(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
`
`(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)
`V'
`
`(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.,
`
`(cid:95)(cid:151)(cid:116)(cid:145)(cid:161)(cid:180)(cid:145)(cid:133)(cid:137)(cid:178)(cid:11)(cid:197)
`Plaintiffs,
`
`(cid:2)(cid:1)(cid:3)
`
`(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)
`Apotex, Inc., et al.,
`
`(cid:69)(cid:127)(cid:138)(cid:161)(cid:123)(cid:117)(cid:161)(cid:181)(cid:175)(cid:20)(cid:197)
`Defendants.
`
`
`
`
`(cid:2)(cid:6)(cid:1)(cid:8)(cid:4)(cid:3)(cid:5)(cid:7)(cid:9)
`
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`oATT. 393193"); _9/19/2017
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`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
`(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)
`CONCLUSIONS OF LAW
`
`(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 Filings .......................................................................... 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)
`II. The Parties .............................................................................................................................. 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)
`III.
`Livalo® ................................................................................................................................. 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)
`IV.
`The ‘993 Patent .................................................................................................................... 8
`(cid:111)(cid:21) (cid:104)(cid:141)(cid:125)(cid:197)(cid:80)(cid:161)(cid:175)(cid:181)(cid:116)(cid:165)(cid:185)(cid:197)(cid:70)(cid:148)(cid:175)(cid:170)(cid:187)(cid:185)(cid:125)(cid:197)(cid:18)(cid:16)(cid:19)(cid:19)(cid:18)(cid:18)(cid:33)(cid:17)(cid:20)(cid:20)(cid:20)(cid:31)(cid:25)(cid:22)(cid:21)(cid:17)(cid:29)(cid:23)(cid:34)(cid:23)(cid:16)(cid:20)(cid:25)(cid:20)(cid:20)(cid:21)(cid:20)(cid:17)(cid:17)(cid:22)(cid:25)(cid:17)(cid:20)(cid:20)(cid:18)(cid:29)(cid:20)(cid:22)(cid:35)(cid:20)(cid:20)(cid:26)(cid:29)(cid:18)(cid:21)(cid:19)(cid:25)(cid:22)(cid:21)(cid:21)(cid:21)(cid:17)(cid:20)(cid:20)(cid:26)(cid:19)(cid:21)(cid:20)(cid:21)(cid:17)(cid:17)(cid:22)(cid:21)(cid:21)(cid:26)(cid:20)(cid:20)(cid:20)(cid:21)(cid:21)(cid:17)(cid:18)(cid:26)(cid:22)(cid:20)(cid:20)(cid:25)(cid:18)(cid:18)(cid:25)(cid:21)(cid:22)(cid:22)(cid:22)(cid:20)(cid:20)(cid:20)(cid:20)(cid:26)(cid:44)(cid:26)(cid:20)(cid:21)(cid:17)(cid:19)(cid:25)(cid:18)(cid:18)(cid:17)(cid:21)(cid:18)(cid:17)(cid:29)(cid:29)(cid:17)(cid:17)(cid:25)(cid:22)(cid:25)(cid:29)(cid:17)(cid:197)(cid:46)(cid:50)(cid:197)
`V. The Instant Dispute ............................................................................................................... 12
`(cid:111)(cid:80)(cid:21)
`(cid:86)(cid:125)(cid:140)(cid:118)(cid:154)(cid:197)(cid:102)(cid:179)(cid:116)(cid:161)(cid:122)(cid:117)(cid:172)(cid:124)(cid:176)(cid:197)(cid:17)(cid:21)(cid:21)(cid:21)(cid:21)(cid:22)(cid:21)(cid:26)(cid:16)(cid:21)(cid:17)(cid:25)(cid:20)(cid:21)(cid:17)(cid:20)(cid:22)(cid:17)(cid:21)(cid:21)(cid:25)(cid:17)(cid:21)(cid:21)(cid:21)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:21)(cid:20)(cid:36)(cid:17)(cid:36)(cid:22)(cid:21)(cid:20)(cid:21)(cid:21)(cid:29)(cid:21)(cid:21)(cid:21)(cid:17)(cid:17)(cid:19)(cid:21)(cid:19)(cid:26)(cid:17)(cid:17)(cid:16)(cid:22)(cid:17)(cid:20)(cid:22)(cid:21)(cid:20)(cid:26)(cid:17)(cid:22)(cid:22)(cid:20)(cid:19)(cid:20)(cid:17)(cid:20)(cid:17)(cid:22)(cid:38)(cid:21)(cid:25)(cid:20)(cid:26)(cid:17)(cid:21)(cid:21)(cid:17)(cid:22)(cid:18)(cid:29)(cid:19)(cid:17)(cid:21)(cid:26)(cid:17)(cid:26)(cid:37)(cid:21)(cid:26)(cid:26)(cid:22)(cid:18)(cid:29)(cid:21)(cid:18)(cid:18)(cid:25)(cid:18)(cid:18)(cid:25)(cid:25)(cid:16)(cid:18)(cid:29)(cid:17)(cid:17)(cid:20)(cid:20)(cid:20)(cid:17)(cid:17)(cid:17)(cid:197)(cid:46)(cid:51)(cid:197)
`VI.
`Legal Standards .................................................................................................................. 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 .......................................................................................... 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 ........................................................................... l3
`(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
`(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)
`l-MAK v. Gilead
`(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)
`|PR2018—OO390
`
`1
`
`

`

`Case l:l4~cv—02758-PAC Document 168 Filed 09l19/17 Page 2 of 98
`
`i'. Anticipation (3S U.S.C. § 102)
`
`14
`
`ii.
`
`Ohviousncss (3S U.S.C. §103) 16
`
`c.
`
`Infringement ....................................................................._......................................I............ 18
`
`i. Claim Construction
`
`VII. Crystals and Polymorphs
`
`1.9
`
`20
`
`VIII.
`
`X—Ray Powder Diffraction and Characterization,.......................................................... 23
`
`IX.
`
`Jurisdiction.......-......L .......................................................................................................... 28
`
`X. Person ofOrdinary Skill in theA1128
`
`XI.
`
`Validity ofthe ‘993Patent 29
`
`a.
`
`Anticipation (35 U,S.C.§102) 29
`
`ii.
`
`iii.
`
`iv-
`
`The ‘993 Patent ProsecutionHistory 31
`
`Defendants’ InherencyArguinents 3'?
`
`Conclusion Regarding InherentAnticipation 40
`
`b. Obviousncss (35 use. § 103L148
`
`i. LevelofOrdinarySkillin eArtSO
`
`Scope and Content of the Prior Art and Differences Between Claimed Subject Matter
`ii.
`and the PriorA1150
`
`iii. Whether Obtaining Form A Would Have Been Obvious to a POSA in 2003......m-.. 52
`
`iv.
`
`v.
`
`Objective indicia ofNonobviousness (Secondary Considerations)
`
`59
`
`Conclusion RegardingObvrousness 75
`
`c.
`
`Conclusion Regarding Validity............................................................................................. 7’5
`
`XII.
`
`Infringement of the ‘993 Patent ......................................................................................... 76
`
`a.
`
`Step One: Construing the AssortedClaims 77
`
`i. Claims 1 and 24: “exhibits a characteristic x~ray diffraction pattern with characteristic
`
`peaks expressed in 29 at .
`
`. .” ............... -................................................................................. 7'?
`
`ii.
`
`Claims 23 and 25: “having an X-ray powder diffraction pattern substantially as
`
`in.
`
`Step Two: Comparison ot'Asserted Claims to Apotex’s Proposed ANDA Product......... 81
`
`i. Apotex’s Proposed ANDAProduc182
`
`ii.‘
`
`iii.
`
`Dr. Kaduk’s Analysis and Conclusions ...................................................................... 85
`
`Dr. Sacchctti’s Analysis and Conclusmns 89
`
`2
`
`

`

`Case 1:14-cv-02758-PAC Document 168 Filed ogilgm Page 3 of 98
`
`iv;
`
`Claims; 1 and24 91
`
`0. Conclusion Regarding h1fi1ngcmcnt 96
`CONCLUSION -
`'
`
`TABLE OF ABBREVIATIONS
`
`
`‘ ‘993 Patent
`
`us. Patent No. 8,557,993
`
`
`
`Abbreviated New Drug Application
`
`
`
`API
`
`Active phannaccutical ingredient
`
`
`Bing master file
`
`
`
`
`
`
`
`
`1 ANDA
`
`
`
`European Patent Office;
`
`
`
`
`
`fiiéEan Chemical Industries, Ltd.“
`
`EPO
`
`European Patent Application No. EP 0 520 406A]
`
`I US. Food and Drug Administration
` Information Disclosure Statement
`
`
`hKowa Company, Ltd.
`Kowa Phamlaoeuticals America, Inc.
`
`MSN Laboratories Pvt. Ltd.
`
`
`
`
`
`U.S. Patent and Trademark Office
`
`
` Third Party Observation ”
`
` U.S. Pharmacopcia- I
` X—ray powder diffi'acfion
`
`

`

`Case 1:14—cv—02758-PAC Document 168 Filed 09i19il7 Page 4 of 98
`
`HONORABLE PAUL A. CROTTY, United States District Judge:
`
`I This is a Hatch-Wm patent infi‘ingement litigation initiated by Plaintiffs Kowa
`
`Company, Ltd, Kowa PharmaCeuticals America, Inc, and NissanIChemical Industries, Ltd.
`
`(collectively, “Plainfifis”), manufacturers of the cholesterol-lowering drug Livalo®, against
`
`defendants Amneal Pharmaceuticals, LLC (“Amneal”), and Apotex, Inc. and Apotex Corp.
`
`(“Apotex”), generic drug manufacturers (together, “De fentiants").1 Plaintiffs allege that
`
`Defendants’ proposed Abbreviated New Drug Application (“ANDA”) products would infiinge
`
`US. Patent No. 8,557,993 (the ““993 patent”). Both Amneal and Apotex contend that the ‘993
`
`patent is invalid as (l) anticipated based on prior art, under 35 U.S.C. § 102(b); andfor (2) obvious
`
`in view of prior art, under 35 U.S.C. § 103. Only Apotex asserts non-infringement; Amneal
`
`concedes infiingement.
`
`The Court held a ten-day bench trial fi’Om January 17 through January 30, 2017, with
`
`closing arguments on February 3, 2017. Each of the parties submitted extensive post-trial '
`
`briefing on the ‘993 patent’s validity and infringement. After considering the documentary
`
`evidence and testimony, the Court makes the following findings of fact and conclusions of law
`
`pursuant to Fed. R. Civ. P. 52(3). As set forth below, the Court determines that the ‘993 patent is
`
`valid; and that Apotex’s proposed ANDA product would infringe the ‘993 patent.
`
`
`
`
`1 Plaintiffs commenced this litigation against eight. generic drug manufacturer defendants. Defendants asserted
`defenses of invalidity and non-infringement. Four defendants settled before commencement of the ten~day bench
`tn'al. The fifth defendant settled mid-trial; and the sixth settled post-trial. Only Armies! and Apotex remain. On
`April 1 I, 2017, the Court issued its Findings of Fact and Conclusions of Law regarding the other patent at issue at
`trial, U.S. PatentNo. 5,856,336, finding it valid. (Kowa Co, Ltd. v. Amoco! Phann., LLC., No. 14-CV-2758 {PAC}
`(S.D.N.Y. Apr. 11, 2017)).
`
`4
`
`

`

`_ Case 1:14—cv-02758-PAC Document 168 Filed 0911911? Page 5 of 98
`
`INTRODUCTION AND LEGAL STANDARDS
`
`I.
`
`The Hatch—Waxman Act and'ANDA Filings2
`
`1. The Hatch«Waxman Act, titled the Drug Price Competition and Patent Tenn Restoration
`
`'Act of 1984, Pub. L. No. 98-417, permits phannaceutical 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 1.1.8.0 § 3550){2)(A), (8)(B)). In so doing, the
`
`generic manufacturet 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
`
`must file a “Paragraph IV” certification, establishing bioequivalence of the proposed generic
`
`version with the approved branded version of the drug. (See 21 U.S.C. § 3551])(2)(A)(vii)(IV};
`21 CPR. § 314.94(a)(9)). The certification must also state and explain either that the generic
`
`product will not infiinge the branded manufacturer’s patent, or that the patent is invalid.
`
`(See 21
`
`U.S.C. § 355(1')(2)(B)(iv)(11)}.
`
`3. “An ANDAJV certification itself constitutes an act of infiinge‘m ent, triggering the
`
`branded manufacmer’s right to sue.” (Ark. Carpenters Health & Wegfare Fund v. BayerAG,
`
`604 F.3d 98, 101 (2d Cir. 2010), cert. denied, 131 s. Ct. 1606 (2011) (citing 35 Use. §
`
`271(c)(2)(A)). If litigation is initiated, the generic’s entry to matket is automatically stayed.
`
`(21
`
`U.S.C. § 355U)(5)(B)(iii)). “[T1his structure allows the parties to try the dueling issnes ofpatent
`
`infringement and patent invalidity simultaneously.” (In re: OxyContin Antitrust Litig, No. 13-
`
`011-3372 (SHS), 2015 WL 1121-7239, at *5 (S.D.N.Y. Apr. 8, 2015)).
`
`2 For additional background on. the policy goals of the Hatch-Woman Act, see this Court’s April I I, 201? Findings
`of Fact and Conclusions of Law regarding the other patent at issue at trial, US. Patent No. 5,856,336. (Kowa Co,
`Ltd. v. Amma!Pkar-rn., LLC, No. l4-CV—2758 (PAC) (S.D.N.Y. Apr. 11, 201?) at 940).
`
`5
`
`

`

`Case 1:14—cv-02758-PAC Document 168 Filed 09i19i17 Page 6 of 98
`
`II.
`
`The Parties
`
`4. Plaintific Kowa Company, Ltd. (“KCL”) is a Japanese corporation with its corporate
`
`headquarters and principal place ofbusiness in Aichi, Japan. (Compl. 1i 2). PlaintiffKowa
`
`Pharmaceuticals America, Inc. (“KPA”) is a Wholly-ontned subsidiary ofKCL organized under
`
`the laws of Delaware, with its corporate headquarters and principal place of business in
`
`Montgomery, Alabama. (Id). Plaintiff Nissan Chemical Industries, Ltd. (“NOW or “Nissan“? is
`
`a Japanese corporation with its corporate headquarters and principal place ofbusiness in Tokyo,
`
`Japan. (Id. 1i 3). Plaintiffs are manufacturers, researchers, developers, and marketers of the
`
`cholesteroi~.lowering drug Livalo®. (Id. 1i 4).
`
`5. Defendant Amneal is incorporated in Delaware, with a place ofbusiness in Bridgewater,
`
`New Jersey. (Amneal Answer 1] S). Amneal filed ANDA No. 206961 seeking FDA approval to
`
`market 1 mg, 2 mg, and 4 mg pitavastatin calcium tablets. (Id. 1] 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 Answerer-1] 5). Defendant Apotex Corp.
`
`is incorporated in and exists under the laws of Delaware, with a place of business in Weston,
`
`Florida. (Id. 1[ 6). Apotex Corp. sells and markets Apotex, Inc’s products in the United States.
`(Id). Apotex Corp. is Apotex lnc.’s agent for purpOSes ofmaking regulatory submissions,
`
`including its ANDA No. 206068 filing, seeking FDA approval to market 1 mg, 2 rug, and 4 mg
`
`pitavastatin calcium tablets. (Id, 1111 6, 20). Apotex’s ANDA filing contains a Paragraph IV -
`
`certification respecting the ‘993 patent. (M. ‘H 22).
`
`

`

`Case 1:14—cv—02758-PAC Document 168 Filed 09l19l17 Page 7 of 98
`
`III.
`
`Livalo®
`
`7. At trial, Dr. Craig Sponseller, KPA’s Chief Medical Officer, provided an initial
`
`explanation of the history and workings of Livalo® pitavastatin. (See generally Tr. 67—136). A
`
`brief summary of relevant and uncontested facts is recited here.
`
`8. Statins are medications that address and control abnormal increases in blood cholesterol by
`
`inhibiting the Way in 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 of statin tolerance (or intolerance). (Tr. 71:25-74:13),
`
`Approximately 10-15% ofpatients with elevated cholesterol are statin intolerant, which amounts
`
`to approximately 4 to 6 million statin—intolerant patients in the United States. (Tr. 73:22~74:?).
`
`10. Livalo® is a statin used to treat elevated cholesterol; or more specifically, as reflected on
`
`its label, hyperlipidemia or mixed dyslipidemia. (Tr. 7?:5—1 1; FIX-1098 (Livalo® Label
`(Revised: November 2016)) at KNOO3466196)- 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
`
`KN003466196).
`
`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—759). By contrast,
`
`Livalo® mostly avoids, and is only minimally metabolized by, the CYP450 pathway. (Tr. 75:10w
`
`l6:1,85:6—21).
`
`

`

`Case 1:14—cv—02758-PAC Document 168 Filed 09(191‘17 Page 8 of 98
`
`12. There. are currently seven available statins on the market; at the time Livalo® launched in
`
`the U.S. in mid-2010, fliere were six available statins with which Livalo® competed} (Tr.
`
`7015420).
`
`IV.
`
`The ‘993 Patent
`
`13. The ‘993 patent, “Crystalline Fonns ofPitavastatin Calcium,” is assigned to NCI. (PTX-
`
`1063). KCL is NCI’S licensee for the ‘993 patent, and KPA holds a license from KCL for the
`
`‘993 patent. (Amneal Comp]. 1] 15; Apotex Compl. T] 15). KPA sells the pitavastatin drug
`
`product under the trade name Livalo® in the United States; KCL manufactures the Livalo®
`
`products as sold by KPA. (Amneal Compl. W 16—17; Apotex Comp]. M 16—17).
`
`[4. The ‘993 patent issued on October 15, 2013, from US. Patent Application No.
`
`13f664,498 (the ““498 Application”), filed October 31, 2012. (PTX-1063 (“993 patent); PT):-
`
`0172 (‘498 Application (’993 patent file history))). The ‘498 Application is a continuation of
`
`US. Patent Application No. 10}544,152 (the ““752 Application). (PTX~1337 and DTX-1359).4
`
`15. The earliest priority date to which the ‘993 patent claims entitlement is February 12,
`
`2003. (FIX-1063 (claiming entitlement to‘ European Application No. 03405080».
`16. The ‘993 patent states:
`I
`
`The present invention is directed to new crystalline forms and the amorphous form of
`Pitavastatin calcium, processes for the preparation thereof and pharmaceutical
`compositions comprising these forms .
`.
`. Pitavastatin calcium is known by the
`chemical name: (3R,SS)—7-[Z-cyclOpropyl-4—(4-fluorophcnyi)quinolin-3—y]]-3,5-
`dihydroxy—6(E)—hcptenoic acid hemicalcium salt.
`
`(Id. at 1:17—26),
`
`3 Livalo's’ was approved by Japanese regulators and launched in Japan in 2003; was approved by the FDA inAugnst
`2009; and launched in the United States in June 2010. (Tr. 153417—20, 10328—9; see PTX40480; P'I‘X»0482).
`" Both Plaintiffs and Defendants submitted the ‘752 Application and file history. (See FIX—133?; DTXa1359). Due
`to a copying error, DIX-1359 was missing some pages; but the relevant testimony did not involve any such pages.
`(See Tr. 166119—21). For ease of reference, the Court cites both exhibits and Bates pages used and referenced in the
`corresponding trial testimony.
`
`

`

`Case 1:14-0w02758—PAC Document 168 Filed 09l19l17 Page 9 of 98
`
`17. The ‘993 patent explains that Plaintiffs recently developed pitavastatin calcium “as a new
`
`chemically synthesized and powerfiil static .
`
`.
`
`. {that} is safe and Well tolerated in the treatment of
`
`patients with hypercholestcrolemiaf‘ and that the statin has “extremely low” interactions with
`
`other commonly—used drugs. (Id. at 1:43—50).
`
`18. Claims 1, 22, 23, 24, and 25 of the ‘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 amount of the form, and a pharmaceutically
`acceptable carrier.
`(12’. at 10504137, 13:?41). Each claimed form includes a recitation of a
`
`characteristic X-ray powder diffraction pattern having specific characteristic peaks (claims 1 and
`
`24) or a diffraction pattern substantially as depicted in specified Figures (claims 23 and 25).
`
`(1d,).
`
`19. Crystalline polynicrph A of pitavastatin calcium (“Fons A” or “Polymorph Form A”) is
`
`the subject of this action.5
`
`20. The ‘993 patent specification discloses that “Form A may contain up to 15% water,
`
`preferably about 3 to 12%, more preferany 9 to 11% of Water.“ (Id. at 6: 1344).
`
`'
`
`21. Claims I and 24 are directed to, inter alia, Form A exhibiting “a characteristic X—ray
`
`powder diffraction pattern with characteristic peaks expressed in 29 at [recited peak positions
`
`and relative intensities] .” The relevant parts of claims I and 24 are set forth below:
`
`I.
`
`A crystalline polymorph A, B, C, D, E, F, or the amorphous form,
`
`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.? (w), 15.9 (vw), 16.9 (w), 17.1
`
`5 The other polymorphic forms and the amorphous form of pitavastatin calcium claimed in the ‘993 patent are
`irrelevant to this action, and are not discussed further.
`
`

`

`Case 1:14—cv—02758-PAC Document 168 Filed 09119/17 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 (In), 29.6 (vw), 30.2
`(W); 34-0 (W);
`I
`.
`.
`. wherein, for each of said polymorphs, (vs) stands for very
`
`strong intensity; (3) stands for strong intensity; (111) stands for
`medium intensity; (w) stands for weak intensity; (vw) stands
`
`for very weak-intensity.
`
`24. A crystalline polymorph A of [pitavastatin calcium] salt, which
`exhibits a characteristic X-ray powder diffraction 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.] (vw),_18.4 (m), 19.1 (w), 20.8 (vs), 21.1 (in), 21.6 (111),
`22.9 (r11), 23.? (m), 24.2 (s), 25.2 (w), 27.] (110,296 (vw), 30.2 (w), and
`34.0 (1710, wherein (vs) stands for very streng intensity; (5) stands for
`strong intensity; (in) stands for medium intensity; (w) stands for weak
`intensity; and (vw) stands for very weak intensity.
`
`22. Claims 23 and 25 are directed to, inter alia, Form A having “an X-ray powder diffraction
`
`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:
`
`. of [pitavastatin calcium] salt of
`.
`A crystalline polymorph A .
`23.
`claim 1, wherein polymorph A has an X-ray powder diffraction pattern
`substantially as depicted in FIG. 1 .
`.
`.
`'
`
`A crystalline pol ymorph A of [pitavastatin caicium] salt, having
`25.
`an X—ray powder diffi‘action substantially as depicted in FIG. 1.
`
`10
`
`

`

`Case 1:14-ov-02758—PAC Document 168 Filed 09(19117 Page 11 of 98
`
`1599
`
`—- w -- wuv—h-w-"n-n
`
`l3
`P"
`:2
`I?
`E
`
`E
`3
`g
`
`61"I““15
`
`Wm‘m‘aSi!
`
`NW
`mm
`m m -__ ..
`
`1350
`
`..
`
`
`
`23. Claim 2:2 states:
`
`A pharmaceutical composition comprising an effective amount
`22.
`of the crystalline polymorph or amorphous form according to claim 1,
`and a pharmaceutically acceptable carrier.
`
`24. The specification of the ‘993 patent provides:
`
`Powder X—ray diffraction is performed on a Philips 1210 powder X~ray
`diffractometer using CuK (in) radiation (1.54060 A); 26 angles are recorded
`with an experimental error of+f- 0.1-0.2“. A discussion of the theory of X~
`ray powder diffraction patterns can be found in “X-ray diffraction
`procedures” by HP. Klug and LE. Alexander, J. Wiley, New York (1974).
`
`(Id. at 5:61—67 (citing PTX-lOll (Harold P. Klug & Leroy E. Alexander, X-ray Dfiactz‘on
`
`Proceduresfor Polycrystalline and Amorphous Marerz‘ais (2d ed. 1974))).
`
`25. Example I. of the ‘993 patent details preparation of Form A. It instructs:
`
`EXAWLE 1
`
`Preparation of Form A
`
`4.15 gr of (3R,SS)~7-[2—cyclopropyl-4—(4-fluor0phenyl)quinolin-3~yl]-3,5—
`
`dihydroxy—6(E)—heptenoie acid tert~butyl ester (Pita