Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 1 of 42 PageID #: 47470
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 1 of 42 PagelD #: 47470
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERNDISTRICT OF WEST VIRGINIA
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Case No. 1:22-cv-00061-TSK.
`
`HIGHLY CONFIDENTIAL:
`
`FILED UNDER SEAL
`
`
`
`Plaintiff,
`
`Vv.
`
`MYLAN PHARMACEUTICALSINC.,
`
`Defendant.
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.
`OPENING CLAIM CONSTRUCTION BRIEF
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 2 of 42 PageID #: 47471
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 2 of 42 PagelD #: 47471
`
`TABLE OF CONTENTS
`
`1.
`
`Il.
`
`INTRODUCTION. 00. cececsescnseeecsseenesesaeesecnevsecneveeensessesaecaeenecnavercnaeseenaeseesaeeaevareneessente i
`
`PROCEDURAL BACKGROUND ANDLITIGATION STATUS. 00... eeeeeeeneeeeenee 1
`
`A.
`
`The Abbreviated Schedule Regeneron Demanded For This Case Has Proven
`Prejudicial To Mylan’s Claim Construction Arguments. ...........c:ccesseeseeeeeeeeeeeeneees 1
`
`1.
`
`2.
`
`Regeneron failed to comply with the Court’s scheduling order regarding
`exchange of preliminary constructions (Dkt. No. 87). .0...ccceeccesseeeeeeeereeenee 1
`
`Regeneron continuesto assert nearly 130 claims against Mylan and
`refuses to streamline the Case... cee cecesseeseceeeceseseeseeseceesevaeceaesaeennereness 3
`
`ll.
`
`THE INITIAL PATENTS AND INTRINSIC RECORDS OF EACH... ccececeseneeenee 4
`
`A.
`
`B.
`
`Cc.
`
`The 865 Patent. oo... cece cecceecesecsnececnsesaeeeeeesessaeseaecnsessasenesseeaeenaeenaessereateaeesaees 4
`
`The 601 and 572 Patents (collectively, “Dosing Patents”). 0.0... ec ceeceeeeeseeeeeees 5
`
`The 280, 715, and 532 Patents (collectively, “Tustian Patents’’).....0..0.....eceees 5
`
`TV.
`
`LEGAL STANDARDS, 000... eeceseccnseeeenseseeeseseevseeseesecnaesecsaeceesaesarenaeseenaeseesaesaevaeeneesrenaees 7
`
`Vv.
`
`ARGUMENT: THE 865 PATENT CLAIM TERMS. ......:cccscesessverceceseeveeseeeneenevercnersecneesaeeateatens 8
`
`A.
`
`B.
`
`Person of Ordinary Skill in the Art of the 865 Patent (“Formulation-POSA”). ..... 8
`
`“Organic Co-Solvent?oe ceceececeeeceseeeeneeseeceseeeeneesaeeceaneeeeeseeesacecaeeesenseneesaeesnanenes 9
`
`1.
`
`2.
`
`3.
`
`4,
`
`The intrinsic evidence does not expressly define “organic co-solvent.”.... 9
`
`The claim term “organic co-solvent” has a widely-known, well-understood
`plain and ordinary meaning that should govern............eeeecceeeeeeteeeteeeeee 10
`
`Regeneron’s proposalis not a construction andit should be rejected...... 11
`
`Regeneron’s proposal improperly targets accused products... il
`
`Cc.
`
`“Present In] Native Conformation”.............cccccecsseceeseseseeeceeseeensneesenseeesseeesseeneess il
`
`1.
`
`2.
`
`3,
`
`The intrinsic evidence does not expressly define “native conformation”
`but instead applies the term’s plain and ordinary meaning.................06 12
`
`The term “native conformation”has a widely-known,well-understood
`plain and ordinary meaning, which is confirmed by the specification. .... 12
`
`Regeneron’s proposalis not a construction andit should be rejected...... 13
`
`

`

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`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 3 of 42 PagelD #: 47472
`
`VI.
`
`ARGUMENT: THE DOSING PATENTS CLAIM TERMG..........:ccccessecneececceerseseceenaneeeeeeeeceenens 13
`
`A.
`
`B.
`
`Person of Ordinary Skill in the Art of the Dosing Patents (““Clinical-POSA”). ... 13
`
`“Wherein Exclusion Criteria For The Patient Include” (“Exclusion Criteria”)... 14
`
`1.
`
`2.
`
`The claim elementis printed matter, entitled no patentable weight......... 14
`
`“TE]xclusion Criteria” are limited to the clinical trial context. ............... 16
`
`C.
`
`“Best Corrected Visual Acuity” (BCVA)... ccccecceeeceeeeceneeeeneesaeecnaeeneeeseeenanes 17
`
`1.
`
`2.
`
`3.
`
`4.
`
`“Best Corrected Visual Acuity”refers to a clinical trial endpoint............ 17
`
`The specification demonstrates BCVAis a clinical trial endpoint........... 19
`
`The claim language contradicts Regeneron’s construction........0...e 21
`
`Regeneron should be held to its prior representations to the PTAB......... 21
`
`VU.
`
`ARGUMENT: THE TUSTIAN PATENTS CLAIM TERMS(280, 715, 532 PATENTS). .......00- 23
`
`A.
`
`B.
`
`Person of Ordinary Skill in the Art of the Tustian Patents (“Processing-POSA”).
`sevecneceevseeatesecnsessesseecessersesacenevsesnavcessessesaecaevaeenevsnsaceeessesaceaecaevsesateceenaeseeeaeeaeeneratate 23
`
`“Chemically Defined Medium (CDM)”.........eeeccceceeeeeceeeeeeeeeeeeeeaeeceneensneeseeesaeees 23
`
`1.
`
`2.
`
`3.
`
`The specification provides an express definition.............ccceeeeeeeeneereees 23
`
`Other claim language confirms the express definition. ....0........eceeeee 24
`
`Provisional application confirms the express definition. ........... cee 24
`
`C.
`
`“Clarified Harvest of Cells/Harvested From a Host Cell Cultured in a Chemically
`Defined Media (CDM)?........::cceccessceceeeceteeesneeseecnaeeeeeseneesaeecasenseeeeneeseesnaeenereesnes 25
`
`D.
`
`“Anti-Oxidants” and “Formulated As An Isotonic Solution.”’........0000... 30
`
`li
`
`

`

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`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 4 of 42 PagelD #: 47473
`
`TABLE OF AUTHORITIES
`
`Cases
`
`AFG Indus., Inc. v. Cardinal IG Co.,
`239 F.3d 1239 (Fed. Cir, 2001) oo... ccccceccseeesccecceeecesecececneeseeeseceneeaeeaeesaeeneeveeeeaeenseseeeseeeeees 11, 13
`
`Atlas PowderCo. v. Ireco, Inc.,
`190 F.3d 1342 (Fed. Cir, 1999) oo... cccceccceccesssecsseceseceseeesseeesseessesseeeessseesseecnseesseeseneesssessseeneesegs 7
`
`Baxter Healthcare Corp. v.Mylan Lab’ys Ltd.,
`346 F. Supp. 3d 643 (D.N.J. 2016) eee secesescessesneeeceeseeneeseenaeseevaesaesaecnevseenevseenaeenesaeseesareneeats 3
`
`CR Bard Inc. v. AngioDynamics, Inc.,
`979 F.3d 1372 (Fed. Cir, 2020) oo. cceececesccesesseesecneeeeeneveecaeseessesaeeaesnevsecneeeenaeseesaesanearenees 14, 15
`
`‘elltrion Inc. v. Regeneron Pharm.,
`PGR2021-00117, Paper 1 (PTAB September 7, 2021) ........e cc eccceeseeeecceeeeeseeceeeesseecnaeeenesteneeenees 5
`
`Data Engine Techs. LLC v. Google LLC,
`10 F.4th 1375 (Ped. Cir. 2021) oo... ccc ceeccecccecseceneceeneeseeeseeecensceeeseeeecseesaeeeeneeseeesaeeceasensneeeeeenses 23
`
`Embrex, Inc. v. Serv. Eng'g Corp.,
`216 F.3d 1343 (Fed. Cir, 2000) oo... ee eeceseeecesessesseeeeeseeneesecneeeeesaesaesaecaevseeneveeenaeseesaesaeensenevats 11
`
`Exigent Tech., Inc. v. Atrana Sols., Inc.,
`442 F.3d 1301 (Fed. Cir, 2006) ooo... ccc ccceccccecceeeceseescesaeeesesseeaeceaecaeesaeeseseareseceeeceeeneesneseenaes 11
`
`Housey Pharms., Inc. v. AstraZeneca UK Ltd.,
`366 F.3d 1348 (Fed. Cir, 2004) oo. cceceseceeecceeneeneveeceeesevseeseceaeseevaeseceaecneveesnaesessaveneeaesaneneenerets 8
`
`In re Distefano,
`808 F.3d 845 (Fed. Cir. 2015) oo... eeseecccenecneveecscceesevseessesaeesecneveccnaeveesaecateaeeneverceaeseesaeeeseness 15
`
`Intel Corp. v. Qualcomm Inc.,
`21 F.4th 801 (Fed. Cir, 2021) oe eecceseeeneeeecneesscnsescessessevsecnevseenaveeenaeseeaeseeeaesneveeeneesess 26, 27
`
`Kaneka Corp. v. Xiamen Kingdomway Grp. Co.,
`790 F.3d 1298 (Fed. Cir, 2015) oo. ccceescecccccsseseessecseeeeneverceceseevaeceeeaesseveecaessesneeseeeaeeesvaveaeseesaeeats 9
`
`Liebel-Flarsheim Co. v. Medrad Inc.,
`No. 1:04-CV-607, 2006 WL 335846 (S.D. Ohio Feb. 14, 2006)... ecscceteeeeeeereeenees 2,11
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir, 2009) oo... eescececccsseseeseecseeecneverceaeseevaececeaecseveecaessesneeseeeaeeeesaveaeseseaees 24
`
`Moba, B.V. vy. Diamond Automation, Inc.,
`325 F.3d 1306 (Fed. Cir, 2003) .....ccececcccesceeccenecesecseeseeeeneeseesaeeeaecanesaeesaesneusesaeennesaeeeneesneeseenaes 10
`
`il
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 5 of 42 PageID #: 47474
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 5 of 42 PagelD #: 47474
`
`Moore U.S.A. Inc. v. Standard Reg. Co.,
`2000 WL 876884 (W.D.N.Y. May 26, 2000)... ee cececceceeecseeseenevereeesecsseseeeaeseevsesateeseneens 2,11
`
`NeoMagic Corp. v. Trident Microsystems, Inc.,
`287 F.3d 1062 (Fed. Cir, 2002) oo. ceecccceccesseecsseseessesasesecnevseceseeeeaesseeaeeaevsesavecenaesestaeeaeeaeeners 8
`
`O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir, 2008) ooo ec eccesecceeneseeesceneesecneseseeaeseesaecsevsessevsrsaeesessaeeeeeaesseveetateaes 2
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir, 2005) oo... ee ceccceceeeneceneeeeeeesneeceaeeeeeessneesaeeceaeeneesseeesaeecsaeesneesenes passim
`
`Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd.,
`890 F.3d 1024 (Fed. Cir. 2018) occ cc eeececceecneeeecnseeeensesseeseseessesevaceneesesaseresaeseesaeeneeaeens 15, 16
`
`Samsung Elecs. Co. v. Elm 3DS Innovations, LLC,
`925 F.3d 1373 (Fed. Cir, 2019) ooo eeeccccesesesssecneesecneseseseeseesaecsevsesneversaeeseesaeeeeeaeseeveeates 26, 27
`
`Sinorgchem Co., Shandong v. Int'l Trade Comm’n,
`S11 F.3d 1132 (Fed. Cir, 2007) oo ec eccceesescceneceessecnevsecsavereaeseesaecneveesnevsesaeeseesseeeseaeeaeeeeeated 23
`
`SRI Int'l v. Matsushita Elec. Corp. ofAm.,
`775 F.2d 1107 (Fed. Cir, 1985) ooo eccecesesseeseseeesecneveceseesecsaeesesaeseessecaeesecnavseeaaeeeesaesaneneenenaes 8
`
`Tate Access Floors, Inc. v. Interface Architectural Res., Inc.,
`279 F.3d 1357 (Fed. Cir, 2002) oo. ccecccceceseesessesesecevecnevecseeseeaesecenecaessesateeeeaeseesaeseesnesnenage 17
`
`U.S. Surgical Corp. v. Ethicon, Inc.,
`103 F.3d 1554 (Fed. Cir, 1997) ooo cceecceceeeceseesesseseesecsevsecnaveecseeseesesatesecnevseenteeeaesansaeeaeeaeens 7
`
`V-Formation, Inc. v. Benetton Grp. SpA,
`401 F.3d 1307 (Fed. Cir, 2005) ooo eceseecseesecssecseeecevrcaeeseeseseeenesaevsesateeecsaeseeaeseesaevantacens 8
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) woo eecseeecsscesceceseessesacesecnevsecnseseessessesaeseesaessevaceneeseenaees 7, 8,9
`
`Volterra Semiconductor LLC v. Monolithic Power Systems, Inc.,
`C.A. No. 19-2240-CFC-SRF (D. Del. Nov. 12, 2021) .o.cieecccccnseeeccneesecnesesesseseeeaeeseeeeneveneaee 3
`
`Zelinski v. Brunswick Corp.,
`185 F.3d 1311 (Fed. Cir, 1999) oo ececescnsesecnseseevseseeeaecnevsecneeseenaeseesaesansaeeneeaes 9, 10, 12, 16
`
`Statutes
`
`35 U.S.C. § 102 ee ceceeeecsseecessecsessecneesecnevscensessessesseeaecnevaecnaeseenaessesaesaevaesaeesecneeseenaeseesaesaeaeenees 29
`
`35 U.S.C. § LQ ce ceceeseceseeceseeeaeveccneeseceeseceaevaeaecaessesneverceasenevaeseseaesneversnacesnavenesaesaeentenees 19, 30
`
`35 U.S.C. § 271(C)(4)(D) oe ce ceceeeeseceeecnsenecneeeccnseveesaecaneaecnevercuaesevsaececaessevaesiessesneeseceaeeesaveatsaeeatente 6
`
`iv
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 6 of 42 PageID #: 47475
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 6 of 42 PagelD #: 47475
`
`Exhibit
`No.
`
`Description
`
`Table of Exhibits
`
`N
`
`3
`
`4
`
`5
`
`6
`
`|
`
`9
`
`Regeneron’s Preliminary Constructions and Intrinsic Support, dated November
`10, 2022
`
`Mylan’s Preliminary Constructions and Intrinsic Support, dated November10,
`2022
`
`9/28/22 Status Conference Transcript
`
`Email from N. McLaughlin to Regeneron, dated November4, 2022
`
`Certified U.S. Patent No. 11,084,865 (RGN-EYLEA-MYLAN-00028406-419)
`(“865 patent”)
`
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc., 1PR2021-00881, Paper 94
`
`USS. Patent No. 10,857,231
`
`(“572 patent”)
`
`Certified U.S. Patent No. 10,888,601 (RGN-EYLEA-MYLAN-00017798-820)
`(“601 patent”)
`
`10
`
`Certified U.S. Patent No. 11,053,280 (RGN-EYLEA-MYLAN-00028420-607)
`(“280 patent”)
`
`Allowance (RGN-EYLEA-MYLAN-00015173-80)
`
`(P.T.A.B. Nov. 9, 2022)
`Certified U.S. Patent No. 11,253,572 (RGN-EYLEA-MYLAN-00036361-87) :
`
`Regeneron Protected Material |
`13|Quality Overall Summary (MYL-AFL-BLA0001570-603)
`
`y[isietreeerrr neevearastraarreeaaaarareaaateraanseaatreaaaaereaters
`
`12
`
`U.S. Provisional Patent Application No. 62/944,635
`
`Mylan BLA No. 761274, Section 2.3.8.2 Drug Substance - Manufacture-
`
`14
`
`U.S. Patent No. 6,417,335 (“335 patent”)
`
`File History of U.S. Patent Application No. 16/159,269, 8/21/2019 Notice of
`
`— Oo
`
`File History of U.S. Patent Application No. 16/159,269, 7/22/2019 Response
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 7 of 42 PageID #: 47476
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 7 of 42 PagelD #: 47476
`
`
`(RGN-EYLEA-MYLAN-00015158-64)
`
`7
`
`Investigation of
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye:
`Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW
`2),
`NCT0063 7377,
`ClinicalTrials.gov
`(Mar.
`17,
`2008),
`https://clinicaltrials.gov/ct2/history/NCT00637377?A=1&B=1&C=merged
`from Certified File History of U.S. Patent No. 10,888,601 (RGN-EYLEA-
`MYLAN-00003330-96) (“NCT 377”)
`
`Peter K. Kaiser, Prospective Evaluation of Visual Acuity Assessment: A
`Comparison ofSnellen Versus ETDRS Charts in Clinical Practice (An AOS
`18
`Thesis), 107 TRANSACTIONS AM. OPHTHALMOLOGYSoc’y 311 (2009)
`
` | (RGN-EYLEA-MYLAN-00024664-93)
`
`
`
`
`
`Trini Chatziralli et al., Intravitreal Aflibercept for Neovascular Age-Related
`Macular Degeneration in Patients Aged 90 Years or Older: 2-Year Visual
`Acuity Outcomes, 32 EYE 1523 (2018) from Certified File History ofU.S. Patent
`No. 10,888,601 (RGN-EYLEA-MYLAN-00002088-94)
`
`
`19
`
`Mylan Pharms. Ine. v. Regeneron Pharms., Inc., YPR2021-00881, Paper 39
`0
`(P.T.A.B. Feb. 11, 2022)
`
`
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc., 7PR2021-00881, Exhibit No.
`4
`2051 (P.T.A.B. Feb. 11, 2022) (“Do Declaration”)
`
`
`Certified U.S. Patent No. 11,104,715 (RGN-EYLEA-MYLAN-00036 163-360)
`22
`(“715 patent”)
`
`
`WO 2007/0077217 from Certified File History of U.S. Patent No. 11,053,280
`73
`eeeeeeeeeeeeeeedeereeeeeeeeeeemceeneeenererenceeemeeeeeeeeeeeeeeeeeeeeeeeeeemeeeeeeeemeeeeeeeeeeee
`
`eeeeeeee eeemeeeeeeemermeeemeeemeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeameseeeeensemer
`
`12/2/2020 Non-Final Rejection from Certified File History of U.S. Patent No.
`11,104,715 (RGN-EYLEA-MYLAN-00030241-60)
`
`8/18/2020 Preliminary Amendment from Certified File History of U.S. Patent
`26 No. 11,104,715 (RGN-EYLEA-MYLAN-00029392-98)
`
`
`
`
`
`
`
`3/2/2021 Response to Non-Final Office Action from Certified File History of
`U.S. Patent No. 11,104,715 (RGN-EYLEA-MYLAN-00032370-92) (“3/2/2021
`27
`Remarks”)
`
`28
`
`4/23/2021 Proposed Agenda for Interview from Certified File History of U.S.
`Patent No. 11,104,715 (RGN-EYLEA-MYLAN-00033643-46) (‘4/23/2021
`Proposed Agenda’)
`
`vi
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 8 of 42 PageID #: 47477
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 8 of 42 PagelD #: 47477
`
`
`
`4/30/2021 Examiner Interview Summary from Certified File History of U.S.
`Patent No. 11,104,715 (RGN-EYLEA-MYLAN-00033649-5 1)
`
`
`29
`
`5/6/2021 Interview Summary from Certified File History of U.S. Patent No.
`30
`11,104,715 (RGN-EYLEA-MYLAN-00033657-59)
`
`
`6/11/2021 Amendments to Claims from Certified File History of U.S. Patent
`31
`No. 11,104,715 (RGN-EYLEA-MYLAN-00033673-79)
`
`
`6/1/2021 Examiner Interview Summary from Certified File History of U.S.
`30
`Patent No. 11,104,715 (RGN-EYLEA-MYLAN-0003367 1-72)
`
`
`5/25/16 Certificate Extending Patent Term from Certified File History of U.S.
`Patent No. 7,070,959 (RGN-EYLEA-MYLAN-00048524-25)
`(“959 PTE
`33
`Certificate’)
`
`
`
`34 Email from H. Salmen to Regeneron, dated November 11, 2022
`
`
`
`
`
`
`
`
`
`35 Email from A. Argall to Mylan, dated November 14, 2022
`
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc., 7PR2022-01226, Paper 19
`36 (P.T.A.B. Nov.14, 2022)
`
`
`
`
`
`37 US. Patent No. 10,464,992
`
`File History of U.S. Application No. 90/014,448, 4/1/2020 Grant of
`38 Reexamination Request for U.S. Patent No. 10,464,992
`
`
`
`Celltrion, Inc. v. Regeneron Pharms., Inc., PGR2021-00117, Paper 1 (P.T.A.B.
`39 Sept. 7, 2021)
`
`
`
`
`
`40 Email from T. Fletcher to Mylan, dated November 14, 2022
`
`4]
`
`Regeneron BLA No. 125387, Section 2.5 Clinical Overview (RGN-EYLEA-
`MYLAN-0028047 1-517)
`
`Certified U.S. Patent No. 11,299,532 (RGN-EYLEA-MYLAN-00041 136-331)
`43 (“532 patent”)
`
`
`
`Florian Krattenmacher, Beyond Chemically Defined—-Characterization of
`
`
`
`Loyd V. Allen, Jr. et al., Dosage Form Design: Pharmaceutical and
`Formulation Considerations, in ANSEL’S PHARMACEUTICAL DOSAGE FORMS
`44
`AND DRUG DELIVERY SYSTEMS92 (8th ed. 2005) (““Ansel’s 2005”)
`
`45
`
`Vil
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 9 of 42 PageID #: 47478
`Case 1:22-cv-00061-TSK-JPM Document 610 Filed 09/01/23 Page 9 of 42 PagelD #: 47478
`
`
`
`
`
`
`
`Chemically Defined Cell Culture Mediumforthe Cultivation ofCHO Cells(Dec.
`2019) (Doctoral thesis, Bielefeld University) from Certified File History of U.S.
`Patent
`No.
`11,053,280
`(RGN-EYLEA-MYLAN-00027425-634)
`(“Krattenmacher’’)
`
`
`
`46 U.S. Publication No. 2018/0223249 (MYL-AFL0001496-5 13) (‘Johnson’)
`
`Ryan J. Graham et al., Consequences of Trace Metal Variability and
`Supplementation on CHO Cell Culture Performance: A Review of Key
`Mechanisms and Considerations, 116 BIOTECH. AND BIOENGINEERING 3446
`(2019) from Certified File History of U.S. Patent No. 11,053,280 (RGN-
`EYLEA-MYLAN-00027635-71)
`
`47
`
`
`
`48 Eylea Label, dated May 2017
`
`Pardeep K. Gupta, Solutions and Phase Equilibria, in REMINGTON THE SCIENCE
`AND PRACTICE OF PHARMACY 211 (David B. Troy ed. 2006) (“Remington
`49
`2006”)
`
`in MARTIN’S
`Patrick J. Sinko, Solubility and Distribution Phenomena,
`PHYSICAL PHARMACY AND PHARMACEUTICAL SCIENCES 331 (Sth ed. 2006)
`50
`(“Martin’s 2006”)
`
`PHARMACEUTICAL
`in
`Joanne Broadhead, Parenteral Dosage Forms,
`PREFORMULATION AND FORMULATION 331
`(Mark Gibson ed.
`2004)
`$1
`(“Broadhead 2004”)
`
`Samuel H. Yalkowsky et al., In Vitro Method for Detecting Precipitation of
`Parenteral Formulations After Injection, 72 J. PHARM. Scr. 1014 (1983)
`52
`(“Yalkowsky 1983”)
`
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`in
`Theodore W. Randolph & LaToya S. Jones, Surfactant-Protein Interactions,
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`55
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`56
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`Dave A. Parkins & Ulla T. Lashmar, The Formulation of Biopharmaceutical
`Products, in 3 PHARMACEUTICAL SCIENCE & TECHNOLOGY TODAY 129 (Debbie
`Tranter ed., 2000) (see also RGN-EYLEA-MYLAN-00015789-97) (“Parkins
`
`Vill
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