Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 1 of 152
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals, LLC,
`
`Defendant.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Orient Pharma Co., Ltd.,
`
`Defendant.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Zydus Pharmaceuticals (USA) Inc., et al.,
`
`Defendants.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Sawai USA, Inc., et al.,
`
`Defendants.
`
`Civil Action No. 14-CV-2758 (PAC)
`
`Civil Action No. 14-CV-2759 (PAC)
`
`Civil Action No. 14-CV-2760 (PAC)
`
`Civil Action No. 14-CV-5575 (PAC)
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 2 of 152
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Apotex, Inc., et al.,
`
`Defendants.
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`v.
`
`Lupin Ltd., et al.,
`
`Defendants.
`
`Civil Action No. 14-CV-7934 (PAC)
`
`Civil Action No. 15-CV-3935 (PAC)
`
`PLAINTIFFS’ PRETRIAL MEMORANDUM
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 3 of 152
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Abbott Labs. v. Torpharm, Inc.,
`300 F.3d 1367 (Fed. Cir. 2002) ....................................................................30, 31
`
`Abbvie Inc. v. Mathilda & Terence Kennedy Inst, of Rheumatology
`Trust,
`764 F.3d 1366 (Fed. Cir. 2014) ..........................................................................20
`
`Acumed LLC v. Stryker Corp.,
`483 F.3d 800 (Fed. Cir. 2007) ............................................................................29
`
`Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d
`1329 (Fed. Cir. 2001) .........................................................................................30
`
`Advanced Display Sys., Inc. v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000) ..................................................................88, 128
`
`Allergan, Inc. v. Alcon Labs., Inc.,
`324 F. 3d 1322 (Fed. Cir. 2003) .........................................................................31
`
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ....................................................................82, 83
`
`Am. Innotek, Inc. v. United States,
`126 Fed. Cl. 468 (2016)......................................................................................67
`
`Amgen, Inc. v. F. Hoffmann La Roche Ltd.,
`581 F. Supp. 2d 160 (D. Mass. 2008).................................................................22
`
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ..........................................................16
`
`AstraZeneca Pharms. LP v. Mayne Pharma (USA) Inc.,
`No. 02 Civ. 7936 (WHP), 2005 U.S. Dist. LEXIS 26196 (S.D.N.Y.
`Nov. 2, 2005) ...............................................................................................passim
`
`Aventis Pharms., Inc. v. Amino Chems. Ltd., 715 F.3d 1363 (Fed. Cir.
`2013...............................................................................................................69, 79
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 4 of 152
`
`Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP,
`616 F.3d 1249 (Fed. Cir. 2010) ..........................................................................30
`
`Biosig Instruments, Inc. v. Nautilus, Inc.,
`783 F.3d 1374 (Fed. Cir. 2015) ..........................................................................68
`
`Bristol-Myers Squibb Co. v. Apotex, Inc.,
`No. 10-5810 (MLC), 2013 U.S. Dist. LEXIS 44481 (D.N.J. Mar.
`28, 2013) ......................................................................................................passim
`
`Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294 (Fed. Cir. 2003) ..............................................................40, 60, 80
`
`Brown & Williamson Tobacco Corp. v. Phillip Morris Co.,
`229 F.3d 1120 (Fed. Cir. 2000) ........................................................................118
`
`Cadence Pharms., Inc. v. Exela PharmSci Inc.,
`780 F.3d 1364 (Fed. Cir. 2015) ..........................................................................31
`
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) ....................................................................33, 62
`
`Central Admixture Pharmacy Servs., Inc. v. Advanced Cardiac
`Solutions, P.C.,
`482 F.3d 1347 (Fed. Cir. 2007) ............................................................32, 61, 133
`
`Cephalon, Inc. v. Watson Labs., Inc.,
`939 F. Supp. 2d 456 (D. Del. 2013).............................................................passim
`
`Cephalon, Inc. v. Watson Pharms., Inc.,
`707 F.3d 1330 (Fed. Cir. 2013) ..........................................................................81
`
`Cephalon, Inc. v. Watson Pharms., Inc.,
`769 F. Supp. 2d 761 (D. Del. 2011)....................................................................29
`
`CertainTeed Corp. v. Modern Prods. Indus.,
`No. 03-CV-2131, 2005 U.S. Dist. LEXIS 7638 (E.D. Pa. May 2,
`2005) .............................................................................................................68, 75
`
`Cont’l Can Co. USA v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991) ....................................................................92, 96
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 5 of 152
`
`Creative Compounds, LLC v. Starmark Labs.,
`651 F.3d 1303 (Fed. Cir. 2011) ..........................................................................30
`
`Crocs, Inc. v. Int’l Trade Comm.,
`598 F.3d 1294,1310-11 (Fed. Cir. 2010)..................................113, 116, 118, 130
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016)........................................................................................14
`
`Daiichi Sankyo Co., Ltd. v. Matrix Labs, Ltd.,
`619 F.3d 1346 (Fed. Cir. 2010) ..................................................................18, 125
`
`Demaco Corporation v. F. Von Langsdorff Licensing, 851 F.2d 1387
`(Fed. Cir. 1988) ........................................................................................117, 118
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314
`(Fed. Cir. 2009) ................................................................................................107
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012) ..........................................................................32
`
`Effective Exploration, LLC v. Pa. Land Holdings Co., LLC, No. 14-cv-
`00845, 2015 U.S. Dist. LEXIS 111504 (W.D. Pa. May 8, 2015)........................72
`
`Eisai Co. v. Glenmark Pharms., Ltd.,
`No. 13-1279, 2015 U.S. Dist. LEXIS 32462 (D. Del. Mar. 17,
`2015) ............................................................................................................passim
`
`Eli Lilly & Co. v. Zenith Goldline Pharms., Case No. IP 99-38, 2001
`U.S. Dist. LEXIS 25246, 2001 WL 1397304 (S.D. Ind. Oct. 29,
`2001) .....................................................................................................18, 88, 131
`
`Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.,
`689 F.3d 1368 (Fed. Cir. 2012) ..................................................................24, 114
`
`Eli Lilly & Co. v. Zenith Goldline Pharm. Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) ....................................................................18, 88
`
`Eli Lilly and Co. v. Barr Laboratories, Inc.,
`251 F.3d 955 (Fed. Cir. 2001) ............................................................................19
`
`Fenner Investment, Ltd. v. Microsoft Corp.,
`632 F. Supp. 2d 627 (E.D. Tex. 2009)................................................................32
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 6 of 152
`
`Fenner Investments, Ltd. v. Microsoft Corp., 369 F. Appx 132 (Fed.
`Cir. 2010)............................................................................................................32
`
`Gator Tail, LLC v. Mud Buddy LLC,
`618 F. Appx. 992 (Fed. Cir. 2015) ...................................................................116
`
`Genentech, Inc. v. Amgen, Inc.,
`289 F.3d 761 (Fed. Cir. 2002) ............................................................................62
`
`General Foods Corp. v. Studiengesellschaft Kohle GmbH,
`972 F.2d 1272 (Fed. Cir. 1992) ....................................................................20, 24
`
`Gillette Co. v. S.C. Johnson & Son, Inc., 919 F.2d 720 (Fed. Cir.
`1990) .................................................................................................................130
`
`Glaxo, Inc. v. Novopharm, Ltd.,
`110 F.3d 1562 (Fed. Cir. 1997) ..........................................................................30
`
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995) ......................................................................93, 94
`
`Goodyear Tire & Rubber Co. v. Ray-O-Vac Co.,
`321 U.S. 275 (1944)..........................................................................................114
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966)......................................................................................100, 113
`
`Heidelberg Harris, Inc. v. Mitsubishi Heavy Indus.,
`2000 U.S. App. LEXIS 23757 (Fed. Cir. 2000) ...............................................117
`
`In re Armodafinil Patent Litig. Inc.,
`939 F. Supp. 2d 456, 491 (D. Del. 2013) (finding that a skilled
`artisan would not have had a reasonable expectation of success that
`armodafinil is polymorphic in 2002) ................................................................102
`
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) ..........................................................................118
`
`In re Berg, 140 F.3d 1428........................................................................................22
`
`In re Depomed Patent Litig.,
`No. 13-4507, 2016 U.S. Dist. LEXIS 166077 (D.N.J. Sep. 30,
`2016) .........................................................................................................102, 107
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 7 of 152
`
`In re Depomed Patent Litig.,
`No. 13-CV-04507, 2016 U.S. Dist. LEXIS 14455 (D.N.J. Feb. 5,
`2016) ............................................................................................................passim
`
`In re Emert,
`124 F.3d at 1461 .................................................................................................22
`
`In re Gurley,
`27 F.3d at 553 .....................................................................................................23
`
`In re Hedges,
`783 F.2d at 1041 .................................................................................................23
`
`In re Hitachi Metals, Ltd.,
`603 Fed. Appx. 976 (Fed. Cir. 2015)..................................................................20
`
`In re Hubbell,
`709 F.3d 1140 (Fed. Cir. 2013) ....................................................................19, 21
`
`In re Mayne,
`104 F.3d 1339 (Fed. Cir. 1997) ........................................................................118
`
`In re Rosuvastatin Calcium Patent Litig. v. Aurobindo Pharma Ltd.,
`703 F.3d 511 (Fed. Cir. 2012) ............................................................................19
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d
`1111 (Fed. Cir. 2004) .........................................................................................33
`
`InterDigital Commc’s LLC v. Int’l Trade Comm’n, 690 F.3d 1318,
`(Fed. Cir. 2012) ..................................................................................................62
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) ........................................................................114
`
`Janssen Prods., L.P. v. Lupin Ltd.,
`109 F. Supp. 3d 650 (D.N.J. 2014)...................................................................102
`
`Janssen Prods., L.P. v. Lupin Ltd.,
`No. 2:10-cv-05954 (WHW), 2014 U.S. Dist. LEXIS 155248
`(D.N.J. Mar. 12, 2014)........................................................................................31
`
`Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341 (Fed. Cir. 2009) ....................33
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 8 of 152
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F. 3d 1342 (Fed. Cir. 2012) .......................................................................130
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007)..................................................................................100, 101
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) ......................................................................33, 62
`
`Mallinckrodt, Inc. v. Masimo Corp.,
`147 Fed. App’x. 158 (Fed. Cir. 2005) (unpublished)...................................68, 75
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995) (en banc) ..................................................32, 33, 61
`
`Medinol Ltd. v. Guidant Corp.,
`412 F. Supp. 2d 301 (S.D.N.Y. 2005) ..............................................................118
`
`Merck & Cie,
`supra, 125 F. Supp. 3d at 514...........................................................102, 107, 109
`
`Merck & Cie, Bayer Pharma AG v. Watson Labs, Inc., 125 F. Supp.
`3d 503 (D. Del. 2015) .......................................................................................102
`
`Merck & Co., Inc. v. Hi-Tech Pharmacal Co.,
`482 F.3d 1317 (Fed. Cir. 2007) ..........................................................................21
`
`Merck Sharp & Dohme Corp. v. Sandoz Inc.,
`No. 3:12-cv-03289, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug.
`27, 2015) ...................................................................................................108, 109
`
`Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916) ........................................67
`
`Minn. Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc.,
`976 F.2d 1559 (Fed. Cir. 1992) ........................................................................129
`
`Mitsubishi Chem. Corp. v. Barr Labs., Inc.,
`718 F. Supp. 2d 382 (S.D.N.Y. 2010) ..............................................................114
`
`Monarch Knitting Machinery v. Sulzer Morat GmbH,
`139 F. 3d 877 (Fed. Cir. 1998) .........................................................113, 125, 130
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 9 of 152
`
`Nat’l Inst. for Strategic Tech. Acquisition & Commercialization v.
`Nissan of N. Am.,No. 11-11039, 2012 U.S. Dist. LEXIS 139337
`(E.D. Mich. Sep. 27, 2012).................................................................................67
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014)..................................................................................66, 67
`
`Neupak, Inc. v. Ideal Mfg. & Sales Corp.,
`41 F. App’x 435 (Fed. Cir. 2002) .............................................................114, 115
`
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) ....................................................................17, 18
`
`P&G v. Team Techs., Inc.,
`2014 U.S. Dist LEXIS 119060 (S.D. Ohio July 3, 2014)...........................19, 125
`
`P&G v. Team Techs., Inc.,
`46 F. Supp. 3d 764 (S.D. Ohio 2014) .................................................................67
`
`Perfect Web Techs., Inc. v. Info USA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) ........................................................................125
`
`Pfizer Inc. v. Teva Pharms. USA, Inc.,
`555 F. App’x 961 (Fed. Cir. 2014) (unpublished)............................67, 81, 82, 83
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ...................................................passim
`
`Plantronics, Inc. v. Aliph, Inc.,
`724 F.3d 1343 (Fed. Cir. 2013) ..........................................................................33
`
`Power-One, Inc. v. Artesyn Technologies, Inc.,
`599 F.3d 1343 (Fed. Cir. 2010) ........................................................................129
`
`Proctor & Gamble Co. v. Teva Pharma. USA, Inc., 566 F.3d 989
`(Fed. Cir 2009) .......................................................................................................
`
`Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc.,
`75 F.3d 1568 (Fed. Cir. 1996) ..........................................................................114
`
`Purdue Pharma L.P. v. Amneal Pharms., LLC (In re OxyContin
`Antitrust Litig.),No. 04-Md-1603 (SHS), 2015 U.S. Dist. LEXIS
`45967 (S.D.N.Y. Apr. 8, 2015).........................................................................125
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 10 of 152
`
`Richardson-Vicks v. Upjohn Co.,
`122 F.3d 1476 (Fed. Cir. 1997) ................................................................100, 120
`
`Sandisk Corp. v. Memorex Prods.,
`415 F.3d 1278 (Fed. Cir. 2005) ..........................................................................62
`
`Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms., Inc.,
`No. 07- CV-5855, 2011 U.S. Dist. LEXIS 10512 (D.N.J. Feb. 3,
`2011) .................................................................................................................131
`
`Schering Corp. v. Apotex Inc.,
`No. 09-6373, 2012 U.S. Dist. LEXIS 83414 (D.N.J. June 15, 2012) ..............102
`
`Schering Corp. v. Geneva Pharm., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) ....................................................................93, 96
`
`Schoell v. Regal Marine Indus., Inc., 247 F.3d 1202 (Fed. Cir. 2001)...................31
`
`Shire Dev. LLC v. Osmotica Kereskedelmi Es Szolgaltato Kft,
`No. 1:12-cv-00904-AT, 2013 U.S. Dist. LEXIS 191170 (N.D. Ga.
`Sep. 24, 2013) ...............................................................................................65, 80
`
`Shire LLC v. Amneal Pharms., LLC,
`No. 11-3781, 2013 U.S. Dist. LEXIS 111773 (D.N.J. Aug. 8,
`2013) ............................................................................................................passim
`
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005) ........................................................................102
`
`Stairmaster Sports/Med. Prods., Inc. v. Groupe Procycle, Inc.,
`25 F. Supp. 2d 270 (D. Del. 1998)......................................................................61
`
`Stratoflex, Inc. v. Aeroquip Corp.,
`713 F.2d 1530 (Fed. Cir. 1983) ................................................................113, 114
`
`Streck, Inc. v. Research & Diagnostic Sys.,
`665 F.3d 1269 (Fed. Cir. 2012) ..........................................................................83
`
`Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir.
`2010) ...................................................................................................................20
`
`Sunrace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298 (Fed. Cir.
`2003) ...................................................................................................................63
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 11 of 152
`
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) ....................................................................17, 72
`
`Takeda Pharm. Co. v. Handa Pharms., LLC,
`No. C-11-00840 JCS, 2012 U.S. Dist. LEXIS 51013 (N.D. Cal.
`Apr. 11, 2012)..............................................................................................passim
`
`Takeda Pharm. Co. v. Mylan Inc.,
`No. 13-cv-04001, 2014 U.S. Dist. LEXIS 159527 (N.D. Cal. Nov.
`11, 2014) ......................................................................................................passim
`
`Takeda v. Handa,
`2013 U.S. Dist. LEXIS 187604 ........................................................102, 108, 109
`
`Tandon Corp. v. U.S. Int’l Trade Comm’n,
`831 F.2d 1017 (Fed. Cir. 1987) ..........................................................................63
`
`Teva Pharms. United States v. Sandoz, Inc.,
`876 F. Supp. 2d 295 (S.D.N.Y. 2012) ......................................................116, 131
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`2015 U.S. App. LEXIS 10229 (Fed. Cir., June 18, 2015)................................116
`
`Teva Pharms. USA v. Sandoz, Inc.,
`135 S. Ct. 831 (2015)..........................................................................................32
`
`Texas Instruments Inc. v. United States Int’l Trade Comm’n,
`988 F.2d 1165 (Fed. Cir. 1993) ........................................................................125
`
`TK Holdings, Inc. v. CTS Corp.,
`No. 08-14266, 2012 U.S. Dist. LEXIS 92818 (E.D. Mich. July 5,
`2012) ...................................................................................................................61
`
`Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364 (Fed.
`Cir. 2002)............................................................................................................92
`
`Union Oil Co. v. Atlantic Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) ............................................................................16
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) ....................................................................15, 16
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 12 of 152
`
`Velcro Indus. B.V. v. Taiwan Paiho Ltd.,
`No. 04-cv-242-JD, 2005 U.S. Dist. LEXIS 47020 (D.N.H. Oct. 12,
`2005) ...................................................................................................................61
`
`Voda v. Cordis Corp.,
`536 F.3d 1311 (Fed. Cir. 2008) ..........................................................................31
`
`Warner–Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003) ..........................................................................30
`
`Warner-Lambert Co. v. Teva Pharms., USA, Inc.,
`418 F.3d 1326 (Fed. Cir. 2005) ..........................................................................30
`
`WBIP,LLC v. Kohler Co., 829 F.3d 1317 (Fed. Cir. 2016) ..................................125
`
`Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355 (Fed. Cir. 2011) ..........................................................................67
`
`Yamanouchi Pharm. Co. v. Danbury Pharmacal, Inc.,
`21 F. Supp. 2d 366 (S.D.N.Y. 1998) ................................................................129
`
`Yodlee, Inc. v. Plaid Techs., Inc.,
`No. 14-1445, 2016 U.S. Dist. LEXIS 5603 (D. Del. Jan. 15, 2016)..................67
`
`Statutes
`
`21 U.S.C. §355(j)(2)(b)(vii)(IV)................................................................................9
`
`35 U.S.C. § 102(b) ...................................................................................................88
`
`35 U.S.C. § 103.................................................................................................passim
`
`35 U.S.C. § 112, first paragraph ............................................................15, 66, 81, 82
`
`35 U.S.C. § 120........................................................................................................15
`
`35 U.S.C. § 271(e)(2).........................................................................................30, 31
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 13 of 152
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`PRELIMINARY STATEMENT .........................................................................................1
`
`THE ‘336 PATENT .............................................................................................................6
`
`A.
`
`B.
`
`C.
`
`Pitavastatin Calcium ................................................................................................6
`
`The Claims of the ‘336 Patent Would Be Infringed ................................................9
`
`The Claims of the ‘336 Patent Would Be Valid ......................................................9
`
`1.
`
`Relevant Factual Background Regarding the ‘336 Patent .........................10
`
`a.
`b.
`
`c.
`
`The Claims of the ‘336 Patent .......................................................10
`Nissan and Kowa’s Research and Development Efforts
`Ultimately Leading to Pitavastatin Calcium..................................12
`Procedural History Regarding Prosecution of and
`Challenges to the ‘336 Patent ........................................................13
`
`2.
`
`3.
`
`4.
`
`Defendants’ § 103 obviousness challenge to the ‘336 patent
`lacks merit..................................................................................................15
`
`Defendants’ obviousness-type double patenting challenge to the
`‘336 patent lacks merit...............................................................................19
`
`Compelling evidence of “secondary considerations” supports the
`validity of the ‘336 patent..........................................................................25
`
`III.
`
`THE ‘993 PATENT ...........................................................................................................25
`
`A.
`
`B.
`
`Introduction to crystallinity and Powder X-ray Diffraction (PXRD) ....................25
`
`THE CLAIMS OF THE ‘993 PATENT ARE INFRINGED ................................29
`
`1.
`
`2.
`
`Applicable Legal Principles.......................................................................29
`
`Level of Ordinary Skill in the Art..............................................................34
`
`a. Exhibits a characteristic X-ray diffraction pattern with characteristic
` Peaks expressed in 2θ at” had a plain and ordinary meaning to those
`skilled in the art......................................................................................35
`
`b. An X-ray powder diffraction pattern substantially as depicted” had
`a plain and ordinary meaning to those skilled in the art. ......................37
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 14 of 152
`
`C.
`
`Defendants infringe the ‘993 patent.......................................................................40
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`D.
`
`Validity ..................................................................................................................65
`
`1.
`
`Indefiniteness .............................................................................................66
`
`a. The claim term “substantially as depicted” has a plain and ordinary
`meaning to those skilled in the art ........................................................69
`
`b. The claim terms “very strong,” “strong,” “medium,” “weak,”
`“very weak,” “broad” and “shoulder” have ordinary meanings
`to those skilled in the art .......................................................................73
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 15 of 152
`
`2.
`
`3.
`
`4.
`
`Enablement ................................................................................................81
`
`Written description.....................................................................................82
`
`The claims of the ‘993 patent are not anticipated by the Asserted
`prior art.......................................................................................................84
`
`a. The ‘993 patent .....................................................................................84
`
`b. Prosecution History of the ‘993 Patent .................................................85
`
`c. Prosecution History of the ‘993 Counterpart Application EP ‘232 ......86
`
`d. Background of the Technology Relating to Defendants’
`Invalidity Contentions (Polymorph Crystal Formation).......................86
`
`of the’993 patent Are Not
`e. Claims
`Anticipated............................................................................................88
`
`i. EP ‘406 Does Not Anticipate
`of the ‘993 Patent .......................................................................88
`
`a. EP ‘406 Does Not Expressly Anticipate
`of the ‘993 Patent .........................................88
`
`b. EP ‘406 Does Not Inherently Anticipate
`........................................................89
`
`i. Example 3 of EP ‘406 Does Not Inherently
`Anticipate
`...............................89
`
`ii. The December 14, 2006 Third Party Observation
`Submitted in the EP 232.7 Prosecution Does Not Show
`Example 3 of EP ‘406 Inherently Anticipates Any of
`...................................93
`
`ii. WO ‘392 Does Not Anticipate
`of the ‘993 Patent ................................................................95
`
`a. WO ‘392 Does Not Expressly Anticipate
`of the ‘993 patent ..............................95
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 16 of 152
`
`b. WO ‘392 Does Not Inherently Anticipate Any of
`Asserted
`................................96
`
`i. Example 1(i) of EP WO ‘392 Does Not
`Inherently Anticipate Any of
`.........................................................96
`
`iii. WO ‘382 Does Not Anticipate
`of the ‘933 patent ........................................................98
`
`a. WO ‘382 Does Not Expressly Anticipate
`of the ‘993 Patent ..................................98
`
`b. WO ‘382 Does Not Inherently Anticipate
`of the ‘993 Patent ..................................99
`
`5.
`
`of the ‘993 patent would not have
`Claims
`been obvious ............................................................................................100
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`Obviousness – 35 U.S.C. § 103 ...................................................100
`
`A POSA Could Not Have Engaged in Routine Solvent
`Screening To Identify
`or Pitavastatin Calcium With A Reasonable
`Expectation of Success ................................................................101
`
`Each of EP ‘406, WO ‘392, WO ‘382 and Suzuki 1999 in view
`of Byrn 1995, Byrn 1999, Threlfall, Brittain and Jozwiakowski
`Do Not Render Obvious the
`Pitavastatin Calcium ..................................108
`
`WO ‘804 In View of Byrn 1999, Jozwiakowski And Garside
`Does Not Render Obvious
`.....110
`
`The ‘930 Patent In View of Brittain, Threlfall and Byrn 1999
`does not provide a POSA with a reasonable expectation of
`success for obtaining
`................112
`
`IV.
`
`SECONDARY CONSIDERATIONS .............................................................................113
`
`A.
`
`B.
`
`Commercial Success ............................................................................................114
`
`Unexpected Results..............................................................................................119
`
`1.
`
`Superior Activity......................................................................................119
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 17 of 152
`
`2.
`
`Clinical Results........................................................................................120
`
`Long-Felt Need ....................................................................................................125
`
`Failure of Others ..................................................................................................128
`
`Praise of Others....................................................................................................130
`
`Industry skepticism ..............................................................................................130
`
`Copying................................................................................................................131
`
`Summary of Secondary Considerations...............................................................133
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`V.
`
`CONCLUSION................................................................................................................133
`
`

`

`Case 1:14-cv-02758-PAC Document 118 Filed 12/19/16 Page 18 of 152
`
`Plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan
`
`Chemical Industries, Ltd. hereby respectfully submit their Pretrial Memorandum.
`
`I.
`
`PRELIMINARY STATEMENT
`
`Heart disease has been the leading cause of death in the United States for years. This
`
`remains so despite extensive research devoted to the causes and treatment of heart disease, and
`
`despite the development of several different classes of drugs for its prevention and treatment.
`
`Well-known contributors to cardiac disease are undesired high low-density lipoprotein (LDL, or
`
`“bad” cholesterol) and/or high triglycerides. The drug at issue in this case, Livalo® (pitavastatin
`
`calcium), is a novel statin which plays an unique role in the physician’s armamentarium for
`
`attacking these insidious conditions, and thus for the prevention and treatment of consequent
`
`conditions, such as heart disease and heart attacks.
`
`Livalo® is not as well-known as certain statins seen regularly on TV commercials such as
`
`Lipitor® or Crestor®, nor was it the first drug in the statin class. Livalo®, however, is unique due
`
`to its