Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 1 of 9 PageID #: 6783
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`)
`)
`)
`
`))
`
`
`) C.A. No. 22-252-MSG
`)
`REDACTED - PUBLIC VERSION
`
`))
`
`)
`
`))
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Counterclaim-Plaintiffs,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`JOINT APPENDIX TO CLAIM CONSTRUCTION BRIEF
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No. 6779)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`
`Attorneys for Plaintiffs
`
`Jack B. Blumenfeld (No. 1014)
`Brian P. Egan (No. 6227)
`Travis J. Murray (No. 6882)
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Patricia A. Carson
`Jeanna M. Wacker
`Mark C. McLennan
`Nancy Kaye Horstman
`Caitlin Dean
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`
`

`

`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 2 of 9 PageID #: 6784
`
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street 47th Floor
`Boston, MA 0211
`(617) 385 -7500
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`
`Attorneys for Defendants
`
`David I. Berl
`Adam D. Harber
`Thomas S. Fletcher
`Shaun P. Mahaffy
`Jessica Palmer Ryen
`Anthony H. Sheh
`Jihad J. Komis
`Philip N. Haunschild
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`(202) 434-5000
`
`Attorneys for Plaintiff Genevant
`Sciences GmbH
`
`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Annie A. Lee
`Shaelyn K. Dawson
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-6080
`
`Kira A. Davis
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`(213) 892-5200
`
`David N. Tan
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`(202) 887-1500
`
`Attorneys for Plaintiff Arbutus
`Biopharma Corporation
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 3 of 9 PageID #: 6785
`
`JOINT APPENDIX TABLE OF CONTENTS
`
`J.A. #
`
`Reference
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`Page Range
`(JA00)
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`1
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`2
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`3
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`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`U.S. Patent No. 8,058,069 (“the ’069 patent”)
`
`U.S. Patent No. 8,492,359 (“the ’359 patent”)
`
`U.S. Patent No. 8,822,668 (“the ’668 patent”)
`
`U.S. Patent No. 9,364,435 (“the ’435 patent”)
`
`U.S. Patent No. 9,504,651 (“the ’651 patent”)
`
`U.S. Patent No. 11,141,378 (“the ’378 patent”)
`
`Declaration of Professor David H. Thompson Ph.D. Regarding Claim
`Construction
`
`’069 Patent File History, Jan. 31, 2011 Reply to Office Action
`
`’069 Patent File History, May 12, 2011 Non-Final Rejection
`
`10
`
`’069 Patent File History, Aug. 11, 2011 Response
`
`11
`
`12
`
`’069 Patent File History, Sept. 12, 2011 Notice of Allowance
`
`’378 Patent File History, Apr. 14, 2021 Claims (excerpt)
`
`13
`
`’378 Patent File History, June 14, 2021 Non-Final Rejection
`
`14
`
`’378 Patent File History, Aug. 20, 2021 Response
`
`15
`
`’651 Patent File History, Aug. 14, 2014 Non-Final Rejection
`
`16
`
`’651 Patent File History, Oct. 22, 2014 Response & Declaration
`
`17
`
`’651 Patent File History, Jan. 5, 2015 Third Party Submission
`
`3
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`JA00595
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`JA00600
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`

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`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 4 of 9 PageID #: 6786
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`Reference
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`Page Range
`(JA00)
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`J.A. #
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`18
`
`19
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`’651 Patent File History, Feb. 13, 2015 Non-Final Rejection
`
`’651 Patent File History, May 12, 2015 Response & Declaration
`
`JA00601 -
`JA00616
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`JA00617 -
`JA00632
`
`JA00633 -
`JA00651
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`JA00652 -
`JA00663
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`JA00664 -
`JA00673
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`JA00696
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`JA00708
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`JA00725 -
`JA00776
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`JA00870 -
`JA00903
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`JA00904 -
`JA00942
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`JA00943 -
`JA00945
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`JA00946 -
`JA00951
`
`20
`
`’651 Patent File History, June 19, 2015 Final Rejection
`
`21
`
`’651 Patent File History, Aug. 18, 2015 Response
`
`22
`
`’651 Patent File History, Oct. 9, 2015 Non-Final Rejection
`
`23
`
`’651 Patent File History, Dec. 14, 2015 Response & Declaration
`
`24
`
`’651 Patent File History, Apr. 15, 2016 Rejection
`
`25
`
`’651 Patent File History, May 19, 2016 Response & Declaration
`
`26
`
`’651 Patent File History, Oct. 3, 2016 Rejection
`
`27
`
`’651 Patent File History, Oct. 19, 2016 Notice of Allowance (“NOA”)
`
`’435 Patent Final Written Decision, IPR2018-00739, Paper No. 51
`(P.T.A.B. Sept. 11, 2019)
`
`28
`
`29
`
`30
`
`31
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`Declaration of David H. Thompson, Ph.D., IPR2018-00739, Exhibit No.
`2009 (“Thompson ’435 IPR Decl.”)
`
`JA00777 -
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`Moderna Initial Invalidity Contentions (May 19, 2023) (excerpt)
`(“Invalidity Contentions”) [Moderna Confidential Information Redacted]
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`I. MacLachlan, Liposomal Formulations for Nucleic Acid Delivery,
`Antisense Drug Techs. (2d ed. 2007) (“MacLachlan 2007”)
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`U.S. Patent No. 5,830,430 (“Unger”)
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`33
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`34
`
`E. Check, RNA to the rescue?, Nature, vol. 425, pp. 10-12 (2003)
`(“Check 2003”)
`
`B. Sternberg et al., New structures in complex formation between DNA
`and cationic liposomes visualized by freeze-fracture electron
`microscopy, FEBS Letters, vol. 356, pp. 361-66 (1994) (“Sternberg
`1994”)
`
`4
`
`

`

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`J. A. Kulkarni et al., On the Formation and Morphology of Lipid
`Nanoparticles Containing Ionizable Cationic Lipids and siRNA, ACS
`Nano, vol. 12, pp. 4787-95 (2018) (“Kulkarni 2018”)
`
`Michael D. Buschmann et al., Nanomaterial Delivery Systems for mRNA
`Vaccines, Vaccines (Basel), vol. 9, no. 65 pp. 1-30 (Jan. 19, 2021)
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`JA001488
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`U.S. Patent No. 7,901,708 (“the ’708 Patent”)
`
`54
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`European Patent No. 2 279 254 (“EP2279254”)
`
`55
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`’069 Patent File History, Apr. 15, 2009 Claims
`
`56
`
`’069 Patent File History, Nov. 12, 2009 Claims
`
`57
`
`’069 Patent File History, June 1, 2010 Claims
`
`58
`
`’069 Patent File History, July 30, 2010 Non-Final Rejection
`
`59
`
`’359 Patent File History, Oct, 5, 2011 Claims
`
`60
`
`’359 Patent File History, Mar. 28, 2012 Claims
`
`61
`
`’435 Patent File History, Aug. 18, 2014 Claims
`
`62
`
`’435 Patent File History, Feb. 26, 2015 Claims
`
`63
`
`’668 Patent File History, June 26, 2013 Claims
`
`64
`
`’668 Patent File History, Nov. 6, 2013 Claims
`
`65
`
`66
`
`Patent Owner’s Response, IPR2019-00554, Paper 15 (P.T.A.B. Nov. 31,
`2019)
`
`JA002284 -
`JA002357
`
`Patent Owner’s Sur-Reply, IPR2019-00554, Paper 30 (P.T.A.B. Mar. 31,
`2020)
`
`JA002358 -
`JA002391
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`6
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`

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`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 7 of 9 PageID #: 6789
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`(JA00)
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`67
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`68
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`69
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`71
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`72
`
`73
`
`74
`
`75
`
`76
`
`77
`
`78
`
`79
`
`80
`
`Declaration of David H. Thompson, Ph.D., IPR2019-00554, Exhibit No.
`2004 (“Thompson Decl”)
`
`JA002392 -
`JA002479
`
`Patent Owner’s Response, IPR2018-00739, Paper 24 (P.T.A.B. Dec. 21,
`2018)
`
`Record of Oral Hearing, IPR2018-00680 & IPR2018-00739, Paper 49
`(P.T.A.B. June 6, 2019)
`
`Declaration of Andrew S. Janoff, Ph.D., IPR2018-00739, Exhibit No.
`1007
`
`Liposome Drug Products, FDA Guidance for Industry, IPR2018-00739,
`Exhibit No. 2013
`
`Nonconfidential Opening Brief of Cross-Appellant Protiva
`Biotherapeutics, Inc. (ModernaTX, Inc. v. Protiva Biotherapeutics, Inc.,
`No. 2020-1184 (Fed. Cir. July 28, 2020) (D.I. 67))
`
`Reply Brief of Cross-Appellant Protive Biotherapeutics, Inc.
`(ModernaTX, Inc. v. Protiva Biotherapeutics, Inc., No. 2020-1184 (Fed.
`Cir. Nov. 9, 2020) (D.I. 83))
`
`Unofficial Transcript, Oral Argument (ModernaTX, Inc. v. Protiva
`Biotherapeutics, Inc., No. 2020-1184 (Fed. Cir. Oct. 7, 2021), argument
`available at https://oralarguments.cafc.uscourts.gov/default.aspx?fl=20-
`1184_10072021.mp3
`
`Decision (ModernaTX, Inc. v. Protiva Biotherapeutics, Inc., No. 2020-
`1184 (Fed. Cir. Dec. 1, 2021) (D.I.135))
`
`Protive Biotherapeutics Inc.’s Response to Oppositions by Merck, Sharp
`& Dohme Corp. and Moderna TX, Inc. Regarding EP No. 2 279 254
`(Sept. 3, 2018)
`
`ModernaTX, Inc., 3.2.S.2.2 Description of Manufacturing Process and
`Process Controls (BLA No. 125752) (MRNA-GEN-00034354)
`
`Moderna Therapeutics Press Release, Moderna Announces $40 Million
`in Financing to Advance Development of New Biotherapeutic Modality:
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`https://www.prnewswire.com/news-releases/moderna-announces-40-
`million-in-financing-to-advance-development-of-new-biotherapeutic-
`modality-messenger-rna-therapeutics-182304241.html
`
`JA002480 -
`JA002551
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`JA002684
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`JA002996
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`Patent Owner’s Sur-Reply, IPR2018-00739, Paper 34 (P.T.A.B. Apr. 17,
`2019)
`
`JA002997 -
`JA003041
`
`Summary table listing the Molar Ratio Patents and related IPR
`proceedings.
`
`JA003042
`
`7
`
`

`

`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 8 of 9 PageID #: 6790
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`J.A. #
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`81
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`
`Moderna Experimental Report, DH-07346 (MRNA-GEN-00044173–
`MRNA-GEN-00044182)
`
`Petitioner’s Reply to Protiva’s Response, IPR2019-00554, Paper 21
`(P.T.A.B. Mar. 2, 2020)
`
`Petition for Inter Partes Review of U.S. Patent No. 8,058,069, IPR2019-
`00554, Paper 1 (P.T.A.B. Jan. 9, 2019)
`
`Declaration of Andrew S. Janoff, Ph.D., IPR2019-00554, Exhibit No.
`1008 (P.T.A.B. Jan 2, 2019)
`
`Declaration of Thomas J. Anchordoquy, Ph.D., IPR2019-00554, Exhibit
`No. 1020 (P.T.A.B. Mar. 2, 2020)
`
`Arbutus Biopharma Corp.’s observations on behalf of Opponent-
`Appellant 2, Appeal No. T0505/20-3.3.08 (Munich, Mar. 22, 2022)
`
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`279 254 (Munich, Apr. 5, 2018)
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`(Jan. 15, 2020) (excerpt)
`
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`/s/ Nathan R. Hoeschen
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No. 6779)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`Attorneys for Plaintiffs
`
`/s/ Travis J. Murray
`Jack B. Blumenfeld (No. 1014)
`Brian P. Egan (No. 6227)
`Travis J. Murray (No. 6882)
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`Attorneys for Defendants
`
`8
`
`

`

`Case 1:22-cv-00252-MSG Document 181 Filed 01/03/24 Page 9 of 9 PageID #: 6791
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on December 20, 2023, this document was served on the persons
`
`listed below in the manner indicated:
`
`BY EMAIL:
`Jack B. Blumenfeld
`Brian P. Egan
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`James F. Hurst
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`(312) 862-2000
`james.hurst@kirkland.com
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`alina.afinogenova@kirkland.com
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker
`Mark C. McLennan
`Nancy Kaye Horstman
`Shaoyao Yu
`Caitlin Dean
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`patricia.carson@kirkland.com
`jeanna.wacker@kirkland.com
`mark.mclennan@kirkland.com
`kaye.horstman@kirkland.com
`shaoyao.yu@kirkland.com
`caitlin.dean@kirkland.com
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`yanxin.li@kirkland.com
`
`/s/ Nathan R. Hoeschen
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`Emily S. DiBenedetto (No. 6779)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`edibenedetto@shawkeller.com
`Attorneys for Plaintiffs
`
`9
`
`