Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 1 of 16 PageID #: 64687
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`NATERA, INC.,
`
`
`
`v.
`
`ARCHERDX, INC., ARCHERDX, LLC,
`and INVITAE CORPORATION,
`
`
`
`Plaintiff,
`
`Defendants.
`
`
`
`
`
`
`
`C.A. No. 20-cv-125-GBW
`(Consolidated)
`
`
`
`
`REPLY IN SUPPORT OF DEFENDANTS’ RENEWED MOTION FOR JUDGMENT AS
`A MATTER OF LAW AND ALTERNATIVE REQUEST FOR A NEW TRIAL
`
`
`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
`
`Aaron J. Curtis (admitted pro hac vice)
`Kathryn Leicht (admitted pro hac vice)
`Barry Zhang (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`Tel: (212) 310-8000
`aaron.curtis@weil.com
`kathryn.leicht@weil.com
`barry.zhang@weil.com
`
`Attorneys for Invitae Corp., ArcherDX, Inc.
`and ArcherDX, LLC
`
`
`
`
`Dated: December 4, 2023
`
`Edward R. Reines (admitted pro hac vice)
`Derek C. Walter (admitted pro hac vice)
`Karnik F. Hajjar (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
`karnik.hajjar@weil.com
`
`Elizabeth Y. Ryan (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`200 Crescent Court, Suite 300
`Dallas, TX 75201
`Tel: (214) 746-7700
`liz.ryan@weil.com
`
`Matthew D. Sieger (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street, NW, Suite 600,
`Washington, DC 20036
`Tel: (202) 682-7000
`matthew.sieger@weil.com
`
`
`
`
`

`

`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 2 of 16 PageID #: 64688
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`
`TABLE OF CONTENTS
`
`ARGUMENT .................................................................................................................................. 1 
`
`I. 
`
`II. 
`
`III. 
`
`IV. 
`
`V. 
`
`VI. 
`
`Natera Cannot Recover Royalties For Non-PCM Kits ....................................................... 1 
`
`Natera Cannot Recover Royalties For Foreign Kit Sales ................................................... 3 
`
`The ’708 Patent Is Invalid for Indefiniteness ...................................................................... 5 
`
`The Accused Products Do Not Infringe The ’172 And ’220 Patents ................................. 6 
`
`Archer’s PCM Product Is Covered By The Safe Harbor .................................................... 7 
`
`The ’220 And ’172 Patents Do Not Have Written Description Support ............................ 8 
`
`VII.  The ’220 And ’172 Patents Are Unenforceable Due To Prosecution Laches .................... 9 
`
`VIII. 
`
`In The Alternative, The Court Should Order A New Trial Or Remittitur Of
`Damages ............................................................................................................................ 10 
`
`CONCLUSION ............................................................................................................................. 10 
`
`
`
`
`
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`
`
`
`
`
`i
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 3 of 16 PageID #: 64689
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`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`ArcherDX, LLC v. Qiagen Scis., LLC,
`2021 WL 3857460 (D. Del. Aug. 30, 2021) ..................................................................3, 10, 12
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`35 F.4th 1328 (Fed. Cir. 2022) ..................................................................................................9
`
`Dow Chemical Co. v. Nova Chemicals Corp. (Canada),
`803 F3d 620 (Fed. Cir. 2015).....................................................................................................5
`
`Go Med. Indus. Pty., Ltd. v. Inmed Corp.,
`471 F.3d 1264 (Fed. Cir. 2006)..................................................................................................3
`
`Infernal Technology LLC v. Activision Blizzard Inc.,
`2021 WL 4391250 (N.D. Tex. Sept. 16, 2021) ..........................................................................4
`
`Momenta Pharms., Inc. v. Amphastar Pharms., Inc.,
`686 F.3d 1348 (Fed. Cir. 2012)..................................................................................................8
`
`Morrison v. Nat’l Australia Bank Ltd.,
`561 U.S. 247 (2010) .............................................................................................................4, 10
`
`NTP, Inc. v. Rsch. in Motion, Ltd.,
`418 F.3d 1282 (Fed. Cir. 2005)..................................................................................................3
`
`Promega Corp. v. Life Techs. Corp.,
`875 F.3d 651 (Fed. Cir. 2017)................................................................................................2, 3
`
`PSC Comput. Prods., Inc. v. Foxconn Int’l,
`355 F.3d 1353 (Fed. Cir. 2004)..................................................................................................7
`
`Sonos, Inc. v. Google LLC,
`2023 WL 6542320 (N.D. Cal. Oct. 6, 2023) ........................................................................9, 10
`
`Standard Havens Prod., Inc. v. Gencor Indus., Inc.,
`953 F.2d 1360 (Fed. Cir. 1991)..................................................................................................1
`
`TecSec, Inc. v. Adobe Inc.,
`978 F.3d 1278 (Fed. Cir. 2020)..................................................................................................1
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`789 F.3d 1335 (Fed. Cir. 2015)..................................................................................................5
`
`TQ Delta, LLC v. 2Wire, Inc.,
`486 F. Supp. 3d 803 (D. Del. 2020) ...........................................................................................4
`
`
`
`ii
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 4 of 16 PageID #: 64690
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`
`U.S. Gypsum Co. v. Schiavo Bros.,
`668 F.2d 172 (3d Cir. 1981).......................................................................................................9
`
`Vectura Ltd. v. Glaxosmithkline LLC,
`981 F.3d 1030 (Fed. Cir. 2020)..................................................................................................2
`
`Williamson v. Consol. Rail Corp.,
`926 F.2d 1344 (3d Cir. 1991)...................................................................................................10
`
`Zenith Radio Corp. v. Hazeltine Rsch., Inc.,
`395 U.S. 100 (1969) ...................................................................................................................2
`
`
`
`
`
`iii
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 5 of 16 PageID #: 64691
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`I.
`
`Natera Cannot Recover Royalties For Non-PCM Kits
`
`ARGUMENT
`
`The need for a JMOL grant is unusually compelling given the jury’s flat rejection of
`
`Natera’s indirect infringement theory, an adverse verdict Natera has not challenged.
`
`In short, the jury improperly awarded Natera royalties on sales of non-PCM kits for
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`customer use, even though such sales (1) legally cannot infringe a method patent directly and
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`(2) were found not to infringe indirectly. Natera does not dispute that its liability theory at trial
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`for kits sold for customer use was that Archer indirectly infringed the patents by providing
`
`customers with the kits and information about how to use them. See, e.g., Trial Tr. 504:22–509:24,
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`1238:7–11. Natera cannot, and does not, dispute that the jury rejected that theory and found no
`
`infringement for those kit sales. Opp. 4. And Natera does not dispute that the jury included those
`
`non-infringing sales in the royalty base it used to calculate royalties. Id. at 4–5.
`
`In response, Natera speculates the jury “may have” awarded a lower royalty rate than what
`
`Natera requested to account for the non-infringing customer use. Opp. 2–4. But Natera improperly
`
`conflates the royalty rate with the royalty base. The jury’s 10% royalty rate was lower than
`
`Natera’s proposed 19.7% rate. Opp. 3–4. But the jury then applied that royalty rate to a royalty
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`base that erroneously included sales that did not infringe Natera’s patents. Mot. 4. Such sales
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`were not “properly included in a patent damages award” because Natera failed to prove indirect
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`infringement with respect to them. See Standard Havens Prod., Inc. v. Gencor Indus., Inc., 953
`
`F.2d 1360, 1374 (Fed. Cir. 1991). If the jury intended to reduce the royalties to account for non-
`
`infringing sales, the jury should have reduced the royalty base, not the royalty rate. But the jury
`
`had no way of doing so because Natera “presented no evidence of damages caused by [Archer’s
`
`alleged] direct infringement, which was the only form of infringement that the jury found [Archer]
`
`to have committed.” TecSec, Inc. v. Adobe Inc., 978 F.3d 1278, 1291 (Fed. Cir. 2020).
`
`
`
`1
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 6 of 16 PageID #: 64692
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`Next, Natera faults Archer’s expert for agreeing on a royalty base that included “revenue
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`from all accused products without separating out direct and indirect infringing uses.” Opp. 5. But
`
`it was not Archer’s burden to prove Natera’s damages. Natera had the burden of proving its own
`
`damages. Promega Corp. v. Life Techs. Corp., 875 F.3d 651, 660 (Fed. Cir. 2017). Moreover,
`
`Archer’s expert only agreed that “worldwide sales revenue” would be the appropriate royalty base
`
`if Natera proved liability and causation of damages for all accused products. Trial Tr. 1002:12–
`
`20. But Natera failed to prove liability on the non-PCM kits Archer sold for customer use. Thus,
`
`the jury’s inclusion of those sales in the royalty base was legal error that this Court must correct.
`
`Natera also speculates that the jury’s 10% royalty rate may have included “built-in
`
`apportionment to account for any non-infringing use”—even though Natera never presented that
`
`theory. Opp. 3–4. But unlike Vectura Ltd. v. Glaxosmithkline LLC, where the plaintiff “offered
`
`evidence … that principles of apportionment were effectively baked into the 2010 license,” 981
`
`F.3d 1030, 1041 (Fed. Cir. 2020), Natera’s damages expert, Mr. Sullivan, said nothing indicating
`
`that the Becton-Dickinson agreement he used as a baseline for the royalty rate included royalties
`
`for products that were not covered by the license, Trial Tr. 638:2–640:7; see also id. at 1242:9–
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`13, 1243:20–23.1 Nor would it be proper to charge a royalty for non-infringing sales. See Zenith
`
`Radio Corp. v. Hazeltine Rsch., Inc., 395 U.S. 100, 135 (1969).
`
`Finally, Natera asserts that “Defendants waived this argument by failing to raise it in their
`
`Rule 50(a) motion.” Opp. 6–7. Not so. Archer’s Rule 50(a) motion clearly argued that Natera
`
`“failed to meet its burden of proof that Defendants directly or indirectly infringed the Asserted
`
`
`1 Natera points out that Archer’s expert referenced another agreement—the MGH license—that
`reduced the royalty rate by 50% for uses of the technology in countries where the licensor had no
`patent rights. Trial Tr. 994:7–995:3. But neither Natera nor Archer argued a 50% reduction in the
`royalty rate for all sales was an appropriate way to exclude non-infringing sales from the damages.
`
`
`
`2
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 7 of 16 PageID #: 64693
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`Patents,” and “failed to meet its burden to prove … that it is entitled to compensatory damages for
`
`any of these categories.” D.I. 604 at 14.2 Moreover, “[i]t would have been impossible” for Archer
`
`“to challenge the jury’s award of damages as excessive in a Rule 50(a) motion.” Go Med. Indus.
`
`Pty., Ltd. v. Inmed Corp., 471 F.3d 1264, 1272 (Fed. Cir. 2006). Archer had no way to know the
`
`jury would find Archer’s sales of non-PCM kits for customer use did not infringe Natera’s patents,
`
`while at the same time awarding royalties on those same non-infringing sales. That is the purpose
`
`of a post-trial motion. The Court should eliminate the jury’s award of non-PCM damages because
`
`Natera gave the jury no way to exclude non-infringing sales just as in Promega.
`
`II.
`
`Natera Cannot Recover Royalties For Foreign Kit Sales
`
`Natera also failed to prove it is entitled to royalties for kits sold for customer use outside
`
`the United States. Natera concedes that “one would not expect Defendants to use the kits that are
`
`to be shipped out.” Opp. 10. That is exactly Archer’s point. Archer does not perform all the steps
`
`of the allegedly patented method for kits shipped to customers abroad. Mot. 7. And “a process
`
`cannot be used ‘within’ the United States as required by section 271(a) unless each of the steps is
`
`performed within this country.” NTP, Inc. v. Rsch. in Motion, Ltd., 418 F.3d 1282, 1318 (Fed. Cir.
`
`2005). Thus, to the extent there is any use of the patented method for kits sold abroad, it occurs
`
`outside the U.S. and cannot constitute infringement. See ArcherDX, LLC v. Qiagen Scis., LLC,
`
`2021 WL 3857460, at *1 (D. Del. Aug. 30, 2021).
`
`None of the facts Natera identifies establish a causal connection between Archer’s internal
`
`domestic kit use and its foreign sales. Natera asserts the products were “designed” and
`
`“developed” in the United States. Opp. 8. If that were enough, a plaintiff would be able to recover
`
`damages for foreign sales whenever a product was developed in the United States, and the
`
`
`2 Emphasis supplied and citations omitted throughout.
`
`
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`3
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 8 of 16 PageID #: 64694
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`exception would swallow the rule. But that is not how the rule against extraterritorial application
`
`of United States patent law works. See Morrison v. Nat’l Australia Bank Ltd., 561 U.S. 247, 266
`
`(2010). This would also eliminate the need for the concept of indirect infringement if sales could
`
`be deemed caused for damages purposes by infringing use in product development.
`
`Natera also argues that “[a]ll of the products are tested … in the U.S.” Opp. 8. But Natera
`
`admits the kits Archer sold to foreign customers were not actually tested in the U.S. Id. at 10.
`
`Natera quibbles over whether tests were “run on patient samples” or some other kind of “biological
`
`sample.” Opp. 10. But Dr. Daber testified there was no infringing testing because “there was
`
`never a high level [quality control] for the RUO kits where all of the components were tested
`
`together.” Trial Tr. 967:23–25.3 And even if all the steps had been used (there is no evidence of
`
`this), testing other kits in the U.S. would not establish causation for kits sold to foreign customers.
`
`Infernal Technology LLC v. Activision Blizzard Inc., 2021 WL 4391250, at *13 (N.D. Tex. Sept.
`
`16, 2021). Natera also misdirects the Court by arguing that, “[f]or trials performed abroad, the lab
`
`tests were run in the U.S.” Id. But the clinical trials involved the PCM product, Trial Tr. 621:3–
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`12, and the jury only awarded royalties for foreign sales of non-PCM kits, D.I. 609 at 10.
`
`Natera further argues “the jury was free to conclude that a customer would not purchase
`
`such products without data of the test’s capability.” Opp. 8. But Natera never made—much less
`
`developed—that argument at trial, and cannot raise it for the first time in opposition to Archer’s
`
`JMOL motion. See, e.g., TQ Delta, LLC v. 2Wire, Inc., 486 F. Supp. 3d 803, 808 (D. Del. 2020)
`
`(rejecting argument for which there was “no testimony at trial”). In support of this new argument,
`
`
`3 Natera speculates that “the jury may not have given weight to Dr. Daber’s testimony given that
`he was never employed by Archer.” Opp. 10. But Dr. Daber is deeply familiar with Archer’s
`business. He “served on the scientific advisory board at Archer starting back at 2012,” and he
`serves as chief scientific officer at Invitae, which acquired Archer in 2020. Trial Tr. 962:2–14.
`
`
`
`4
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 9 of 16 PageID #: 64695
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`Natera relies heavily on statements buried deep within a single exhibit—PTX1180. Opp. 8–9. But
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`Natera never showed those statements to the jury. See Trial Tr. 625:1–11. There is no reason to
`
`believe the jury relied on—or was even aware of—the statements in PTX1180 that Natera
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`emphasizes now. And because the evidence did not show Archer’s internal domestic kit use was
`
`a substantial cause of the foreign sales, the jury erred in awarding damages for those sales.
`
`III. The ’708 Patent Is Invalid for Indefiniteness
`
`The ’708 Patent is indefinite because it does not inform the public which methods to use
`
`to measure primer melting temperature. This is a straightforward case of indefiniteness
`
`indistinguishable from Dow Chemical Co. v. Nova Chemicals Corp. (Canada), where there were
`
`multiple measurement methods, and the patent, specification, and prosecution history failed to
`
`inform skilled artisans reliably which one to use. 803 F.3d 620, 631–35 (Fed. Cir. 2015).
`
`Natera states the patent discloses “two techniques for determining primer melting
`
`temperature,” but then takes the perplexing position that the patent is not indefinite simply because
`
`it “teaches the two methods.” Opp. 11. Natera misses the point. The ’708 Patent is indefinite
`
`because it identifies multiple measurement methods that lead to different infringement conclusions
`
`but fails to specify which method should be used in which circumstances. Mot. 9–11.
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`In the face of this, Natera tries to narrow the potential measurement methods by relying on
`
`Dr. Zimmermann’s testimony “that the Bolton & McCarthy method cannot be used for purpose of
`
`the ’708 Patent.” Opp. 12. This only makes a bad mess worse. During prosecution, Natera said
`
`the opposite to obtain its claims—that melting temperature for the claimed invention in situations
`
`involving long primers is properly “calculated using the formula from Bolton and McCarthy.”
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`DTX233. The conflicting message to skilled artisans as to whether to use Bolton & McCarthy—
`
`or not—as the measurement method proves “the patentee has failed to inform with reasonable
`
`certainty those skilled in the art about the scope of the invention.” Teva Pharms. USA, Inc. v.
`
`
`
`5
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 10 of 16 PageID #: 64696
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`Sandoz, Inc., 789 F.3d 1335, 1345 (Fed. Cir. 2015). Dr. Zimmerman argues “one could” instead
`
`use the UV method for primers longer than 35 bases. Trial Tr. 434:17–25. But the existence of
`
`one possible method does not negate the potential option of using a different method promoted by
`
`the patentee during prosecution that leads to a different infringement outcome.
`
`Natera also doubles down on its claim that “a skilled artisan would use the latest version
`
`of Primer3 available on the day of use.” Opp. 12. But deciding which version to use based on the
`
`technology that exists on any given day would create even more confusion about whether a
`
`competitor’s product infringes and create a ridiculous burden on citizens attempting to figure out
`
`if and when they infringe. A product that does not infringe on one day might infringe the next day
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`because the “primer melting temperature has changed” due to updates to the Primer3 software—
`
`and then it might not infringe the following day as the software is updated yet again. Trial Tr.
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`799:17–800:6. Natera does not address this argument at all.
`
`Natera also contends “the Primer3 version available as of 2014 incorporated the Owczarzy
`
`method.” Opp. 12. But this argument only highlights the lack of clarity in the ’708 Patent. The
`
`’708 Patent indicates Primer3 should sometimes be used without specifying whether to use the
`
`2014 version of Primer3 (which purportedly incorporated the Owczarzy method), the current
`
`version of Primer3, or some other version. The patent is invalid for indefiniteness.
`
`IV.
`
`The Accused Products Do Not Infringe The ’172 And ’220 Patents
`
`Natera has also failed to show the accused products infringe the ’172 and ’220 Patents.
`
`First, Natera argues the accused products infringe the ’172 Patent because Archer said it used “the
`
`same ‘P5 primer’” in the first and second PCR steps in its “submission to the FDA.” Opp. 13. But
`
`Archer’s FDA submission, while accurate, was never intended to show every detail of its products.
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`And the FDA submission does not change the undisputed fact that the P5_1 and P5_2 primers are,
`
`in fact, different—as Natera’s own expert acknowledged. Trial Tr. 532:25–534:1.
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`
`
`6
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 11 of 16 PageID #: 64697
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`As to the doctrine of equivalents, Natera admits the specification discloses an alternative
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`in which “the primer pairs used in the first and second round of PCR … are different,” but insists
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`“[a] generic statement” such as that is “insufficient” under the disclosure-dedication rule. Opp.
`
`13–14. Yet the rule’s applicability does not turn on whether a patent discloses, but leaves
`
`unclaimed, the precise accused embodiments. The rule only requires that one “understand the
`
`unclaimed disclosed teaching upon reading the written description.” PSC Comput. Prods., Inc. v.
`
`Foxconn Int’l, 355 F.3d 1353, 1360 (Fed. Cir. 2004). Here, there is no dispute the specification
`
`discloses non-identical primers in consecutive PCRs. JTX3 at 7:19–20; Trial Tr. 728:2–729:10.
`
`Natera also argues the doctrine of equivalents applies because Dr. Quackenbush said the
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`P5_1 and P5_2 primers “carry[] out exactly the same function.” Opp. 14. But when asked whether
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`the primers were the same, Dr. Quackenbush compared them to “a claw hammer and a ball peen
`
`hammer.” Trial Tr. 532:25–534:1. A claw hammer and a ball peen hammer are both hammers
`
`and may perform overlapping functions, but that does not mean they are the same. Likewise, the
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`P5_1 and P5_2 primers are both primers, but they are not the same. Id. at 725:22–726:8.
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`Second, the Court erred in excluding evidence concerning the construction of “target loci.”
`
`Natera argues the evidence would “risk confusion to the jury.” Opp. 14. But the Court already
`
`held “the segments containing the target loci must be selected from a single individual.” D.I. 243
`
`at 5. And Archer sought to question Dr. Quackenbush about how “the court has construed ‘target
`
`loci’ to be limited to the genetic loci of a [single] individual.” D.I. 669-1. That testimony was
`
`highly probative because it would have demonstrated the accused products did not infringe the
`
`patents. See D.I. 430 at 11–13. And any risk of prejudice to Natera did not substantially outweigh
`
`that probative value under FRE 403. Thus, the Court erred in excluding the testimony.
`
`V.
`
`Archer’s PCM Product Is Covered By The Safe Harbor
`
`Overwhelming record evidence showed Archer’s PCM product is protected by the safe
`
`
`
`7
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`

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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 12 of 16 PageID #: 64698
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`harbor. Natera attempts to undermine that evidence by pointing to Mr. Wojcik’s conjecture about
`
`the purpose of the clinical studies. Opp. 15–16. But Natera does not dispute Mr. Wojcik lacked
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`first-hand knowledge of whether Archer had “a reasonable basis for believing” the studies “might
`
`yield information that would be appropriate to include in a submission to the FDA.” Momenta
`
`Pharms., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348, 1356–57 (Fed. Cir. 2012).
`
`Natera contends Dr. Daber “had no relevant personal knowledge” because he “was not
`
`involved in the FDA submissions and he was working at a different company” when Archer
`
`entered agreements with AstraZeneca and Bristol Myers Squibb. Opp. 15. But Dr. Daber was “a
`
`cofounder of Genosity,” and “each and every test for … Archer’s PCM sales to AstraZeneca and
`
`BMS are run from the laboratory at Genosity.” Trial Tr. 977:4–18. It is only logical that Dr. Daber
`
`knew the purpose of the tests he oversaw as part of those studies. Indeed, he testified the studies
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`sought to “develop … a companion diagnostic” and were “related to seeking regulatory approval.”
`
`Id. at 964:2–965:1. And contrary to Mr. Wojcik’s outsider view, Dr. Daber testified “there was a
`
`design history file” for the AstraZeneca study, and the reason “there was not a design history file
`
`for BMS” was because Archer was “in the early feasibility stages.” Id. at 965:22–966:4.
`
` Natera also speculates “the jury may have discredited [Dr. Daber’s] testimony given that
`
`Dr. Daber conceded that the end goal was no longer happening.” Opp. 16. But the mere fact that
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`Invitae later called off some of its studies with AstraZeneca does not change the fact that the studies
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`originally related to seeking FDA approval. Trial Tr. 964:2–965:1. In sum, the jury erred by
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`ignoring the only relevant evidence and rejecting Archer’s safe harbor defense.
`
`VI.
`
`The ’220 And ’172 Patents Do Not Have Written Description Support
`
`Archer has also demonstrated that the ’220 and ’172 Patents are invalid because the claims
`
`have no written description support. First, Natera admits the alleged inventions are directed at
`
`designing primers in a way that “reduces the number of potential interactions between primers.”
`
`
`
`8
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 13 of 16 PageID #: 64699
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`Opp. 17. Natera attempts to recast this alleged invention as “a workflow.” Id. But Dr. Zimmerman
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`testified that the claims do “not state a specific way of reducing primer dimers.” Trial Tr. 402:21–
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`24. Thus, the patents do not adequately describe the “workflow” Natera claims to have invented.
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`See, e.g., Arthrex, Inc. v. Smith & Nephew, Inc., 35 F.4th 1328, 1342–44 (Fed. Cir. 2022).
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`Second, Natera contends the ’220 and ’172 Patents disclose the elements of the claims as
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`a whole because Natera’s expert, Dr. Spellman, supposedly “explained in detail that the ’235 patent
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`application (to which the ’172 and ’220 Patent[s] claim priority) describes the claimed workflow.”
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`Opp. 18. But Dr. Spellman identified only “isolated disclosure of merely one element” at a time,
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`and each disclosure was “out of context, not arranged as it is in the claim.” Trial Tr. 762:2–765:16.
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`Indeed, Dr. Spellman’s own citations show that the components of the claims were scattered all
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`over the patent applications—not in one cohesive whole. See PDX5-4–PDX5-13.
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`VII. The ’220 And ’172 Patents Are Unenforceable Due To Prosecution Laches
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`Archer has shown that the ’220 and ’172 Patents are unenforceable due to prosecution
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`laches. Natera claims Archer’s Rule 52(b) motion does not satisfy the applicable standard, but
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`incorrectly applies the standard for a Rule 59(e) motion. Opp. 18–19 (quoting North River Ins., a
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`case involving a motion under FRCP 59(e)). Under FRCP 52(b), a party may “ask the court to
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`correct, on the non-jury record before it, any errors of law, mistakes of fact or oversights that
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`require correction.” U.S. Gypsum Co. v. Schiavo Bros., 668 F.2d 172, 180 (3d Cir. 1981).
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`Here, as in Sonos, Inc. v. Google LLC, 2023 WL 6542320 (N.D. Cal. Oct. 6, 2023),
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`Natera’s years-long prosecution delay was unreasonable and unexplained, and Archer suffered
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`prejudice as a result. Natera argues Sonos is distinguishable because Archer “never informed
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`Natera about its plan for LiquidPlex, STRATAFIDE or PCM.” Opp. 19. But the record shows
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`Natera was aware of Archer’s product design at least as early as 2014. D.I. 642 ¶¶ 1–13. Natera
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`also seeks to distinguish Sonos because “the earlier specification did not disclose the claimed
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 14 of 16 PageID #: 64700
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`invention” in that case. Opp. 19. But that is true here as well. The applications Natera relied on
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`for priority involved analyzing the genes of gestating fetuses, and did not make clear that Natera
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`would later seek claims directed to nested PCR on cell-free DNA for cancer testing. JTX73;
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`JTX83. Natera further notes that “Sonos failed to provide any explanation for the timing of its
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`patent claims.” Opp. 19. That is also the case here. Dr. Rabinowitz testified that the reason for
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`the delay was “a legal question” and Natera “kind of leave[s] it to the lawyers to determine the
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`claims.” Laches Trial Tr. 72:10–73:16. But no Natera lawyer testified to explain the delay. Thus,
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`just as Judge Alsup did in Sonos, this Court should find the patents unenforceable.
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`VIII. In The Alternative, The Court Should Order A New Trial Or Remittitur Of Damages
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`The verdict in this case “cries out to be overturned,” and “a miscarriages of justice would
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`result if the verdict were to stand.” Williamson v. Consol. Rail Corp., 926 F.2d 1344, 1352–53
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`(3d Cir. 1991). First, the Court improperly instructed the jury on the legal standard for foreign
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`sales. Natera contends “[t]he jury instruction reflects the current binding law.” Opp. 20. But
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`binding precedent requires more than “some domestic activity” to recover for foreign sales.
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`Morrison, 561 U.S. at 266. Here, the record showed at most “a tangential relationship between
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`the infringement asserted” and the sales abroad. Qiagen, 2021 WL 3857460, at *2 n.8.
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`Second, the damages award was excessive because it included royalties on sales of non-
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`PCM kits for customer use that did not infringe the patents and on foreign sales. Acknowledging
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`that reality, Natera includes a remittitur request itself. Opp. 7 n.3. And Natera’s assertion that the
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`award “is well-supported by evidence” (Opp. 20) ignores the fact that the jury awarded damages
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`for non-infringing sales. At a minimum, the Court should order a new trial with remittitur.
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`CONCLUSION
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`For these reasons and those stated in the motion, the Court should enter judgment as a
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`matter of law in Archer’s favor, or in the alternative, order a new trial with remittitur.
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`10
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 15 of 16 PageID #: 64701
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`Dated: December 4, 2023
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`Respectfully submitted,
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`
`
`FARNAN LLP
`
`/s/ Brian E. 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
`
`Edward R. Reines (admitted pro hac vice)
`Derek C. Walter (admitted pro hac vice)
`Karnik F. Hajjar (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
`karnik.hajjar@weil.com
`
`Elizabeth Y. Ryan (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`200 Crescent Court, Suite 300
`Dallas, TX 75201
`Tel: (214) 746-7700
`liz.ryan@weil.com
`
`Aaron J. Curtis (admitted pro hac vice)
`Kathryn Leicht (admitted pro hac vice)
`Barry Zhang (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`Tel: (212) 310-8000
`aaron.curtis@weil.com
`kathryn.leicht@weil.com
`barry.zhang@weil.com
`
`Matthew D. Sieger (admitted pro hac vice)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street, NW, Suite 600,
`
`
`
`11
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`Case 1:20-cv-00125-GBW Document 680 Filed 12/04/23 Page 16 of 16 PageID #: 64702
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`
`Washington, DC 20036
`Tel: (202) 682-7000
`matthew.sieger@weil.com
`
`Attorneys for Invitae Corp., ArcherDX, Inc. and
`ArcherDX, LLC
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`
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`12
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