Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 1 of 28
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`BOSTON DIVISION
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`CARIS MPI, INC.,
`
`Plaintiff,
`
`v.
`
`1:17-CV-12194
`C.A. No. __________________
`
`FOUNDATION MEDICINE, INC.,
`
`JURY TRIAL DEMANDED
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Caris MPI, Inc. (“Plaintiff” or “Caris”) brings this Complaint for patent
`
`infringement against Defendant Foundation Medicine, Inc. (“Defendant” or “FMI”). Caris
`
`alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for infringement of United States Patent Nos. 8,880,350;
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`9,372,193; 9,383,365; 9,092,392; and 9,292,660 (collectively, “the Asserted Patents”) under
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`United States Patent Laws, 35 U.S.C. §§ 1 et seq.
`
`2.
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`Caris brings this action against Defendant because of Defendant’s infringement of
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`Caris’ valuable patent rights.
`
`THE PARTIES
`
`3.
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`Caris MPI, Inc. is a privately held corporation existing under the laws of the state
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`of Texas and doing business as Caris Life Sciences. Caris MPI, Inc. has its principal place of
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`business at 750 West John Carpenter Freeway, Suite 800, Irving, Texas 75039.
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 2 of 28
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`4.
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`Caris is a pioneer and leading developer and provider of molecular profiling to aid
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`physicians’ selection of cancer treatments. Through its Caris Molecular Intelligence® product, a
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`comprehensive genomic profiling product formerly known as Target Now®, Caris has provided
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`molecular profiling for more than 123,000 clinical cases.
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`5.
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`On information and belief, Foundation Medicine, Inc. is a Delaware corporation
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`having its headquarters and principle place of business at 150 Second Street, Cambridge,
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`Massachusetts 02141. On information and belief, Foundation Medicine, Inc.’s registered agent is
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`The Corporation Trust Company, Corporation Trust Center 1209 Orange St., Wilmington,
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`Delaware 19801.
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`JURISDICTION AND VENUE
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`6.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 1 et
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`seq. This Court has subject matter jurisdiction over Caris’ patent infringement claims under at
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`least 28 U.S.C. §§ 1331 and 1338.
`
`7.
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`This Court has personal jurisdiction over Defendant because, on information and
`
`belief, Defendant continuously, systematically, and purposefully conducts business within this
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`District, including but not limited to making, using, selling, offering to sell, and/or importing the
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`FoundationOne®, FoundationOne® Heme and FoundationACT® Products. Defendant has
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`purposefully availed itself to the privileges and benefits of the laws of the state of Massachusetts
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`by maintaining its headquarters in Cambridge, Massachusetts.
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`8.
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`Venue is proper in this District under at least 28 U.S.C. § 1400(b) because
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`Defendant has, on information and belief, committed acts of infringement in this District and has
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`a regular and established place of business in Cambridge, Massachusetts.
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`
`
`
`
`2
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 3 of 28
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`FACTUAL BACKGROUND
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`9.
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`Drug therapy for cancer patients has long been a challenge. Before the invention
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`of the Asserted Patents, when a patient was diagnosed with cancer, a treating physician would
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`typically select from a defined list of therapy options conventionally associated with the patient’s
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`observable clinical factors, such as type and stage of cancer. As a result, cancer patients
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`generally received the same treatment as others who had the same type and stage of cancer.
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`Efficacy of such treatment would be determined through trial and error because patients with the
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`same type and stage of cancer often respond differently to the same therapy. Moreover, when
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`patients failed to respond to any such “one-size-fits-all” treatment, either immediately or when a
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`previously successful treatment began to fail, a physician’s treatment choice would often be
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`based on anecdotal evidence at best.
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`10. While not widely utilized at the time, limited molecular testing was available to
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`aid the physician in making a more informed selection from the list of conventional therapies
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`associated with the patient’s type of cancer, also known as “cancer lineage.” For example, a
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`physician with a breast cancer patient, presented with a list of conventional therapy options
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`including Herceptin®, could have tested the patient’s tumor for overexpression of the gene
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`HER2/neu. HER2/neu was known at that time to be associated with breast cancer and
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`responsiveness to Herceptin®. For a portion of breast cancer patients whose tumor was found to
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`overexpress the HER2/neu gene, the physician would have at least some indication that the
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`patient may have an initial response to treatment with Herceptin®. While this type of molecular
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`testing helped explain why a known treatment for a particular type of cancer was more effective
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`in treating some patients with that type of cancer than others, this testing did not identify or
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`exclude any additional therapy options for patients.
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`3
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 4 of 28
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`11.
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`Dissatisfied with the one-size-fits-all approach to treating cancer patients, and
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`faced with the reality that many patients’ tumors progress and eventually exhaust all
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`conventional therapies, Dr. Daniel Von Hoff, an oncologist, sought to identify additional,
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`unconventional treatment options for his patients. He recognized the limitations of making
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`treatment decisions based on clinical observation and the limitations of the few lineage-specific
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`molecular tests available at that time. He believed that effective treatment options were
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`overlooked because of these limitations.
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`12.
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`Dr. Von Hoff teamed up with Dr. Robert Penny, a pathologist who was also a
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`pioneer in molecular science, and together they identified “a need for determining an
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`individualized medical intervention for a disease state based on molecular profiling that is used
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`to target specific genes and/or gene expressed proteins with specific drugs or agents that is
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`independent of disease lineage diagnosis.” (Ex. 1, ’350 Patent, at 2:28-33.) They invented and
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`patented a novel system of performing molecular profiling of tumors to identify treatment
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`options independent of cancer type, based on groups of molecular targets not traditionally or
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`conventionally associated with a specific type of cancer. They recognized that “[i]f a larger
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`number of targets or molecular findings such as molecular mechanisms, genes, gene expressed
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`proteins, and/or combinations of such were measured in a patient’s tumor, one may find
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`additional targets or molecular findings that can be exploited by using specific therapeutic
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`agents. Identifying multiple agents that can treat multiple targets or underlying mechanisms
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`would provide cancer patients with a viable therapeutic alternative to those treatment regimens
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`which currently exist.” (Ex. 2, ’392 Patent, at 2:11-20; see Ex. 1, ’350 Patent, at 2:17-27.)
`
`13.
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`The patented system of molecular profiling uses various testing techniques to
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`gather molecular information from a patient’s tumor to create a unique molecular profile
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`4
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 5 of 28
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`independent of the type of cancer. In this way, the molecular profiling can potentially identify
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`treatments for the patient’s tumor that would not conventionally be identified as a treatment
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`option, or expected to work, for that particular type of cancer. The physician can then use the
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`results of the molecular profile to aid in selection of a candidate treatment for the patient
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`regardless of the stage, anatomical location, or anatomical origin of the cancer cells. (Ex. 2, ’392
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`Patent, at 135:10-12.)
`
`14.
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`By utilizing the patented system, new uses of known drugs can be found in the
`
`field of cancer treatment. For example, U.S. Patent No. 8,880,350 (“the ’350 Patent”) utilizes the
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`molecular targets EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA, and ESR1. This combination of
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`molecular targets was not associated with a particular type of cancer. By utilizing this
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`combination, the ’350 patented invention yields treatment options for cancer that were not
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`previously utilized.
`
`15.
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`The same is true for the combinations utilized in U.S. Patent Nos. 9,372,193 (“the
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`’193 Patent”) and 9,383,365 (“the ’365 Patent”). Each of those combinations utilized by the
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`claimed systems yields new, nonconventional treatment options for cancer that were not
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`previously utilized. (See Ex. 3, ’193 Patent; Ex. 4, ’365 Patent.)
`
`16.
`
`In addition to being useful broadly for cancer, Caris’ invention can be utilized
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`very specifically for particular types of cancer. For example, the ’392 Patent utilizes the
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`molecular targets BRAF, EGFR, PIK3CA, and PTEN in the context of treatments for colorectal
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`cancer. At the time of the invention, at least BRAF, PIK3CA, and PTEN were not conventionally
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`associated with treatments for colorectal cancer, and BRAF, EGFR, PIK3CA, and PTEN had not
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`been used in combination to identify treatments for colorectal cancer patients. By using this
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`combination in Caris’ patented system, new treatment options for colorectal cancer can be
`
`5
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 6 of 28
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`identified. (See Ex. 2, ’392 Patent.) Similarly, U.S. Patent No. 9,292,660 (“the ’660 Patent”)
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`utilizes the molecular targets BRAF, CTNNB1, cKIT, PIK3A, and PTEN in the context of
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`treatments for lung cancer. At the time of the invention, at least CTNNB1, cKIT, PIK3CA, and
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`PTEN were not associated with treatments for lung cancer, and CTNNB1, cKIT, PIK3CA,
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`PTEN, and BRAF had not been used in combination to identify treatments for lung cancer
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`patients. By using this combination in Caris’ patented system, new treatment options for lung
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`cancer can be identified. (See Ex. 5, ’660 Patent.)
`
`17.
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`Caris’ inventions also aid physicians in eliminating therapies that might otherwise
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`have been used that will not be useful for the particular patient. This guidance saves patients
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`from needless suffering and, perhaps more importantly, allows physicians to maximize the
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`chances of a successful therapy in patients who often are in a race against time.
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`18.
`
`All these results are provided to the treating physician in a molecular profiling
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`report, which the treating physician may then use to develop a personalized treatment plan for
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`the patient. In this way, the treating physician can select treatments that are most likely to help
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`patients based on a molecular understanding of their disease.
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`19.
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`Dr. Von Hoff and Dr. Penny, along with other colleagues, conducted a
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`prospective multi-center study to compare the progression-free survival (PFS) using a treatment
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`regimen selected by molecular profiling of a patient’s tumor with the PFS for the most recent
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`regimen on which the patient had experienced progression.
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`20.
`
`The results of this study were published in the Journal of Clinical Oncology on
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`November 20, 2010, in a report titled, “Pilot Study Using Molecular Profiling of Patients’
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`Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers”
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`(hereinafter, “2010 Pilot Study”). (Ex. 6, 2010 Pilot Study.)
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`6
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 7 of 28
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`21.
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`The 2010 Pilot Study found that 27% of the patients treated according to the
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`patented molecular profiling techniques had progression-free survival of at least 30% longer than
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`they had on their last prior therapy (a PFS ratio of ≥ 1.3). Of those patients, the median PFS
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`ratio was 2.9 and the maximum PFS ratio was 8.15.
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`22.
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`The following chart shows the comparison of progression-free survival of those
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`patients on their last line of prior therapy (gold bars) to their progression-free survival on a
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`treatment selected with the patented molecular system (blue bars).
`
`
`
`
`
`23.
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`The 2010 Pilot Study also concluded that “this MP approach resulted in a longer
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`PFS for patients on an MP-suggested regimen than on the regimen the patients had just
`
`experienced progression on for 27% of the patients.” In other words, the patented invention
`
`showed a five-fold improvement in patient response as compared to the expected patient
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`response for conventional therapies, which at the time was approximately 5%. Thus, the
`
`patented system improves the treatment of cancer patients.
`
`24.
`
`In the same issue, the Journal of Clinical Oncology also published an
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`accompanying editorial to the 2010 Pilot Study by Dr. James Doroshow of the National Cancer
`
`7
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 8 of 28
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`Institute. (Ex. 7, Doroshow Editorial on Pilot Study.) He explained that in the 2010 Pilot Study,
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`“Von Hoff et al take the novel approach of developing individualized molecular tumor profiles to
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`define therapy for every patient enrolled onto their prospective study – in essence, performing a
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`series of gene expression-guided pilot studies, each with a sample size of one (so-called N=1
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`design).”
`
`25.
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`Dr. Doroshow also compared the patented molecular profiling technique to the
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`conventional method of selecting treatment, noting that “[t]he hypothesis underlying the bold
`
`and potentially practice-changing effort undertaken by Von Hoff et al is that currently available
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`molecular profiling technologies are sufficiently robust to allow selection of an additional
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`treatment for this patient population in a fashion superior to that of an experienced clinician’s
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`best judgment.”
`
`26.
`
`Dr. Doroshow further praised the patented molecular profiling technique as
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`innovative for “[e]stablishing a novel algorithm for the use of unique molecular profiles to
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`determine an individual patient’s treatment.”
`
`27.
`
`Building off the success of Dr. Von Hoff and Dr. Penny’s invention, today
`
`molecular profiling is rapidly becoming accepted as part of the standard of care for the treatment
`
`of cancer patients.
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`THE ASSERTED PATENTS
`
`The ’350 Patent
`
`28.
`
`On November 4, 2014, the United States Patent and Trademark Office
`
`(“USPTO”) duly and legally issued the ’350 Patent titled “System and Method for Determining
`
`Individualized Medical Intervention for a Disease State,” to Daniel Von Hoff and Robert Penny.
`
`A true and correct copy of the ’350 Patent is attached hereto as Exhibit 1.
`
`8
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 9 of 28
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`29.
`
`Caris MPI, Inc. is the assignee of the entire right, title, and interest in and to the
`
`’350 Patent.
`
`The ’193 Patent
`
`30.
`
`On June 21, 2016, the USPTO duly and legally issued the ’193 Patent titled
`
`“System and Method for Determining Individualized Medical Intervention for a Disease State,”
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`to Daniel Von Hoff and Robert Penny. A true and correct copy of the ’193 Patent is attached
`
`hereto as Exhibit 3.
`
`31.
`
`Caris MPI, Inc. is the assignee of the entire right, title, and interest in and to the
`
`’193 Patent.
`
`The ’365 Patent
`
`32.
`
`On July 5, 2016, the USPTO duly and legally issued the ’365 Patent titled
`
`“System and Method for Determining Individualized Medical Intervention for a Disease State,”
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`to Daniel Von Hoff and Robert Penny. A true and correct copy of the ’365 Patent is attached
`
`hereto as Exhibit 4.
`
`33.
`
`Caris MPI, Inc. is the assignee of the entire right, title and interest in and to the
`
`’365 Patent.
`
`The ’392 Patent
`
`34.
`
`On July 28, 2015, the USPTO duly and legally issued the ’392 Patent titled
`
`“Molecular Profiling of Tumors,” to Daniel Von Hoff, David Loesch, Arlet Alarcon, Robert
`
`Penny, Alan Wright, Matthew McGinniss, Ryan Bender, and Traci Pawlowski. A true and
`
`correct copy of the ’392 Patent is attached hereto as Exhibit 2.
`
`35.
`
`Caris MPI, Inc. is the assignee of the entire right, title, and interest in and to the
`
`’392 Patent.
`
`9
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 10 of 28
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`The ’660 Patent
`
`36.
`
`On March 22, 2016, the USPTO duly and legally issued the ’660 Patent titled
`
`“Molecular Profiling of Tumors,” to Daniel Von Hoff, David Loesch, Arlet Alarcon, Robert
`
`Penny, Alan Wright, Matthew McGinniss, Ryan Bender, and Traci Pawlowski. A true and
`
`correct copy of the ’660 Patent is attached hereto as Exhibit 5.
`
`37.
`
`Caris MPI, Inc. is the assignee of the entire right, title, and interest in and to the
`
`’660 Patent.
`
`38.
`
`39.
`
`The Accused Products
`
`On information and belief, Defendant was founded in 2010.
`
`Defendant makes, uses, sells, offers for sale, and/or imports products under the
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`Foundation brand that include molecular profiling technology. These products include, but are
`
`not limited to, the FoundationOne®, FoundationOne® Heme, and FoundationACT® products.
`
`40.
`
`Defendant acknowledges in public statements that the “increasing availability and
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`understanding of molecular information within the practice of oncology is driving a revolution in
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`the treatment of cancer.” (Ex. 8, FMI 2016 10-K, at 6.)
`
`41.
`
`Defendant has described its infringing FoundationOne® product as “a validated
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`comprehensive genetic profile (CGP) for solid tumors” that is “designed to provide physicians
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`with clinically actionable information to guide treatment decisions for patients based on the
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`genomic profile of their disease.” (https://www.foundationmedicine.com/genomic-
`
`testing/foundation-one.) The FoundationOne® test results “provide information about clinically
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`significant alterations, potential targeted therapies, available clinical trials, and quantitative
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`markers of response for immunotherapy.” (Id.) These results are summarized in the
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`FoundationOne® test report, including genomic alterations, therapies associated with clinical
`
`10
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 11 of 28
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`benefit, therapies associated with lack of response, and a list of potential clinical trials for which
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`the patient may qualify. (Ex. 9, FoundationOne® Report, available at
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`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocgW/5400d5a2c9a21fc616e
`
`54c93dd21f067/FoundationOne_Sample_Report.pdf)
`
`42.
`
`The results of the FoundationOne® test are presented in a report which lists the
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`molecular targets and alterations detected, the frequency and prognosis, and potential treatment
`
`
`
`11
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 12 of 28
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`strategies. The full list of molecular targets tested is included in an appendix at the end of the
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`FoundationOne® report.
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`43.
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`Based on those test results, the FoundationOne® report provides a list of therapies
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`with potential benefit as well as a list of therapies associated with lack of response.
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`
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`12
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 13 of 28
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`44.
`
`Finally, the FoundationOne® report provides a list of clinical trials for which the
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`patient may qualify based on the patient’s molecular profiling results. This list includes the title,
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`the specific molecular targets identified, and the location of the clinical trial.
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`
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`13
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 14 of 28
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`
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`45.
`
`On information and belief, FMI commercially launched its FoundationOne®
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`product in the United States at least as early as May 30, 2012.
`
`46.
`
`Defendant describes its infringing FoundationOne® Heme product as “a
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`comprehensive genomic profiling assay for hematologic malignancies and sarcomas” that is
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`“designed to provide physicians with clinically actionable information to help with diagnostic
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`subclassification, prognosis assessment, and targeted therapeutic selection.”
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`(https://www.foundationmedicine.com/genomic-testing/foundation-one-heme.) The
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`FoundationOne® Heme test results “provide information about clinically significant alterations,
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`potential targeted therapies, available clinical trials, and quantitative markers that may support
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`immunotherapy clinical trial enrollment.” (Id.) On information and belief, these results are
`
`14
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`

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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 15 of 28
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`summarized in the FoundationOne® Heme test report, including genomic alterations, therapies
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`associated with clinical benefit, therapies associated with lack of response, and a list of potential
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`clinical trials for which the patient may qualify.
`
`47.
`
`On information and belief, FMI commercially launched its FoundationOne®
`
`Heme product in the United States at least as early as December 7, 2013.
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`48.
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`Defendant describes its infringing FoundationACT® product as “a blood-based
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`circulating tumor DNA (ctDNA) assay for solid tumors that identifies clinically relevant
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`genomic alterations driving the growth of a patient’s cancer.”
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-act.) “This liquid biopsy can
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`help physicians identify treatment options by providing clinically actionable information relevant
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`to diagnosis, risk-stratification, and prognosis.” (Id.) The FoundationACT® test results “provide
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`information about potential targeted therapies and/or available clinical trials to better inform
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`treatment decisions.” (Id.) These results are summarized in the FoundationACT™ test report,
`
`including genomic alterations, therapies associated with clinical benefit, therapies associated
`
`with lack of response, and a list of potential clinical trials for which the patient may qualify. (Ex.
`
`10, FoundationACT® Sample Report, available at
`
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Pages/031917%20-
`
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Documents/FACT%20Sample
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`%20Report_EGFR_T790mF_052516%5B1%5D.pdf?t=1493919601061.)
`
`49.
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`On information and belief, FMI commercially launched its FoundationACT®
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`product in the United States at least as early as May 3, 2016.
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`15
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 16 of 28
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`50.
`
`The Accused FoundationOne®, FoundationOne® Heme, and FoundationACT®
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`Products infringe the Asserted Patents. As a result of Defendant’s infringement and the threat of
`
`its continued infringement, Caris faces a substantial risk of irreparable harm.
`
`Count I: Infringement of the ’350 Patent
`
`Caris realleges Paragraphs 1-50 herein as if repeated verbatim in this Paragraph.
`
`Claim 1 of the ’350 Patent states as follows:
`
`51.
`
`52.
`
`1. A system for generating a report identifying at least one therapeutic agent for an
`individual with a cancer comprising:
`a. at least one device configured to assay a plurality of molecular targets in a
`biological sample to determine individualized molecular profile test values for
`the plurality of molecular targets, wherein the molecular targets comprise
`EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and ESR1; and
`b. at least one computer database comprising:
`i. a reference value for the plurality of molecular targets; and
`ii. a listing of available therapeutic agents for said plurality of molecular
`targets;
`c. a computer-readable program code comprising instructions to input the
`individualized molecular profile test values and to compare said test values
`with a corresponding reference value in (b)(i);
`d. a computer-readable program code comprising instructions to access the at
`least one computer database and to identify at least one therapeutic agent from
`the listing of available therapeutic agents for the plurality of molecular targets
`wherein said comparison to said reference in (c) indicates a likely benefit of
`the at least one therapeutic agent; and
`e. a computer-readable program code comprising instructions to generate a
`report that comprises a listing of the molecular targets wherein said
`comparison to said reference indicated a likely benefit of the at least one
`therapeutic agent in (d) along with the at least one therapeutic agent identified
`in (d).
`
`Defendant directly infringes at least claims 1 and 5 of the ’350 Patent under 35
`
`53.
`
`U.S.C. § 271(a) either literally or under the doctrine of equivalents, by making, using, selling,
`
`offering to sell, and/or importing the Accused FoundationOne® and FoundationOne® Heme
`
`Products. Attached hereto as Exhibit 11 is a non-limiting example demonstrating how the
`
`16
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 17 of 28
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`Accused FoundationOne® and FoundationOne® Heme Products meet each and every limitation
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`of at least claims 1 and 5 of the ’350 Patent.
`
`54.
`
`As a result of Defendant’s direct infringement of the ’350 Patent, Caris has
`
`suffered monetary damages and is entitled to recovery of such damages.
`
`55.
`
`Defendant’s infringement of the ’350 Patent has caused and will continue to cause
`
`irreparable harm to Caris.
`
`56.
`
`Defendant identifies Caris as one of its competitors in its public statements. (Ex.
`
`8, FMI 2016 10-K, at 44.) Defendant also acknowledges that its competitors “may also use their
`
`patent portfolios, developed in connection with developing their tests, to allege that
`
`[Defendant’s] products infringe their patents, and [Defendant] could face litigation with respect
`
`to such allegations and the validity of such patents.” (Id. at 45.) On information and belief,
`
`Defendant monitors the patents of its competitors and has known about the ’350 Patent at least
`
`since it issued on November 4, 2014, and knew or was willfully blind to the fact that its actions
`
`constituted infringement of at least claims 1 and 5 of the ’350 Patent. Defendant continues to
`
`infringe the ’350 Patent despite such knowledge and its knowledge as of the filing and/or service
`
`of this complaint.
`
`57.
`
`Despite Defendant’s knowledge of and notice of the ’350 patent and its ongoing
`
`infringement, Defendant continues to manufacture, use, sell, offer for sale, and/or import the
`
`Accused FoundationOne® and FoundationOne® Heme Products in a manner that infringes the
`
`’350 Patent. Defendant lacks a justifiable belief that it does not infringe the ’350 patent, or that
`
`the ’350 patent is invalid, and has acted recklessly in its infringing activity, justifying an increase
`
`in the damages to be awarded Caris up to three times the amount found or assessed, in
`
`accordance with 35 U.S.C. § 284.
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`17
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 18 of 28
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`58.
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`At least Defendant’s willful infringement of the ’350 patent renders this case an
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`exceptional case, justifying an award to Caris of its reasonable attorneys’ fees, in accordance
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`with 35 U.S.C. § 285.
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`Count II: Infringement of the ’193 Patent
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`Caris realleges Paragraphs 1-58 herein as if repeated verbatim in this Paragraph.
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`Claim 1 of the ’193 Patent states as follows:
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`59.
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`60.
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`1. A system for generating a report identifying at least one therapeutic agent for an
`individual with a cancer comprising:
`a. at least one device configured to assay a plurality of molecular targets in a
`biological sample to determine molecular profile test values for the plurality
`of molecular targets, wherein the plurality of molecular targets comprises AR,
`EGFR, HER2, KIT, MLH1, PTEN, and PDGFRA; and
`b. at least one computer database comprising:
`i. a reference value for each of the plurality of molecular targets; and
`ii. a listing of available therapeutic agents for each of the plurality of
`molecular targets;
`c. a computer-readable program code comprising instructions to input the
`molecular profile test values and to compare each of the molecular profile test
`values with a corresponding reference value from the at least one computer
`database in (b)(i);
`d. a computer-readable program code comprising instructions to access the at
`least one computer database and to identify at least one therapeutic agent from
`the listing of available therapeutic agents for the plurality of molecular targets
`wherein the comparison to the reference values in (c) indicates a likely benefit
`of the at least one therapeutic agent; and
`e. a computer-readable program code comprising instructions to generate a
`report that comprises a listing of the molecular targets for which the
`comparison to the reference value indicated a likely benefit of the at least one
`therapeutic agent in (d) and the at least one therapeutic agent identified in (d).
`Defendant directly infringes at least claims 1 and 5 of the ’193 Patent under 35
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`61.
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`U.S.C. § 271(a) either literally or under the doctrine of equivalents, by making, using, selling,
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`offering to sell, and/or importing the Accused FoundationOne® and FoundationOne® Heme
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`Products. Attached hereto as Exhibit 12 is a non-limiting example demonstrating how the
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 19 of 28
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`Accused FoundationOne® and FoundationOne® Heme Products meet each and every limitation
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`of at least claims 1 and 5 of the ’193 Patent.
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`62.
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`As a result of Defendant’s direct infringement of the ’193 Patent, Caris has
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`suffered monetary damages and is entitled to recovery of such damages.
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`63.
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`Defendant’s infringement of the ’193 Patent has caused and will continue to cause
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`irreparable harm to Caris.
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`64.
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`Defendant identifies Caris as one of its competitors in its public statements. (Ex.
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`8, FMI 2016 10-K, at 44.) Defendant also acknowledges that its competitors “may also use their
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`patent portfolios, developed in connection with developing their tests, to allege that
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`[Defendant’s] products infringe their patents, and [Defendant] could face litigation with respect
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`to such allegations and the validity of such patents.” (Id. at 45.) On information and belief,
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`Defendant monitors the patents of its competitors and has known about the ’193 Patent at least
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`since it issued on June 21, 2016, and knew or was willfully blind to the fact that its actions
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`constituted infringement of at least claims 1 and 5 of the ’193 Patent. Defendant continues to
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`infringe the ’193 Patent despite such knowledge and its knowledge as of the filing and/or service
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`of this complaint.
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`65.
`
`Despite Defendant’s knowledge of and notice of the ’193 patent and its ongoing
`
`infringement, Defendant continues to manufacture, use, sell, offer for sale, and/or import the
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`Accused FoundationOne® and FoundationOne® Heme Products in a manner that infringes the
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`’193 Patent. Defendant lacks a justifiable belief that it does not infringe the ’193 patent, or that
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`the ’193 patent is invalid, and has acted recklessly in its infringing activity, justifying an increase
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`in the damages to be awarded Caris up to three times the amount found or assessed, in
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`accordance with 35 U.S.C. § 284.
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`Case 1:17-cv-12194-MLW Document 1 Filed 11/07/17 Page 20 of 28
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`66.
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`At least Defendant’s willful infringement of the ’193 patent renders this case an
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`exceptional case, justifying an award to Caris of its reasonable attorneys’ fees, in accordance
`
`with 35 U.S.C. § 285.
`
`Count III: Infringement of the ’365 Patent
`
`Caris realleges Paragraphs 1-66 herein as if repeated verbatim in this Paragraph.
`
`Claim 1 of the ’365 Patent states as follows:
`
`67.
`
`68.
`
`1. A system for generating a report identifying at least one therapeutic agent for an
`individual with a cancer comprising:
`a. at least one device configured to assay a plurality of molecular targets in a
`biological sample to determine molecular profile test values for the plurality
`of molecular targets, wherein the plurality of molecular targets comprises
`EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and ERBB21; and
`b. at least one computer database comprising:
`i. a reference value for each of the plurality of molecular targets; and
`ii. a listing of available therapeutic agents for each of the plurality of
`molecular targets;
`c. a computer-readable program code comprising instructions to input the
`molecular profile test values and to compare each of the molecular profile test
`values with a corresponding reference value from the at least one computer
`database in (b)(i);
`d. a computer-readable program code comprising instructions to access the at
`least one computer database and to identify at least one therapeutic agent from
`the listing of available therapeutic agents for the plurality of molecular targets
`wherein the comparison to the reference values in (c) indicates a likely benefit
`of the at least one therapeutic agent; and
`e. a computer-readable program code comprising instructions to generate a
`report that comprises a listing of the molecular targets for which the
`comparison to the reference value