Case 1:20-cv-01580-LPS Document 11 Filed 12/10/20 Page 1 of 18 PageID #: 2188
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` IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`GUARDANT HEALTH, INC.,
`
`Plaintiff,
`
`v.
`
`FOUNDATION MEDICINE, INC.,
`
`Defendant.
`
`C.A. No. 20-cv-1580-LPS
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`JURY TRIAL DEMANDED
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`DECLARATION OF DANIEL SIMON
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`

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`Case 1:20-cv-01580-LPS Document 11 Filed 12/10/20 Page 2 of 18 PageID #: 2189
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`1.
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`I, Daniel Simon, have personal knowledge of the following facts or believe them
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`to be true based on information provided to me by others and a reasonable investigation. I would
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`testify that the facts in this declaration are true and correct, to the best of my knowledge, if given
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`the opportunity to do so.
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`2.
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`This declaration includes facts known to me at the time I signed this declaration.
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`I reserve the right to supplement or amend this declaration in the future, including through
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`testimony in deposition or at trial.
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`I.
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`Background
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`3.
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`I am the Senior Vice President of Biopharmaceutical Business Development at
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`Guardant Health, Inc. (“Guardant”). I have been with Guardant since January 2015 (consulting
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`at first, full time since June 2015) and have been responsible for biopharma business
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`development since I joined Guardant.
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`4.
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`Guardant is a precision oncology company entirely focused on helping conquer
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`cancer through use of proprietary blood-based tests, large data sets and advanced analytics. For
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`example, Guardant’s Guardant360® blood-based test is the first FDA-approved liquid biopsy
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`for comprehensive tumor mutation profiling across all solid cancers.
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`5.
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`Guardant invests heavily in research in development. Since 2015, Guardant has
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`spent more than $280 million on research and development, primarily focused on its blood-based
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`liquid biopsy products.
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`6.
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`My responsibilities for biopharma business development require that I be
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`knowledgeable about marketing and sales of the solutions that Guardant offers its customers. I
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`am familiar with industry trends for liquid biopsy products for tumor genetic profiling, including
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`demand for Guardant’s solutions, Guardant’s competitors, and purchasing customs and habits in
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`the industry.
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`7.
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`I am aware that Guardant owns the rights to U.S. Patent No. 10,704,085 and U.S.
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`Patent No. 10,704,086.
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`8.
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`Guardant relies on intellectual property to protect its investments in developing
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`technology. Protection of our intellectual property is fundamental to the long-term success of
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`our business.
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`9.
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`I earned an MA degree with First Class Honors in Biological Natural Sciences
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`from Cambridge University in 2000.
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`10.
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`I earned an MBA degree with a major in health care from the Wharton School of
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`the University of Pennsylvania in 2006.
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`11.
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`Before joining Guardant I held positions at McKinsey & Company and Onyx
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`Pharmaceuticals and worked as a consultant for MyoKardia.
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`II.
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`Comprehensive Genetic Profiling For Oncology
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`12.
`
`Traditional oncology categorizes cancer by the organ in which it is first located,
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`and treats it independently of its genomic profile.
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`13.
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`In contrast, the goal of precision oncology is to match cancer patients with
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`personalized, targeted therapies based on the genomic profiles of their tumors. Such therapies
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`can provide better outcomes, and fewer side effects, than broad-based chemotherapy, but an
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`individual’s response often depends on the genomic profile of their tumor.
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`14.
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`Precision oncology is an increasingly important approach to cancer treatment.
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`Many important types of cancer, including lung, breast, colorectal and melanoma, for example,
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`are often classified and treated on the basis of their genomic profile.
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`15.
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`Precision oncology is also an important focus for biopharmaceutical drug
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`development. Many tumors have specific genomic profiles, and drug companies are working to
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`develop therapies for patients with alterations in specific genes, which can not only significantly
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`increase the likelihood that clinical trials of such candidate drugs will succeed, but also do so
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`based on enrollment of fewer patients, thus shortening time to market and accelerating patient
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`access.
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`16.
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`As new genomic biomarkers are discovered, cancer populations may be further
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`divided into sub-classifications for treatment. This may lead to yet more optimal treatments, and
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`outcomes, for patients, but it can also make the oncologist’s job of matching patients with the
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`right treatments even more complicated.
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`17.
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`Previously, most genomic liquid biopsies were for single mutations in a gene, or
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`a short selection of nucleotides within a gene (called a “hotspot”). These biopsies were usually
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`targeted for a single type of cancer. Matching a patient with a targeted therapy using these tests
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`often requires repeated testing as multiple genes should be tested. As the number of available
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`therapies has increased, it has become more difficult to select an appropriate therapy using
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`single-gene tests.
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`18.
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`Treatment guidelines published by the National Cancer Center Network (NCCN)
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`now support multi-biomarker testing across many cancer types. For example, for non-small cell
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`lung cancer (NSCLC), NCCN treatment guidelines now include recommendations for testing
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`across nine genes as well as tumor mutational burden (TMB). Alterations in each gene are
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`associated with one or more targeted therapies.
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`19.
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`Comprehensive Genetic Profiling (CGP) helps by providing more complete
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`information about a tumor’s molecular characteristics than individual tests that focus on just one
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`or a few biomarkers (e.g., hotspot testing). Guardant’s Guardant360® CGP liquid biopsy can
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`deliver results from a single test that would have required repeated testing using hotspot tests.
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`20.
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`Traditionally, tissue biopsies were used to analyze tumors. Tissue biopsies are
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`often expensive and time-consuming as well as invasive, requiring, for example, a needle to be
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`inserted into a tumor to collect a sample. Medical imaging is typically required to locate a tumor
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`for biopsy, a procedure is usually required to collect it, and a pathologist is required to analyze
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`it, which all requires complex coordination among multiple doctors. This can require additional
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`time, which advanced-stage cancer patients cannot always afford. Invasive tissue biopsy
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`procedures, such as surgery, are also often associated with increased morbidity and mortality.
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`21.
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`Tissue biopsies typically sample just a small portion of the patient’s tumor, which
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`may not be representative of the rest of the tumor, or tumor metastases, which have spread to
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`other parts of the body, and may thus not include all relevant and actionable biomarkers. This
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`can result in targetable mutations going undetected, something that has been seen in many types
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`of tumors.
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`III. Guardant’s Liquid CGP Biopsies
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`22.
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`Guardant360® was the first commercial comprehensive genetic profiling (CGP)
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`liquid biopsy for clinical or research use when Guardant released it in 2014. Comprehensive
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`genetic profiling liquid biopsies analyze a blood sample for multiple genetic targets and multiple
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`solid tumors. Guardant360® is designed to identify clinically actionable mutations in a patient’s
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`cancer and match them with FDA-approved therapies, or therapies under clinical study for FDA
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`approval. Guardant360® covers all genes recommended by the National Comprehensive Cancer
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`Network, including the 55 genes most relevant to clinical care. Guardant360® is used for
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`patients with metastatic, or recurring, cancers to avoid repeated tissue biopsies. Guardant360®
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`is also used when tissue is not available, or a tissue biopsy is not possible.
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`23.
`
`Since it was introduced, Guardant360® has become widely accepted for blood-
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`based CGP with more than 190 peer-reviewed publications. It has been trusted by more than
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`7,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by
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`4
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`Medicare and many private payers, representing over 190 million lives. Guardant360® has been
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`adopted by all 27 National Comprehensive Cancer Network Centers and 52 of 64 National
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`Cancer Institute cancer centers. The most common uses for Guardant360® to date are for lung,
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`breast, colorectal and gastric cancers.
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`24.
`
`Guardant360® is currently covered by Cigna, Priority Health, multiple Blue
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`Cross Blue Shield plans, as well as the health plans associated with eviCore, which have adopted
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`policies that specifically cover Guardant360® test for non-small cell lung cancer, or NSCLC.
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`25.
`
`Guardant360® also helps pharmaceutical companies accelerate clinical
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`development programs through prospective patient screening to find patients with the
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`appropriate alterations for enrollment, referral of patients from clinical testing who also have
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`relevant alterations, and companion diagnostic development to support approval and
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`commercialization of new drugs.
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`26.
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`In 2020 Guardant bifurcated Guardant360® into two separate products.
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`Guardant360® CDx is the first CGP liquid biopsy to receive FDA approval, which was granted
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`on August 7, 2020. Guardant360® CDx covers all genes recommended by the National
`
`Comprehensive Cancer Network, including the 55 genes most relevant to clinical care.
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`Guardant360® LDT is a more comprehensive test for oncologists who want genomic profiling
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`to guide treatment beyond the standard of care. It reports on alterations in more than 80 genes,
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`allowing oncologists to explore treatment options for patients for whom standard of care
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`treatments are failing, as well as tumor mutational burden.
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`27.
`
`GuardantOMNI, which was launched in 2017, uses the same genetic profiling
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`technology as Guardant360®, and is designed as a comprehensive genomic profiling tool for
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`biopharmaceutical companies. GuardantOMNI can help accelerate clinical development in
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`5
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`immuno-oncology and targeted therapy. GuardantOMNI provides a 500-gene panel that
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`includes the vast majority of all genes being evaluated in cancer drug development pipelines and
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`biomarkers
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`for
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`immuno-oncology applications,
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`including
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`tumor mutational burden.
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`GuardantOMNI can help biopharmaceutical companies identify patients whose cancer has the
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`right molecular profile for their clinical program. GuardantOMNI also helps monitor patient
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`response to investigational drugs, and perform retrospective analyses on patient plasma samples.
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`28.
`
`Guardant360® and GuardantOMNI have each been designated by the FDA as a
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`breakthrough device for use as a companion diagnostic in connection with certain specified
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`therapeutic products of our biopharmaceutical customers. Both tests are both being developed as
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`companion diagnostics under collaborations with biopharmaceutical companies, including
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`AstraZeneca, Amgen and Janssen.
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`29.
`
`Compared to tissue biopsies, Guardant’s liquid biopsies are minimally invasive,
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`quick and easy to administer, cost effective and readily available. Guardant’s liquid biopsy
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`requires only a routine blood draw and typically takes seven days or less to provide a
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`comprehensive genotype, allowing the oncologist to select an effective treatment or potential
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`clinical trial enrollment, if any appropriate alterations are found. The genotype can reflect the
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`entire molecular profile of the patient’s tumor or tumors and not just a portion of a single tumor,
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`potentially identifying more targetable mutations than a tissue biopsy.
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`30.
`
`Guardant’s liquid biopsies use cell-free DNA (“cfDNA”) from a patient’s blood
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`to develop the comprehensive genetic profile. cfDNA from tumors circulating in blood plasma
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`is called circulating tumor DNA (“ctDNA”). Analyzing ctDNA poses challenges in part because
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`it is found at very low concentrations. Although the sensitivity and specificity of next generation
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`DNA sequencing platforms is sufficient for genomic profiling of tumors from tissue biopsies, it
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`is inadequate for liquid biopsies, without the technology Guardant has developed, because of the
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`low concentration of ctDNA in blood. For example, Guardant’s testing has found that the median
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`concentration of ctDNA genomic alterations in blood of advanced cancer patients is 0.46% of
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`the total cell-free DNA present and can be at levels below 0.01% in early stage cancer patients.
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`31.
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`Comprehensive genetic profiling for precision oncology requires detection of all
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`four classes of genetic alterations: single nucleotide variants, copy number variants,
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`insertions/deletions and fusions, across multiple genes. This is particularly challenging with
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`ctDNA, due to its low concentration.
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`32.
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`Guardant’s CGP liquid biopsy technology combines biochemistry, next-
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`generation sequencing, signal processing, bioinformatics, machine learning and process
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`engineering to enable the world’s market-leading comprehensive liquid biopsy test, with a
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`typical turnaround time of less than seven days after Guardant receives the sample.
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`33.
`
`I understand that the ’085 and ’086 Patents are directed to methods of detecting
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`genetic mutations in cell-free DNA. I am informed that the ’085 and ’086 Patents cover
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`important aspects of Guardant’s liquid biopsy technology that enables Guardant to provide
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`comprehensive genetic profiles from ctDNA despite the very low concentrations found in
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`patients’ blood. I have also been informed that Guardant has asserted the ’085 and ’086 Patents
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`against FMI’s CGP liquid biopsy products.
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`IV.
`
`FMI and FMI liquid biopsies
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`34.
`
`FMI is Guardant’s biggest competitor for CGP liquid biopsy for therapy selection
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`in late-stage cancer patients.
`
` FMI competes with Guardant for both clinical and
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`biopharmaceutical sales.
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`35.
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`FMI is a wholly-owned subsidiary of Roche Pharmaceuticals, a division of
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`Hoffman-LaRoche, a large multinational company based in Switzerland.
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`7
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`36.
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`FMI offers two main CGP biopsy products, FoundationOne® CDx and
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`FoundationOne® Liquid CDx. FoundationOne® CDx is a tissue biopsy product, not a liquid
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`biopsy product, and I understand that Guardant does not accuse FoundationOne® CDx of
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`infringing the ’085 and ’086 Patents. FoundationOne® CDx is FDA-approved and analytically
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`validated for CGP tissue biopsy of solid tumors. FMI markets FoundationOne® CDx as the
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`“gold standard” CGP test for therapy selection and describes it as its “flagship product.”
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`37.
`
`FMI launched FoundationOne® Liquid CDx as a successor to FoundationOne®
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`Liquid, in 2018. FoundationOne® Liquid was a rebranding of its original FoundationACT liquid
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`biopsy, which was launched in 2016. FoundationOne® Liquid CDx received FDA approval as
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`a companion diagnostic on August 26, 2020.
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`V.
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`Overview of the market for liquid CGP biopsies
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`38.
`
`The market for liquid CGP biopsies is at an early stage. Guardant360® was the
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`first commercial comprehensive genetic profiling (CGP) liquid biopsy for clinical or research
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`use when Guardant released it in 2014. The first FDA approval for any CGP liquid biopsy was
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`granted to Guardant360® CDx on August 7, 2020. The FDA’s announcement said that the
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`approval “marks a new era for mutation testing”:
`
` “Approval of a companion diagnostic that uses a liquid biopsy and leverages next-
`generation sequencing marks a new era for mutation testing,” said Tim Stenzel,
`M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health
`in the FDA’s Center for Devices and Radiological Health. “In addition to
`benefitting from less invasive testing, patients are provided with a simultaneous
`mapping of multiple biomarkers of genomic alterations, rather than one biomarker
`at a time, which can translate to decreased wait times for starting treatment and
`provide insight into possible resistance mechanisms.”
`
`https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-
`generation-sequencing-companion-diagnostic-test
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`39.
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`Today, there are only two FDA-approved liquid CGP biopsies on the market,
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`Guardant360® CDx, and FoundationOne® Liquid CDx.
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`40.
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`The growing importance of liquid CGP biopsies is reflected in Guardant’s sales.
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`Guardant’s revenue from its liquid CGP biopsies has approximately doubled every year since
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`2016, from $25.2 million in 2016 to $214.4 million in 2019.
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`VI.
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`FMI’s FoundationOne® Liquid CDx poses a threat of irreparable harm to
`Guardant
`
`41.
`
`Guardant’s success, and its ability to deliver leading diagnostic solutions,
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`depends on a number of critical factors that are irreparably harmed and threatened by FMI’s
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`FoundationOne® Liquid CDx.
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`42.
`
`Guardant’s market-leading technology allowed Guardant to earn the first FDA
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`approval for any CGP liquid biopsy for Guardant360® CDx on August 7, 2020. If not for FMI’s
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`unauthorized use of Guardant’s patented technology, Guardant would have the only FDA-
`
`approved CGP liquid biopsy in the market today. FoundationOne® Liquid CDx competes
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`directly with all of Guardant’s current products including Guardant360® CDx.
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`43.
`
`The FDA approval of Guardant360® CDx was an important milestone for liquid
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`CGP cancer diagnostic testing. FDA approval is a signal of diagnostic utility and quality that
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`many oncologists rely on. Before Guardant360® CDx received FDA approval, many
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`oncologists preferred tissue biopsy to liquid biopsy for CGP testing. In fact, FMI still touts its
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`tissue biopsy as the “gold standard” for cancer diagnosis, implying that tissue biopsy is superior
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`to liquid biopsy. FDA approval assures oncologists that they can rely on Guardant360® CDx
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`and FoundationOne® Liquid CDx for treating patients. As a result, it is much easier to sell an
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`FDA-approved diagnostic test to oncologists, than the same test without FDA approval.
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`44.
`
`Guardant expended a great deal of effort and resources to obtain FDA approval
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`for Guardant360® CDx, and it required a great deal of interaction between Guardant and the
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`FDA, in part because the FDA had never approved a CGP liquid biopsy for cancer therapy
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`selection before. By using Guardant’s patented technology in its FoundationOne® Liquid CDx,
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`FMI may have had an easier time gaining FDA approval for FoundationOne® Liquid CDx
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`because the FDA had already learned about the technology during the Guardant360® CDx
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`approval process.
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`45.
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`The “CDx” in Guardant360® CDx and FoundationOne® Liquid CDx signify that
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`they are companion diagnostic tests. The FDA approval for these companion diagnostic tests
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`means that they are approved to identify patients who may benefit from specific targeted
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`therapies. The therapies for which these tests are approved are not made or sold by Guardant or
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`FMI. For example, Guardant360® CDx is FDA approved to identify patients with NSCLC who
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`may benefit from Tagrisso®, a therapeutic drug made and sold by AstraZeneca, for patients with
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`alterations in their EGFR gene.
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`46.
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`Demonstrating the diagnostic utility of a companion diagnostic test requires
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`extensive collaboration with the biopharmaceutical company that makes and sells the targeted
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`therapy, for which the test will be used. Developing such a collaborative relationship with a
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`biopharmaceutical company requires a great deal of effort and resources. Simply negotiating a
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`collaboration agreement for a companion diagnostic test often requires months, even after the
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`parties have tentatively agreed to pursue the collaboration. It is much easier to enter additional
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`collaborations (e.g., for different drugs or indications) with an existing biopharmaceutical
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`collaborator than it is to recruit new collaborators. It is also very difficult to persuade a
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`biopharmaceutical company to switch diagnostic test providers after they have agreed to
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`collaborate.
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`47.
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`FMI has acknowledged the importance of relationships with biopharmaceutical
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`companies:
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`Our success in the future depends in part on our ability to maintain relationships
`and to enter into new relationships with biopharmaceutical partners. This can be
`difficult due to several factors, including internal and external constraints placed on
`these organizations that can limit the number and type of relationships with
`companies like us they can consider and consummate….If we fail to maintain these
`relationships, or enter into new ones, our business could suffer.
`
`FMI 2017 Form 10-K at 46.
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`48.
`
`Guardant and FMI compete to collaborate with biopharmaceutical partners to
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`develop liquid biopsies as companion diagnostic tests. FMI’s participation in such relationships
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`restricts Guardant’s ability to cultivate and maintain such relationships. It also means that
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`Guardant may be required to offer less favorable terms to its biopharmaceutical partners.
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`49.
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`Despite its later entry into the field of liquid biopsies, FMI has used its position
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`as a trusted tissue biopsy provider, and Guardant’s patented liquid biopsy technology, to develop
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`collaborations with a number biopharmaceutical companies for use of FoundationOne® Liquid
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`CDx as a companion diagnostic test. The FDA Label for FoundationOne® Liquid CDx includes
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`indications for six different therapeutic drugs: gefitinib, osimertinib, erlotinib, alectinib,
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`rucaparib and alpelisib.
`
`50.
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`FoundationOne® Liquid CDx
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`is also substantially
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`less sensitive
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`than
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`Guardant360® CDx, meaning that the FoundationOne® Liquid CDx will identify fewer patients
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`with actionable alterations than if those same patients were tested using Guardant360® CDx,
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`resulting in some patients being denied access to the appropriate therapy for their cancer. For
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`example, for the L858R mutation of the EGFR gene, a biomarker for non-small cell lung cancer,
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`the FoundationOne® Liquid CDx FDA Label claims a Limit of Detection – a measure of a test’s
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`sensitivity – of 0.34% Variant Allele Frequency (VAF). (FoundationOne® Liquid CDx FDA
`
`Label, p.13). This means that FoundationOne® Liquid CDx will not reliably detect this
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`biomarker unless at least 0.34% of the cfDNA from the patient’s blood that encodes the EGFR
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`gene has the L858R mutation. In contrast, Guardant360® CDx has a Limit of Detection for the
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`same mutation of 0.2% VAF, meaning that it will reliably detect the biomarker even when it is
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`present at a much lower level. This has meaningful consequences for patients, as Guardant360®
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`CDx will provide a test result for the L858R mutations for 34% more patients than
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`FoundationOne® Liquid CDx. However, because FoundationOne® Liquid CDx now has FDA
`
`approval, and given FMI’s position as a trusted tissue biopsy provider, some oncologists will
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`likely select FoundationOne® Liquid CDx even though Guardant360® CDx would perform
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`better for their patients.
`
`51.
`
`FMI also competes with Guardant to have its liquid biopsy products used in
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`clinical trials and studies, and included in publications and conferences that discuss their results.
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`FMI has acknowledged the important role that clinical trials, studies, publications and
`
`presentations play in gaining acceptance for new diagnostic services:
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`We believe that the successful completion of clinical trials, publication of scientific
`and medical results in peer-reviewed journals, and presentations at leading
`conferences are critical to the broad adoption of our services. Publication in leading
`medical journals is subject to a peer-review process, and peer reviewers may not
`consider the results of studies involving our services sufficiently novel or worthy
`of publication.
`
`FMI 2017 Form 10-K at 42.
`
`52.
`
`Successful clinical trials and studies, and publications and presentations that
`
`discuss their results increase awareness of Guardant’s tests and make it more likely that others
`
`will use the same tests in future clinical trials, studies, publications and presentations at leading
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`conferences. On the other hand, once results of a clinical study using an FMI liquid biopsy are
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`published, a second study establishing equivalent results using a Guardant liquid biopsy are
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`typically of less interest to clinical researchers, peer-reviewed journals and leading conferences.
`
`Competition with FMI’s FoundationOne® CDx deprives Guardant of critical opportunities to
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`foster broader adoption of Guardant’s liquid biopsies.
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`53.
`
`Clinical trials and studies that use CGP liquid biopsies generally select one vendor
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`and do not change once the trial study starts. Therefore, each clinical trial or study that uses an
`
`FMI liquid biopsy does not use a Guardant liquid biopsy, depriving Guardant of important
`
`opportunities to gain market acceptance, and valuable clinical data for its liquid biopsies.
`
`54.
`
`Guardant has lost numerous opportunities to FMI to provide liquid biopsies for
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`clinical trials and studies, many of which have involved publications in prestigious journals.
`
`These include TRITON3, a prostate cancer study published in the Journal of Clinical Oncology;
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`a study of metastatic bladder cancer by Rainier Therapeutics; a study and trial concerning non-
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`small cell lung cancer (NSCLC) by Genentech published in the Annals of Oncology; a joint
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`study and trial by the University of California and Genentech concerning NSCLC published in
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`Nature Medicine; a study by Aix Marseilles University of NSCLC published in Therapeutic
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`Advances in Respiratory Disease; and a study of bile duct cancer (cholangiocarcinoma) by
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`Incyte. These studies and trials have collectively involved thousands of test subjects.
`
`55.
`
`Guardant and FMI also compete for the support of Key Opinion Leaders, such as
`
`prestigious cancer institutions and oncology networks, for its liquid biopsies. FMI has
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`acknowledged that Key Opinion Leaders are important in “validating [a company’s] testing
`
`platform, driving adoption, or establishing [a company’s] molecular information platform and
`
`tests as a standard of care….” FMI 2017 Form 10-K at 46.
`
`56.
`
`FMI has claimed to have relationships with a number of Key Opinion Leaders,
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`including the Children’s Hospital of Philadelphia Cancer Center, the Sylvester Comprehensive
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`Cancer Center at the University of Miami, The Ohio State University Comprehensive Cancer
`
`Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, and the
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`Case 1:20-cv-01580-LPS Document 11 Filed 12/10/20 Page 15 of 18 PageID #: 2202
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`Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. FMI 2017 Form
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`10-K at 46.
`
`57.
`
`FMI’s engagement with key opinion leaders restricts Guardant’s opportunities to
`
`engage with Key Opinion Leaders to validate its liquid biopsies, drive adoption of them, and
`
`establish them as a standard of care.
`
`58.
`
`Since FoundationOne® Liquid CDx received FDA approval, it has attracted
`
`attention from Key Opinion Leaders that would otherwise have been focused on Guardant360®
`
`CDx, and FMI’s sales and marketing team has focused attention on Guardant’s leading
`
`customers, especially those in an academic setting.
`
`59.
`
`Guardant’s ability to collect revenue for performing its liquid biopsies depends
`
`importantly on its ability to persuade public and commercial payers to provide coverage for those
`
`tests. Coverage is primarily influenced by clinical evidence, endorsements by Key Opinion
`
`Leaders, and treatment guidelines. The analytical and clinical data that Guardant has generated
`
`in its efforts to establish clinical utility, combined with the support Guardant has developed with
`
`Key Opinion Leaders in the oncology space has led to positive coverage decisions by a number
`
`of commercial payers. FMI’s competition with Guardant for clinical trials and studies and
`
`endorsements by Key Opinion Leaders restricts Guardant’s ability to gain coverage for its
`
`products. Coverage decisions have broad and lasting effects, as many patients and their
`
`oncologists are reluctant to order a Guardant CGP liquid biopsy, if it is not covered by the
`
`patient’s insurance.
`
`60.
`
`The harmful effects I have described are self-reinforcing. Positive coverage
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`decisions result in wider adoption, which makes it easier for Guardant to recruit Key Opinion
`
`Leaders, biopharmaceutical partners, clinical trials and studies and peer-reviewed publications
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`Case 1:20-cv-01580-LPS Document 11 Filed 12/10/20 Page 16 of 18 PageID #: 2203
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`and presentations at prestigious conferences. All of these factors are important to the success of
`
`Guardant’s CGP liquid biopsies.
`
`61.
`
`The data generated by Guardant’s tests is also critical to Guardant’s long term
`
`success. CGP liquid biopsies generate large amounts of data concerning the genomic profiles of
`
`patients and their associated disease states. This information has great potential to enable
`
`progress in cancer diagnostics and therapies and to enhance the value of the CGP liquid biopsies
`
`to patients and doctors. As Dr. Phil Frebbo, Chief Medical Officer of Illumina, the leading maker
`
`of next generation DNA sequencers explained in August of 2019, we are only beginning to
`
`understand how to use the information from liquid biopsies, but they are already proving very
`
`useful in managing cancer:
`
`Even with our incredible tissue biopsy analysis advances, accessibility challenges
`and tumor heterogeneity demand complementary solutions to evaluate tumors more
`frequently and comprehensively.
`
`That’s why many, including myself, are enthusiastic about liquid biopsies, which
`can provide crucial molecular information with simple blood draws. As cancers
`grow, they slough off cells, cell fragments, and DNA from apoptotic or necrotic
`cancer cells, which enter the blood stream and offer tremendous opportunities to
`better assess cancer.
`
`Though we’re only beginning to understand how to use this information to optimize
`patient outcomes, blood samples are already outlining cancer aggressiveness,
`identifying treatment options, tracking efficacy, and precisely managing each
`patient’s unique disease….
`
`Because liquid biopsies interrogate cell-free DNA (cfDNA) from an entire tumor
`(or tumors), rather than a single tissue sample, they can provide more
`comprehensive information about their makeup to more fully capture mutational
`complexity.
`
`https://www.illumina.com/company/news-center/feature-articles/Febbo-Liquid-Biopsy.html
`
`62.
`
`Guardant incorporates the data generated from its liquid biopsies into Guardant’s
`
`machine learning facilities, which is used to improve performance of subsequent tests, and to
`
`develop new applications of Guardant’s liquid biopsy technology. As a result, every Guardant
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`Case 1:20-cv-01580-LPS Document 11 Filed 12/10/20 Page 17 of 18 PageID #: 2204
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`CGP biopsy performed provides additional data that potentially enhances the value of every
`
`subsequent CGP biopsy. And every FoundationOne® liquid CDx biopsy that is performed
`
`instead of a Guardant liquid biopsy deprives Guardant of the long-term benefits that flow from
`
`that test.
`
`63.
`
`For the reasons I have discussed above, FMI’s FoundationOne® CDx is causing,
`
`and threatens to continue to cause, serious and irreparable harm to Guardant’s Guardant360®
`
`and GuardantOMNI liquid biopsy business.
`
`VII. Guardant can meet the public’s need for CGP liquid biopsies
`
`64.
`
`Guardant360® LDT reports all of the genetic biomarkers currently suitable for
`
`selecting FDA-approved therapies. Genes reported by FoundationOne® Liquid CDx that are
`
`not rep