Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 1 of 9 PageID #: 53408
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`NATERA, INC.,
`
`Plaintiff / Counter Defendant,
`
`v.
`
`ARCHERDX, INC., ARCHERDX, LLC and
`INVITAE CORP.
`
`Defendants / Counter Claimants.
`
`)
`)
`)
`)
`)
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`)
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`
`C.A. No. 20-125 (GBW)
`
`JURY TRIAL DEMANDED
`
`DEFENDANTS’ COUNTERSTATEMENT OF FACTS IN OPPOSITION TO
`PLAINTIFF’S MOTION FOR SUMMARY JUDGEMENT OF NO INVALIDITY BASED
`ON IMPROPER INVENTORSHIP (D.I. 441 at 12-23).
`
`Dated: October 25, 2022
`
`OF COUNSEL:
`
`Edward R. Reines (admitted pro hac vice)
`Derek C. Walter (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Tel: (650) 802-3000
`Fax: (650) 802-3100
`edward.reines@weil.com
`derek.walter@weil.com
`
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`FARNAN LLP
`919 North Market St., 12th Floor
`Wilmington, DE 19801
`Tel: (302) 777-0300
`Fax: (302) 777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
`
`Attorneys for Invitae Corp., ArcherDX, Inc.
`and ArcherDX, LLC
`
`
`
`
`
`
`
`
`

`

`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 2 of 9 PageID #: 53409
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`
`
`I.
`
`RESPONSE TO NATERA’S ALLEGEDLY UNDISPUTED FACTS
`
`Defendants’
`Evidentiary Support
`See, e.g., Ex. 1 (Eubank
`Tr.) at 61:17-62:13; Ex. 2
`(Lacroute Tr.) at 40:20-25,
`41:14-22, 43:14-20, 69:2-
`20, 69:25-70:4, 73:1-8,
`74:16-75:8, 77:7-12;
`166:6-167:13; D.I. 444-23
`at 111:15-113:19; .I. 444-
`18 at 114:10-115:4; D.I.
`444-17 at 48:9-49:10; D;
`D.I. 444-19 at 116:8-
`118:23; D.I. 444-16 at
`163:12-165:6; D.I. 444-20
`at 66:12-67:4; D.I. 444-21
`at 133:17-134:4; D.I. 444-5
`at 246:11-247-24; D.I. 444-
`22 at 103:9-22; D.I. 444-3
`at 239:6-240:1,; D.I. 444-
`24 at 134:21-135:8.
`See, e.g., D.I. 441 at 15-22;
`D.I. 444-17 at 48:9-49:10;
`D.I. 444-18 at 114:10-
`115:4; D.I. 444-19 at
`116:8-118:23; D.I. 444-16
`at 163:12-165:6; D.I. 444-
`20 at 66:12-67:4; D.I. 444-
`21 at 133:17-134:4; D.I.
`444-5 at 246:11-247-24;
`D.I. 444-22 at 103:9-22;
`D.I. 444-3 at 239:6-240:1,
`D.I. 444-23 at 111:15-
`113:19; D.I. 444-24 at
`134:21-135:8.
`
`
`Natera’s “Fact”
`No.
`1. None of the named
`inventors, added inventors,
`removed inventors, assignee
`Natera, or any third party
`dispute the inventorship of
`the ’814, ’172, ’482 and
`’220 Patents as currently
`listed on the face of these
`patents. No inventor testified
`that he or she did not believe
`he or she was an inventor.
`No individual not named an
`inventor testified that he or
`she believed he or she was in
`fact an inventor.
`
`Defendants’
`Response
`Disputed. For instance,
`Lane Eubank and Phillipe
`Lacroute, who gave
`testimony confirming that
`they are inventors, were
`removed as inventors,
`while Allison Ryan and
`Milena Banjevic, gave
`testimony establishing that
`they could not possibly be
`inventors, were added as
`inventors.
`
`
`2. The Patent Office rules and
`underlying statutes permit
`applicants to correct
`inventorship errors of
`patents and pending
`applications. Natera sought
`to correct, and did correct,
`the inventorship in the
`issued ’814, ’172, ’482 and
`’220 Patents in compliance
`with all of the PTO’s
`requirements as set forth in
`37 C.F.R. § 1.324.
`
`3. With respect to the ’814,
`’172, and ’220 Patents, each
`of the named inventors,
`added inventors and assignee
`Natera, submitted a signed
`statement under 37 C.F.R. §
`1.324 agreeing to change the
`inventorship of these patents
`“in adding Johan Baner,
`
`Disputed in part. Natera’s
`filing to change
`inventorship was not in
`compliance with
`requirements set forth in 37
`C.F.R. § 1.324 due to the
`omission of inventors.
`
`Undisputed.
`
`1
`
`

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`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 3 of 9 PageID #: 53410
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`
`
`Defendants’
`Response
`
`Defendants’
`Evidentiary Support
`
`Undisputed.
`
`Undisputed.
`
`Disputed. Defendants
`presented corroborating
`evidence on inventorship in
`the form of inventor
`testimony, including the
`inability of inventors to
`explain their attestations
`and the omission of Natera
`employees whose work
`does correspond to the
`alleged invention.
`
`
`
`
`
`See, e.g., D.I. 444-17 at
`48:9-49:10; D.I. 444-18 at
`114:10-115:4; D.I. 444-19
`at 116:8-118:23; D.I. 444-
`16 at 163:12-165:6; D.I.
`444-20 at 66:12-67:4; D.I.
`444-21 at 133:17-134:4;
`D.I. 444-5 at 246:11-247-
`24; D.I. 444-22 at 103:9-
`22; D.I. 444-3 at 239:6-
`240:1, D.I. 444-23 at
`111:15-113:19; D.I. 444-24
`at 134:21-135:8.; D.I. 419-
`10 ¶¶ 945-47; D.I. 391-2,
`Ex. 5 at 48:4-50:18.
`
`No.
`
`Natera’s “Fact”
`Milena Banjevic, Allison
`Ryan and Zachary Demko
`and removing Joshua
`Babiarz, Tudor Pompilin
`Constantin, Lane A. Eubank,
`Huseyin Eser Kirkizlar and
`Onur Sakarya as named
`Inventors of this patent.”
`4. With respect to the ’482
`Patent, each of the named
`inventors, added inventor
`Bernhard Zimmermann, and
`assignee Natera, submitted a
`signed statement under 37
`C.F.R § 1.324 agreeing to
`the change of inventorship
`of the ’482 Patent in “adding
`Bernhard Zimmermann as a
`named Inventors [sic] of this
`patent.”
`5. The PTO issued certificates
`of correction.
`6. Defendants’ improper
`inventorship claim is not
`supported by corroborating
`evidence. Natera identified
`and produced documents
`that corroborate its
`inventorship claim.
`Defendants did not evaluate
`any corroborating Natera
`documents, such as
`laboratory notebooks, in
`evaluating inventorship.
`Defendants’ expert Dr.
`Cooper only relied on select
`testimony excerpts (and
`resumes in some cases) and
`did not review laboratory
`notebooks or any Natera
`document in his inventorship
`evaluation.
`
`2
`
`

`

`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 4 of 9 PageID #: 53411
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`Natera’s “Fact”
`No.
`7. The removed Natera
`inventors joined Natera after
`the filing of the priority
`patent application in
`November 2011. Joshua
`Babiarz joined Natera in
`December 2012, Tudor
`Constantin in January of
`2013, Lane Eubank became
`a Natera employee in
`January 2014, Huseyin
`Kirkizlar joined Natera in
`May or June 2012, and Onur
`Sakarya in early 2014.
`
`
`
`Defendants’
`Evidentiary Support
`See, e.g., D.I. 419-10 ¶¶
`50-67; D.I. 433-3, Ex. 28 at
`8:11-19; Ex. 29 at 10:16-
`11:2 & Exh. 1; Ex. 30 at
`12:3-17; Ex. 31 at 18:17;
`Ex. 32 at 14:20-21.
`
`Defendants’
`Response
`Disputed in part and
`irrelevant. The ’814, ’172,
`’482 and ’220 are not
`entitled to claim the benefit
`of Natera’s November
`2011 application.
`Therefore, the mere fact
`that certain individuals
`joined Natera in 2011 or
`later does not preclude
`them from being inventors.
`
`3
`
`

`

`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 5 of 9 PageID #: 53412
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`
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`II. MATERIAL FACTS ON WHICH THERE REMAIN A GENUINE ISSUE
`REGARDING INVALIDITY BASED ON IMPROPER INVENTORSHIP
`A.
`
`Natera Dramatically Changed The Inventorship On Its Patents Eighteen
`Months Into Litigation
`
`1.
`
`Named inventor Zachary Demko, a patent agent and who is in charge of Natera’s
`
`intellectual property function at the time of the alleged inventions, testified that Natera does its
`
`best to identify the right inventors. See, e.g., D.I. 444-16 at 20:12-14, 105:10-107:7, 108:3-109:15,
`
`142:17-143:8.
`
`2.
`
`In June 2021, Natera filed petitions with the Patent Office to change the
`
`inventorship on the ’814, ’172, and ’220 patents. See, e.g., Ex. 3 (’127 Request for Inventorship
`
`Correction), Ex. 4 (’814 Request for Inventorship Correction), Ex. 5 (’220 Request for
`
`Inventorship Correction).
`
`3.
`
`For three of the patents, Natera sought to add Johan Baner, Milena Banjevic,
`
`Allison Ryan, and Zachary Demko as inventors. See, e.g., id.
`
`4.
`
`For three of the patents, Natera sought to remove Joshua Barbiarz, Tudor
`
`Constantin, Lane Eubank, Huseyin Kirkizlar, and Onur Sakarya as inventors. See, e.g., id.
`
`5.
`
` None of the inventors who were added or removed were able to explain their
`
`attestations to the Patent Office at deposition. See, e.g., D.I. 444-17 at 48:9-49:10; D.I. 444-18 at
`
`114:10-115:4; D.I. 444-19 at 116:8-118:23; D.I. 444-16 at 163:12-165:6; D.I. 444-20 at 66:12-
`
`67:4; D.I. 444-21 at 133:17-134:4; D.I. 444-5 at 246:11-247-24; D.I. 444-22 at 103:9-22; D.I. 444-
`
`3 at 239:6-240:1, D.I. 444-23 at 111:15-113:19; D.I. 444-24 at 134:21-135:8.
`
`B.
`
`A Reasonable Jury Could Find The Omission Of Dr. Lacroute As Sufficient
`To Invalidate The ’220 Patent
`1.
`
`Expert Testimony Corroborates Dr. Lacroute’s Contributions To The
`Invention
`
`6.
`
`Dr. Phillippe Lacroute worked at Natera on algorithms for primer design to avoid
`
`4
`
`

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`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 6 of 9 PageID #: 53413
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`
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`primer dimers. See, e.g., D.I. 419-10 ¶¶ 945-947.
`
`7.
`
`Dr. Cooper, Defendants’ expert, identified passages of the ’220 Patent describing
`
`the use of the Primer3 software to identify problematic primers based on the computation of their
`
`“undesirability” scores. See, e.g., id.; D.I. 391-2, Ex. 5 at 48:4-50:18.
`
`8.
`
`Natera, throughout the case, has asserted that its alleged inventions pertain to the
`
`avoidance of primer dimer side products. See, e.g., D.I. 430 at 3; D.I. 419-10 ¶¶ 754-756, 937-39.
`
`9.
`
`At his deposition, Dr. Phillipe Lacroute confirmed that he worked on techniques
`
`for the avoidance of primer dimer side products and is thus an inventor of the claims in the Asserted
`
`Patents. See, e.g., Ex. 2 (Lacroute Tr.) at 40:20-25, 41:14-22, 43:14-20, 69:2-20, 69:25-70:4, 73:1-
`
`8, 74:16-75:8, 77:7-12; 166:6-167:13
`
`10.
`
`Dr. Quackenbush, Natera’s technical expert, was asked to identify the techniques
`
`used in the “claimed invention” of the ’220 patent and identified the exact thing that Mr. Lacroute
`
`developed, designing primers “as instructed by the written description using a tool such as Primer3
`
`. . . in a way to avoid the formation of primer dimers.” See, e.g., D.I. 434-12 at 150:25-151:5.
`
`11.
`
`Dr. Spellman, Natera’s expert on inventorship, was unable to explain Dr.
`
`Lacroute’s omission as an inventor during his deposition when confronted with Dr. Lacroute’s
`
`contribution. See, e.g., D.I. 444-28 at 243:10-19.
`
`2.
`
`Natera’s Own Patent Filings Corroborate Dr. Lacroute’s Testimony As
`To His Contributions To The Invention
`
`12.
`
`Natera’s patents are based on the use of Primer3 to compute “undesirability scores.”
`
`See, e.g., D.I. 444-29 ¶¶ 185-86.
`
`13.
`
`The technique of using “undesirability scores” first appeared in Natera’s November
`
`21, 2012 patent application entitled “Highly Multiplex PCR Methods And Compositions”
`
`(application number 13/683,604). See, e.g., D.I. 444-29 ¶¶ 185-86.
`
`5
`
`

`

`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 7 of 9 PageID #: 53414
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`
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`14.
`
`The application was filed after Dr. Lacroute began work at Natera in early spring
`
`2012. See, e.g., D.I. 444-6 at 20:14-21:11.
`
`15.
`
`Dr. Lacroute is listed as an inventor on the application. See, e.g., D.I. 444-29 at
`
`(72).
`
`16.
`
`Natera’s ’220, ’172, and ’814 patents each claim the benefit of this application.
`
`See, e.g., D.I. 391-2, Ex. 5 at (63); D.I. 17-1, Ex. 1 at (63); D.I. 17-1, Ex. 2 at (63).
`
`17.
`
`Natera admits that prior to April 2013, Dr. Lacroute did work related to “primer
`
`pool design.” See, e.g., D.I. 433-3, Ex. 21 at 422.
`
`18.
`
`Natera cites documents authored by Dr. Lacroute that describe the primer design
`
`technique he said he developed. See, e.g., D.I. 444-30 at 4, 7-8.
`
`19.
`
`Internal email correspondence within Natera confirm that Dr. Lacroute was
`
`engaged on the primer design problem throughout 2012. See, e.g., D.I. 444-32; 444-33.
`
`3.
`
`Inventor And Non-Inventor Witnesses Additionally
`Natera’s
`Corroborate Dr. Lacroute’s Role
`
`20. Michael Dodd admitted at deposition that “as far as the multiplex pool design tool,
`
`I believe when I was working on it, Phil Lacroute would have been the primary person that – that
`
`may have also worked on it.” See, e.g., D.I. 444-4 at 41:6-21.
`
`21. Matthew Micah Hill, in his deposition, stated that Phil Lacroute worked with him
`
`on the project related to primer design to avoid off-target products and primer dimers. See, e.g.,
`
`D.I. 444-5 at 137:15-25.
`
`22.
`
`Alexander Wong stated that Dr. Lacroute was someone he “worked with directly”
`
`on designing the primer design algorithm. See, e.g., D.I. 444-7 at 53:8-14.
`
`C.
`
`Natera’s Added Inventors Have No Idea How PCR Works And Did Not
`Contribute To The Invention
`
`23.
`
`Dr. Ryan is an algorithms engineer with no knowledge of how PCR works. See,
`
`6
`
`

`

`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 8 of 9 PageID #: 53415
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`
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`e.g., D.I. 444-23 at 23:7-8.
`
`24.
`
`Dr. Ryan also testified that she conceived of no solutions to the primer dimer
`
`problem in multiplex PCR, and had no idea how the issue might be addressed. See, e.g., id. at
`
`30:12-20, 65:23-66, 68:11-14.
`
`25.
`
`Dr. Gemelos had no understanding of how either PCR or nested PCR works or
`
`whether he may have contributed to solving the primer dimer problem in multiplex PCR. See,
`
`e.g., D.I. 444-21 at 17:24-18:4, 41:3-20, 45:3-20, 53:15-24, 55:9-15, 58:16-59:10, 60:10-20.
`
`26.
`
`Dr. Banjevic, at deposition, also testified to having little to know knowledge of
`
`PCR’s mechanics nor the methods required to conduct PCR. See, e.g., D.I. 444-18 at 15:12-18,
`
`17:24-20:25, 74:14-75:9.
`
`27.
`
`Natera points to its “approximately 100-page long” interrogatory response to show
`
`that its inventors did work on PCR concepts and Dr. Ryan’s testimony. See, e.g., D.I. 432 at 25-
`
`26.
`
`28.
`
`For example, one document is related to “optimiz[ing] mapping of sequence data.”
`
`See, e.g., D.I. 433-3, Ex. 21 at 332.
`
`29.
`
`Dr. Ryan testified that the document merely has to do with “loading sequence data”
`
`and confirmed the document makes no mention of PCR. See, e.g., D.I. 444-23 at 41:9-42:5.
`
`30.
`
`Dr. Ryan had no memory of the document being related to the development tof
`
`multiplex PCR methods. See, e.g., id. at 41:22-25.
`
`
`
`7
`
`

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`Case 1:20-cv-00125-GBW Document 492 Filed 10/25/22 Page 9 of 9 PageID #: 53416
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`
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`
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`October 25, 2022
`
`OF COUNSEL
`
`Edward R. Reines (admitted pro hac vice)
`Derek C. Walter (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Tel: (650) 802-3000
`Fax: (650) 802-3100
`edward.reines@weil.com
`derek.walter @weil.com
`
`Respectfully submitted,
`
`FARNAN LLP
`
`/s/ Michael J. Farnan
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 North Market St., 12th Floor
`Wilmington, DE 19801
`Tel: (302) 777-0300
`Fax: (302) 777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
`
`
`
`Attorneys for Invitae Corp., ArcherDX, Inc.
`and ArcherDX, LLC
`
`8
`
`