Case 1:20-cv-01524-VAC Document 48 Filed 08/04/22 Page 1 of 5 PageID #: 990
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No. 20-1524-VAC
`
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`DAIICHI SANKYO, INC., DAIICHI
`SANKYO COMPANY, LIMITED, and
`ASTRAZENECA PHARMACEUTICALS LP,
`
`
`
`
`
`SEAGEN INC.,
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`Plaintiffs,
`
`Defendant.
`
`
`JOINT STATUS REPORT
`
`Pursuant to the Court’s August 1, 2022 Order (D.I. 47), the parties report on the status of
`
`
`
`the above-captioned stayed action, as well as the status of a related action in the Eastern District
`
`of Texas1, Eastern District of Virginia,2 and administrative proceedings regarding the patent at
`
`issue in these cases (“the ’039 patent”). The parties also provide their positions as to how the
`
`case should proceed.
`
`
`
`This Case. On November 13, 2020, Plaintiffs Daiichi Sankyo, Inc. (“Daiichi Sankyo
`
`US”), Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo Japan”), and AstraZeneca Pharmaceuticals LP
`
`(“AstraZeneca US”) filed this action seeking declaratory judgment that the importation into the
`
`United States, manufacture, use, offer for sale, or sale of ENHERTU does not infringe the ’039
`
`patent. D.I. 1. On October 20, 2020 at 12:02 am Eastern Time, Defendant Seagen Inc.
`
`(“Seagen”) filed the Texas case against Daiichi Sankyo Japan for ENHERTU’s infringement of
`
`the ’039 patent. On December 18, 2020, Seagen moved to stay this case to permit the Eastern
`
`
`1 Seagen Inc. v. Daiichi Sankyo Company, Limited, No. 2:20-337 (E.D. Tex.) (“Texas case”).
`2 Daiichi Sankyo, Inc. v. Hirshfeld, No. 1:21-cv-00899 (E.D. Va.) (“Virginia case”).
`1
`
`
`
`

`

`Case 1:20-cv-01524-VAC Document 48 Filed 08/04/22 Page 2 of 5 PageID #: 991
`
`District of Texas to apply the first-to-file rule or otherwise proceed or, in the alternative, to
`
`dismiss this case. See D.I. 10-12, 17-19, 23, 32. Following oral argument on Seagen’s motion,
`
`Judge Stark stayed this case for 90 days. D.I. 34. Seagen asserted that the case should be
`
`dismissed, but Plaintiffs argued that the case should remain stayed, because, among other
`
`reasons, the requested relief would address claims 6-8 of the ’039 patent, which had been
`
`dropped in the Texas case. See D.I. 37, 39, 41. Judge Stark extended the stay through May 4,
`
`2022. D.I. 38, 40, 42. On March 25, 2022, the case was assigned to the Vacant Judgeship and
`
`administratively closed. D.I. 45.
`
`Texas Case. A jury trial before Judge Gilstrap was held from April 4-8, 2022. The jury
`
`returned a verdict of willful infringement, that invalidity was not proven by clear and convincing
`
`evidence, and awarded $41,820,000 in damages. Ex. A. On June 28, 2022, Judge Gilstrap held
`
`a bench trial on Daiichi Sankyo Japan’s equitable defenses of prosecution laches and invalidity
`
`under § 112(b). On July 15, 2022, Judge Gilstrap denied these defenses. On July 19, 2022,
`
`Judge Gilstrap issued Final Judgment. Ex. B. Any Rule 50(b) post-trial motions are due in that
`
`court by August 16, 2022. Fed. R. Civ. P. 50(b). On August 2, 2022, Seagen filed an agreed Bill
`
`of Costs and a motion for a finding of exceptional case and attorney fees. Judge Gilstrap granted
`
`Seagen’s agreed Bill of Costs on August 3, 2022. Ex. C. Motion practice concerning Seagen’s
`
`motion for exceptional case and attorney fees is ongoing.
`
`PTAB Proceedings Regarding the ’039 Patent. On December 23, 2020, Plaintiffs
`
`Daiichi Sankyo US and AstraZeneca US filed a Petition for Post-Grant Review of the ’039
`
`patent (PGR2021-00030), seeking cancellation of claims 1-5, 9, and 10. (D.I. 14.) On January
`
`22, 2021, Daiichi Sankyo US and AstraZeneca US filed another Petition for Post-Grant Review
`
`of the ’039 patent (PGR2021-00042), seeking cancellation of claims 6-8. (D.I. 22.) On June 24,
`
`
`
`2
`
`

`

`Case 1:20-cv-01524-VAC Document 48 Filed 08/04/22 Page 3 of 5 PageID #: 992
`
`2021, the Patent Trial and Appeal Board (“the Board”) denied institution of both petitions. (D.I.
`
`37.) Daiichi Sankyo US and AstraZeneca US filed a rehearing request on July 26, 2021. On
`
`April 7, 2022, before the Texas jury verdict, the Board granted the rehearing request and
`
`instituted Daiichi Sankyo US and AstraZeneca US’s petitions for post-grant review of the ’039
`
`patent. See D.I. 37, 39. Plaintiffs note that institution was granted for reasons “including the
`
`strong merits of Petitioner’s argument that the claims lack enablement.” Ex. D at 3.
`
`On April 20, 2022, Seagen disclaimed claims 6-8 of the ’039 patent. Ex. E. Claims 6-8
`
`had previously been withdrawn by Seagen from the Texas action, but remained pending in the
`
`above-captioned action. (D.I. 37, 39, 41.) On May 11, 2022, Seagen requested the Board enter
`
`adverse judgment under 37 CFR § 42.73 against it as to claims 6-8, the only claims in Daiichi
`
`Sankyo US and AstraZeneca US’s PGR2021-00042 petition. Ex. F. The Board subsequently
`
`granted Seagen’s request. Ex. G.
`
`On April 21, 2022, Seagen filed a request for rehearing of the Board’s decision granting
`
`institution of PGR2021-00030. Ex. H (motion exhibits excluded). The Board granted Seagen’s
`
`rehearing request on July 15, 2022 and again denied institution of PGR2021-00030. Ex. I.
`
`Seagen notes that, in doing so, the Board explained that “continuing with [the PGR proceeding]
`
`would result in duplicative efforts and potentially conflicting results between the district court
`
`and the Board.” Id. at 7. The Board further noted that because the “district court already has
`
`substantially completed its review of the enablement issue, and a jury has determined that the
`
`claims do not lack enablement . . . we cannot conclude that Petitioner’s enablement case is
`
`compelling.” Id. at 6. Daiichi Sankyo US and AstraZeneca US filed a request for rehearing, a
`
`request for review by the Precedential Opinion Panel, and sent a communication regarding
`
`Director review on August 4, 2022 noting, among other things, “the Board’s deference to the
`
`
`
`3
`
`

`

`Case 1:20-cv-01524-VAC Document 48 Filed 08/04/22 Page 4 of 5 PageID #: 993
`
`jury’s validity finding and treatment of the ‘compelling evidence of unpatentability’ standard in
`
`view of Director Vidal’s guidance.” Ex. J; Ex. K; Ex. L.
`
`
`
`Virginia Case. On July 22, 2022, Plaintiffs Daiichi Sankyo US and AstraZeneca US
`
`(“Virginia Plaintiffs”) filed a status report in the Virginia case, where Virginia Plaintiffs have
`
`filed suit challenging the NHK-Fintiv rule under the Administrative Procedure Act as arbitrary
`
`and capricious. Ex. M.
`
`
`
`Parties’ Positions.
`
`Plaintiffs’ position: In this action, Plaintiffs assert, among other things, that they are
`
`entitled to judgment in their favor as to claims 6-8 of the patent-in-suit. In light of the foregoing,
`
`Plaintiffs respectfully submit that the case should remain stayed, for another 90 days to permit a
`
`further joint report as to the status of the Texas action, the PGR proceedings, and the Virginia
`
`action.
`
`Defendant’s position: Seagen requests that this case be dismissed in light of the
`
`disclaimer of claims 6-8—the only claims not overlapping with the Texas case.
`
`
`
`4
`
`

`

`Case 1:20-cv-01524-VAC Document 48 Filed 08/04/22 Page 5 of 5 PageID #: 994
`
`ASHBY & GEDDES
`
`
`/s/ Andrew C. Mayo
`
`
`
`
`Steven J. Balick (No. 2114)
`Andrew C. Mayo (No. 5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-1888
`sbalick@ashbygeddes.com
`amayo@ashbygeddes.com
`
`Attorneys for Plaintiffs Daiichi
`Sankyo, Inc. and Daiichi
`Sankyo Company, Limited
`
`
`MCCARTER & ENGLISH, LLP
`
`/s/ Alexandra M. Joyce
`
`
`
`
`Daniel M. Silver (No. 4758)
`Alexandra M. Joyce (No. 6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiff
`AstraZeneca Pharmaceuticals LP
`
`Dated: August 4, 2022
`
`
`
`
`
`
`
`29633314.1
`
`
`
`
`
`
`
`YOUNG CONAWAY STARGATT
`& TAYLOR, LLP
`
`/s/ Samantha G. Wilson
`
`
`
`
`Anne Shea Gaza (No. 4093)
`Samantha G. Wilson (No. 5816)
`Rodney Square
`1000 North King Street
`Wilmington, Delaware 19801
`(302) 571-6600
`agaza@ycst.com
`swilson@ycst.com
`
`Attorneys for Defendant
`
`
`
`5
`
`