Esoterix Genetic Laboratories, LLC
`and The Johns Hopkins University,
`
`
`Plaintiffs,
`
`
`vs.
`
`Ambry Genetics Corporation,
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
`GREENSBORO DIVISION
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Civil Action No. 16-cv-1111
`
`JURY TRIAL DEMANDED
`
`Defendant.
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Esoterix Genetic Laboratories, LLC (“EGL”) and The Johns Hopkins
`
`University (“JHU”) (collectively, “Plaintiffs”) for their complaint against Defendant
`
`Ambry Genetics Corporation (“Ambry”) allege as follows:
`
`NATURE OF ACTION
`
`
`1.
`
`This is an action under the patent laws of the United States, 35 U.S.C. § 1,
`
`et seq., for infringement by Ambry of patents owned by JHU and exclusively licensed by
`
`EGL.
`
`THE PARTIES
`
`
`2.
`
`Plaintiff EGL is a Delaware limited liability company with a principal place
`
`of business at 531 South Spring Street, Burlington, North Carolina 27215. EGL is a
`
`wholly-owned subsidiary of Laboratory Corporation of America Holdings (also known as
`
`LabCorp), which is headquartered in Burlington, North Carolina.
`
`
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 1 of 19
`
`
`and The Johns Hopkins University,
`
`
`Plaintiffs,
`
`
`vs.
`
`Ambry Genetics Corporation,
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
`GREENSBORO DIVISION
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Civil Action No. 16-cv-1111
`
`JURY TRIAL DEMANDED
`
`Defendant.
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Esoterix Genetic Laboratories, LLC (“EGL”) and The Johns Hopkins
`
`University (“JHU”) (collectively, “Plaintiffs”) for their complaint against Defendant
`
`Ambry Genetics Corporation (“Ambry”) allege as follows:
`
`NATURE OF ACTION
`
`
`1.
`
`This is an action under the patent laws of the United States, 35 U.S.C. § 1,
`
`et seq., for infringement by Ambry of patents owned by JHU and exclusively licensed by
`
`EGL.
`
`THE PARTIES
`
`
`2.
`
`Plaintiff EGL is a Delaware limited liability company with a principal place
`
`of business at 531 South Spring Street, Burlington, North Carolina 27215. EGL is a
`
`wholly-owned subsidiary of Laboratory Corporation of America Holdings (also known as
`
`LabCorp), which is headquartered in Burlington, North Carolina.
`
`
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 1 of 19
`
`
`
`
`3.
`
`Plaintiff JHU is a private not-for-profit corporation organized under the
`
`laws of the State of Maryland and has its principal place of business in Baltimore,
`
`Maryland.
`
`
`4.
`
`On information and belief, Defendant Ambry is a corporation incorporated
`
`under the laws of the State of California with a principal place of business at 15
`
`Argonaut, Aliso Viejo, California, 92656.
`
`JURISDICTION AND VENUE
`
`
`5.
`
`This is a patent infringement action, and this Court has jurisdiction over the
`
`subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`
`6.
`
`This Court has personal jurisdiction over Defendant Ambry because, at a
`
`minimum, Ambry regularly conducts business in this District and has offered for sale and
`
`sold infringing services in this District, among other places. Ambry sells, offers for sale,
`
`and has sold genetic testing products and services to residents of this District. Ambry has
`
`advertised, presented, and marketed to residents in this jurisdiction products and services
`
`it sells, offers for sale, and has sold relating to its genetic testing products. Ambry has
`
`marketed that it is able to conduct genetic testing on samples received from any state in
`
`the United States. Ambry has business relationships and/or has collaborated with
`
`medical service providers, businesses, and/or research entities, including Wake Forest
`
`School of Medicine in Winston-Salem, NC, in this District. On information and belief,
`
`Ambry employs persons to provide education and support concerning its products and
`
`services to healthcare providers that are residents in this jurisdiction.
`
` 2
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 2 of 19
`
`
`
`
`7.
`
`Venue is proper in this judicial district pursuant to at least 28 U.S.C. §§
`
`1391 and 1400 at least because injuries from Ambry’s actions are felt in this District,
`
`Ambry engages in actions of infringement in this District, Ambry is subject to personal
`
`jurisdiction in this District, and Ambry conducts substantial business and has substantial
`
`contacts with the State of North Carolina and within this District.
`
`BACKGROUND FACTS
`
`
`8.
`
`Plaintiffs are leaders in the field of genetic testing for hereditary cancer
`
`risk-markers. Each of the patents asserted herein relate generally to genetic testing,
`
`including for hereditary cancer risk-markers.
`
`
`9.
`
`The two named inventors on United States Patent No. 6,440,706, United
`
`States Patent No. 7,824,889, United States Patent No. 7,915,015, and United States Patent
`
`No. 8,859,206 (collectively “Patents-in-Suit”) are Dr. Bert Vogelstein and Dr. Kenneth
`
`W. Kinzler. Both Dr. Vogelstein and Dr. Kinzler are affiliated with The Johns Hopkins
`
`Sidney Kimmel Comprehensive Cancer Center. Dr. Vogelstein is a very well-known
`
`pioneer in the field of cancer genomics. Among other awards and achievements, Dr.
`
`Vogelstein is a prolific author of scientific articles in the genetics field, which include
`
`some of the most frequently cited references in the field, and was named as one of the 11
`
`scientists who received The Breakthrough Prize in Life Sciences in its inaugural year.
`
`Dr. Kinzler is likewise well known in the genetics field and was recently elected to the
`
`National Academy of Medicine, an honor to which Dr. Kinzler was elected by his peers
`
`for his accomplishments and contributions to medical sciences, health care, and public
`
`health.
`
` 3
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 3 of 19
`
`
`
`
`10.
`
`EGL, as the exclusive licensee of the Patents-in-Suit, provides tests that
`
`detect mutations in genes, including mutations which have been associated with an
`
`increased risk of developing cancers.
`
` Ambry makes, uses, offers for sale, and sells, without authorization,
`11.
`
`services, products, and/or methods that infringe the Patents-in-Suit.
`
`
`12.
`
`EGL is the exclusive licensee of United States Patent No. 6,440,706
`
`(hereinafter referred to as “the ’706 patent”) which duly and legally issued on August 27,
`
`2002 and is entitled “Digital Amplification.” The ’706 patent is assigned to and owned
`
`by JHU. The ’706 patent was reexamined by the United States Patent and Trademark
`
`Office (“USPTO”). After reexamination, the USPTO certified the ’706 patent, as
`
`amended, as valid on October 24, 2014. A true and correct copy of the ’706 patent,
`
`including the reexamination certificate, is attached to this Complaint as Exhibit A.
`
`
`13.
`
`EGL is the exclusive licensee of United States Patent No. 7,824,889
`
`(hereinafter referred to as “the ’889 patent”) which duly and legally issued on November
`
`2, 2010 and is entitled “Digital Amplification.” The ’889 patent is assigned to and owned
`
`by JHU. The ’889 patent was reexamined by the USPTO. After reexamination, the
`
`USPTO certified the ’889 patent, as amended, as valid on October 31, 2014. A true and
`
`correct copy of the ’889 patent, including the reexamination certificate, is attached to this
`
`Complaint as Exhibit B.
`
`
`14.
`
`EGL is the exclusive licensee of United States Patent No. 7,915,015
`
`(hereinafter referred to as “the ’015 patent”) which duly and legally issued on March 29,
`
`2011 and is entitled “Digital Amplification.” The ’015 patent is assigned to and owned
`
` 4
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 4 of 19
`
`
`
`by JHU. The ’015 patent was reexamined by the USPTO. After reexamination, the
`
`USPTO certified the ’015 patent, as amended, as valid on October 23, 2014. A true and
`
`correct copy of the ’015 patent, including the reexamination certificate is attached to this
`
`Complaint as Exhibit C.
`
`
`15.
`
`EGL is the exclusive licensee of United States Patent No. 8,859,206
`
`(hereinafter referred to as “the ’206 patent”) which duly and legally issued on October
`
`14, 2014 and is entitled “Digital Amplification.” The ’206 patent is assigned to and
`
`owned by JHU. A true and correct copy of the ’206 patent is attached to this Complaint
`
`as Exhibit D.
`
`
`16.
`
`Previously, Plaintiffs accused Life Technologies, Inc. (“Life
`
`Technologies”) of infringing the ’706 patent, the ’889 patent, and the ’015 patent before
`
`this Court in Civil Action No. 1:12-cv-01173. In response to the complaint, Life
`
`Technologies sought reexamination of the ’706 patent, the ’889 patent, and the ’015
`
`patent before the USPTO. In each of the patent reexaminations, Life Technologies
`
`identified prior art that had not been considered before by the USPTO. After its review
`
`and consideration of the prior art, the USPTO issued reexamination certificates for all
`
`three patents, finding each patent valid.
`
`
`17.
`
`The USPTO has found the claims of the asserted patents to claim novel and
`
`non-obvious methods after reviewing over 100 prior art documents, including scientific
`
`articles from peer-reviewed journals. Over 180 U.S. patent publications have cited one or
`
`more of the asserted patents.
`
` 5
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 5 of 19
`
`
`
`
`
` Moreover, the combination of the diluting (or distributing) and amplifying 18.
`
`steps as specified in the claims is often referred to as “digital PCR,” itself an inventive
`
`concept. A 1999 paper by the inventors of the asserted patents discussed the digital PCR
`
`method. (Vogelstein and Kinzler, 1999). Subsequent literature by other scientists
`
`recognized digital PCR as a “powerful new tool” (Zimmermann, et al., 2008) that
`
`“provides unprecedented opportunities” (Pohl, et al., 2004). For example, a Nature
`
`Methods article in 2012 quoted a prominent British scientist who had studied the new
`
`technology in comparison with the prior art: “Digital PCR offers more accuracy and less
`
`ambiguity” than earlier technologies. (Baker, 2012). As another example, scientists
`
`explain that digital PCR allows “much higher accuracy and sensitivity” than previous
`
`technologies. (Li, et al., 2016). This “recently invented ‘digital’ PCR format” enabled
`
`scientists to overcome known problems with quantitative aspects of PCR. (Chetverina, et
`
`al., 2002). Claims of the asserted patents claim applications of this inventive concept to
`
`improve detection of particular gene sequences in a sample, to determine the composition
`
`of the original sample, to improve diagnoses, and for other purposes. As such, digital
`
`PCR provides a technical improvement for genetics, genomics, and medical science. The
`
`claims recite processes to achieve a desired outcome using a new and useful laboratory
`
`technique. The claim elements, when viewed individually and as a whole, are far from
`
`routine or conventional.
`
`
`19.
`
`EGL has the right to enforce the Patents-in-Suit, including the right to
`
`recover past damages, collect ongoing royalties, and pursue any other legal or equitable
`
`relief.
`
` 6
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 6 of 19
`
`
`
`ACCUSED INFRINGER
`
`
`
` Defendant Ambry is a diagnostic company that provides various services, 20.
`
`products, kits, and devices, directly and through its subsidiaries, that are used in methods
`
`for detecting ratios of genetic sequences, detecting allelic imbalances, or detecting a
`
`quantity of a genetic sequence in a mixed population of human genomic nucleic acid
`
`sequences.
`
` Ambry makes, uses, offers for sale, and sells, among other products and
`21.
`
`services, products and services known as its BRCAplus, BRCAplus-Expanded,
`
`CancerNext, CancerNext-Expanded, and other tests and services that are a multi-gene
`
`panels that identify an elevated risk for multiple types of cancers. Ambry’s BRCAplus,
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded tests and services, as well as
`
`other Ambry tests and services, use digital polymerase chain reaction (“dPCR”)
`
`technology available through RainDance Technologies.
`
` On information and belief, Ambry’s BRCAplus, BRCAplus-Expanded,
`22.
`
`CancerNext, CancerNext-Expanded, and other tests and services dilute or distribute
`
`nucleic acid template molecules that have been isolated from a biological sample into
`
`droplets to form a set of assay samples. In conducting the BRCAplus, BRCAplus-
`
`Expanded, CancerNext, CancerNext-Expanded, and other tests, Ambry amplifies the
`
`isolated nucleic acid molecules within the assay samples to form a population of
`
`amplified molecules in the assay samples of the set. On information and belief, Ambry
`
`uses the “ThunderStorm®” system available through RainDance Technologies to carry
`
`out these steps.
`
` 7
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 7 of 19
`
`
`
`
`
` On information and belief, Ambry analyzes the amplified molecules in the 23.
`
`assay samples of the set to determine a first number of assay samples which contain the
`
`selected genetic sequence and a second number of assay samples which contain a
`
`reference genetic sequence (or first and second alleles of the selected sequence). On
`
`information and belief, Ambry then compares the first number to the second number to
`
`determine the composition of the biological sample.
`
` Ambry’s combination of steps infringes at least claim 1 of each of the
`24.
`
`Patents-in-Suit.
`
` Without permission, Ambry is making, using, offering for sale, and/or
`25.
`
`selling products and services that constitute direct infringement of the Patents-in-Suit.
`
`On information and belief, Ambry, either directly or through entities under its control or
`
`influence, makes, uses, offers for sale, and/or sells products or services that fall within the
`
`scope of one or more claims of the Patents-in-Suit, in the United States, including at least
`
`claim 1 of the ’706 patent, claim 1 of the ’889 patent, claim 1 of the ’015 patent, and
`
`claim 1 of the ’206 patent. For example, Ambry’s infringing products and services
`
`include the services marketed as, or otherwise known as, Ambry’s BRCAplus,
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other tests, as described
`
`above. These activities and others, including other similar products, tests, and services,
`
`directly infringe the Patents-in-Suit.
`
` Ambry has knowledge of the Patents-in-Suit at least through the filing of
`26.
`
`this Complaint.
`
`
`
`
`
` 8
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 8 of 19
`
`
`
`COUNT I
`(Direct Infringement of United States Patent No. 6,440,706 by Ambry)
`
`
`27.
`
`Plaintiffs reallege and incorporate herein by reference the allegations stated
`
`
`
`in paragraphs 1-26 of this Complaint.
`
` Ambry has infringed and continues to directly infringe the ’706 patent in
`28.
`
`violation of 35 U.S.C. § 271(a). For example, Ambry, directly or through entities under
`
`its control or influence, makes, uses, offers for sale, and sells products and/or services
`
`within the United States that utilize methods for the detection of ratios of genetic
`
`sequences in a biological sample that infringe the claims of the ‘706 patent, including, for
`
`example, through use of its BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-
`
`Expanded, and other tests. For example, Ambry’s making, using, offering for sale, and
`
`selling its BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and
`
`other products and services infringes at least claims 1, 2-3, 7-11, 15-16, 19, 20, 24, 27,
`
`38-43, 47-48, 51-52, 56, and 59 of the ’706 patent.
`
` Concerning claim 1 of the ‘706 patent and the Ambry BRCAplus,
`29.
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other Ambry products
`
`and services, for example, Ambry “dilut[es] isolated nucleic acid template molecules
`
`isolated from a biological sample to form a plurality of assay samples.” Ambry does so,
`
`for example, per published literature on test validation, as well as press releases, by
`
`extracting and purifying genomic DNA from blood or saliva samples to isolate the DNA,
`
`after which “PCR droplet reactions were generated and processed,” using a machine for
`
`target enrichment. (Chong, et al, 2014). Ambry targets specific sequences via “[a]
`
` 9
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 9 of 19
`
`
`
`custom primer library,” for example, per the 2014 paper. By using the target-enrichment
`
`machine Ambry “amplif[ies] the template molecules with the assay samples to form a
`
`population of amplified molecules,” for example, per the 2014 paper. Ambry then
`
`“analyz[es] the amplified molecules in the assay samples of the set to determine a first
`
`number of assay samples which contain the selected genetic sequence and a second
`
`number of assay samples which contain a reference genetic sequence.” It does so, for
`
`example, per the 2014 paper, by using a sequencing step wherein the “[s]equencing was
`
`conducted” on a NextGen sequencing machine which provides sequence data and thereby
`
`determines the first and second numbers of assay samples. Ambry “compar[es] the first
`
`number to the second number to ascertain a ratio which reflects the composition of the
`
`biological sample,” as described in the 2014 paper, for example, to ascertain a ratio to
`
`reflect the composition of the DNA sample. By performing each of the activities
`
`described above in connection with its BRCAplus, BRCAplus-Expanded, CancerNext,
`
`CancerNext-Expanded products and services, Ambry conducts each and every step
`
`recited in claim 1 of the ’706 patent and thus infringes at least claim 1 of the ‘706 patent.
`
` Ambry’s infringement of the ’706 patent has caused damage to and
`30.
`
`continues to cause damage to Plaintiffs.
`
` On information and belief, Ambry will continue in and enlarge its
`31.
`
`infringement of the ’706 patent unless and until it is enjoined by this Court.
`
`
`
`
`
` 10
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 10 of 19
`
`
`
`COUNT II
`(Direct Infringement of United States Patent No. 7,824,889 by Ambry)
`
`
`32.
`
`Plaintiffs reallege and incorporate herein by reference the allegations stated
`
`in paragraphs 1-31 of this Complaint.
`
` Ambry has infringed and continues to directly infringe the ’889 patent in
`33.
`
`violation of 35 U.S.C. § 271(a). For example, Ambry, directly or through entities under
`
`its control or influence, makes, uses, offers for sale, and sells products and/or services
`
`within the United States that utilize methods for the determination of allelic imbalances
`
`in a biological sample that infringe the claims of the ‘889 patent, including, for example,
`
`through use of its BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded,
`
`and other products and services. For example, Ambry’s making, using, offering for sale,
`
`and selling its BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded,
`
`and other products and services infringes at least claims 1, 4-9, and 12-22 of the ’889
`
`patent.
`
` Concerning claim 1 of the ‘889 patent and the Ambry BRCAplus,
`34.
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other products and
`
`services, for example, Ambry “distribut[es] isolated nucleic acid template molecules to
`
`form a set comprising a plurality of assay samples.” Ambry does so, for example, per the
`
`2014 paper related to test validation, as well as press releases, by extracting and purifying
`
`genomic DNA from blood or saliva samples to isolate the DNA, after which “PCR
`
`droplet reactions were generated and processed using” a machine for target enrichment.
`
`(Chong, et al., 2014). Ambry targets specific sequences via “[a] custom primer library,”
`
` 11
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 11 of 19
`
`
`
`for example, per the 2014 paper. By using the target-enrichment machine Ambry
`
`“amplif[ies] the template molecules within the set to form a population of amplified
`
`molecules in individual assay samples of the set,” for example, per the 2014 paper.
`
`Ambry then “analyz[es] the amplified molecules in the assay samples of the set to
`
`determine a first number of assay samples which contain a selected genetic sequence on a
`
`first chromosome and a second number of assay samples which contain a reference
`
`genetic sequence on a second chromosome.” It does so, for example, per the 2014 paper,
`
`by using a sequencing step wherein the “[s]equencing was conducted on” a NextGen
`
`sequencing machine which provides sequence data and thereby determines the first and
`
`second numbers of assay samples. In using the target-enrichment machine to perform the
`
`amplification, “between 0.1 and 0.9 of the assay samples yield an amplification product
`
`of at least one of the selected and reference genetic sequences,” per the 2014 paper, for
`
`example. Ambry “compar[es] the first number of assay samples to the second number of
`
`assay samples to ascertain an allelic imbalance in the biological sample,” for example, as
`
`described in the 2014 paper, to ascertain an allelic imbalance in the biological sample.
`
`By performing each of the activities described above in connection with its BRCAplus,
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded products and services, Ambry
`
`conducts each and every step recited in claim 1 of the ’889 patent and thus infringes at
`
`least claim 1 of the ‘889 patent.
`
` Ambry’s infringement of the ’889 patent has caused damage to and
`35.
`
`continues to cause damage to Plaintiffs.
`
` 12
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 12 of 19
`
`
`
`
`
` On information and belief, Ambry will continue in and enlarge its 36.
`
`infringement of the ’889 patent unless and until it is enjoined by this Court.
`
`COUNT III
`(Direct Infringement of United States Patent No. 7,915,015 by Ambry)
`
`
`37.
`
`Plaintiffs reallege and incorporate herein by reference the allegations stated
`
`
`
`in paragraphs 1-36 of this Complaint.
`
` Ambry has infringed and continues to directly infringe the ’015 patent in
`38.
`
`violation of 35 U.S.C. § 271(a). For example, Ambry, directly or through entities under
`
`its control or influence, makes, uses, offers for sale, and sells products and/or services
`
`within the United States that utilize methods for the determination of allelic imbalances
`
`in a biological sample that infringe the claims of the ‘015 patent, including, for example,
`
`through use of its BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded,
`
`and other tests. For example, Ambry’s making, using, offering for sale, and selling its
`
`BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other
`
`products and services infringes at least claims 1, 5-13, 16, and 18 of the ’015 patent.
`
` Concerning claim 1 of the ‘015 patent and the Ambry BRCAplus,
`39.
`
`BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other products and
`
`services, for example, Ambry “distribut[es] isolated nucleic acid template molecules to
`
`form a set comprising a plurality of assay samples.” Ambry does so, for example, per
`
`published literature on test validation, as well as press releases, by extracting and
`
`purifying genomic DNA from blood or saliva samples to isolate the DNA, after which
`
`“PCR droplet reactions were generated and processed using” a machine for target
`
` 13
`
`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 13 of 19
`
`
`
`enrichment (Chong, et al., 2014). Ambry targets specific sequences via “[a] custom
`
`primer library,” for example, per the 2014 paper. By using the target-enrichment
`
`machine Ambry “amplif[ies] the isolated nucleic acid template molecules within the set
`
`to form a population of amplified molecules in individual assay samples of the set.” In
`
`using the target-enrichment machine to perform the amplification, “between 0.1 and 0.9
`
`of the assay samples yield an amplification product of at least one of the first and second
`
`allelic forms of the marker,” per the 2014 paper, for example. Ambry then “analyz[es]
`
`the amplified molecules in the assay samples of the set to determine a first number of
`
`assay samples which contain a first allelic form of a marker and a second number of
`
`assay samples which contain a second allelic form of the marker.” It does so, for
`
`example, per the 2014 paper, by using a sequencing step wherein the “[s]equencing was
`
`conducted on” a NextGen sequencing machine which provides sequence data and thereby
`
`determines the first and second numbers of assay samples. Ambry “compar[es] the first
`
`number of assay samples to the second number of assay samples to ascertain an allelic
`
`imbalance in the biological sample,” for example, as described in the 2014 paper, to
`
`ascertain an allelic imbalance in the biological sample. By performing each of the
`
`activities described above in connection with its BRCAplus, BRCAplus-Expanded,
`
`CancerNext, CancerNext-Expanded products and services, Ambry conducts each and
`
`every step recited in claim 1 of the ’015 patent and thus infringes at least claim 1 of the
`
`‘015 patent.
`
` Ambry’s infringement of the ’015 patent has caused damage to and
`40.
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`continues to cause damage to Plaintiffs.
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` 14
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 14 of 19
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` On information and belief, Ambry will continue in and enlarge its 41.
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`infringement of the ’015 patent unless and until it is enjoined by this Court.
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`COUNT IV
`(Direct Infringement of United States Patent No. 8,859,206 by Ambry)
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`42.
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`Plaintiffs reallege and incorporate herein by reference the allegations stated
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`in paragraphs 1-41 of this Complaint.
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` Ambry has infringed and continues to directly infringe the ’206 patent in
`43.
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`violation of 35 U.S.C. § 271(a). For example, Ambry, directly or through entities under
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`its control or influence, makes, uses, offers for sale, and sells products and/or services
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`within the United States that utilize methods for the detection of a quantity of a genetic
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`sequence in a mixed population of human genomic sequences that infringe the claims of
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`the ‘206 patent, including, for example, through use of its BRCAplus, BRCAplus-
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`Expanded, CancerNext, CancerNext-Expanded, and other tests. For example, Ambry’s
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`making, using, offering for sale, and selling its BRCAplus, BRCAplus-Expanded,
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`CancerNext, CancerNext-Expanded, and other products and services infringes at least
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`claims 1-19, 21-22, and 24-28 of the ’206 patent.
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` Concerning claim 1 of the ‘206 patent and the Ambry BRCAplus,
`44.
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`BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other products and
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`services, for example, Ambry “distribut[es] or dilut[es] a mixed population of cell-free,
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`human genomic nucleic acid template molecules from a sample in which the fraction of
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`mutant alleles is less than 20%, into a set comprising at least fifteen assay samples such
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`that said at least fifteen assay samples each comprises less than ten template molecules.”
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` 15
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 15 of 19
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`Ambry does so, for example, per the 2014 paper on test validation, as well as press
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`releases, by extracting and purifying genomic DNA from blood or saliva samples to
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`isolate the DNA, after which “PCR droplet reactions were generated and processed
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`using” a machine for target enrichment (Chong, et al., 2014). Ambry targets specific
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`sequences via “[a] custom primer library,” for example, per the 2014 paper. By using the
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`target-enrichment machine Ambry “amplif[ies] the template molecules in the assay
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`samples, wherein an assay sample with a single template molecule forms homogeneous
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`amplification products in the assay sample.” Ambry then “analyz[es] by determining
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`nucleic acid sequence of amplification products in the assay samples of the set with
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`homogeneous amplification products to determine a first number of assay samples in the
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`set which contain the first sequence and a second number of assay samples in the set
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`which contain the second sequence.” It does so, for example, per the 2014 paper, by
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`using a sequencing step wherein the “[s]equencing was conducted on” a NextGen
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`sequencing machine which provides sequence data and thereby determines the first and
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`second numbers of assay samples. Ambry “compar[es] the first number to the second
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`number to ascertain a ratio which reflects the composition of the mixed population,” for
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`example, per the 2014 paper, to ascertain an allelic imbalance in the biological sample.
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`Ambry “identif[ies] a mutation in the mixed population if a statistically significant
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`fraction of assay samples comprises the second sequence,” for example, as shown in the
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`2014 paper. By performing each of the activities described above in connection with its
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`BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded products and
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` 16
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 16 of 19
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`
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`services, Ambry conducts each and every step recited in claim 1 of the ’206 patent and
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`thus infringes at least claim 1 of the ’206 patent.
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` Ambry’s infringement of the ’206 patent has caused damage to and
`45.
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`continues to cause damage to Plaintiffs.
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` On information and belief, Ambry will continue in and enlarge its
`46.
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`infringement of the ’206 patent unless and until it is enjoined by this Court.
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` With respect to all of the counts and patents asserted in this complaint,
`47.
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`when discussing ways in which Ambry infringes or meets various limitations of the
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`claims, Plaintiffs are providing examples of such ways and examples of infringing
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`methods. These examples are not intended to identify all such ways or all infringing
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`methods.
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`PRAYER FOR RELIEF
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`
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`WHEREFORE, Plaintiffs pray that this Court:
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`A.
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`Enter a judgment that Ambry has directly infringed each of the Patents-in-
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`Suit;
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`B.
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`Grant a permanent injunction restraining and enjoining Ambry, its officers,
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`directors, agents, servants, employees, successors, assigns, parents, subsidiaries, affiliated
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`or related companies, and attorneys from making, using, offering for sale, and selling its
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`BRCAplus, BRCAplus-Expanded, CancerNext, CancerNext-Expanded, and other
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`products and services and infringing the Patents-in-Suit, including a permanent injunction
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`prohibiting Ambry from making, using, offering for sale, and selling its BRCAplus,
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`BRCAplus-Expanded, CancerNext, CancerNext-Expanded products and services;
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` 17
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 17 of 19
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`C.
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`Award Plaintiffs damages in an amount sufficient to compensate Plaintiffs
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`for Ambry’s infringement of the Patents-in-Suit, but not less than a reasonable royalty;
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`D.
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`E.
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`Award prejudgment interest to Plaintiffs pursuant to 35 U.S.C. § 284;
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`Declare this case exceptional under 35 U.S.C. § 285 and award Plaintiffs its
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`reasonable attorneys’ fees, expenses and costs incurred in this action;
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`F.
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`Award Plaintiffs its costs incurred in this action, including its attorneys’
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`fees; and
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`G.
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`Grant such other and further relief as this Court may deem just and proper.
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`DEMAND FOR JURY TRIAL
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`Plaintiffs hereby demand a jury trial on all issues appropriately triable by a jury.
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`Dated: Sept. 7, 2016
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`Respectfully submitted,
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`/s/ Steven Gardner
`
`
`Steven Gardner (N.C. Bar No. 20984)
`sgardner@kilpatricktownsend.com
`Matias Ferrario (N.C. Bar No. 38723)
`mferrario@kilpatricktownsend.com
`N. Dean Powell, Jr. (N.C. Bar No. 35511)
`dpowell@kilpatricktownsend.com
`Allison W. Dobson (N.C. Bar No. 40693)
`adobson@kilpatricktownsend.com
`
`
`KILPATRICK TOWNSEND & STOCKTON LLP
`1001 West Fourth Street
`Winston-Salem, NC 27101
`(336) 607-7300 (telephone)
`(336) 607-7500 (facsimile)
`
`Attorneys for Esoterix Genetic
`Laboratories, LLC
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` 18
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 18 of 19
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`/s/ Paul K. Sun, Jr.
`Paul K. Sun, Jr.
`N.C. State Bar No. 16847
`ELLIS &WINTERS LLP
`Post Office Box 33550
`Raleigh, North Carolina 27636
`Telephone: (919) 865-7000
`Facsimile: (919) 865-7010
`E-mail: paul.sun@elliswinters.com
`
`Attorney for The Johns Hopkins University
`
`Katrina M. Quicker
`Jason P. Grier
`BAKER & HOSTETLER LLP
`1170 Peachtree Street, NE, Suite 2400
`Atlanta, GA 30309-7676
`Telephone:
`(404) 459-0050
`Facsimile:
`(404) 459-5734
`kquicker@bakerlaw.com
`jgrier@bakerlaw.com
`
`Attorneys for The Johns Hopkins University
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` 19
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`Case 1:16-cv-01111-WO-JEP Document 1 Filed 09/07/16 Page 19 of 19
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`
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