`Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 1 of 10 PageID #: 916
`
`
`
`
`
`EXHIBIT 24
`
`
`
`
`
`EXHIBIT 24
`
`
`
`
`
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 1 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 2 of 10 PageID #: 917
`
`
`
`
`
`EDWARD R. REINES (Bar No. 135960)
`edward.reines@weil.com
`DEREK C. WALTER (Bar No. 246322)
`derek.walter@weil.com
`WEIL, GOTSHAL & MANGES LLP
`Silicon Valley Office
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Telephone: (650) 802-3000
`Facsimile: (650) 802-3100
`Attorneys for Plaintiff/Counterclaim-Defendant
`ILLUMINA, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`SAN FRANCISCO DIVISION
`
`
`
`ILLUMINA, INC.,
`Plaintiff/Counterclaim-
`Defendant,
`
`v.
`NATERA, INC.,
`
`
`
`
`
`
`Defendant/Counterclaim-
`Plaintiff.
`
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`
`
`
`
`Case No. 3:18-CV-01662-SI
`PLAINTIFF/COUNTERCLAIM-
`DEFENDANT ILLUMINA, INC.’S
`ANSWER TO NATERA, INC.’S
`COUNTERCLAIMS
`
`JURY TRIAL DEMANDED
`
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 2 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 3 of 10 PageID #: 918
`
`
`
`ANSWER
`
`Plaintiff/Counterclaim-Defendant Illumina, Inc. (“Illumina”), through its undersigned counsel,
`hereby answers the Counterclaims (“Counterclaims”) of Defendant and Counterclaim-Plaintiff Natera,
`Inc. (“Natera”) as follows:
`
`THE PARTIES
`
`1.
`Illumina admits, upon information and belief, that Natera is a company organized and
`existing under the laws of Delaware, with its principle [sic] place of business at 201 Industrial Rd, San
`Carlos, California 94070.
`2.
`Illumina lacks the knowledge or information sufficient to form a belief as to the truth of
`the allegations of paragraph 2 of the Counterclaims and therefore denies those allegations.
`3.
`Illumina admits that it is a company organized and existing under the laws of Delaware,
`with its principle [sic] place of business at 5200 Illumina Way, San Diego, California 92122.
`JURISDICTION AND VENUE
`4.
`Illumina admits that these counterclaims arise under federal law, and this Court has
`jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338, and the Declaratory Judgment Act, 28 U.S.C. §§
`2201 and 2202, and the patent laws of the United States, 35 U.S.C. § 1, et seq.
`5.
`Illumina admits it has voluntarily submitted to the personal jurisdiction of the United
`States District Court, Northern District of California, by virtue of, inter alia, bringing this present
`action in this Court. Illumina admits that it is also subject to personal jurisdiction in this judicial
`district for the purposes of Natera’s Counterclaims.
`6.
`Illumina admits that venue is proper under at least 28 U.S.C. §§ 1391 and 1400(b)
`because Illumina has consented to the propriety of venue in this Court by filing its Complaint for
`patent infringement in this Court, and these Counterclaims are filed in response to that Complaint.
`BACKGROUND
`Answer to Natera’s Allegations Regarding “General Background of the Invention”
`7.
`Illumina admits, on information and belief, on March 25, 2014, the United States Patent
`Office issued United States Patent No. 8,682,592 (the “’592 Patent”) (Ex. 1), which is entitled “System
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 3 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 4 of 10 PageID #: 919
`
`
`
`and Method for Cleaning Noisy Genetic Data from Target Individuals Using Genetic Data from
`Genetically Related Individuals,” and which is assigned to Natera. Except as so admitted, denied.
`8.
`Illumina lacks the knowledge or information sufficient to form a belief as to the truth of
`the allegations of paragraph 8 of the Counterclaims and therefore denies those allegations.
`9.
`Denied.
`
`Answer to Natera’s Allegations Regarding
`“Improvements and Problems Solved by the ’592 Patent Invention”
`10.
`Denied.
`11.
`Illumina admits, on information and belief, the ’592 Patent states that the “system
`disclosed enables the cleaning of incomplete or noisy genetic data as a source of information” by
`“address[ing] [various] shortcomings of prior art” discussed in the patent. Illumina further admits, on
`information and belief, paragraph 11 of the Counterclaims contains a quote from the ’592 Patent.
`Except as so admitted, denied.
`12.
`Illumina admits, on information and belief, the ’592 Patent states that “[a] need exists
`for a method for more extensive genotyping of embryos at the pre-implantation stage. The number of
`known disease associated genetic alleles is currently at 389 according to OMIM and steadily climbing.
`Consequently, it is becoming increasingly relevant to analyze multiple embryonic SNPs that are
`associated with disease phenotypes.” Illumina further admits, on information and belief, that the ’592
`Patent states “[t]he disclosed method is equally applicable to the context of Non-Invasive Prenatal
`Diagnosis (NIPD) where only a small number of fetal cells, or fragments of fetal DNA, have been isolated
`
`from the mother’s blood.” Except as so admitted, denied.
`13.
`Illumina lacks the knowledge or information sufficient to form a belief as to the truth of
`the allegations of paragraph 13 of the Counterclaims and therefore denies those allegations.
`14.
`Illumina lacks the knowledge or information sufficient to form a belief as to the truth of
`the allegations of paragraph 14 of the Counterclaims and therefore denies those allegations.
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`2
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 4 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 5 of 10 PageID #: 920
`
`
`
`15.
`In response to the allegations in paragraph 15 of the Counterclaims, Illumina states that
`the express language of claim 1 of the ’592 Patent appears at 62:38-62 of the ’592 Patent. Except as so
`admitted, Denied.
`16.
`Denied.
`17.
`Illumina admits that paragraph 17 of the Counterclaims contains what purports to be a
`quote from the ’592 patent application. Except as so admitted, denied.
`18.
`Illumina admits that paragraph 18 of the Counterclaims contains what purports to be a
`quote from the ’592 patent application. Except as so admitted, denied.
`19.
`Illumina admits that paragraph 19 of the Counterclaims contains what purports to be a
`quote from the ’592 patent application. Except as so admitted, denied.
`20.
`Illumina admits that paragraph 20 of the Counterclaims contains what purports to be a
`quote from the ’592 patent application. Except as so admitted, denied.
`21.
`Denied.
`22.
`Denied.
`23.
`Denied.
`24.
`Denied.
`25.
`Denied.
`26.
`Denied.
`27.
`Denied.
`28.
`Denied.
`29.
`Denied.
`30.
`Denied.
`31.
`Denied.
`32.
`Denied.
`33.
`Denied.
`34.
`Denied.
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`3
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 5 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 6 of 10 PageID #: 921
`
`
`
`Answer to Natera’s Allegations Regarding
`“Background Regarding the Infringing Activities”
`35.
`Illumina admits that Verinata began providing the verifi® prenatal test on or around
`March 2012. Except as so admitted, denied.
`36.
`Illumina admits Verifi® uses massively parallel sequencing to analyze genetic material
`from a maternal blood sample to test for fetal aneuploidies. Except as so admitted, denied.
`37.
`Illumina admits it began providing the Verifi® Plus prenatal test in 2017. Except as so
`admitted, denied.
`38.
`Illumina admits Verifi® Plus uses massively parallel sequencing to analyze genetic
`material from a maternal blood sample to test for fetal aneuploidies and five specific microdeletion
`regions. Except as so admitted, denied.
`39.
`Illumina admits it began providing the VeriSeq™ PGS test in 2014. Except as so
`admitted, denied.
`40.
`Illumina admits VeriSeq™ PGS uses massively parallel sequencing to analyze genetic
`material from cells from an embryonic biopsy to test for fetal aneuploidies. Except as so admitted,
`denied.
`41.
`Illumina admits it began providing VeriSeq™ NIPT test in 2017. Except as so
`admitted, denied.
`42.
`Illumina admits VeriSeq™ NIPT uses massively parallel sequencing to analyze genetic
`material from a maternal blood sample to test for fetal aneuploidies. Ecxept as so admitted, denied.
`43.
`Illumina admits it signed an Agreement to acquire Verinata on January 7, 2013, and
`completed its acquisition of Verinata on February 21, 2013.
`44.
`Denied.
`45.
`In response to the allegations of paragraph 45 of the Counterclaims, Illumina states that
`it provides equipment and reagents to customers that allows them to perform the VeriSeq™ PGS test.
`Except as so admitted, Denied.
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`4
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 6 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 7 of 10 PageID #: 922
`
`
`
`46.
`In response to the allegations of paragraph 46 of the Counterclaims, Illumina states that
`it provides equipment and reagent to customers that allows them to perform the VeriSeq™ NIPT test.
`Except as so admitted, Denied.
`ANSWER TO NATERA’S FIRST COUNTERCLAIM
`(NON-INFRINGEMENT OF THE ’831 PATENT)
`47.
`As its answer to paragraph 47 of the Counterclaims, Illumina repeats and realleges its
`responses to paragraphs 1-46 of the Counterclaims as fully set forth above.
`48.
`Illumina denies that Natera does not infringe the asserted claims of the ’831 patent.
`Illumina admits that there is an actual and justiciable controversy between Illumina and Natera with
`regard to the validity and infringement of the ’831 patent. Except as so admitted, denied.
`49.
`Denied.
`50.
`Denied.
`51.
`Denied.
`ANSWER TO NATERA’S SECOND COUNTERCLAIM
`(INVALIDITY OF THE ’831 PATENT)
`52.
`As its answer to paragraph 52 of the Counterclaims, Illumina repeats and realleges its
`responses to paragraphs 1-51 of the Counterclaims as fully set forth above.
`53.
`Denied.
`54.
`Illumina denies that the ’831 patent is invalid. Illumina admits that there is an actual
`and justiciable controversy between Illumina and Natera with regard to the validity and infringement
`of the ’831 patent. Except as so admitted, denied.
`55.
`Denied.
`56.
`Denied.
`57.
`Denied.
`58.
`Denied.
`
`
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`5
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 7 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 8 of 10 PageID #: 923
`
`
`
`ANSWER TO NATERA’S THIRD COUNTERCLAIM
`(DIRECT INFRINGEMENT OF U.S. PATENT NO. 8,682,592)
`59.
`As its answer to paragraph 59 of the Counterclaims, Illumina repeats and realleges its
`responses to paragraphs 1-58 of the Counterclaims as fully set forth above.
`60.
`Denied.
`61.
`Illumina admits that paragraph 61 includes a recitation of claim 1 of the ’592 Patent.
`Except as so admitted, denied.
`62.
`Illumina admits that documents purporting to be claim charts are attached as
`Appendices A, B, and C of the Complaint. Except as so admitted, denied.
`63.
`Denied.
`64.
`Denied.
`65.
`Denied.
`66.
`In response to the allegations in paragraph 66 of the Counterclaims, Illumina states that
`the application that resulted in the ’592 Patent was mentioned by Natera in a September 26, 2017
`correspondence to Illumina that identified a number of additional patents and patent applications.
`Except as so admitted, Denied.
`ANSWER TO NATERA’S FOURTH COUNTERCLAIM
`(INDIRECT INFRINGEMENT OF U.S. PATENT NO. 8,682,592)
`67.
`As their answer to paragraph 67 of the Counterclaims, Illumina repeats and realleges
`their responses to paragraphs 1-66 of the Counterclaims as fully set forth above.
`68.
`Denied.
`69.
`Denied.
`RESPONSE TO NATERA’S DEMAND FOR JURY TRIAL
`Illumina has demanded a trial by jury on all issues so triable in this case in its Complaint
`against Natera.
`
`
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`6
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 8 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 9 of 10 PageID #: 924
`
`
`
`RESPONSE TO NATERA’S PRAYER FOR RELIEF
`Illumina denies that Natera is entitled to any relief whatsoever, including the relief stated in
`paragraphs A through L in the Counterclaims, from either Illumina or the Court, either as prayed for in
`the Counterclaims or otherwise.
`
`GENERAL DENIAL
`Illumina further denies each and every allegation in the Counterclaims that is not specifically
`admitted, denied, or otherwise responded to in this Answer.
`DEFENSES
`Illumina alleges and asserts the following defenses in response to the allegations in the
`Counterclaims.
`
`First Defense – Non-Infringement
`70.
`Illumina has not infringed and is not infringing directly, indirectly, contributorily, by
`inducement, or in any other manner any valid and enforceable claim of the ’592 Patent, either literally
`or by the doctrine of equivalents.
`
`Second Defense – Invalidity
`71.
`One or more claims of the ’592 Patent are invalid for failure to satisfy one or more of
`the requirements of the Patent Act, 35 U.S.C. § 1, et seq., including, but not limited to, the conditions
`of patentability set forth in 35 U.S.C. §§ 101, 102, 103, and 112. For example, one or more claims of
`the ’592 Patent is ineligible under 35 U.S.C. § 101. Briefly, other than a limitation directed to a
`conventional fetal DNA sample, the claims of the ’592 patent claim nothing more than the abstract
`idea of testing to determine whether a hypothesis is true. In addition, one or more claims of the ’592
`Patent are invalid in view of the prior art, including references cited on the face of the ’592 Patent, and
`articles, products, and processes that were publicly available or disclosed before the priority date of the
`’592 Patent. This prior art includes, without limitation, U.S. Patent No. 6,100,029; U.S. Patent
`Application Publication 2004/0137470; U.S. Patent Application Publication 2005/0221341; U.S.
`Patent No. 7,332,277; and U.S. Patent Application Publication 2008/0090239. In addition, one or
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`7
`
`CASE NO.: 3:18-CV-01662-SI
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`Case 3:18-cv-01662-SI Document 63 Filed 09/06/18 Page 9 of 9Case 1:20-cv-01644-RGA Document 1-24 Filed 12/03/20 Page 10 of 10 PageID #: 925
`
`
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`
`
`
`
`
`more claims of the ’592 Patent are invalid because the full scope of those claims is not enabled, nor
`described, by the written description of the ’592 Patent, and those claims are indefinite.
`Third Defense – Failure to State a Claim
`72.
`Natera may not claim or recover any relief, including the relief stated in paragraphs A
`through L in the Counterclaims, from either Illumina or the Court, because the Counterclaims and each
`and every cause of action therein fail to state a claim upon which relief may be granted or facts
`sufficient to support a cause of action.
`
`DATED: September 6, 2018
`
`
`
`
`
`
`
`
`/s/ Edward R. Reines
`Edward R. Reines
`
`Respectfully submitted,
`
`WEIL, GOTSHAL & MANGES LLP
`
`By:
`
`
`EDWARD R. REINES (Bar No. 135960)
`edward.reines@weil.com
`DEREK C. WALTER (Bar No. 246322)
`derek.walter@weil.com
`WEIL, GOTSHAL & MANGES LLP
`Silicon Valley Office
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Telephone: (650) 802-3000
`Facsimile: (650) 802-3100
`
`Attorneys for Plaintiff/Counterclaim-Defendant,
`ILLUMINA, INC.
`
`
`ANSWER TO NATERA’S
`COUNTERCLAIMS
`
`
`8
`
`CASE NO.: 3:18-CV-01662-SI
`
`