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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`HIKMA PHARMACEUTICALS USA INC.,
`HIKMA PHARMACEUTICALS PLC,
`Petitioner,
`
`v.
`
`AMARIN PHARMACEUTICALS IRELAND LIMITED,
`Patent Owner.
`
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
`
`JOINT MOTION TO TERMINATE
`UNDER 35 U.S.C. § 317
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`Case IPR2022-00215
`Patent 8,642,077 B2
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`PETITIONER’S UPDATED EXHIBIT LIST
`Description
`U.S. Patent No. 8,642,077 B2 to Manku et al. (the “ʼ077 patent”)
`
`No.
`1001
`1002
`Expert Declaration of Edward A. Fisher, M.D., Ph.D., M.P.H.
`1003 WO 2007/142118 to Yokoyama et al. (2007) (certified English
`translation) (“Yokoyama I”)
`
`1004
`
`Trevor A. Mori et al., Purified Eicosapentaenoic and
`Docosahexaenoic Acids Have Differential Effects on Serum Lipids
`and Lipoproteins, LDL Particle Size, Glucose, and Insulin in Mildly
`Hyperlipidemic Men, 71 Am. J. Clinical Nutri. 1085 (2000) (“Mori”)
`1005 Mitsuhiro Yokoyama et al., Effects of Eicosapentaenoic Acid on
`Major Coronary Events in Hypercholesterolaemic Patients (JELIS):
`a Randomized Open- Label, Blinded Endpoint Analysis, 369 Lancet
`1090 (2007) (“Yokoyama II”)
`
`1006
`
`1007
`
`1008
`
`1009
`
`Noriko Satoh et al., Purified Eicosapentaenoic Acid Reduces Small
`Dense LDL, Remnant Lipoprotein Particles, and C-Reactive Protein
`in Metabolic Syndrome, 30 Diabetes Care 144 (2007) (“Satoh”)
`
`Sameline Grimsgaard et al., Highly Purified Eicosapentaenoic Acid
`and Docosahexaenoic Acid in Humans Have Similar
`Triacylglycerol-Lowering Effects but Divergent Effects on Serum
`Fatty Acids, 66 Am. J. Clinical Nutri. 649 (1997) (“Grimsgaard”)
`
`Third Report of the National Cholesterol Education Program
`(NCEP) Expert Panel on Detection, Evaluation, and Treatment of
`High Blood Cholesterol in Adults (Adult Treatment Panel 111) Final
`Report, 106 Circulation 3143 (2002) (“ATP-III”)
`
`Plaintiffs’ Corrected Post-Trial Proposed Findings of Fact and
`Conclusions of Law (Feb. 27, 2020) from Amarin Pharma, Inc. v.
`Hikma Pharm. USA Inc., No. 16-2525, D.I. 377, ¶ 510 (D. Nev.)
`(“Amarin FFCL”)
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`
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`- i -
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`
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`No.
`1010
`
`Description
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
`
`Day 2 (Jan. 14, 2020) Trial Transcript from Amarin Pharma, Inc. v.
`Hikma Pharm. USA Inc., No. 16-2525 (D. Nev.) (Testimony of Dr.
`Budoff) (“Bufoff Tr.”)
`1011 Margaret Carroll, et al., Serum Lipids of Adults 20–74 Years: United
`States, 1976–80, Nat’l Ctr for Health Statistics, Vital & Health
`Statistics, 11(242) (1993) (“Nat’l Health Survey”)
`
`1012
`
`1013
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`Hartmut H-J Schmidt et al., Lipid Evaluation in HIV-1-Positive
`Patients Treated with Protease Inhibitors, 4 Antiviral Ther. 163
`(1999) (“Schmidt”)
`
`Expert Declaration of Sylvia Hall-Ellis, Ph.D.
`
`Lovaza®, Physicians’ Desk Reference 2699 (62d ed. 2007) (“Lovaza
`PDR”)
`
`Shuichi Nozaki et al., Effects of Purified Eicosapentaenoic Acid
`Ethyl Ester on Plasma Lipoproteins in Primary
`Hypercholesterolemia, 62 Int’l J. Vitamin & Nutr. Res. 256(1992)
`(“Nozaki”)
`
`Koji Shinozaki et al., The Long-Term Effect of Eicosapentaenoic
`Acid on Serum Levels of Lipoprotein (a) and Lipids in Patients with
`Vascular Disease, 2(2) J. Atheroscl. Thromb. 107 (1996)
`(“Shinozaki”)
`
`Joint Stipulations of Fact from Amarin Pharma, Inc. v. Hikma
`Pharm. USA Inc., No. 16-2525, D.I. 324 (D. Nev.)
`
`Day 7 (Jan. 28, 2020) Trial Transcript from Amarin Pharma, Inc. v.
`Hikma Pharm. USA Inc., No. 16-2525 (D. Nev.) (Testimony of Dr.
`Toth) (“Toth Tr.”)
`
`Plaintiffs’ Validity Contentions from Amarin Pharma, Inc. v. Hikma
`Pharm. USA Inc., No. 16-2525 (D. Nev.)
`
`Plaintiffs’ Infringement Contentions from Amarin Pharma, Inc. et al.
`v. Hikma Pharm. USA Inc. et al., C.A. No. 20-1630 (D. Del.)
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`- ii -
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`No.
`1021
`
`1022
`
`1023
`
`1024
`
`Description
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`Plaintiffs’ Opposition to Motion to Dismiss from Amarin Pharma,
`Inc. et al. v. Hikma Pharm. USA Inc. et al., C.A. No. 20-1630 (D.
`Del.)
`
`Plaintiffs’ First Amended Complaint from Amarin Pharma, Inc. et
`al. v. Hikma Pharm. USA Inc. et al., C.A. No. 20-1630, D.I. 17 (D.
`Del.) (“Complaint”)
`
`Exhibit U to Plaintiffs’ First Amended Complaint from Amarin
`Pharma, Inc. et al. v. Hikma Pharm. USA Inc. et al., C.A. No. 20-
`1630, D.I. 17-22 (D. Del.) (Christie Ballantyne et al., Efficacy and
`Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in
`Statin-Treated Patients with Persistent High Triglycerides, Am. J.
`Cardiol. 1 (2012)) (“Ballantyne”)
`
`Exhibit V to Plaintiffs’ First Amended Complaint from Amarin
`Pharma, Inc. et al. v. Hikma Pharm. USA Inc. et al., C.A. No. 20-
`1630, D.I. 17-23 (D. Del.) (Deepak L. Bhatt et al., Cardiovascular
`Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia, 380
`N. Engl. J. Med. 11 (2018)) (“Bhatt”)
`
`1025
`
`Amarin Response to U.S. Patent Office re U.S. Patent Application
`No. 13/768,906 (Aug. 26, 2013)
`1026 Michael H. Davidson et al., Efficacy and Tolerability of Adding
`Prescription Omega-3 Fatty Acids 4 g/d to Simvastatin 40 mg/d in
`Hypertriglyceridemic Patients: An 8-Week, Randomized, Double-
`Blind, Placebo-Controlled Study, 29 Clin. Therapeutics 1354 (2007)
`(“Davidson”)
`
`1027
`
`Yasushi Saito et al., Effects of EPA on Coronary Artery Disease in
`Hypercholesterolemic Patients with Multiple Risk Factors: Sub-
`Analysis of Primary Prevention Cases from the Japan EPA Lipid
`Intervention Study (JELIS), 200 Atherosclerosis 135 (2008) (“Saito”)
`
`1028
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`Notice of Allowability from U.S. Patent Office re U.S. Patent
`Application No. 13/768,906 (Sept. 30, 2013)
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`- iii -
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`Description
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`FDA Briefing Document, Endocrinologic and Metabolic Drugs,
`Advisory Committee Meeting regarding ANCHOR trial (Oct. 16,
`2013)
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`U.S. Patent Office Interview Summary re U.S. Patent Application
`No. 13/614,111 (Dec. 12, 2012)
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`Amarin Supplemental Response to U.S. Patent Office re U.S. Patent
`Application No. 13/614,111 (Jan. 11, 2013)
`
`Notice of Allowability from U.S. Patent Office re U.S. Patent
`Application No. 13/614,111 (Feb. 11, 2013)
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`No.
`1029
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`1030
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`1031
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`1032
`
`1033
`Vascepa® Label (rev. Dec. 2019)
`1034 World Health Organization Memorandum, Classification of
`Hyperlipoproteinemias and Hyperlipoproteinemias, 43 Circulation
`501 (1972) (“WHO Memo”)
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`1035
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`1036
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`1037
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`1038
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`1039
`1040
`1041
`1042
`1043
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`Declaration of C. Rosebraugh from Amarin Pharma, Inc. et al. v.
`U.S. F.D.A. et al., No. 15-3588, D.I. 54 (S.D.N.Y.)
`
`Scheduling Order from Amarin Pharma, Inc. et al. v. Hikma Pharm.
`USA Inc. et al., C.A. No. 20-1630, D.I. 50 (D. Del.)
`
`Hikma’s Motion to Dismiss from Amarin Pharma, Inc. et al. v.
`Hikma Pharm. USA Inc. et al., C.A. No. 20-1630, D.I. 19 (D. Del.)
`
`Office Action from U.S. Patent Office re U.S. Patent Application No.
`13/768,906 (May 24, 2013)
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`Original Japanese version of WO 2007/142118 to Yokoyama et al.
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`U.S. Patent No. 6,384,077 to Peet et al.
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`U.S. Patent No. 6,479,544 to Horrobin
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`U.S. Patent No. 7,119,118 to Peet et al.
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`Amarin Reports Fourth Quarter and Full Year 2004 Results Report
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`- iv -
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`No.
`1044
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`Description
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`U.S. Patent Application Publication No. 2007/0021504 A1 to
`Yokoyama et al.
`1045 Mitsuhiro Yokoyama et al., Effects of Eicosapentaenoic Acid on
`Cardiovascular Events in Japanese Patients with
`Hypercholesterolemia: Rationale, Design, and Baseline
`Characteristics of the Japan EPA Lipid Intervention Study (JELIS),
`146 Am. Heart J. 613 (2003)
`
`1046
`
`1047
`1048
`1049
`1050
`
`Joint Claim Construction Chart from Amarin Pharma, Inc. et al. v.
`Hikma Pharm. USA Inc. et al., C.A. No. 20-1630, D.I. 94 (D. Del.)
`
`Curriculum vitae of Edward A. Fisher
`
`Lipitor® (atorvastatin calcium) tablets, labeling (rev. Sept. 2007)
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`Crestor® (rosuvastatin calcium) tablets, labeling (rev. Nov. 2007)
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`Confidential Agreement
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`- v -
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`Pursuant to 35 U.S.C. § 317, 37 C.F.R § 42.74, and the authorization
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`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`provided by the Board’s email of March 10, 2022, Petitioner (Hikma
`
`Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC) and Patent Owner
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`(Amarin Pharmaceuticals Ireland Limited) jointly request termination of this
`
`proceeding concerning U.S. Patent No. 8,642,077 (“the ’077 Patent”).
`
`I.
`
`CERTIFICATION
`
`Pursuant to 35 U.S.C. § 317(b) and 37 C.F.R § 42.74(b), the parties’
`
`agreement is in writing, and the parties are submitting as Exhibit 1050 a true and
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`correct copy of the parties’ agreement made in connection with, or in
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`contemplation of, the termination of the proceeding. The parties request that the
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`agreement be treated as business confidential information and be kept separate
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`from the files of this proceeding in accordance with 37 C.F.R. § 42.74(c). A
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`request for treatment of the agreement as confidential business information is being
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`submitted contemporaneously with this joint request to terminate.
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`II.
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`STATUS OF RELATED PROCEEDINGS
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`Petitioner and Patent Owner have resolved their disputes regarding the ’077
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`Patent, including this proceeding and Patent Owner’s assertion of the ’077 Patent
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`against Petitioner in related district court litigation captioned Amarin Pharma, Inc.
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`et al. v. Hikma Pharmaceuticals USA Inc. et al., No. 1:20-cv-01630-RGA-JLH, in
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`the United States District Court for the District of Delaware. The parties have,
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`- 1 -
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`accordingly, agreed to jointly seek termination of this proceeding. The parties do
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`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`not anticipate any further litigation between them concerning the ’077 Patent.
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`III. RELIEF REQUESTED
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`
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`As authorized by the Board, the parties are filing: (i) this joint motion to
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`terminate the proceeding; (ii) a true and correct copy of the parties’ agreement (Ex.
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`1050) made in connection with, or in contemplation of, the requested termination;
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`and (iii) a joint request to treat the agreement as business confidential information
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`and keep it separate from the files of this proceeding under 37 C.F.R. § 42.74(c).
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`Petitioner and Patent Owner jointly request that the Board terminate this
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`proceeding in its entirety. Termination is appropriate at this stage and in view of
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`the agreement between Petitioner and Patent Owner. An inter partes review shall
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`be terminated with respect to any petitioner upon the joint request of the petitioner
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`and the patent owner unless the Office has decided the merits of the proceedings
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`before the request for termination is filed. 35 U.S.C. § 317(a). Good cause exists
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`to terminate this proceeding because (1) Petitioner and Patent Owner have resolved
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`their disputes regarding the ’077 Patent; (2) this proceeding is still at an early stage
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`and the Office has not yet decided the merits, or even whether to institute trial; and
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`(3) terminating now would serve the interests of judicial economy as well as the
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`mutual interest of the parties.
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`Dated: March 10, 2022
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`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: 202-282-5000
`Fax: 202-282-5100
`Email: HikmaIPR@winston.com
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`
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`PERKINS COIE LLP
`110 North Wacker Drive, Suite 3400
`Chicago, Illinois 60606-1511
`Phone: 312-324-8400
`fournier-ptab@perkinscoie.com
`merrill-ptab@perkinscoie.com
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
`
`Respectfully submitted,
`
`
` /Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioner
`
`
`/Kourtney Mueller Merrill/
`Lead Counsel
`David B. Fournier, Reg. No. 51,696
`
`Back-Up Counsel
`Kourtney Mueller Merrill, Reg. No. 58,195
`
`Counsel for Patent Owner
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`- 3 -
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`Case IPR2022-00215
`Patent 8,642,077 B2
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`CERTIFICATE OF COMPLIANCE WITH
`TYPE-VOLUME LIMITATION, TYPEFACE REQUIREMENTS,
`AND TYPE STYLE REQUIREMENTS
`
`This paper complies with the page limitation of 15 pages excluding
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`1.
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`the parts exempted by 37 C.F.R. § 42.24.
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`2.
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`This paper complies with the general format requirements of 37
`
`C.F.R. § 42.6.
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`
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`Dated: March 10, 2022
`
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: 202-282-5000
`Fax: 202-282-5100
`Email: HikmaIPR@winston.com
`
`Respectfully submitted,
`
`
` /Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioner
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that I caused to be
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`
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`served a true and correct copy of the foregoing: JOINT MOTION TO
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`TERMINATE UNDER 35 U.S.C. § 317 and Exhibit 1050 by electronic mail on
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`March 10, 2022, on the following attorneys:
`
`David B. Fournier (fournier-ptab@perkinscoie.com)
`Kourtney Mueller Merrill (merrill-ptab@perkinscoie.com)
`PERKINS COIE LLP
`110 North Wacker Drive, Suite 3400
`Chicago, Illinois 60606-1511
`
`Respectfully submitted,
`
`
` /Jovial Wong/
`Jovial Wong
`Reg. No. 60,115
`
`Lead Counsel for Petitioner
`
`
`
`
`Dated: March 10, 2022
`
`WINSTON & STRAWN LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: 202-282-5000
`Fax: 202-282-5100
`Email: HikmaIPR@winston.com
`
`
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