutations and Copy Number Variation,” and on its face recites an issue date of
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`December 12, 2017. Foundation Medicine is without information or knowledge sufficient to form
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`a belief as to the truth of the remaining allegations of Paragraph 68 of the Complaint, and therefore
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`denies those allegations.
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`69.
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`Foundation Medicine denies the allegations of Paragraph 69 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 20 to the Complaint.
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`70.
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`Foundation Medicine denies the allegations of Paragraph 70 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 20 to the Complaint.
`
`COUNT VII
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`71.
`
`Foundation Medicine repeats, re-alleges, and incorporates by reference the
`
`foregoing paragraphs as if fully set forth herein.
`
`72.
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`Foundation Medicine admits that the ’822 patent is entitled “Systems and Methods
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`to Detect Rare Mutations and Copy Number Variation,” and on its face recites an issue date of
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`December 5, 2017. Foundation Medicine is without information or knowledge sufficient to form
`
`a belief as to the truth of the remaining allegations of Paragraph 72 and therefore denies those
`
`allegations.
`
`73.
`
`Foundation Medicine denies the allegations of Paragraph 73 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 21 to the Complaint.
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`74.
`
`Foundation Medicine denies the allegations of Paragraph 74 of the Complaint,
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`including to the extent those allegations are set forth in Exhibit 21 to the Complaint.
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`JURY DEMAND
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`75.
`
`The Complaint sets forth a demand for a trial by jury. Pursuant to Fed. R. Civ. P.
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`38, Foundation Medicine likewise demands a trial by jury on all issues so triable.
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`PRAYER FOR RELIEF
`
`1.
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`Foundation Medicine denies that Guardant is entitled to any of its requested relief,
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`including that sought in paragraphs A – F of Guardant’s Prayer for Relief or any other type of
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`recovery from Foundation Medicine. Guardant’s prayer should, therefore, be denied in its entirety
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`and with prejudice.
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`2.
`
`Foundation Medicine asks that the Complaint be dismissed and that judgment be
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`entered for Foundation Medicine.
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`3.
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`Foundation Medicine asks that the Court determine that this is an exceptional case
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`under 35 U.S.C. § 285 and award attorneys’ fees, costs, and other expenses to Foundation Medicine
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`in this action.
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`4.
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`Foundation Medicine denies any allegation in the Complaint not specifically
`
`admitted.
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`AFFIRMATIVE/ADDITIONAL DEFENSES
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`Without assuming any burden that it would not otherwise have under the applicable law
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`and rules, Foundation Medicine asserts the following Affirmative and Additional Defenses:
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`First Defense
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`(Failure to State a Claim)
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`The Complaint fails to state a claim upon which relief can be granted.
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`Second Defense
`
`(Non-Infringement)
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`Foundation Medicine does not infringe and has not infringed, literally or by the doctrine of
`
`equivalents, any valid and enforceable claim of the ’810, ’085, ’086, ’916, ’063, ’743, and ’822
`
`patents.
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`Third Defense
`
`(Invalidity)
`
`The claims of the ’810, ’085, ’086, ’916, ’063, ’743, and ’822 patents are invalid because
`
`they fail to satisfy one or more of the conditions for patentability stated in Title 35 of the United
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`States Code, including without limitation, §§ 101, 102, 103, and 112, and/or the claims are
`
`otherwise unenforceable. Foundation Medicine incorporates by reference its allegations in
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`paragraphs 1-140, infra.
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`Fourth Defense
`
`(Limitation on Damages)
`
`Guardant’s claim for damages is limited by 35 U.S.C. §§ 286 and 287(a).
`
`Fifth Defense
`
`(Adequate Remedy at Law)
`
`Guardant’s claim for injunctive relief is barred because it has an adequate remedy at law;
`
`it is not being, and is not in danger of being, irreparably injured; the balance of the hardships is not
`
`in its favor; and the public interest is not served by the granting of injunctive relief.
`
`Sixth Defense
`
`(Prosecution History Estoppel)
`
`Guardant’s claims are barred by the doctrine of prosecution history estoppel. During
`
`prosecution of the ’810, ’085, ’086, ’916, ’063, ’743, and ’822 patents, Guardant or its patent agent
`
`or attorney made amendments, took positions, or made concessions, statements, or representations
`
`that estop Guardant from asserting the ’810, ’