(cid:20)(cid:29)(cid:44)(cid:34)(cid:48)(cid:8)(cid:17)(cid:8)(cid:11)(cid:1)(cid:31)(cid:47)(cid:2)(cid:7)(cid:10)(cid:14)(cid:12)(cid:15)(cid:3)(cid:27)(cid:18)(cid:20)(cid:48) (cid:21)(cid:43)(cid:31)(cid:46)(cid:41)(cid:34)(cid:42)(cid:45)(cid:48)(cid:8)(cid:13)(cid:15)(cid:48) (cid:22)(cid:38)(cid:39)(cid:34)(cid:32)(cid:48)(cid:7)(cid:16)(cid:6)(cid:8)(cid:16)(cid:6)(cid:8)(cid:14)(cid:48) (cid:27)(cid:29)(cid:37)(cid:34)(cid:48)(cid:8)(cid:48)(cid:43)(cid:36)(cid:48)(cid:16)(cid:15)(cid:48)
`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 1 of 98
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`}
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`(cid:2)(cid:6)(cid:1)(cid:8)(cid:4)(cid:3)(cid:5)(cid:7)(cid:9)
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`i
`| ELECTRONICALLY BILED ||
`(cid:9)(cid:16)(cid:10)(cid:1)(cid:5)(cid:23)(cid:22)(cid:21)(cid:20)(cid:14)(cid:6)(cid:3)(cid:17)(cid:19)(cid:25)(cid:26)
`
`i
`(cid:4)(cid:5)(cid:3)(cid:1)(cid:2)(cid:6)
`TE FILED: 9/19/2017
`(cid:7)(cid:4)(cid:24)(cid:11)(cid:26)(cid:13)(cid:15)(cid:18)(cid:12)(cid:8)(cid:2)(cid:26) (cid:6)(cid:1)(cid:3)(cid:6)(cid:1)(cid:4)(cid:2)(cid:3)(cid:5)(cid:7)
`AnhHEAofAPONEYASMINSAENOMENmm
`
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`
`(cid:67)(cid:144)(cid:189)(cid:144)(cid:152)(cid:197)(cid:62)(cid:120)(cid:181)(cid:143)(cid:167)(cid:161)(cid:197)(cid:92)(cid:167)(cid:16)(cid:197)(cid:45)(cid:53)(cid:13)(cid:66)(cid:111)(cid:13)(cid:49)(cid:57)(cid:54)(cid:59)(cid:197)(cid:1)(cid:95)(cid:62)(cid:67)(cid:3)(cid:197)
`Civil Action No. 14-CV-2758 (PAC)
`
`(cid:66)(cid:146)(cid:190)(cid:147)(cid:153)(cid:197)(cid:63)(cid:120)(cid:181)(cid:145)(cid:167)(cid:161)(cid:197)(cid:92)(cid:167)(cid:18)(cid:197)(cid:45)(cid:53)(cid:14)(cid:67)(cid:111)(cid:15)(cid:57)(cid:60)(cid:51)(cid:53)(cid:197)(cid:1)(cid:96)(cid:64)(cid:67)(cid:2)(cid:197)
`Civil Action No. 14-CV-7934 (PAC)
`
`(cid:4)(cid:6)(cid:8)(cid:3)(cid:6)(cid:8)(cid:5)(cid:10)(cid:14)(cid:9)(cid:4)(cid:14)(cid:4)(cid:1)(cid:2)(cid:11)(cid:14)(cid:1)(cid:8)(cid:3)(cid:14)
`FINDINGS OF FACT AND
`CONCLUSIONS OF LAW
`(cid:2)(cid:9)(cid:8)(cid:2)(cid:7)(cid:12)(cid:10)(cid:6)(cid:9)(cid:8)(cid:10)(cid:14)(cid:9)(cid:4)(cid:14)(cid:7)(cid:1)(cid:13)(cid:14)
`
`(cid:107)(cid:91)(cid:82)(cid:103)(cid:72)(cid:69)(cid:197)(cid:101)(cid:103)(cid:62)(cid:104)(cid:73)(cid:101)(cid:197)(cid:69)(cid:80)(cid:101)(cid:103)(cid:97)(cid:81)(cid:66)(cid:105)(cid:197)(cid:67)(cid:93)(cid:108)(cid:98)(cid:103)(cid:197)
`UNITED STATES DISTRICT COURT
`(cid:101)(cid:94)(cid:109)(cid:103)(cid:79)(cid:72)(cid:97)(cid:92)(cid:197)(cid:69)(cid:81)(cid:101)(cid:103)(cid:99)(cid:80)(cid:67)(cid:104)(cid:197)(cid:93)(cid:76)(cid:197)(cid:92)(cid:72)(cid:112)(cid:197)(cid:114)(cid:93)(cid:97)(cid:84)(cid:197)
`SOUTHERN DISTRICT OF NEW YORK
`
`(cid:85)(cid:167)(cid:192)(cid:115)(cid:197)(cid:66)(cid:168)(cid:156)(cid:170)(cid:116)(cid:161)(cid:194)(cid:4)(cid:197)(cid:86)(cid:179)(cid:122)(cid:21)(cid:5)(cid:197)(cid:125)(cid:179)(cid:197)(cid:116)(cid:151)(cid:21)(cid:6)(cid:197)
`Kowa Company,Ltd., et al.,
`
`(cid:95)(cid:151)(cid:116)(cid:143)(cid:161)(cid:180)(cid:143)(cid:135)(cid:136)(cid:175)(cid:7)(cid:197)
`Plaintiffs,
`
`(cid:2)(cid:1)(cid:3)
`
`(cid:62)(cid:157)(cid:162)(cid:126)(cid:116)(cid:151)(cid:197)(cid:95)(cid:141)(cid:117)(cid:173)(cid:158)(cid:115)(cid:121)(cid:125)(cid:187)(cid:179)(cid:143)(cid:121)(cid:118)(cid:152)(cid:175)(cid:9)(cid:197)(cid:87)(cid:86)(cid:66)(cid:197)
`Amneal Pharmaceuticals, LLC
`
`(cid:69)(cid:125)(cid:135)(cid:131)(cid:161)(cid:122)(cid:115)(cid:163)(cid:179)(cid:21)(cid:197)
`Defendant.
`
`(cid:84)(cid:169)(cid:192)(cid:117)(cid:197)(cid:68)(cid:167)(cid:158)(cid:170)(cid:116)(cid:161)(cid:194)(cid:8)(cid:197)(cid:86)(cid:179)(cid:122)(cid:17)(cid:9)(cid:197)(cid:125)(cid:182)(cid:197)(cid:115)(cid:152)(cid:20)(cid:10)(cid:197)
`Kowa Company,Ltd., et al.,
`
`Plaintiffs,
`(cid:95)(cid:151)(cid:116)(cid:145)(cid:161)(cid:180)(cid:145)(cid:133)(cid:137)(cid:178)(cid:11)(cid:197)
`
`(cid:2)(cid:1)(cid:3)
`v.
`
`(cid:62)(cid:170)(cid:167)(cid:180)(cid:126)(cid:193)(cid:12)(cid:197)(cid:80)(cid:161)(cid:120)(cid:19)(cid:9)(cid:197)(cid:125)(cid:179)(cid:197)(cid:116)(cid:152)(cid:17)(cid:10)(cid:197)
`Apotens Ine ef als
`
`(cid:69)(cid:127)(cid:138)(cid:161)(cid:123)(cid:117)(cid:161)(cid:181)(cid:175)(cid:20)(cid:197)
`Defendants.
`
`
`
`(cid:10)(cid:1)(cid:2)(cid:6)(cid:4)(cid:11)(cid:8)(cid:5)(cid:11)(cid:3)(cid:8)(cid:7)(cid:10)(cid:4)(cid:7)(cid:10)(cid:9)(cid:11)
`TABLE OF CONTENTS
`(cid:105)(cid:64)(cid:65)(cid:87)(cid:74)(cid:197)(cid:94)(cid:77)(cid:197)(cid:62)(cid:65)(cid:65)(cid:99)(cid:75)(cid:111)(cid:80)(cid:62)(cid:103)(cid:80)(cid:94)(cid:92)(cid:101)(cid:197)
`TABLE OF ABBREVIATIONS
`
`(cid:80)(cid:92)(cid:106)(cid:99)(cid:94)(cid:69)(cid:110)(cid:67)(cid:105)(cid:82)(cid:94)(cid:92)(cid:197)(cid:64)(cid:91)(cid:70)(cid:197)(cid:87)(cid:72)(cid:78)(cid:62)(cid:88)(cid:197)(cid:101)(cid:103)(cid:62)(cid:92)(cid:69)(cid:62)(cid:100)(cid:69)(cid:101)(cid:197)
`INTRODUCTION AND LEGAL STANDARDS
`
`(cid:106)(cid:142)(cid:127)(cid:197)(cid:79)(cid:115)(cid:183)(cid:120)(cid:141)(cid:13)(cid:113)(cid:117)(cid:193)(cid:157)(cid:116)(cid:161)(cid:197)(cid:62)(cid:121)(cid:182)(cid:197)(cid:116)(cid:162)(cid:122)(cid:197)(cid:64)(cid:92)(cid:71)(cid:197)(cid:62)(cid:197)(cid:76)(cid:145)(cid:154)(cid:145)(cid:164)(cid:140)(cid:175)(cid:197)(cid:25)(cid:29)(cid:21)(cid:18)(cid:19)(cid:16)(cid:18)(cid:17)(cid:17)(cid:20)(cid:22)(cid:22)(cid:26)(cid:20)(cid:20)(cid:20)(cid:20)(cid:21)(cid:22)(cid:17)(cid:17)(cid:21)(cid:21)(cid:21)(cid:22)(cid:21)(cid:19)(cid:25)(cid:21)(cid:20)(cid:21)(cid:22)(cid:21)(cid:21)(cid:36)(cid:21)(cid:18)(cid:25)(cid:19)(cid:17)(cid:21)(cid:17)(cid:17)(cid:25)(cid:19)(cid:21)(cid:20)(cid:26)(cid:26)(cid:29)(cid:18)(cid:20)(cid:17)(cid:17)(cid:21)(cid:19)(cid:21)(cid:23)(cid:18)(cid:16)(cid:17)(cid:25)(cid:17)(cid:18)(cid:22)(cid:17)(cid:22)(cid:29)(cid:25)(cid:29)(cid:40)(cid:23)(cid:26)(cid:26)(cid:197)(cid:55)(cid:197)
`(cid:83)(cid:17)
`The Hatch-Waxman Act and ANDA Filing.........cccsssssscssceceseseceesecesseesacsaeeeeeeereeeeeseneneees 5
`I.
`(cid:80)(cid:89)(cid:197) (cid:103)(cid:141)(cid:125)(cid:197)(cid:95)(cid:116)(cid:174)(cid:180)(cid:144)(cid:127)(cid:175)(cid:197)(cid:24)(cid:17)(cid:20)(cid:20)(cid:21)(cid:21)(cid:20)(cid:19)(cid:20)(cid:16)(cid:22)(cid:21)(cid:22)(cid:20)(cid:21)(cid:17)(cid:21)(cid:17)(cid:29)(cid:17)(cid:20)(cid:25)(cid:21)(cid:25)(cid:22)(cid:21)(cid:22)(cid:21)(cid:17)(cid:18)(cid:26)(cid:21)(cid:20)(cid:22)(cid:17)(cid:22)(cid:20)(cid:20)(cid:22)(cid:22)(cid:26)(cid:26)(cid:26)(cid:26)(cid:41)(cid:21)(cid:22)(cid:20)(cid:26)(cid:21)(cid:26)(cid:26)(cid:21)(cid:26)(cid:29)(cid:21)(cid:20)(cid:17)(cid:16)(cid:25)(cid:20)(cid:26)(cid:25)(cid:20)(cid:17)(cid:29)(cid:18)(cid:22)(cid:20)(cid:20)(cid:20)(cid:22)(cid:17)(cid:20)(cid:20)(cid:26)(cid:17)(cid:18)(cid:18)(cid:16)(cid:18)(cid:16)(cid:22)(cid:17)(cid:36)(cid:16)(cid:18)(cid:21)(cid:29)(cid:22)(cid:38)(cid:20)(cid:18)(cid:29)(cid:27)(cid:29)(cid:28)(cid:17)(cid:17)(cid:17)(cid:18)(cid:29)(cid:22)(cid:26)(cid:20)(cid:26)(cid:17)(cid:20)(cid:17)(cid:36)(cid:25)(cid:21)(cid:23)(cid:25)(cid:36)(cid:19)(cid:25)(cid:21)(cid:21)(cid:17)(cid:36)(cid:18)(cid:31)(cid:20)(cid:22)(cid:21)(cid:197)(cid:56)(cid:197)
`TT. The Parties 2.0.0... cececssccssseeesceeseseeeesaceeeceeseaaeeneeeceeeeeaueeaaeeananseeeceacesauaesesesaesecusenaeeesaaseeeeneaeeaees 6
`(cid:90)(cid:145)(cid:189)(cid:115)(cid:152)(cid:168)(cid:1)(cid:2)(cid:21)(cid:20)(cid:21)(cid:20)(cid:20)(cid:22)(cid:21)(cid:21)(cid:17)(cid:17)(cid:22)(cid:21)(cid:26)(cid:26)(cid:21)(cid:17)(cid:17)(cid:26)(cid:21)(cid:22)(cid:26)(cid:22)(cid:26)(cid:25)(cid:21)(cid:22)(cid:21)(cid:19)(cid:20)(cid:20)(cid:21)(cid:19)(cid:19)(cid:18)(cid:20)(cid:21)(cid:19)(cid:22)(cid:22)(cid:18)(cid:21)(cid:17)(cid:20)(cid:22)(cid:22)(cid:22)(cid:25)(cid:30)(cid:17)(cid:20)(cid:25)(cid:22)(cid:17)(cid:21)(cid:18)(cid:18)(cid:17)(cid:29)(cid:21)(cid:21)(cid:20)(cid:17)(cid:25)(cid:20)(cid:22)(cid:22)(cid:17)(cid:17)(cid:25)(cid:18)(cid:18)(cid:18)(cid:22)(cid:25)(cid:18)(cid:25)(cid:25)(cid:19)(cid:18)(cid:21)(cid:26)(cid:17)(cid:20)(cid:22)(cid:20)(cid:17)(cid:18)(cid:17)(cid:18)(cid:20)(cid:21)(cid:22)(cid:16)(cid:17)(cid:20)(cid:26)(cid:21)(cid:17)(cid:17)(cid:19)(cid:19)(cid:21)(cid:21)(cid:25)(cid:28)(cid:31)(cid:29)(cid:20)(cid:21)(cid:21)(cid:25)(cid:25)(cid:26)(cid:20)(cid:21)(cid:26)(cid:21)(cid:26)(cid:26)(cid:17)(cid:17)(cid:17)(cid:22)(cid:22)(cid:25)(cid:26)(cid:21)(cid:20)(cid:21)(cid:197)(cid:58)(cid:197)
`(cid:81)(cid:80)(cid:80)(cid:17)
`TI].
`Livalo® voc cscsescscssssesessessssscsessscsscsessesssscsesscsssscseseesssesscsscsessesesssscssscsessascsncecsussesesseesceeseeseenees 7
`(cid:105)(cid:141)(cid:128)(cid:197)(cid:196)(cid:61)(cid:60)(cid:51)(cid:197)(cid:95)(cid:115)(cid:183)(cid:129)(cid:163)(cid:184)(cid:197)(cid:22)(cid:28)(cid:25)(cid:20)(cid:25)(cid:20)(cid:20)(cid:16)(cid:19)(cid:42)(cid:28)(cid:22)(cid:18)(cid:22)(cid:29)(cid:18)(cid:22)(cid:20)(cid:22)(cid:25)(cid:29)(cid:22)(cid:17)(cid:19)(cid:25)(cid:17)(cid:42)(cid:31)(cid:43)(cid:25)(cid:29)(cid:18)(cid:25)(cid:33)(cid:22)(cid:17)(cid:17)(cid:29)(cid:33)(cid:29)(cid:25)(cid:20)(cid:22)(cid:25)(cid:25)(cid:25)(cid:25)(cid:20)(cid:28)(cid:17)(cid:29)(cid:29)(cid:17)(cid:17)(cid:22)(cid:17)(cid:28)(cid:25)(cid:17)(cid:18)(cid:29)(cid:24)(cid:32)(cid:17)(cid:21)(cid:21)(cid:21)(cid:20)(cid:20)(cid:28)(cid:21)(cid:17)(cid:20)(cid:39)(cid:25)(cid:21)(cid:19)(cid:18)(cid:20)(cid:22)(cid:29)(cid:20)(cid:20)(cid:21)(cid:26)(cid:22)(cid:20)(cid:20)(cid:21)(cid:20)(cid:21)(cid:20)(cid:18)(cid:28)(cid:17)(cid:21)(cid:21)(cid:21)(cid:20)(cid:20)(cid:26)(cid:20)(cid:20)(cid:21)(cid:21)(cid:22)(cid:22)(cid:17)(cid:21)(cid:20)(cid:17)(cid:22)(cid:19)(cid:20)(cid:18)(cid:21)(cid:197)(cid:59)(cid:197)
`(cid:80)(cid:111)(cid:20)
`TV.
`The £993 Patent... cseccscessesesscsseesceceeseeeesescesesessesesceesseseaesaesesesacecseraeeeaeenaeseeeeeesaeseaeeeeaeaeers 8
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`V. The Instant Dispute... ccc ce eeeseceseesceseeseeeaccaessesaeesesseeeseseeaeseseacscecersaceesseeeaseateserseresseeasens 12
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`VI.
`Legal Standards... ecscesssssssesecsseseesecesacecscececeseecsaceecesaesaceseseaeecseenesssaecaetaecaeseaesnenseeaes 13
`(cid:96)(cid:173)(cid:126)(cid:177)(cid:188)(cid:159)(cid:171)(cid:179)(cid:147)(cid:167)(cid:164)(cid:197)(cid:167)(cid:132)(cid:197)(cid:95)(cid:117)(cid:181)(cid:130)(cid:166)(cid:179)(cid:197)(cid:111)(cid:117)(cid:152)(cid:150)(cid:124)(cid:150)(cid:185)(cid:195)(cid:197)(cid:20)(cid:21)(cid:25)(cid:16)(cid:18)(cid:21)(cid:17)(cid:21)(cid:17)(cid:17)(cid:25)(cid:22)(cid:22)(cid:17)(cid:25)(cid:21)(cid:22)(cid:22)(cid:20)(cid:17)(cid:17)(cid:38)(cid:28)(cid:17)(cid:17)(cid:25)(cid:23)(cid:36)(cid:39)(cid:19)(cid:18)(cid:17)(cid:29)(cid:22)(cid:29)(cid:17)(cid:21)(cid:17)(cid:26)(cid:25)(cid:17)(cid:18)(cid:16)(cid:19)(cid:21)(cid:18)(cid:20)(cid:19)(cid:20)(cid:20)(cid:17)(cid:17)(cid:20)(cid:22)(cid:21)(cid:21)(cid:31)(cid:25)(cid:26)(cid:20)(cid:20)(cid:21)(cid:22)(cid:29)(cid:22)(cid:20)(cid:21)(cid:22)(cid:20)(cid:37)(cid:26)(cid:20)(cid:21)(cid:20)(cid:20)(cid:25)(cid:25)(cid:21)(cid:26)(cid:20)(cid:20)(cid:25)(cid:25)(cid:20)(cid:20)(cid:21)(cid:19)(cid:21)(cid:26)(cid:17)(cid:197)(cid:47)(cid:51)(cid:197)
`(cid:115)(cid:26)
`a.
`Presumption of Patent Validity... eee cecseseecsesessseescecesesseseeecaeesssaseeseaseecseseaeeaeeseseateaee 13
`(cid:119)(cid:22) (cid:64)(cid:133)(cid:139)(cid:174)(cid:160)(cid:115)(cid:186)(cid:145)(cid:191)(cid:126)(cid:197)(cid:70)(cid:127)(cid:135)(cid:131)(cid:165)(cid:176)(cid:125)(cid:197)(cid:168)(cid:134)(cid:197)(cid:95)(cid:117)(cid:180)(cid:125)(cid:163)(cid:179)(cid:197)(cid:80)(cid:162)(cid:189)(cid:117)(cid:155)(cid:149)(cid:123)(cid:145)(cid:181)(cid:194)(cid:197)(cid:25)(cid:29)(cid:20)(cid:20)(cid:20)(cid:22)(cid:17)(cid:25)(cid:17)(cid:21)(cid:22)(cid:21)(cid:25)(cid:25)(cid:19)(cid:18)(cid:18)(cid:18)(cid:17)(cid:22)(cid:20)(cid:20)(cid:21)(cid:22)(cid:20)(cid:20)(cid:20)(cid:20)(cid:21)(cid:20)(cid:22)(cid:17)(cid:21)(cid:21)(cid:21)(cid:22)(cid:20)(cid:20)(cid:22)(cid:20)(cid:20)(cid:26)(cid:20)(cid:20)(cid:21)(cid:20)(cid:21)(cid:16)(cid:17)(cid:17)(cid:17)(cid:21)(cid:22)(cid:26)(cid:22)(cid:20)(cid:21)(cid:21)(cid:20)(cid:26)(cid:21)(cid:25)(cid:17)(cid:22)(cid:20)(cid:21)(cid:20)(cid:29)(cid:36)(cid:17)(cid:22)(cid:21)(cid:21)(cid:31)(cid:23)(cid:197)(cid:48)(cid:52)(cid:197)
`b. Affirmative Defense of Patent Invalidity... ec eeseesceceeceeescesceeceeseeeseeeeeceaeeeteeteseeees 13
`(cid:23)(cid:38)(cid:40)(cid:35)(cid:30)(cid:33)(cid:48)(cid:10)(cid:7)(cid:9)(cid:9)(cid:48)
`Gilead 2011
`I-MAK v. Gilead
`(cid:24)(cid:4)(cid:26)(cid:19)(cid:25)(cid:48) (cid:47)(cid:5)(cid:48) (cid:23)(cid:38)(cid:40)(cid:35)(cid:30)(cid:32)(cid:48)
`(cid:24)(cid:27)(cid:28)(cid:10)(cid:7)(cid:9)(cid:15)(cid:4)(cid:7)(cid:7)(cid:19)(cid:16)(cid:7)
`IPR2018-00390
`
`|
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 2 of 98
`
`Ke.
`di;
`
`ARERDRGSRIE ES IGE BES: 108 case cocrnencceconnemnimstsarsiconcmnnrnnoamauamammmmenimmeeramnnie
`Obviousness (35 USC, § 109) sssesscinnsiserisncrncrrreniarcssscseminennnsrieasinnnannaeiee LO
` EeiBvingreametttcnc escoreoececessnrecnen:SieerickGUNASeeesenda 18
`
`@;
`
`i. Claim Construction ......ccccceccesecessesessareereessetecsnracceeeeacncesneerateuacenseeatsesuccsesnecerstnasseeeeene LO
`
`VIL Ceysials atid PolGis ccsscscccosss senissneracnvsanseanorennesicnavcaninanmmannisnamvnnemnanannann ee
`
`Vill.
`
`X-Ray Powder Diffraction and Characterization .........cscccssessssesserssseesscseceesensneseraveestoaee 23
`
`TX
`
`FASGHOI ccrssscrsncsemrarmuuinnnanwacnmemanccncguasin pnyaNRRR ANNIEITE 28
`
`x: Person of Ordinary Skill in the Attn ciciiicnianincnnanamumaiinamemmiancmaanawn 28
`
`KL.
`
`‘Viniiity okthee "29S Patent oncsseccniissseraiissnianst¥eonsrsestiseesardipnsernedbesenenteashtasnstontisianseadttnstaanancee
`
`a.
`
`Anticipation (35 U.S.C. § 102) ceececcseescseeccensestersesesessstessesenenensensesesesesestepseessseneeessatesaceeaeee 29)
`
`ii.
`
`li.
`
`The ‘993 Patent Prosecution History..........cccccscssceessesrecsscscecessesecatessecesenesetterseerteene OL
`
`Defendants’ Inherency Argumentsa siisscccsssccsiscmimscnanisisccmiaassmunnmnnasannedt
`
`iv.
`
`Conclusion Regarding Inherent Anticipation ..............cccccecccssssscssessceassesssensesasseceeeee 40
`
`b. Obviousness(35 U.S.C. § cessesee48
`
`{SVS eIOIAAS SUT BUI AFcccaeecesriencummnamanuncuaneewS®
`
`Scope and Contentof the Prior Art and Differences Between Claimed Subject Matter
`ii
`and the Por Artaccususte.scarananien untenaRaro
`
`iii. Whether Obtaining Form A Would Have Been Obvious to a POSAin 2003............ 52
`
`iv.
`
`v.
`
`Objective Indicia of Nonobviousness (Secondary Considerations) ............cccceecee 39
`
`Conclusion Regarding Obviousness.......csessesonssvenssnsctucensenenosensstecersneenresvenstsserstes 1D
`
`Ci
`
`(CRCHIBTOR: RSGAIING Viave carccsnercrcsacmesrconnesavcissansannnsacusuansarestenensauartnebaacampasdatsnnnaces 75
`
`ALL
`
`infkingeient Ol the 993 Patent ciscesscsswrsessnas socsnccvcansencsceccasasecrestaneueciootvenjgiecevossvensciwns 76
`
`a Step One: Construiig the Assorted Clainiss.ccsncsincnninnaunwancaniamurnaratees a4
`
`i. Claims 1 and 24: “exhibits a characteristic x-ray diffraction pattern with characteristic
`peaks expressed in 20 at...” wee SidenapNd hanaankeaR neeiene OES 77
`
`ii.
`
`Claims 23 and 25: “having an x-ray powderdiffraction pattern substantially as
`
`b.
`
`Step Two: Comparison of Asserted Claims to Apotex’s Proposed ANDA Product......... 81
`
`i,
`
`-Apotex’s Proposed ANDA Produtel cnccocseesecsescansncereanavesnseneusvatsnscarsanieaneaneurenragossvenssse OL
`
`ii;
`
`ii.
`
`(Dr. Kaduk’s: Analysis arid Comisionissicccsicscuscesasscjreccncsgaoancasenanegaveanegecncnte 35
`
`Dy. Sacchetti’s Analysis and Conchisions wiccccccnmncawisntansnennn nie 89
`
`2
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 3 of 98
`
`ty,
`
`-Clenne'l and 24... ona cL anumnmaeunn
`
`Vi,
`
`Claim 22 vicceescsseccscsvscsssesesrssvscossuesssuscanscsccsnuccnsusesesssvecssnvecsenn
`
`G;
`(Conchision Reparding PGiPemient: 0. isc cccusncasarecsnvvcrernsraceencnncassanienivansnsnass
`CONCLUSION -
`|
`
`91
`
`95
`
`... 96
`
`TABLE OF ABBREVIATIONS
`
`
`
`
`
`
`Pact U.S. PatentNo.8,557,993
`| ANDA
`AbbreviatedNew Diag Application
`
`API
`Active pharmaceutical ingredient
`
`
`Drug master file
`
`
`EPO
`European Patent Office
`
`
`EP ‘406
`| European Patent Application No. EP 0 520 406A1
`|
`
`
`| U.S. Food and Drug Administration
`
`
`
`
`Kowa Company,Ltd.
`
`Kowa Pharmaceuticals America, Inc.
`MSN Laboratories Pvt. Ltd.
`
`Nissan Chemical Industries, Ltd. —
`
`
`
`
`Third Party Observation — US. Pharmacopeia |
`
`Information Disclosure Statement
`
`
`
`U.S.Patent and Trademark Office
`
`
`
`
`
`
` X
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 4 of 98
`
`HONORABLE PAUL A. CROTTY,United States District Judge:
`
`_ This is a Hatch-Waxman patent infringementlitigation initiated by Plaintiffs Kowa
`
`Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd.
`
`(collectively, “Plaintiffs”), manufacturers ofthe cholesterol-lowering drug Livalo®, against
`
`defendants Amneal Pharmaceuticals, LLC (“Amneal”), and Apotex, Inc. and Apotex Corp.
`
`(“Apotex”), generic drug manufacturers (together, “Defendants”).! Plaintiffs allege that
`Defendants’ proposed AbbreviatedNew Drug Application (“ANDA”) products would ee
`US. Patent No.8,557,993 (the “993 patent”). Both Amneal and Apotex contendthat the *993
`patent is invalid as (1) anticipated based onpriorart, under 35 U.S.C. § 102(b); and/or (2) obvious
`
`in view ofprior art, under 35 U.S.C. § 103. Only Apotex asserts non-infringement; Amneal
`
`concedes infringement.
`
`The Court held a ten-day benchtrial from January 17 through January 30, 2017, with
`
`closing arguments on February 3, 2017. Each ofthe parties submitted extensivepost-trial
`
`briefing on the “993 patent’s validity and infringement. After considering the documentary
`
`evidence and testimony, the Court makesthe following findings of fact and conclusions of law
`
`pursuant to Fed. R. Civ. P. 52(a). As set forth below, the Court determines that the “993 patentis
`
`valid; and that Apotex’s proposed ANDA product would infringe the ‘993 patent.
`
`
`
`
`1 Plaintiffs commencedthislitigation against eight generic drug inanufacturer defendants. Defendants asserted
`defenses ofinvalidity and non-infringement. Four defendants settled before commencementof the ten-day bench
`trial. The fifth defendantsettled mid-trial; and the sixth settled post-trial. Only Amneal and Apotex remain. On
`April 11, 2017, the Court issued its Findings of Fact and Conclusions of Law regarding the other patent at issue at
`trial, U.S. Patent No. 5,856,336, finding it valid. (Kowa Co., Ltd. v. Amneal Pharm., LLC, No, 14-CV-2758 (PAC)
`(S.D.N.Y. Apr. 11, 2017).
`
`4
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page5 of 98
`
`INTRODUCTION AND LEGAL STANDARDS
`
`I.
`
`The Hatch-Waxman Act andANDAFilings?
`1. The Hatch-Waxman Act,titled the Drug Price Competition and Patent T_ Restoration
`er of 1984, Pub. L. No. 98-417, permits pharmaceutical companies to seek United States Food
`
`and Drug Administration (FDA) approval for a generic drug based on an already-approved
`
`branded drug by filing an ANDA. (See 21 U.S.C. § 355G)(2){A), (8)(B)). In so doing,the
`
`generic manufacturer may rely on the branded drug’s safety and efficacy data submitted to the
`FDA. (See id.).
`|
`
`2. If the branded drug manufacturer’s patent has not yet expired, the generic manufacturer
`
`mustfile a “Paragraph IV”certification, establishing bioequivalence of the proposed generic
`
`version with the approved branded version ofthe drug. (See 21 U.S.C. § 355@)(2)(A)(Wii)CV);
`21 CER. § 314.94(a)(9)). The certification mustalso state and explain cither that the generic
`
`product will not infringe the branded manufacturer’s patent, or that the patent is invalid.
`
`(See 21
`
`U.S.C. § 355(7)(2)(B)Gv)CD).
`
`3. “An ANDA-IV certificationitself constitutes an act of infringement, triggering the
`
`branded manufacturer’s right to sue.” (Ark. Carpenters Health & Welfare Fund v, Bayer AG,
`
`604 F.3d 98, 101 (2d Cir. 2010), cert. denied, 131 S. Ct. 1606 (2011) (citing 35 U.S.C. §
`
`271 (e)(2)(A)).
`Iflitigation is initiated, the generic’s entry to market is automatically stayed.
`(21
`U.S.C. § 355(9)(5)(B)(ii). “[T}his structure allows the parties to try the dueling issues ofpatent
`
`infringement andpatent invalidity simultaneously.” (Un re: OxyContin AntitrustLitig., No. \3-
`
`CV-3372 (SHS), 2015 WL 11217239,at *5 (S.D.N.Y. Apr. 8, 2015)).
`
`2 For additional backgroundon the policy goals of the Hatch-Waxman Act, see this Court’s April 11, 2017 Findings
`of Fact and Conclusions of Law regarding the other patentat issueattrial, U.S. Patent No. 5,856,336. (Kowa Co.,
`Ltd. v, Amneal Pharm., LLC, No. 14-CV-2758 (PAC) (S.D.N.Y. Apr. 11, 2017) at 9-10).
`
`5
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 6 of 98
`
`IL.
`
`The Parties
`
`4. Plaintiff Kowa Company, Ltd. (“KCL”) is a Japanese corporation with its corporate
`
`headquarters and principal place ofbusiness in Aichi, Japan. (Compl. § 2). PlaintiffKowa
`Pharmaceuticals America, Inc. (“KPA”) is a shelieawhed subsidiary ofKCL organized under
`
`the laws of Delaware, with its corporate headquarters and principal place of business in
`
`Montgomery, Alabama. (/d.), Plaintiff Nissan Chemical Industries, Ltd. (“NCT” or “Nissan”) is
`aJapanese corporation with its corporate headquarters and principal place ofbusiness in Tokyo,
`Japan. (Id. 43). Plaintiffs are manufacturers, researchers, developers, and marketers of the
`
`cholestero}-lowering drug Livalo®. (Id. 4 4).
`
`5. Defendant Amneal is incorporated in Delaware, with a place ofbusiness in Bridgewater,
`
`New Jersey. (Amneal Answer 5). Amneal filed ANDA No. 20-5961 seeking FDA approval to
`market | mg, 2 mg, and 4 mgpitavastatin calcium tablets. (Id. § 20).
`|
`6. Defendant Apotex, Inc. is organized in and exists under the laws of Canada, with a
`
`principal place of business in Toronto, Ontario, (Apotex Answer 4 5). Defendant Apotex Corp.
`
`is incorporated in and exists under the laws of Delaware, with a place of business in Weston,
`
`Florida. (7d. $6). Apotex Corp. sells and markets Apotex, Inc.’s products in the United States.
`(id.). Apotex Corp. is Apotex Inc.’s agent for purposes ofmaking sadilatoty submissions,
`
`including its ANDA No. 20-6068filing, seeking FDA approval to market 1 mg, 2 mg, and 4 mg
`
`pitavastatin calcium tablets. (Id. {J 6,20). Apotex’s ANDAfiling contains a Paragraph IV.
`
`certification respecting the ‘993 patent. (/d. {| 22).
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 7 of 98
`
`Ill.
`
` Livalo®
`
`7. At trial, Dr. Craig Sponseller, KPA’s Chief Medical Officer, provided an initial
`
`explanation ofthe history and workings of Livalo® pitavastatin. (See generally Tr. 67-136). A
`
`brief summary ofrelevant and uncontested facts is recited here.
`
`8. Statins are medications that address and control abnormal increases in blood cholesterol by
`
`inhibiting the wayin which the liver makes cholesterol, (Tr. 70:8~71:10). All statins generally
`
`work in the same way, but differ in the manner in which they bind to enzymes and dissolve in
`
`solvents; and how they are processed and metabolized by the body. (Tr. 71:5-17).
`
`9. Patients have varying degrees ofstatin tolerance (or intolerance), (Tr. 71:25-74:13),
`
`Approximately 10-15% ofpatients with elevated cholesterolare statin intolerant, which amounts
`
`to approximately 4 to 6 million statin-intolerantpatients in the United States. (Tr. 73:22~74:7).
`
`10. Livalo® is a statin used to treat elevated cholesterol; or morespecifically, as reflected on
`
`its label, hyperlipidemia or mixed dyslipidemia. (Tr. 77:5—11; PTX-1098 (Livalo® Label
`(Revised: November 2016)) at KN003466196). It does so by reducing low density protein
`
`cholesterol (“LDL-C”), total cholesterol, triglycerides, and apolipoprotein B; and/or increasing
`
`high density lipoprotein cholesterol (“HDL-C”). (Tr. Tr. 77:5—11; PTX-1098 (Livalo® Label) at
`
`KN0034661 96).
`
`11. Approximately 75%of all metabolic drugs are metabolized through the “cytochrome |
`P450” pathway(the “CYP450” or “CYP”pathway)in the liver. (Tr. 74:14-75:9). By coum,
`
`Livalo® mostly avoids, and is only minimally metabolized by, the CYP450 pathway. (Tr. 75:10—
`
`76:1, 85:6-21).
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 8 of 98
`
`12. Thereare currently seven available statins on the market; at the time Livalo® launched in
`
`the U.S. in mid-2010, there were six available statins with which Livalo® competed.’ (Tr.
`
`70:15~20).
`
`IV.
`
`The ‘993 Patent
`
`13. The ‘993 patent, “Crystalline FormsofPitavastatin Calcium,”is assigned to NCI. (PTX-
`
`1063). KCL is NCI’s licensee for the ‘993 patent, and KPA holds a license from KCLfor the
`
`‘993 patent. (Amneal Compl.
`
`15; Apotex Compl. § 15). KPA sells the pitavastatin drug
`
`product underthe trade name Livalo® in the United States; KCL manufactures the Livalo®
`
`products as sold by KPA. (Amneal Compl. ff] 16-17; Apotex Compl. ff 16-17).
`
`14. The ‘993 patent issued on October 15, 2013, from U.S. Patent Application No.
`
`13/664,498 (the ““498 Application”), filed October 31, 2012. (PTX-1063 (‘993 patent); PTX-
`
`0172 (‘498 Application (993 patent file history))). The ‘498 Application is a continuation of
`
`U.S. Patent Application No. 10/544,752 (the “752 Application). (PTX-1337 and DTX-1359).*
`
`15. The earliest priority date to which the “993 patent claims entitlement is February 12,
`
`2003, (PTX-1063 (claiming entitlement to European. Application No. 03405080)),
`16. The 993 patentstates:
`|
`
`The present invention is directed to new crystalline forms and the amorphous form of
`Pitavastatin calcium, processes for the preparation thereof and phatmaceutical
`compositions comprising these forms. .
`. Pitavastatin calcium is knownby the
`chemical name: (3R,58)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-y]}-3,5-
`dibydroxy-6(E)-heptenoic acid hemicalcium salt.
`
`(Id. at 1:17--26).
`
`3 Livalo® was approved by Japaneseregulators and launched in Japan in 2003; was approved by the FDA mAugust
`2009; and launched in the United States in June 2010. (Tr. 1534:17-20, 103:8-9; see PTX-0480; PTX-0482),
`4 Both Plaintiffs and Defendants submitted the ‘752 Application and file history. (See PTX-1337; DTX-1359). Due
`to a copying error, DTX-1359 was missing some pages; but the relevant testimony did not involve any such pages.
`(See Tr. 1661:9-21). For ease of reference, the Court cites both exhibits and Bates pages used and referenced in the
`correspondingtrial testimony.
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 9 of 98
`
`17. The ‘993 patent explains that Plaintiffs recently developed pitavastatin calcium “as a new
`
`chemically synthesized and powerful statin .. . [that] is safe and well tolerated in the treatment of
`
`patients with hypercholesterolemia;” and that the statin has “extremely low”interactions with
`
`other commonly-used drugs. (/d. at 1:43-50).
`
`18. Claims 1, 22, 23, 24, and 25 ofthe ‘993 patent claim six different polymorphs of
`pitavastatin calcium, polymorphic forms A, B, C, D, E, and F, and the amorphous form; and a
`pharmaceutical composition comprising an effective amountofthe form, and a pharmaceutically
`acceptable carrier. (/d. at 10:50—11:37, 13:7-41). Each claimed form includesa recitation ofi
`characteristic X-ray powder diffraction pattern having specific characteristic peaks (claims1 and
`
`24) or a diffraction pattern substantially as depicted in specified Figures (claims 23 and 25).
`
`(id.).
`19, Crystalline pélivaurdh A ofpitavastatin calcium (“Form A”or “Polymorph Form A”) is
`
`the subject of this action.
`
`20. The ‘993 patent specification discloses that “Form A may contain up to 15% water,
`
`—
`preferably about 3 to 12%, morepreferably 9 to 11% of water.” (/d. at 6:13-14).
`21. Claims IJ and 24 are directed to, interalk Form A exhibiting “a characteristic X-ray
`
`powder diffraction pattern with characteristic peaks expressed in 20 at (recited peak positions
`
`and relative mtensities|.” The relevant parts of claims | and 24 areset forth below:
`
`A crystalline polymorph A, B, C, D,E, F, or the amorphous form,
`1.
`of [pitavastatin calcium] salt wherein
`a characteristic X-ray powder
`A) polymorph A exhibits
`diffraction pattern with characteristic peaks expressed in 28
`at 5.0 (s), 6.8 (s), 9-1 (s), 10.0 (w), 10.5 (m), 11.0 (m), 13.3
`(vw), 13.7 (s), 14.0 (w), 14.7 (w), 15.9 (vw), 16.9 (w), 17.1
`
`5 The other polymorphic forms and the amorphousform ofpitavastatin calcium claimedin the ‘993 patent are
`irrelevantto this action, and are not discussed further.
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 10 of 98
`
`(vw), 18.4 (m), 19.1 (w), 20.8 (vs), 21.1 (m), 21.6 (m), 22.9
`(m), 23.7 (m), 24.2 (s), 25.2 (w), 27.1 (m), 29.6 (vw), 30.2
`(w), 34.0 (w);
`|
`... wherein, for each of said polymorphs, (vs) stands for very
`strong intensity; (s) stands for strong intensity; (m) stands for
`medium intensity; (w) stands for weak intensity; (vw) stands
`for very weak intensity.
`
`24. Acrystalline polymorph A of[pitavastatin calciuin] salt, which
`exhibits a characteristic X-ray powderdiffraction pattern with
`characteristic peaks expressed in 20 at 5.0 (s), 6.8 (s), 9.1 (s), 10.0 (w),
`10.5 (m), 11.0 (m), 13.3 (vw), 13.7 (s), 14.0 (w), 14.7 (w), 15.9 (vw),
`16.9 (w), 17.1 (vw), 18.4 (m), 19.1 (w), 20.8 (vs), 21.1 (im), 21.6 (m),
`22.9 (m), 23.7 (m), 24.2 (s), 25.2 (w), 27.1 (m), 29.6 (vw), 30.2 (w), and
`34.0 (w), wherein (vs) stands for very strong intensity; (s) stands for
`strong intensity; (m) stands for medium intensity; (w) stands for weak
`intensity; and (vw) stands for very weak intensity.
`
`22. Claims 23 and 25 are directedto, inter alia, Form A having “an X-ray powderdiffraction
`
`pattern substantially as depicted in FIG. 1”of the 993 patent. Relevant parts of claims 23 and
`
`25, and Figure 1, are set forth and reproduced below:
`
`Acrystalline polymorph A... of [pitavastatin calcium] salt of
`23.
`claim 1, wherein polymorph A has an X-ray powder diffraction pattern
`substantially as depicted in FIG. 1. .
`-
`
`Accrystalline polymorph A of[pitavastatin calcium] sait, having
`25.
`an X-ray powderdiffraction substantially as depicted in FIG.1.
`
`10
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed 09/19/17 Page 11 of 98
`
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`23. Claim 22states:
`
`A pharmaceutical composition comprising an effective amount
`22.
`ofthe crystalline polymorph or amorphous form accordingto claim 1,
`and a pharmaceutically acceptable carrier.
`
`24. The specification of the ‘993 patent provides:
`
`Powder X-ray diffraction is performed on a Philips 1710 powder X-ray
`diffractometer u