Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 1 of 96 PageID #: 6687
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`)
`)
`)
`
`))
`
`
`) C.A. No. 22-252-MSG
`)
`
`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 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 180 Filed 01/03/24 Page 2 of 96 PageID #: 6688
`
`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
`
`Dated: December 20, 2023
`
`
`
`ii
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 3 of 96 PageID #: 6689
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`IV.
`
`PLAINTIFFS’ INTRODUCTION.......................................................................................1
`
`MODERNA’S INTRODUCTION.......................................................................................2
`
`PLAINTIFFS’ INTRODUCTION IN REPLY....................................................................4
`
`DISPUTED TERMS............................................................................................................5
`
`A.
`
`“mol % of the total lipid present in the particle” .....................................................5
`
`1.
`
`Plaintiffs’ Opening Position.........................................................................5
`
`a.
`
`b.
`
`Moderna’s construction impermissibly adds the word
`“finished.” ........................................................................................7
`
`The recited ranges follow the standard scientific
`conventions of significant figures and rounding. ...........................10
`
`2.
`
`Moderna’s Answering Position..................................................................15
`
`a.
`
`b.
`
`The claimed ranges should be construed with numerical
`precision.........................................................................................16
`
`The claims recite the lipid amounts in a “finished lipid
`particle.”.........................................................................................25
`
`3.
`
`Plaintiffs’ Reply Position...........................................................................31
`
`a.
`
`b.
`
`Moderna fails to establish that Plaintiffs clearly and
`unmistakably disavowed particles subject to further
`processing. .....................................................................................31
`
`Moderna’s construction impermissibly imports an
`impossible degree of “numerical precision” into the
`claimed mol % ranges. ...................................................................35
`
`4.
`
`Moderna’s Sur-reply Position ....................................................................42
`
`a.
`
`b.
`
`The claimed mol % ranges do not include variability. ..................42
`
`Arbutus defined “particle” as a “finished lipid particle.” ..............46
`
`B.
`
`“a cationic lipid having a protonatable tertiary amine” .........................................48
`
`1.
`
`2.
`
`Plaintiffs’ Opening Position .......................................................................48
`
`Moderna’s Answering Position..................................................................51
`
`iii
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 4 of 96 PageID #: 6690
`
`a.
`
`b.
`
`c.
`
`Arbutus made a clear and unmistakable disclaimer during
`prosecution of the ’069 Patent. ......................................................52
`
`That disclaimer also applies to the ’378 Patent because it
`claims the same subject matter and was never rescinded. .............53
`
`The narrow description of the alleged invention in the
`specification confirms the claims are limited to
`compositions with at least 50 mol% cationic lipids. ......................55
`
`3.
`
`4.
`
`Plaintiffs’ Reply Position...........................................................................56
`
`Moderna’s Sur-reply Position ....................................................................60
`
`C.
`
`“wherein at least 70% / at least 80% / about 90% of the mRNA in the
`formulation is fully encapsulated in the lipid vesicles” / “fully
`encapsulated” .........................................................................................................63
`
`1.
`
`2.
`
`Plaintiffs’ Opening Position .......................................................................63
`
`Moderna’s Answering Position..................................................................69
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`The inventors defined “lipid encapsulated” to distinguish
`between “fully encapsulated” and “partially encapsulated.” .........70
`
`Plaintiffs’ construction ignores the word “fully” and the
`inventors’ definition, instead using phrases that are not
`found in the specification...............................................................71
`
`The inventors did not define “fully encapsulated” as
`“contained inside” during prosecution. ..........................................73
`
`The Court should reject Plaintiffs’ attempt to inject method
`limitations into the ’651 Patent’s composition claims...................73
`
`Plaintiffs’ insinuation that Moderna is manufacturing an
`indefiniteness argument is false. ....................................................74
`
`3.
`
`Plaintiffs’ Reply Position...........................................................................75
`
`a.
`
`b.
`
`c.
`
`The definition of “lipid encapsulated” is irrelevant and
`provides no clarity on what it means for mRNA to be “fully
`encapsulated.” ................................................................................76
`
`Plaintiffs’ construction gives meaning to the word “fully”
`and is supported by the intrinsic evidence. ....................................77
`
`The file history confirms Plaintiffs’ construction. .........................77
`
`iv
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 5 of 96 PageID #: 6691
`
`d.
`
`Plaintiffs’ construction does not inject method limitations. ..........78
`
`4.
`
`Moderna’s Sur-reply Position ....................................................................79
`
`
`
`v
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 6 of 96 PageID #: 6692
`
`TABLE OF AUTHORITIES
`
`3M Innovative Props. Co. v. Avery Dennison Corp.,
`350 F.3d 1365 (Fed. Cir. 2003)................................................................................................78
`
`Actelion Pharms Ltd. v. Mylan Pharms. Inc., --- F.4th ---,
`2023 WL 7289417 (Fed. Cir. Nov. 6, 2023) ..........................................................35, 36, 37, 39
`
`Actelion Pharms. Ltd. v. Mylan Pharms., Inc.,
`2022 WL 446788 (N.D. W. Va. Feb. 14, 2022) ..................................11, 22, 36, 37, 42, 43, 44
`
`AIA Eng’g Ltd. v. Magotteaux Int’l S/A,
`657 F.3d 1264 (Fed. Cir. 2011)................................................................................................42
`
`Allergan Sales, LLC v. Sandoz., Inc., No. 2:12-CV-00207-JRG,
`2013 WL 4854786 (E.D. Tex. Sept. 5, 2013) ..........................................................................74
`
`Amgen Inc. v. Mylan Inc.,
`2018 WL 6061213 (W.D. Pa. Nov. 20, 2018) ...................................................................60, 63
`
`Arlington Indus., Inc. v. Bridgeport Fittings,
`632 F.3d 1246 (Fed. Cir. 2011)..............................................................................49, 51, 56, 66
`
`Astra v. Andrx,
`222 F.Supp.2d 423 (S.D.N.Y. 2002)..............................................................................9, 30, 31
`
`AstraZeneca AB v. Mylan Pharms. Inc.,
`19 F.4th 1325 (Fed. Cir. 2021) ..................................................................13, 21, 35, 37, 42, 43
`
`Aylus Networks, Inc. v. Apple Inc.,
`856 F.3d 1353 (Fed. Cir. 2017)................................................................................3, 29, 34, 47
`
`Baxter Healthcare Corp. v. Nevakar Injectables, Inc.,
`2023 WL 4175261 (D. Del. June 26, 2023) .............................15, 16, 17, 18, 19, 21, 35, 36, 41
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006)..................................................................................................72
`
`Broadridge Fin. Sols., Inc. v. Inveshare, Inc.,
`2012 WL 1245723 (D. Del. Apr. 11, 2012) .......................................................................59, 62
`
`Brooktree Corp. v. Adv. Micro Devices, Inc.,
`977 F.2d 1555 (Fed. Cir. 1993)................................................................................................60
`
`Chamberlain Grp. v. Lear Corp.,
`516 F.3d 1331 (Fed. Cir. 2008)................................................................................................39
`
`vi
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 7 of 96 PageID #: 6693
`
`Cont’l Circuits LLC v. Intel Corp.,
`915 F.3d 788 (Fed. Cir. 2019)............................................................................................68, 80
`
`Cooper Notification, Inc. v. Twitter, Inc.,
`867 F.Supp.2d 485 (D. Del. 2012) ...........................................................................................51
`
`Copan Italia S.p.A. v. Puritan Medical Prods. Co.,
`2019 WL 5699078 (D. Maine Nov. 4, 2019) .........................................................15, 22, 36, 37
`
`Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc.,
`880 F.3d 1356 (Fed. Cir. 2018)..................................................................................................9
`
`Eis, Inc. v. Intihealth Ger GMBH,
`2023 WL 346631 (D. Del. Jan. 9, 2023) ............................................................................49, 56
`
`Endoheart AG v. Edwards Lifesciences Corp.,
`2016 WL 1270127 (D. Del. Mar. 31, 2016) ................................................................39, 76, 80
`
`Exxon Chem. Patents v. Lubrizol Corp.,
` 64 F.3d 1553 (Fed. Cir. 1995).............................................................................1, 9, 10, 30, 31
`
`Funai Elec. Co., Ltd. v. Daewoo Elecs. Corp.,
`616 F.3d 1357 (Fed. Cir. 2010)..........................................................................................76, 80
`
`Gillette Co. v. Energizer Holdings, Inc.,
`405 F.3d 1367 (Fed. Cir. 2005)................................................................................................46
`
`Golight, Inc. v. Wal-Mart Stores, Inc.,
`355 F.3d 1327 (Fed. Cir. 2004)................................................................................................57
`
`Grober v. Mako Products, Inc.,
`686 F.3d 1335 (Fed. Cir. 2012)................................................................................................14
`
`Hakim v. Cannon Avent Grp.,
`479 F.3d 1313 (Fed. Cir. 2007)..............................................................................55, 59, 60, 63
`
`Halliburton Energy Servs., Inc. v. M-I LLC,
`514 F.3d 1244 (Fed. Cir. 2008)................................................................................................74
`
`Heidelberger Druckmaschinen AG v. Hantscho Com. Prods., Inc.,
`21 F.3d 1068 (Fed. Cir. 1994)..................................................................................................42
`
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
`527 F.3d 1379 (Fed. Cir. 2008)..........................................................................................49, 71
`
`Heuft Systemtechnik GMBH v. Indus. Dynamics Co.,
`282 F. App’x 836 (Fed. Cir. 2008) ......................................................52, 53, 54, 56, 58, 59, 62
`
`vii
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 8 of 96 PageID #: 6694
`
`Hill-Rom Services, Inc. v. Stryker Corp.,
`755 F. 3d 1367 (Fed. Cir. 2014)...............................................................................................48
`
`Homeland Housewares, LLC v. Whirlpool Corp.,
`865 F.3d 1372 (Fed. Cir. 2017)............................................................................................7, 31
`
`HW Tech., LC v. Overstock.com, Inc.,
`758 F.3d 1329 (Fed. Cir. 2014)..........................................................................................49, 56
`
`Icon Health & Fitness, Inc. v. Hoist Fitness Sys., Inc.,
`No. 1:10-cv-193, 2015 WL 4077739 (D. Utah July 6, 2015) ............................................54, 59
`
`In re Edwards,
`568 F.2d 1349 (C.C.P.A. 1978) ...............................................................................................77
`
`In re Fenofibrate Patent Litig.,
`910 F.Supp.2d 708 (S.D.N.Y. 2012)........................................................................................14
`
`Integra LifeSciences Corp. v. HyperBranch Med. Tech., Inc.,
`C.A. No. 15-819, 2017 WL 3336274 (D. Del. July 27, 2017)...........................................54, 59
`
`Intel Corp. v. Qualcomm Inc.,
`21 F.4th 801 (Fed. Cir. 2021) ......................................................................................76, 80, 81
`
`Irdeto Access, Inc. v. Echostar Satellite Corp.,
`383 F.3d 1295 (Fed. Cir. 2004)....................................................................................56, 61, 71
`
`Jeneric/Pentron, Inc. v. Dillon Co.,
`205 F.3d 1377 (Fed. Cir. 2000)..............................................................................14, 17, 21, 36
`
`Johnson Matthey Inc. v. Noven Pharms., Inc.,
`2009 WL 2208214 (E.D. Tex. July 21, 2009) .................................................11, 15, 22, 36, 37
`
`Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
`730 F.2d 1452 (Fed. Cir. 1984)................................................................................................42
`
`Liqwd, Inc. v. L’Oréal USA, Inc.,
`C.A. No. 17-14-JFB-SRF, 2019 WL 1977367 (D. Del. May 2, 2019) aff’d sub nom,
`Olaplex, Inc. v. L’Oréal USA, Inc., 845 F. App’x 943 (Fed. Cir. 2021) .................................74
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) .................................................................................................................37
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009)..........................................................................................50, 57
`
`Middleton, Inc. v. Minnesota Mining & Mfg. Co.,
`311 F.3d 1384 (Fed. Cir. 2002)..........................................................................................59, 63
`
`viii
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 9 of 96 PageID #: 6695
`
`Noven Pharms., Inc. v. Actavis Labs. UT, Inc.,
`2016 WL 3625541 (D. Del. July 5, 2016) .......................................................11, 22, 35, 36, 37
`
`Noven Pharms., Inc. v. Amneal Pharms., LLC,
`C.A. No. 18-699, 2019 WL 1102681 (D. Del. Mar. 8, 2019)............................................20, 22
`
`O2 Micro Intern. Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)..........................................................................................47, 69
`
`Oatey Co. v. IPS Corp.,
`514 F.3d 1271 (Fed. Cir. 2008)..................................................................................................8
`
`Omega Engineering, Inc, v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003)................................................................................................69
`
`Ormco Corp. v. Align Tech., Inc.,
`498 F.3d 1307 (Fed. Cir. 2007)..............................................................................52, 54, 59, 61
`
`Otsuka Pharm. Co. v. Lupin Ltd.,
`2022 WL 2952759 (D. Del. July 26, 2022) .................................................................12, 20, 21
`
`Par Pharm., Inc. v. Eagle Pharms. Inc.,
`2021 WL 3886418 (D. Del. Aug. 31, 2021) .....................................................................11, 22
`
`Par Pharm., Inc. v. Eagle Pharms., Inc.,
`44 F.4th 1379 (Fed. Cir. 2022) ..............................................................................11, 22, 36, 37
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc)....................................................................... passim
`
`Rambus, Inc. v. Infineon Techs. AG,
`318 F.3d 1081 (Fed. Cir. 2003)................................................................................................34
`
`Raytheon Co., v. Roper Corp.,
`724 F.2d 951 (Fed Cir. 1983).............................................................................................68, 69
`
`Regents v. AGA Medical Corp.,
`717 F.3d 929 (Fed. Cir. 2013)............................................................................................58, 62
`
`Rembrandt Data Techs., LP v. AOL, LLC,
`641 F.3d 1331 (Fed. Cir. 2011)................................................................................................57
`
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`175 F. App’x 350 (Fed. Cir. 2006)
`............................................................................................................................................30, 55
`
`Rheox, Inc. v. Entact, Inc.,
`276 F.3d 1319 (Fed. Cir. 2002)....................................................................................30, 55, 61
`
`ix
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 10 of 96 PageID #: 6696
`
`Sanofi v. Glenmark Pharms. Inc., USA,
`204 F. Supp. 3d 665 (D. Del. 2016)...................................................................................59, 60
`
`Sanofi v. Watson Labs. Inc.,
`875 F.3d 636 (Fed. Cir. 2017)......................................................................................58, 59, 62
`
`Saunders Grp., Inc. v. Comfortrac, Inc.,
`492 F.3d 1326 (Fed. Cir. 2007)..........................................................................................58, 62
`
`Searfoss v. Pioneer Consol. Corp.,
`374 F.3d 1142 (Fed. Cir. 2004)..........................................................................................39, 40
`
`SkinMedica, Inc. v. Histogen Inc.,
`727 F.3d 1187 (Fed. Cir. 2013)..........................................................................................71, 80
`
`Speyside Med., LLC v. Medtronic Corevalve, LLC,
`C.A. No. 20-361-GBW-CJB, 2023 WL 4043955 (D. Del. June 16, 2023) .............................27
`
`Takeda Pharm. Co. v. Zydus Pharm. USA, Inc.,
`743 F.3d 1359 (Fed. Cir. 2014)........................................................................13, 20, 21, 36, 43
`
`Talbert Fuel Sys. Patents Co. v. Unocal Corp.,
`275 F.3d 1371 (Fed. Cir. 2002)................................................................................................14
`
`Teva Pharm. USA, Inc. v. Sandoz Inc.,
`810 F.Supp.2d 578 (S.D.N.Y. 2011)........................................................................................34
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`574 U.S. 318 (2015).................................................................................................................42
`
`Texas Instruments Inc. v. U.S. Int’l Trade Comm’n,
`988 F.2d 1165 (Fed. Cir. 1993)................................................................................................72
`
`Thorner v. Sony Comput. Ent. Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012)....................................................................7, 10, 27, 32, 39, 50
`
`Tubular Rollers, LLC v. Maximus Oilfield Prods., LLC,
`No. 2021-2319, 2023 WL 4230371 (Fed. Cir. June 28, 2023) ................................................71
`
`TwinStrand Biosciences, Inc. v. Guardant Health, Inc.,
`C.A. No. 21-1126-GBW-SRF, 2022 WL 17986012 (D. Del. Dec. 29, 2022) .........................21
`
`U.S. Philips Corp. v. Iwasaki Elec. Co.,
`505 F.3d 1371 (Fed. Cir. 2007)..............................................1, 7, 11, 12, 20, 35, 36, 37, 42, 43
`
`Unicorn Energy GMBH v. Tesla Inc.,
`2023 WL 322891 (N.D. Cal. 2023) .........................................................................................47
`
`x
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 11 of 96 PageID #: 6697
`
`Unimed Pharms. LLC v. Perrigo Co.,
`2015 WL 1094601 (D. Del. Mar. 11, 2015) ......................................................................11, 22
`
`Unwired Planet, LLC v. Apple Inc.,
`829 F.3d 1353 (Fed Cir. 2016).....................................................................................34, 47, 57
`
`Vanguard Prod. Corp. v. Parker Hannifin Corp.,
`234 F.3d 1370 (Fed. Cir. 2000)................................................................................................74
`
`Viskase Corp. v. Am. Nat’l Can Co.,
`261 F.3d 1316 (Fed. Cir. 2001)........................................1, 7, 11, 13, 14, 22, 35, 37, 39, 42, 43
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)..................................................................................................72
`
`Warner Chilcott Co., LLC v. Amneal Pharms., LLC,
`2014 WL 1391536 (D.N.J. Apr. 9, 2014) ..........................................................................59, 63
`
`Yoon Ja Kim v. ConAgra Foods, Inc.,
`465 F.3d 1312 (Fed. Cir. 2006)................................................................................................58
`
`
`
`xi
`HIGHLY CONFIDENTIAL – OUTSIDE COUNSEL’S EYES ONLY
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 12 of 96 PageID #: 6698
`
`I.
`
`PLAINTIFFS’ INTRODUCTION
`
`Unlike typical claim construction proceedings, in which parties fiercely dispute the
`
`meaning of words amenable to multiple interpretations, the parties here generally agree that the
`
`terms at issue use straightforward language with a clear meaning. The disputes arise because
`
`Moderna seeks to redraft the claims to include requirements that the claims simply do not recite.
`
`1. The claims recite a “particle” with various lipids. Moderna refuses to accept the plain
`
`language of “particle,” seeking to limit the claim to the “finished” particle that is not subject to
`
`any further processing. This temporal limitation violates both controlling precedent, Exxon Chem.
`
`Patents v. Lubrizol Corp., 64 F.3d 1553, 1558 (Fed. Cir. 1995), and the patent’s disclosure that the
`
`invention includes particles subject to further manufacturing processes.
`
`2. Moderna casts aside the plain meaning of the numerical percentages of lipids in the
`
`claims, ignoring the “standard scientific convention” of significant figures and rounding, Viskase
`
`Corp. v. Am. Nat’l Can Co., 261 F.3d 1316, 1320 (Fed. Cir. 2001), thereby construing “the
`
`endpoints of [a] claimed range with greater precision than the claim language warrants,” U.S.
`
`Philips Corp. v. Iwasaki Elec. Co., 505 F.3d 1371, 1377 (Fed. Cir. 2007).
`
`3. Even where the claims manifestly omit a numerical limitation, Moderna seeks to impose
`
`one by importing language from the specification—the “cardinal sin” of claim construction.
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1320 (Fed. Cir. 2005) (en banc).
`
`4. And Moderna seeks to confuse, rather than to clarify, the claims of an asserted patent
`
`that recites percentages of “fully encapsulated” material. The claim language, read in context and
`
`through the skilled artisan’s lens as the law requires, refutes Moderna’s professed confusion and
`
`effort to use claim construction to conjure an indefiniteness defense.
`
`Plaintiffs’ constructions, by contrast, reflect the plain meaning of the claims in light of the
`
`intrinsic evidence and should be adopted.
`
`1
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 13 of 96 PageID #: 6699
`
`II.
`
`MODERNA’S INTRODUCTION
`
`For more than a decade, Moderna had been pioneering a new class of medicines made of
`
`messenger RNA (“mRNA”) and its proprietary lipid nanoparticle (“LNP”) technologies. Moderna
`
`invested years of work to develop LNPs that function to protect mRNA and deliver it into cells.
`
`Plaintiffs did not invent Moderna’s COVID-19 vaccine, the mRNA technology upon which it is
`
`based, nor the LNP technology that delivers it. Instead, Plaintiffs’ Asserted Patents focus on lipids
`
`containing very different types of nucleic acid—plasmid DNA and siRNA—not mRNA. Yet,
`
`Plaintiffs attempt to expand the scope of their patents to cover Moderna’s pioneering technology.
`
`The asserted family of Molar Ratio Patents claim priority to an application filed in 2008. 1
`
`They claim nothing new: four-component lipid systems were known long before 2008. See, e.g.,
`
`J.A. 52 (U.S. Patent No. 6,287,591) (“Charged therapeutic agents encapsulated in lipid particles
`
`containing four lipid components,” issued Sept. 11, 2001). The only allegedly novel feature of the
`
`Molar Ratio Patents is the purportedly “surprising discovery” that particles with higher molar
`
`amounts of cationic lipid above 50 mol % and lower amounts of polyethylene glycol (“PEG”)-
`
`lipid conjugate below 2 mol % “provide advantages” over the overlapping ratios in the prior art.
`
`J.A. 1 (’069 Patent) at 5:44–51.2 Because the commercial formulations of Moderna’s COVID-19
`
`Vaccine contain lipids in amounts that fall outside of the claimed ranges, Plaintiffs ask the Court
`
`to construe the claims to cover lipid ratios they did not invent. However, each of Plaintiffs’
`
`arguments are contradicted by the intrinsic record.
`
`First, Plaintiffs ask the Court to expand the numerical ranges recited in the claims under
`
`
`1 The ’069, ’359, ’668, ’435, and ’378 patents (“Molar Ratio Patents”) share a common
`specification. Moderna does not concede that any Asserted Patent is entitled to the priority dates
`on the face of the patents.
`2 All emphasis added, except where otherwise stated.
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 14 of 96 PageID #: 6700
`
`the guise of “standard scientific convention,” ignoring that they disclaimed any variability years
`
`earlier when they deleted “about” from the claimed ranges. Second, to avoid prior art in a related
`
`inter partes review (“IPR”),3 Arbutus4 steadfastly maintained that the claims refer to the lipid
`
`amounts in the “finished lipid particle” (i.e., the output of manufacturing), rather than the starting
`
`materials. Now, to try to cover Moderna’s COVID-19 Vaccine, Plaintiffs ignore their earlier
`
`position
`
` Third, with respect to the ’378 Patent, which Plaintiffs opportunistically filed in
`
`the midst of the pandemic and only after Moderna’s product was in use by patients, Plaintiffs seek
`
`to escape their explicit disclaimers of particles with less than 50 mol % of cationic lipid. Plaintiffs’
`
`contradictory positions across these claims should not be permitted. Black-letter law, including
`
`prosecution disclaimer, prohibits such tactics. See Aylus Networks, Inc. v. Apple Inc., 856 F.3d
`
`1353, 1360 (Fed. Cir. 2017).
`
`Plaintiffs also assert U.S. Patent No. 9,504,651 (the “’651 Patent”), which expired earlier
`
`this year, and purports to claim priority back to an application filed in 2002. J.A. 5 at Cover. The
`
`specification of the ’651 Patent family focuses on encapsulation of one type of nucleic acid:
`
`plasmid DNA. J.A. 5 (’651 Patent) at 14:9–18:61 (Examples 1–8). mRNA appears just once in the
`
`entire specification, in a laundry list definition of “nucleic acids.” Id. at 3:50–4:3. It was not until
`
`2014, over a decade after Arbutus’s provisional application and after Moderna’s founding with a
`
`
`3 Moderna disagrees with Plaintiffs’ overbroad statement that Moderna is estopped from raising
`arguments based on the prior art. 35 U.S.C. 315(e); Br. at 6. Moderna intends to rely on prior art
`formulations that Arbutus disclosed before the priority date that could not have been raised in the
`IPRs, as well as obviousness-type double patenting defenses over Arbutus’s earlier patents which
`have claimed ratios that are patentably indistinct from the asserted claims.
`4 “Arbutus” refers to Arbutus Biopharma Corp. and its predecessors Protiva Biotherapeutics Ltd
`and Tekmira Pharmaceuticals Corp. Arbutus is a part owner of Genevant Sciences GmbH.
`
`3
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 15 of 96 PageID #: 6701
`
`singular focus on making mRNA medicines a reality,5 that Arbutus decided to seek broad and
`
`unsupported claims to lipid compositions comprising mRNA—seemingly to try to capture
`
`Moderna’s and others’ technology. The only purported novel feature of those composition claims
`
`is that they require certain percentages of “fully encapsulated” mRNA. The term “fully
`
`encapsulated” should be construed consistent with the sole definition in the specification, in which
`
`the inventors contrasted “full” encapsulation with “partial.” Plaintiffs ignore the term “fully” and
`
`instead improperly seek to turn composition claims into method claims.
`
`In sum, Plaintiffs turn a blind eye to the intrinsic record of the Asserted Patents to propose
`
`unsupported constructions. Moderna respectfully requests that the Court adopt its proposed
`
`constructions, which are in line with the intrinsic record.
`
`III.
`
`PLAINTIFFS’ INTRODUCTION IN REPLY
`
`Having now seen the validity of many of the asserted claims confirmed three times—by
`
`the Patent Office in allowing the claims, by a unanimous panel from the Patent Trial & Appeal
`
`Board in response to Moderna’s IPR challenges, and then by another unanimous panel of the
`
`Federal Circuit on appeal—Moderna knows that proving invalidity is practically impossible and,
`
`for its primary invalidity defenses, statutorily estopped. Moderna likewise sees the proverbial
`
`writing on the wall on infringement; it would not have undertaken and maintained its expensive
`
`PTAB challenges and appeals without knowing its mRNA vaccines, including for COVID-19,
`
`contain particles with molar ratios that infringe the asserted claims.
`
`Under the guise of claim construction, Moderna therefore seeks to redraft the claims, all
`
`the while accusing Plaintiffs of expanding them. Br. 2-4. Plaintiffs do not seek to expand their
`
`
`5 J.A. 78 (Moderna Announces $40 Million In Financing To Advance Development Of New
`Biotherapeutic Modality: mRNA (Dec. 6, 2012)).
`
`4
`
`

`

`Case 1:22-cv-00252-MSG Document 180 Filed 01/03/24 Page 16 of 96 PageID #: 6702
`
`claims; they simply seek legally mandated claim constructions that confirm the claims mean what
`
`they say. Quite unusually, the plain meaning of the claim language is undisputed here—Moderna
`
`does not and cannot dispute that it a