Case 1:20-cv-01580-LPS Document 1-22 Filed 11/23/20 Page 1 of 9 PageID #: 633
`Case 1:20-cv-01580-LPS Document 1-22 Filed 11/23/20 Page 1 of 9 PageID #: 633
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`EXHIBIT 22
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`EXHIBIT 22
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`Case 1:20-cv-01580-LPS Document 1-22 Filed 11/23/20 Page 2 of 9 PageID #: 634
`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 1 of 8 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GUARDANT HEALTH, INC.,
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`FOUNDATION MEDICINE, INC.,
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`Plaintiff
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`v.
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`C.A. No. __________________
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`JURY TRIAL DEMANDED
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`Defendant.
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`Plaintiff Guardant Health, Inc. (“Guardant”), on behalf of itself, by Guardant’s attorneys,
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`COMPLAINT
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`hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the United
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`States, Title 35, United States Code, against Defendant Foundation Medicine, Inc. (“Foundation”).
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`2.
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`Guardant brings this action to halt Foundations’ infringement of Guardant’s rights
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`under the Patent Laws of the United States 35 U.S.C. § 1, et seq., which arise under U.S. Patent No.
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`9,598,731 (“the ’731 patent”) (attached as Exhibit 1).
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`PARTIES
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`3.
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`Guardant is a corporation organized and existing under the laws of the state of
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`Delaware, having its principal place of business at 505 Penobscot Dr., Redwood City, CA 94063.
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`4.
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`Guardant was founded in 2012 by pioneers in DNA sequencing and cancer
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`diagnostics. Since its inception, Guardant has focused its expertise on the development of liquid
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`biopsy cancer assays. It was the first company to develop and commercialize a comprehensive
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`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 2 of 8 PageID #: 2
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`liquid biopsy assay to identify genomic biomarkers for advanced solid tumors using “cell-free
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`circulating tumor DNA,” or “ctDNA,” from simple, non-invasive blood draws.
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`5.
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`Today, Guardant markets and sells the Guardant360® ctDNA assay. Guardant360
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`uses advanced DNA sequencing methods to identify targeted therapy treatment options based on
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`the specific changes—also known as somatic mutations—that occur within the DNA of cancer
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`cells. Guardant360 has helped thousands of oncologists find accurate and actionable information
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`about tens of thousands of cancer patients, while avoiding the high costs and added risks of tissue
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`biopsies.
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`6.
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`On information and belief, Foundation Medicine, Inc. (“Foundation”) is a
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`corporation organized and existing under the laws of the state of Delaware, having its principal
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`place of business at 150 Second Street, Cambridge, MA 02141. Foundation markets and sells a
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`liquid biopsy known as FoundationACT®. On information and belief, Foundation performs
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`FoundationACT at its facility in Cambridge, MA.
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`JURISDICTION AND VENUE
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`7.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
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`1338(a), 2201 and 2202.
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`8.
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`9.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`This Court has jurisdiction over Foundation because, upon information and belief,
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`Foundation Medicine, Inc. is a Delaware corporation.
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`10.
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`This Court also has jurisdiction over Foundation because, upon information and
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`belief, Foundation, directly or indirectly, uses, offers for sale, and/or sells the FoundationACT
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`throughout the United States and in this judicial district.
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`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 3 of 8 PageID #: 3
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`11.
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`Further, the Court has jurisdiction over Foundation because, inter alia, this action
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`arises from actions of Foundation directed toward Delaware, and because Foundation has
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`purposefully availed itself of the rights and benefits of Delaware law by engaging in systematic
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`and continuous contacts with Delaware. Upon information and belief, Foundation regularly and
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`continuously transacts business within Delaware, including by selling FoundationACT in
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`Delaware, either on its own or through its affiliates. Upon information and belief, Foundation
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`derives substantial revenue from the sale of FoundationACT in Delaware and has availed itself of
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`the privilege of conducting business within Delaware.
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`12.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Foundation.
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`BACKGROUND
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`13.
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`Guardant repeats and re-alleges the foregoing paragraphs as if set forth specifically
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`herein.
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`14.
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`On information and belief, in the mid-2016 time frame Foundation began
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`commercializing a liquid biopsy test known as FoundationACT. According to a Foundation press
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`release, FoundationACT is “an analytically validated and accurate blood-based circulating tumor
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`DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive
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`genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing
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`circulating tumor DNA isolated from a patient’s blood, FoundationACT can identify clinically
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`relevant genomic alterations, and like Foundation Medicine’s tissue-based genomic profiles,
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`FoundationOne® and FoundationOne Heme®, FoundationACT delivers this comprehensive
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`molecular information in a concise report that matches the findings with potentially relevant
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`targeted therapies and clinical trials.” Exhibit 2.
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`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 4 of 8 PageID #: 4
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`15.
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`In February 2017, scientists affiliated with Foundation presented the poster
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`“Genomic profiling of circulating tumor DNA (ctDNA) from patients with advanced cancers of
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`the GI tract and anus” (attached hereto as Exhibit 3) at the American Society of Clinical Oncology
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`meeting. On information and belief, this poster describes the methodology that Foundation uses in
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`its FoundationACT test, an overview of which is presented in the figure below:
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`Exhibit 3.
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`16.
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`Foundation infringes, literally or under the doctrine of equivalents, Guardant’s ’731
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`patent through its activities connected to its performance of the Foundation ACT test. For
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`instance, representative claim 1 of the ’731 patent is listed below:
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`1. A method for quantifying single nucleotide variant tumor markers in
`cell-free DNA from a subject, comprising:
`(a) providing at least 10 ng of cell-free DNA obtained from a bodily sample of
`the subject;
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`(b) attaching tags comprising barcodes having from 5 to 1000 distinct barcode
`sequences to said cell-free DNA obtained from said bodily sample of the
`subject, to generate non-uniquely tagged parent polynucleotides, wherein
`each barcode sequence is at least 5 nucleotides in length;
`(c) amplifying the non-uniquely tagged parent polynucleotides to produce
`amplified non-uniquely tagged progeny polynucleotides;
`(d) sequencing the amplified non-uniquely tagged progeny polynucleotides to
`produce a plurality of sequence reads from each parent polynucleotide,
`wherein each sequence read comprises a barcode sequence and a sequence
`derived from cell-free DNA;
`(e) grouping the plurality of sequence reads produced from each non-uniquely
`tagged parent polynucleotide into families based on i) the barcode
`sequence and ii) at least one of: sequence information at a beginning of the
`sequence derived from cell-free DNA, sequence information at an end of
`the sequence derived from cell-free DNA, and length of the sequence read,
`whereby each family comprises sequence reads of non-uniquely tagged
`progeny polynucleotides amplified from a unique polynucleotide among
`the non-uniquely tagged parent polynucleotides;
`(f) comparing the sequence reads grouped within each family to each other to
`determine consensus sequences for each family, wherein each of the
`consensus sequences corresponds to a unique polynucleotide among the
`non-uniquely tagged parent polynucleotides;
`(g) providing one or more reference sequences from a human genome, said one
`or more reference sequences comprising one or more loci of reported
`tumor markers, wherein each of the reported tumor markers is a single
`nucleotide variant;
`(h) identifying consensus sequences that map to a given locus of said one or
`more loci of reported tumor markers; and
`(i) calculating a number of consensus sequences that map to the given locus
`that include the single nucleotide variant thereby quantifying single
`nucleotide variant tumor markers in said cell-free DNA from said subject.
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`17.
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`Performance of Foundation’s FoundationACT test leads to infringement of this
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`claim in the following way. First, in FoundationACT, more than 10 ng of cell free DNA is
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`obtained from a patient blood draw (step a). Tags comprising barcodes are then attached to both
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`ends of the DNA fragments that are present in the sample of cell free DNA (step b). The tagged
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`DNA sample is then subject to PCR amplification (step c). The amplified DNA is then subject to
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`sequencing on the Illumina sequencing platform, resulting in sequence reads that consist of a
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`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 6 of 8 PageID #: 6
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`barcode sequence and a sequence present in the cell free DNA (step d). Next, the sequence reads
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`are grouped into families based on the barcode and additional sequence information, allowing one
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`to collect sequence information that arises from the same DNA molecule (step e). The sequence
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`reads in each family are then compared to one another to arrive at a “consensus sequence” that
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`represents a more accurate determination of the sequence of the molecule in question (step f).
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`Next, the consensus sequences are mapped to a reference genome to identify sequence that map to
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`regions of the genome associated with cancer tumor markers (steps f-h). Finally, the number of
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`tumor markers present in the original sample are quantified (step i).
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`18.
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`As an example, attached hereto as Exhibit 4 is a preliminary and exemplary claim
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`chart detailing Foundation’s infringement of multiple claims of the ’731 patent. This chart is not
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`intended to limit Guardant’s right to modify this chart or any other claim chart or allege that other
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`activities of Foundation infringe the identified claims or any other claims of the ’731 patent or any
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`other patents. Exhibit 4 is hereby incorporated by reference in its entirety. Each claim element in
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`Exhibit 4 that is mapped to the FoundationACT product shall be considered an allegation within
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`the meaning of the Federal Rules of Civil Procedure and therefore a response to each allegation is
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`required.
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`COUNT I
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`19.
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`Guardant repeats and re-alleges the foregoing paragraphs as if set forth specifically
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`herein.
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`20.
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`On March 21, 2017, the United States Patent and Trademark Office duly and
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`legally issued the ’731 patent, entitled “Systems and Methods to Detect Rare Mutations and Copy
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`Number Variation,” which is solely assigned to Guardant. Guardant is the owner of all rights, title
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`to and interest in the ’731 patent.
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`Case 1:20-cv-01580-LPS Document 1-22 Filed 11/23/20 Page 8 of 9 PageID #: 640
`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 7 of 8 PageID #: 7
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`21.
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`On information and belief, Foundation has infringed and continues to infringe at
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`least claims 1-3, 6-9, 12 and 16-17 of the ’731 patent pursuant to 35 U.S.C. § 271(a), literally or
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`under the doctrine of equivalents, by performing within the United States without authority the
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`FoundationACT test. As an example, attached as Exhibit 4 is a preliminary and exemplary claim
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`chart detailing Foundation’s infringement of these claims of the ’731 patent. This chart is not
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`intended to limit Guardant’s right to modify the chart or allege that other activities of Guardant
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`infringe the identified claims or any other claims of the ’731 patent or any other patents.
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`22.
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`Exhibit 4 is hereby incorporated by reference in its entirety. Each claim element in
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`Exhibit 4 that is mapped to Foundation’s FoundationACT test shall be considered an allegation
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`within the meaning of the Federal Rules of Civil Procedure and therefore a response to each
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`allegation is required.
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`JURY DEMAND
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`23.
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`Guardant demands a jury trial on all issues so triable.
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`PRAYER FOR RELIEF
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`WHEREFORE, Guardant prays that this Court grant the following relief:
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`A.
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`A judgment that Foundation has infringed the ’731 patent and that the ’731
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`patent is valid;
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`B.
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`Damages or other monetary relief, including, but not limited to, costs and
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`pre- and post-judgment interest, to Guardant;
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`C.
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`An order enjoining Foundation and its officers, directors, agents, servants,
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`affiliates, employees, divisions, branches, subsidiaries, parents, and all others acting in active
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`concert therewith from further infringement of the’731 patent;
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`Case 1:20-cv-01580-LPS Document 1-22 Filed 11/23/20 Page 9 of 9 PageID #: 641
`Case 1:17-cv-01616-LPS-CJB Document 1 Filed 11/09/17 Page 8 of 8 PageID #: 8
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`D.
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`Such further and other relief as this Court deems proper and just, including,
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`but not limited to, a determination that this is an exceptional case under 35 U.S.C. § 285 and an
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`award of attorneys’ fees and costs to Guardant in this action.
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`Dated: November 9, 2017
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`Of Counsel:
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`Edward R. Reines
`Derek Walter
`WEIL, GOTSHAL &MANGES LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`(650) 802-3000
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`Respectfully submitted,
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`FARNAN LLP
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`/s/ Michael J. Farnan
`Joseph J. Farnan, Jr. (Bar No. 100245)
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 N. Market St., 12th Floor
`Wilmington, DE 19801
`Tel: (302) 777-0300
`Fax: (302) 777-0301
`farnan@farnanlaw.com
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
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`Attorneys for Plaintiff Guardant Health, Inc.
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