P aperN o.__
`D ate Filed :September25,2017
`
`Filed On Behalf Of:
`N ovartis A G
`
`By:
`N icholas N .Kallas
`N Kallas@ fchs.com
`ZortressA finitorIP R@ fchs.com
`(212)218 -2100
`
`UN ITED STA TES P A TEN T A N D TRA D EM A RK O FFIC E
`
`B EFO RE TH E P A TEN T TRIA L A N D A P P EA L B O A RD
`
`P A R P H A RM A C EUTIC A L ,IN C .,
`
`P etitioner,
`
`v.
`
`N O V A RTIS A G,
`
`P atentO wner.
`
`C ase IP R2016-0147 9
`
`P atentN o.9,006,224
`
`NOVARTIS’S MOTION TO EXCLUDE
`
`
`D ate Filed :September25,2017
`
`Filed On Behalf Of:
`N ovartis A G
`
`By:
`N icholas N .Kallas
`N Kallas@ fchs.com
`ZortressA finitorIP R@ fchs.com
`(212)218 -2100
`
`UN ITED STA TES P A TEN T A N D TRA D EM A RK O FFIC E
`
`B EFO RE TH E P A TEN T TRIA L A N D A P P EA L B O A RD
`
`P A R P H A RM A C EUTIC A L ,IN C .,
`
`P etitioner,
`
`v.
`
`N O V A RTIS A G,
`
`P atentO wner.
`
`C ase IP R2016-0147 9
`
`P atentN o.9,006,224
`
`NOVARTIS’S MOTION TO EXCLUDE
`
`
`
`TABLE OF CONTENTS
`
`I. IN TRO D UC TIO N ...............................................................................................1
`
`II. A RGUM EN T.......................................................................................................2
`
`A . D r.Ratain’s D eclarations Shou ld B e Exclu d ed Und er
`F.R.E.7 02 B ecau se H e Is N otA n ExpertIn The Relevant
`A rt..........................................................................................................2
`
`B . Exhibits N otC ited In P ar’s P etition O rReplyShou ld B e
`Exclu d ed Und erF.R.E.402 A nd 403A nd 37 C .F.R.§ §
`42.6(a)(3)A nd 42.24 A s A n ImproperIncorporation B y
`Reference A nd A V iolation O f The W ord L imitFor
`P etitions A nd Replies............................................................................6
`
`C . A nyO therEvid ence N otInclu d ed In Grou nd s 1-4
`P rovisionallyShou ld B e Exclu d ed Und erF.R.E.402,35
`U.S.C .§ 312(a)(3)A nd 37 C .F.R.§ 42.104(b).....................................8
`
`D . O therP ortions O f D r.Ku lke’s Testimony O u ghtTo B e
`C onsid ered Und erF.R.E.106 B ecau se The C itations To
`D r.Ku lke’s Testimony In The P aragraphs O f D r.
`Ratain’s Su pplementalD eclaration A re Incomplete A nd
`M islead ing.............................................................................................9
`
`III.C O N C L USIO N .................................................................................................14
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Costco Wholesale Corp. v. Robert Bosch LLC,IP R2016-00041,P aper
`7 0 (P .T.A .B .A pril12,2017 )...........................................................................5
`Daubert v. Merrell Dow Pharms., Inc.,509 U.S.57 9 (1993)...................................4
`Extreme Networks, Inc. v. Enterasys Networks, Inc.,395F.A pp’x 7 09
`(Fed .C ir.2010)................................................................................................4
`Fidelity Nat’l Info. Servs., Inc. v. DataTreasury Corp.,
`IP R2014-00490,P aper9 (P .T.A .B .A u g.13,2014)....................................7 ,8
`Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc.,8 25F.3d
`1360 (Fed .C ir.2016).......................................................................................9
`Hamilton Beach Brands, Inc. v. Courtesy Prods. LLC,IP R2014-
`01260,P aper11 (P .T.A .B .Feb.25,2015)..................................................7 ,8
`In re NuVasive, Inc.,8 41 F.3d 966 (Fed .C ir.2016).................................................8
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd,
`IP R2013-00517 ,P aper8 7 at14-16 (P .T.A .B .Feb.11,2015)........................7
`Schott Gemtron Corp. v. SSW Holding Co.,IP R2013-00358 ,P aper
`106 (P .T.A .B .A u g.20,2014),aff’d per curiam,612 F.A pp’x
`614 (Fed .C ir.2015).........................................................................................5
`Seaman v. Seacor Marine L.L.C.,326 F.A pp’x 7 21 (5thC ir.2009).......................4
`Williams v. Michelin N. Am., Inc.,38 1 F.Su pp.2d 1351 (M .D .Fla.
`2005)................................................................................................................4
`Statutes
`
`35U.S.C .§ 312(a)(3).................................................................................................2
`Rules
`
`F.R.E.106.......................................................................................................2,9,12
`
`ii
`
`
`
`F.R.E.402 .....................................................................................................1,2,6,8
`F.R.E. 402 ..................................................................................................... 1, 2, 6, 8
`F.R.E.403.........................................................................................................1,6,8
`F.R.E. 403 ......................................................................................................... 1, 6, 8
`F.R.E.7 02 .....................................................................................................1,2,4,5
`F.R.E. 702 ..................................................................................................... 1, 2, 4, 5
`Regulations
`Regulations
`
`37 C .F.R.§ 42.104(b)............................................................................................2,8
`37 CPR. § 42.104(b) ............................................................................................ 2, 8
`37 C .F.R.§ 42.24.......................................................................................................6
`37 CPR. § 42.24 ....................................................................................................... 6
`37 C .F.R.§ 42.6(a)(3)...................................................................................1,6,7 ,8
`37 CPR. § 42.6(a)(3) ................................................................................... 1, 6, 7, 8
`
`iii
`
`iii
`
`
`
`I.
`
`INTRODUCTION
`
`N ovartis moves to exclu d e:
`
`A . Und erF.R.E.7 02,D r.Ratain’s d eclarations (Exs.1003,1119),
`
`becau se D r.Ratain is notan expertin the relevanttechnology.See IP R2016-
`
`0147 9,P aper11,p.3;P aper24,p.5.
`
`B . Und erF.R.E.402 and 403and 37 C .F.R.§ § 42.6(a)(3)and 42.24,the
`
`exhibits filed byP ar(Exs.1004,1007 ,1008 ,1010,1016,1019,1021,1022,1024,
`
`1025,1026,1030,1032,1040,1050,1053,1055,1060,1062,1064,1066,1067 ,
`
`1068 ,1069,107 1,107 2,107 3,107 5,107 7 ,107 8 ,107 9,108 1,108 2,108 3,108 5,
`
`108 9,1090,1091,1097 ,1098 ,1100,1101,1102,1104,1106,1107 ,1108 ,1109,
`
`1111,1114,1116,1118 ,1120,1121,1122)and the paragraphs of D r.Ratain’s
`
`d eclarations (Ex.1003¶ ¶ 1,2,3,4,5,6,7 ,8 ,9,10,11,12,13,14,15,16,17 ,18 ,
`
`19,22,23,24,25,26,27 ,28 ,29,30,38 ,39,40,41,42,43,44,45,46,47 ,48 ,50,
`
`51,52,54,58 ,61,64,68 ,93,95,109,124,128 ,144,145,147 ,148 ,154,155,158 ,
`
`17 5;Ex.1119 ¶ ¶ 17 ,18 ,19,20,21,22,23,24,25,26,48 ,53,54,55,56,57 ,7 2)
`
`notcited in P ar’s P etition orReply,becau se theirrelevance was notd iscu ssed in
`
`the P etition orReply,and /orbecau se P ar’s reliance on them constitu tes an
`
`improperincorporation byreference and violates the word limits forpetitions and
`
`replies.See IP R2016-0147 9,P aper11,pp.1,2-3,4;P aper24,pp.1,3-4 & n.1,6;
`
`Ex.107 0 at7 0:8 -7 1:17 ,112:17 -113:6.
`
`1
`
`
`
`C . Und erF.R.E.402,35U.S.C .§ 312(a)(3),and 37 C .F.R.§ 42.104(b),
`
`anyevid ence thatd oes notappearin the institu ted Grou nd s bu tthatP arseeks to
`
`relyu pon to establishits prima facie obviou sness case.See IP R2016-0147 9,P aper
`
`11,pp.15-16;P aper24,pp.4,8 -9.
`
`N ovartis fu rthermoves u nd erF.R.E.106 to introd u ce portions of its expert
`
`D r.Ku lke’s testimony thatin fairness shou ld be consid ered becau se citations in the
`
`paragraphs of D r.Ratain’s su pplementald eclaration to D r.Ku lke’s d eposition
`
`testimony(Ex.1119 ¶ ¶ 7 ,8 ,12,45,60,66,7 1,7 2,7 7 ,8 0,8 2,91,92,citing Ex.
`
`107 0)and D r.Ku lke’s priortrialtestimony (Ex.1119 ¶ ¶ 7 0,91,citing Ex.1095)
`
`are incomplete and mislead ing.See IP R2016-0147 9,P aper24,pp.7 -8 .
`
`II.
`
`ARGUMENT
`
`A.
`
`Dr. Ratain’s Declarations Should Be Excluded Under
`F.R.E. 702 Because He Is Not An Expert In The Relevant Art
`
`The ’224 patent-in-su itclaims method s u singeverolimu s to treataspecific
`
`type of neu roend ocrine tu mor(“N ET”)— an ad vanced pancreatic neu roend ocrine
`
`tu mor(“P N ET”)— afterfailu re of cytotoxic chemotherapy.The relevantpriority
`
`d ate forthe ’224 patentis N ovember2005.In N ovember2005,N ETs were known
`
`to constitu te an u nu su alfamilyof d istincttu mors,and as the priorartexpressly
`
`recognized ,rare tu mors like P N ETs presented ad iagnostic and therapeu tic
`
`challenge fornon-specialized physicians.Ex.1052 at94-95;IP R2016-0147 9,
`
`2
`
`
`
`P aper17 ,pp.4-5.Specialized expertise withP N ET treatmentthu s is anecessary
`
`elementof anyexpert’s qu alifications in this proceed ing.
`
`P ar’s expertD r.Ratain ad mits thathe d oes not“have anyspecialexpertise
`
`in P N ET [tod ay],nord id [he] in 2005.”Ex.2040 at304:8 -9;see also Ex.2024 at
`
`995:13-19.A td eposition,D r.Ratain cou ld notid entifyany jou rnalarticle thathe
`
`pu blished on P N ETs,and confirmed thatbefore N ovember2005he had notbeen a
`
`principalinvestigatorforanyclinicaltrialin N ET orP N ET patients.Ex.2040 at
`
`295:13-19,301:8 -13.N oris there anyevid ence thatas oftod ayD r.Ratain has
`
`been aprincipalinvestigatorforanyclinicaltrialfocu sed on treatingN ET or
`
`P N ET patients.
`
`A lthou ghD r.Ratain athis A pril17 ,2017 d eposition claimed to have been
`
`involved in one P hase IIclinicaltrialinvolvingN ET patients before N ovember
`
`2005(Ex.2040 at295:20-296:11),none ofthe pu blications he au thored concerning
`
`thattrialmentions N ET orP N ET patients.Exs.2101-2103.A nd athis A u gu st28 ,
`
`2017 d eposition,D r.Ratain fu rtherconfirmed thatnone of the pu blications cited in
`
`his su pplementald eclaration in d efense ofhis qu alifications (Ex.1119 ¶ ¶ 10-12)
`
`rebu tthe factthatin N ovember2005,he lacked specialized N ET and P N ET
`
`expertise,and stilltod ay,he d oes nothave specialized N ET orP N ET knowled ge.
`
`Specifically,D r.Ratain ad mitted thathe d id notrecalltreatinganyP N ET patients
`
`in the stu d yd escribed in Ex.1106 (Ex.2111 at146:8 -24);thatExs.108 2 and 108 3
`
`3
`
`
`
`d o notd isclose whetheranypatients from the stu d ies d escribed therein had N ETs
`
`orP N ETs (Ex.2111 at259:21-260:14,260:23-261:13);Ex.1108 d id notd isclose
`
`whetherthe one enrolled N ET patientmentioned in D r.Ratain’s d eclaration (Ex.
`
`1119 ¶ 11)had aP N ET and D r.Ratain d id nottreatthatone N ET patient
`
`mentioned in Ex.1108 (Ex.2111 at262:3-17 ,264:13-19);and thatthe stu d ies
`
`d escribed in Exs.108 2,108 3,and 1108 d id notassess the efficacy of the treatment
`
`of N ETs u singthe experimentald ru gA P 2357 3(Ex.2111 at266:17 -20).1
`
`P arbears the bu rd en of provingthe ad missibilityof D r.Ratain’s opinions
`
`u nd erF.R.E.7 02.Daubert v. Merrell Dow Pharms., Inc.,509 U.S.57 9,592 n.10
`
`(1993).F.R.E.7 02 requ ires an expertwitness to have “knowled ge,skill,
`
`experience,training,ored u cation”in the relevanttechnology.D r.Ratain,byhis
`
`own ad mission,tod aylacks the relevantknowled ge,skill,experience,training,or
`
`ed u cation concerningthe relevanttechnologyhere:P N ETs.H is pu rported general
`
`expertise in oncologycannotrectifythatd eficiency— particu larly where the patent
`
`1 W hile D r.Ratain claimed to have been involved in P hase Iclinicaltrials
`
`involvingN ET patients (Ex.2040 at295:20-296:2;Ex.1119 ¶ 10),he has notcited
`
`anyevid ence ofthose trials (otherthan Exs.108 2,108 3,and 1108 ,whichd o not
`
`d emonstrate expertise in N ETs orP N ETs)orthathe has personallytreated N ET or
`
`P N ET patients.
`
`4
`
`
`
`claims atissu e here are specific to the treatmentof P N ETs.See Extreme Networks,
`
`Inc. v. Enterasys Networks, Inc.,395F.A pp’x 7 09,7 15(Fed .C ir.2010)(“General
`
`experience in arelated field may notsu ffice when experience and skillin specific
`
`prod u ctd esign are necessaryto resolve patentissu es.”);Seaman v. Seacor Marine
`
`L.L.C.,326 F.A pp’x 7 21,7 25(5thC ir.2009)(affirmingd istrictcou rt’s exclu sion
`
`of oncologist’s experttestimonyconcerningcau se ofplaintiff’s blad d ercancer
`
`where oncologisthad no “particu larexpertise withblad d ercancerand its cau ses”);
`
`Williams v. Michelin N. Am., Inc.,38 1 F.Su pp.2d 1351,1360-63(M .D .Fla.2005)
`
`(exclu d ingexpert’s testimonyconcerningthe prevention oftread separation in
`
`steel-belted rad ialtires where his expertise layin the realm of metallu rgyrather
`
`than tire d esign).Forthatreason,D r.Ratain’s d eclarations (Exs.1003,1119)
`
`shou ld be exclu d ed u nd erF.R.E.7 02.
`
`If the B oard is notinclined to exclu d e D r.Ratain’s d eclarations,N ovartis
`
`alternatelyasks thatthe B oard accord D r.Ratain’s d eclarations little weightin
`
`view of his lackof P N ET expertise.See Costco Wholesale Corp. v. Robert Bosch
`
`LLC,IP R2016-00041,P aper7 0 at20 (P .T.A .B .A pril12,2017 )(d ecliningto cred it
`
`experttestimonyin partbecau se his experience d id notinclu d e the specific
`
`technologyatissu e and “provid e[d ] little insightinto the knowled ge of a
`
`[P O SA ]”);Schott Gemtron Corp. v. SSW Holding Co.,IP R2013-00358 ,P aper106
`
`at17 -18 (P .T.A .B .A u g.20,2014)(accord ingexpert’s testimony less weightwhere
`
`5
`
`
`
`witness d id notqu alify as aP O SA eitheratthe time of the invention orthe
`
`proceed ing),aff’d per curiam,612 F.A pp’x 614 (Fed .C ir.2015).
`
`In particu lar,D r.Ratain’s opinions failto accou ntforthe u niqu e clinical
`
`challenges presented byad vanced P N ETs afterfailu re of cytotoxic chemotherapy
`
`in N ovember2005.E.g.,IP R2016-0147 9,P aper17 ,pp.13-15.H e wrongly
`
`conclu d ed thattemsirolimu s effectivelytreated ad vanced P N ETs afterfailu re of
`
`cytotoxic chemotherapybased on the D u ran interim observations.Id. at48 -52.
`
`A nd he wronglyconclu d ed thataP O SA wou ld have reasonably expected
`
`rapamycin to effectivelytreatad vanced P N ETs afterfailu re ofcytotoxic
`
`chemotherapybased on Öberg2004 and its assertion thatclinicaltrials in
`
`u nspecified tu mors were “planned .”Ex.1119 ¶ 67 ;IP R2016-0147 9,P aper34,pp.
`
`7 -8 .
`
`B.
`
`Exhibits Not Cited In Par’s Petition Or Reply Should
`Be Excluded Under F.R.E. 402 And 403 And 37 C.F.R. §§
`42.6(a)(3) And 42.24 As An Improper Incorporation By Reference
`And A Violation Of The Word Limit For Petitions And Replies
`
`P ar’s P etition and Replyfailto cite the majorityof exhibits thatP arhas filed
`
`in this IP R,i.e.,Exs.1004,1007 ,1008 ,1010,1016,1019,1021,1022,1024,1025,
`
`1026,1030,1032,1040,1050,1053,1055,1060,1062,1064,1066,1067 ,1068 ,
`
`1069,107 1,107 2,107 3,107 5,107 7 ,107 8 ,107 9,108 1,108 2,108 3,108 5,108 9,
`
`1090,1091,1097 ,1098 ,1100,1101,1102,1104,1106,1107 ,1108 ,1109,1111,
`
`1114,1116,1118 ,1120,1121,1122.P ar’s P etition and Replyalso failto cite
`
`6
`
`
`
`severalparagraphs ofD r.Ratain’s d eclarations,i.e.,Ex.1003¶ ¶ 1,2,3,4,5,6,7 ,
`
`8 ,9,10,11,12,13,14,15,16,17 ,18 ,19,22,23,24,25,26,27 ,28 ,29,30,38 ,39,
`
`40,41,42,43,44,45,46,47 ,48 ,50,51,52,54,58 ,61,64,68 ,93,95,109,124,
`
`128 ,144,145,147 ,148 ,154,155,158 ,17 5;Ex.1119 ¶ ¶ 17 ,18 ,19,20,21,22,23,
`
`24,25,26,48 ,53,54,55,56,57 ,7 2.
`
`P ar’s P etition is 12,329 word s and its Reply is 5,47 9 word s,close to the
`
`respective 14,000-and 5,600-word limits forpetitions and replies.37 C .F.R.§
`
`42.24.Itis apparentthatP arran ou tof space in its P etition and Replyeven to cite
`
`the above-mentioned exhibits and paragraphs,letalone to explain theirrelevance.
`
`Insofaras P arseeks to relyon those u ncited materials in this proceed ing,su ch
`
`reliance constitu tes an improperincorporation byreference u nd er37 C .F.R.
`
`§ 42.6(a)(3)and aviolation of the word limits of37 C .F.R.§ 42.24.See Intelligent
`
`Bio-Sys., Inc. v. Illumina Cambridge Ltd,IP R2013-00517 ,P aper8 7 at14-16
`
`(P .T.A .B .Feb.11,2015)(“N one of the extensive reasoningoranalysis orevid ence
`
`cited in [petitioner’s replyexpertd eclaration] appears in the Reply,however.
`
`A ccord ingly,the Replyalso d oes notcomplywith37 C .F.R.§ 42.6(a)(3),which
`
`states that‘[a]rgu ments mu stnotbe incorporated byreference from one d ocu ment
`
`into anotherd ocu ment.’”);Hamilton Beach Brands, Inc. v. Courtesy Prods., LLC,
`
`IP R2014-01260,P aper11 at7 ,11 (P .T.A .B .Feb.25,2015)(“W ithou tasu fficient
`
`explanation whyL iu and relevanthospitalityind u stryregu lations wou ld rend er
`
`7
`
`
`
`obviou s the preamble of claim 1,the citations to the Krau se and Slocu m
`
`D eclarations amou ntto incorporation byreference of argu ments mad e in those
`
`d eclarations thatcircu mventthe page limits thatapplyto petitions.”);Fidelity Nat’l
`
`Info. Servs., Inc. v. DataTreasury Corp.,IP R2014-00490,P aper9 at11 (P .T.A .B .
`
`A u g.13,2014)(“[T]he P etition’s extensive reliance on citations to the Gray
`
`D eclaration in lieu ofcitations to the references themselves amou nts to an
`
`incorporation byreference of argu ments mad e in the GrayD eclaration into the
`
`P etition,therebycircu mventingthe page limits thatapplyto petitions.W e,
`
`therefore,d ecline to consid erthe information fou nd onlyin the Gray
`
`D eclaration.”).2 Forthose reasons,P ar’s u ncited materials shou ld be exclu d ed
`
`u nd erF.R.E.402 and 403,and 37 C .F.R.§ § 42.6(a)(3)and 42.24.
`
`C.
`
`Any Other Evidence Not Included In
`Grounds 1-4 Provisionally Should Be Excluded Under
`F.R.E. 402, 35 U.S.C. § 312(a)(3) And 37 C.F.R. § 42.104(b)
`
`N ovartis provisionally moves to exclu d e u nd erF.R.E.402,35U.S.C .
`
`§ 312(a)(3)and 37 C .F.R.§ 42.104(b)anyevid ence thatd oes notappearin
`
`2 In Hamilton and Fidelity,the B oard d eclined to consid erportions of expert
`
`d eclarations thathad been cited — albeitnotexplained — bythe petitioner.H ere,by
`
`contrast,P ard id noteven botherto cite the above-mentioned exhibits and
`
`paragraphs of D r.Ratain’s d eclarations.
`
`8
`
`
`
`institu ted Grou nd s 1-4 thatP armayrelyu pon to establishanyelementoftheir
`
`prima facie case againstclaims 1-3of the ’224 patent(otherthan evid ence u sed for
`
`the limited pu rposes of d escribingthe state of the artorreinforcingthe meaningof
`
`apriorartreference thatappears in Grou nd s 1-4).In re NuVasive, Inc.,8 41 F.3d
`
`966,97 2-7 3(Fed .C ir.2016)(B oard abu sed its d iscretion byrelyingon portion of
`
`priorartreference firstid entified bypetitionerin its reply,whichportion d id not
`
`merelyd escribe the state of the art,bu tinstead was the sole priorartd isclosu re of
`
`d ispu ted claim elements relied u pon bythe B oard );Genzyme Therapeutic Prods.
`
`LP v. Biomarin Pharm. Inc.,8 25F.3d 1360,1368 (Fed .C ir.2016)(parties shou ld
`
`move to exclu d e areference notcited in institu ted grou nd s).
`
`D.
`
`Other Portions Of Dr. Kulke’s Testimony Ought To Be
`Considered Under F.R.E. 106 Because The Citations To
`Dr. Kulke’s Testimony In The Paragraphs Of Dr. Ratain’s
`Supplemental Declaration Are Incomplete And Misleading
`
`C ertain paragraphs ofD r.Ratain’s su pplementald eclaration (Ex.1119 ¶ ¶ 7 ,
`
`8 ,12,45,60,66,7 0,7 1,7 7 ,8 0,8 2,91,92)cite portions of D r.Ku lke’s Ju ly12,
`
`2017 d eposition testimony(Ex.107 0)orD r.Ku lke’s testimony in the Su tent
`
`litigation (Ex.1095),bu tomitfollow-u panswers and othertestimonythatin
`
`fairness ou ghtto be consid ered in connection withthe cited portions.
`
`Forexample,in Ex.1119 ¶ 12,D r.Ratain asserts thatD r.Ku lke
`
`“acknowled ged thatexpertise in N ETs inclu d es analysis of clinicald ataon the
`
`9
`
`
`
`treatmentof N ETs”and thu s,D r.Ratain claimed to have expertise in N ETs by
`
`virtu e ofhavingco-au thored Ex.1106.3 H owever,D r.Ku lke in facttestified that
`
`“specializing”in the treatmentof N ETs,inclu d ingP N ETs,“wou ld mean having
`
`some experience in treatingpatients withthese tu mors and an interestin treating
`
`patients withthese tu mors”(Ex.107 0 at46:17 -47 :5),and thatqu alification as a
`
`specialistin P N ETs requ ires a“[c]ombination of knowled ge,experience,interest”
`
`(Ex.107 0 at49:12-50:4);analysis of clinicald ataon the treatmentof N ETs “cou ld
`
`be p art of it”(Ex.107 0 at51:8 -18 (emphasis ad d ed )).
`
`L ikewise,in Ex.1119 ¶ 60,D r.Ratain asserts thatD r.Ku lke testified that“it
`
`wou ld be d ifficu ltto eliminate anyof the possibilities”involved in the oncogenesis
`
`orprogression of P N ETs and thathe agreed withD r.Ku lke thataP O SA wou ld not
`
`have eliminated P TEN as beingrelevantto P N ETs.H owever,D r.Ku lke in fact
`
`testified that“the molecu larevents in P N ETs as of 2005were poorlyu nd erstood ”
`
`and itwas becau se ofthis lackofu nd erstand ingthat“itwou ld have been d ifficu lt
`
`to eliminate any”of the possible cau ses ofP N ETs.Ex.107 0 at120:15-16,120:24-
`
`3 Ex.1106 is aone-page letterto ajou rnalthatd iscu ssed resu lts of aclinicaltrialin
`
`N ETs,withwhichD r.Ratain was notpersonallyinvolved ,pu blished afterthe
`
`priorityd ate ofthe ’224 patent,and thatd rew conclu sions abou tclinicaltrial
`
`d esign.Ex.2111 at144:10-144:24,146:8 -24.
`
`10
`
`
`
`121:19 (“To the extentthatthe molecu larevents were poorlyu nd erstood ,itwou ld
`
`have been d ifficu ltto eliminate anyof those possibilities.H owever,the available
`
`d atad id notstrongly implicate P TEN in the pathogenesis.”).
`
`F.R.E.106 provid es that“[i]f apartyintrod u ces allorpartof awritingor
`
`record ed statement,an ad verse party may requ ire the introd u ction,atthattime,of
`
`anyotherpart— oranyotherwritingorrecord ed statement— thatin fairness
`
`ou ghtto be consid ered atthe same time.”N ovartis asks thatthe B oard ,pu rsu antto
`
`F.R.E.106,consid erthe followingportions of Ex.107 0 in connection withthe
`
`paragraphs of D r.Ratain’s su pplementald eclaration:
`
` ForEx.1119 ¶ ¶ 7 -8 — Ex.107 0 at46:17 -47 :5,49:12-50:4,50:19-
`
`51:7 ,17 2:7 -21 (explainingthataP O SA shou ld have specialized
`
`experience in treatingN ETs and P N ETs);
`
` ForEx.1119 ¶ 12— Ex.107 0 at46:17 -47 :5,49:12-50:4
`
`(explainingthataP O SA wou ld have acombination ofknowled ge,
`
`experience,and interestin treatingN ETs,inclu d ingP N ETs,and
`
`thatapre-2005analysis of clinicald atain N ETs alone cou ld be
`
`part,bu tnotthe totality,of aP O SA ’s experience);
`
` ForEx.1119 ¶ 45— Ex.107 0 at62:21-63:14,65:15-66:7 ,67 :17 -
`
`68 :20,69:19-7 0:2 (explainingthat,forseveralreasons,C A 20948
`
`11
`
`
`
`is notamod elforP N ET and wou ld notreasonablypred ictefficacy
`
`of everolimu s againstad vanced P N ETs in hu mans);
`
` ForEx.1119 ¶ 60— Ex.107 0 at120:15-16,120:24-121:9
`
`(clarifyingthatthe oncogenesis of P N ETs and the role of P TEN in
`
`su choncogenesis were poorlyu nd erstood );
`
` ForEx.1119 ¶ 66— Ex.107 0 at134:8 -18 (notingthatD r.Öberg
`
`d isclosed clinicaltrialresponse rates in excess of30% for
`
`rad ioactive somatostatin analogs— aclass of compou nd s aP O SA
`
`wou ld have consid ered more promisingand thatwas more
`
`extensivelystu d ied than everolimu s);
`
` ForEx.1119 ¶ 7 1— Ex.107 0 at7 4:22-7 5:5,7 5:25-7 6:17 ,7 7 :2-14,
`
`17 2:7 -21 (notingthatwhetheraparticu lard ru gcan be consid ered
`
`“therapeu ticallyeffective”is context-d epend ent;D r.Ku lke
`
`consid ers ad ru gtherapeu ticallyeffective if the drug is helpingthe
`
`ind ivid u alpatientin the clinic;and in an u ncontrolled clinicaltrial,
`
`aP O SA wou ld notd raw conclu sions abou ttherapeu tic efficacy
`
`based on limited observations becau se aP O SA cannotd etermine if
`
`there is ad ru geffectorthe resu lts are d u e to the natu ralcou rse of
`
`N ETs);
`
`12
`
`
`
` ForEx.1119 ¶ 7 2— Ex.107 0 at139:7 -18 (explainingthatD r.
`
`Ku lke consid ered the available artin forminghis opinions on
`
`u nexpected resu lts);
`
` ForEx.1119 ¶ ¶ 7 7 and 91— Ex.107 0 at8 5:20-25,8 6:9-18 ,8 7 :2-
`
`8 8 :20 (explainingthateverolimu s improved progression-free
`
`su rvival(P FS)in the RA D IA N T-3P N ET clinicaltrial);
`
` ForEx.1119 ¶ 8 0— Ex.107 0 at160:11-161:10 (clarifyingthatin
`
`2011,D r.Ku lke had in aslid eshow id entified temsirolimu s as a
`
`therapythathad been te ste d in N ETs);
`
` ForEx.1119 ¶ 8 2— Ex.107 0 at167 :14-169:25(explainingthatthe
`
`RA D IA N T-3P N ET clinicaltrialand Y ao 2011 (Ex.2022)
`
`d emonstrated thateverolimu s is safe and effective withorwithou t
`
`concu rrentsomatostatin therapy);
`
` ForEx.1119 ¶ 92— Ex.107 0 at8 5:20-25(explainingthat
`
`everolimu s improved progression-free su rvival(P FS)in the
`
`RA D IA N T-3P N ET clinicaltrial).
`
`N ovartis fu rtherasks thatthe B oard ,pu rsu antto F.R.E.106,consid erthe
`
`followingportions ofEx.1095in connection withthe paragraphs of D r.Ratain’s
`
`su pplementald eclaration:
`
`13
`
`
`
` ForEx.1119 ¶ 7 0— Ex.1095at7 90:7 -7 91:5(d escribingthe P hase
`
`IIIclinicaltrialthatclearlyd emonstrated the clinicalefficacyof
`
`Su tent(su nitinib)in ad vanced P N ETs,followingthe P hase Itrial
`
`(withthe “d isbelief”thatsu nitinib had cau sed tu morshrinkage or
`
`stable d isease)and the P hase IItrial);
`
` ForEx.1119 ¶ 91— Ex.1095at7 91:21-7 92:15(explainingthat
`
`botheverolimu s and su nitinib are effective forthe treatmentof
`
`ad vanced P N ETs).
`
`III. CONCLUSION
`
`Forthe foregoingreasons,the materials id entified herein shou ld be exclu d ed
`
`and the ad d itionalportions of Exs.107 0 and 1095id entified herein shou ld be
`
`consid ered in connection withEx.1119.
`
`D ated :September25,2017
`
`Respectfu llysu bmitted ,
`
`/N icholas N .Kallas /
`N icholas N .Kallas
`Registration N o.31,530
`L ead C ou nselforP atentO wner
`FITZP A TRIC K,C EL L A ,H A RP ER
`& SC IN TO
`1290 A venu e ofthe A mericas
`N ew Y ork,N Y 10104-38 00
`Tel.212-218 -2100
`
`14
`
`
`
`CERTIFICATE OF SERVICE
`
`Icertifythatacopyof the foregoingN ovartis’s M otion To Exclu d e was
`
`served on September25,2017 bycau singitto be sentbyemailto cou nselfor
`
`P etitioneratthe followingemailad d resses:
`
`D anielG.B rown (d aniel.brown@ lw.com)
`
`Jonathan M .Strang(jonathan.strang@ lw.com)
`
`B rend aL .D anek(brend a.d anek@ lw.com)
`
`D ated :September25,2017
`
`/N icholas N .Kallas /
`N icholas N .Kallas
`Registration N o.31,530
`L ead C ou nselforP atentO wner
`FITZP A TRIC K,C EL L A ,H A RP ER
`& SC IN TO
`
`1290 A venu e ofthe A mericas
`N ew Y ork,N Y 10104-38 00
`Tel.212-218 -2100
`
`1
`
`
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