99 F.Supp.3d 461
OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff
v.
TORRENT PHARMACEUTICALS LIMITED, INC., Torrent Pharma Inc., and Hetero Labs Limited, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Alembic Pharmaceuticals Limited, Alembic Limited, Alembic Global Holding SA, and Alembic Pharmaceuticals Inc., Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Limited, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Sun Pharmaceutical Industries Ltd., Sun Pharma Global Inc., Sun Pharma Global FZE, Sun Pharma USA, Sun Pharmaceuticals Industries, Inc., and Caraco Pharmaceutical Laboratories, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Torrent Pharmaceuticals Limited, Inc., Torrent Pharma Inc., and Hetero Labs Limited, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Teva Pharmaceuticals USA, Inc., Defendant.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Sun Pharmaceutical Industries Ltd., Sun Pharma Global Inc., Sun Pharma Global FZE, Sun Pharma USA, Sun Pharmaceuticals Industries, Inc., and Caraco Pharmaceutical Laboratories, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Teva Pharmaceuticals USA, Inc., Defendant.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Actavis Elizabeth LLC, Actavis, Inc., Actavis PLC, Jubilant Life Sciences Limited, Jubilant Generics Limited, and Jubilant Life Sciences (USA) Inc., Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Alembic Pharmaceuticals Limited, Alembic Limited, Alembic Global Holding SA, and Alembic Pharmaceuticals Inc., Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Apotex Corp., Apotex Inc., Apotex Pharmachem Inc., and Hetero Labs Limited, Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Hetero Drugs Limited, Hetero Labs Limited, and Hetero USA, Inc., Defendants.
Otsuka Pharmaceutical Co., Ltd., Plaintiff
v.
Sandoz Inc., Sandoz Private Ltd., and Sandoz International GMBH, Defendants.
Civil Action Nos. 14–1078 JBS/KMW
14–2982 JBS/KMW
14–3168 JBS/KMW
14–4307 JBS/KMW
14–4671 JBS/KMW
14–5878 JBS/KMW
14–6397 JBS/KMW
14–6398 JBS/KMW
14–7106 JBS/KMW
14–7405 JBS/KMW
14–8074 JBS/KMW
15–161 JBS/KMW
15–1716 JBS/KMW.
United States District Court, D. New Jersey.
Signed April 16, 2015.
Melissa A. Chuderewicz, Esq., Christopher P. Soper, Esq., Brian R. Zurich, Esq., Pepper Hamilton LLP Princeton, NJ, Paul W. Browning, Esq. (argued), Eric J. Fues, Esq. (argued), James B. Monroe, Esq., Denise Main, Esq., Jeffrey A. Freeman, Esq., Samhitha C. Muralidhar, Esq., Eric J. Fues, Esq. (argued), Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, D.C., for Otsuka Plaintiffs.
James E. Cecchi, Esq., Michael Cross, Esq., Carella, Byrne, Cecchi, Olstein, Brody
& Agnello, PC, Roseland, NJ, Claire J. Evans, Esq. (argued), James. H. Wallace (argued), A. Neal Seth, Esq., Lawrence M. Sung, Esq., Matthew J. Dowd, Esq., Wiley Rein LLP, Washington, D.C., for Torrent Defendants.
Lisa J. Rodriguez, Esq., Schnader, Harrison, Segal & Lewis, LLP, Hill, NJ, Dennies Varughese, Pharm.D., Esq. (argued), Chandrika Vira, Esq., H. Keeto Sabharwal, Esq., Uma Everett, Esq., Sterne, Kessler, Goldstein & Fox, Washington, D.C., for Alembic Defendants.
Trent S. Dickey, Esq., Vincent R. Lodato, Esq., Amy Megan Handler, Esq., Sills, Cummis, & Gross, PC, Newark, NJ, Delphine Knight Brown, Esq., Chad A. Landmon, Esq. (argued), Axinn, Veltrop & Harkrider, LLP, New York, NY, for Zydus Defendants.
Gregory D. Miller, Esq., Podvey, Meanor, Catenacci, Hildner, Cocoziello & Chattman, P.C., Newark, NJ, Martin B. Pavane, Esq. (argued), Julia S. Kim, Esq., Darren S. Mogil, Esq., Cozen O'Connor, New York, NY, for the Sun Defendants.
Michael E. Patunas, Esq., Mayra V. Tarantino, Esq., Lite, Depalma & Greenberg, LLC, Newark, NJ, Christopher T. Holding, Esq. (argued), Srikanth K. Reddy, Esq. (argued), Elizabeth J. Holland, Esq., Naomi Birbach, Esq., Goodwin Proctor, LLP, New York, NY, for the Teva Defendants.
Liza M. Walsh, Esq., Christine Intromasso Gannon, Esq., Christopher J. Borchert, Esq., Eleonore Ofosu–Antwi, Esq., Rukhsanah L. Singh, Esq., Connell Foley, LLP, Roseland, NJ, B. Jefferson Boggs, Jr., Esq. (argued), Christopher J. Soreson, Esq., Rachel C. Hughley, Esq., Matthew L. Fedowitz, Esq., Merchant & Gould, Minneapolis, MN, for the Actavis Defendants.
David Leit, Esq., Lawrence Bluestone, Esq., Lowenstein Sandler, PC, Roseland, NJ, William A. Rakoczy, Esq. (argued), Joseph T. Jaros, Esq., Deanne M. Mazzochi, Esq., Yixin H. Tang, Esq., Neil B. Mclaughlin, Esq., Rakoczy, Molina, Mazzochi, Siwik, LLP, Chicago, IL, for the Apotex Defendants.
David Leit, Esq., Lawrence Bluestone, Esq., Lowenstein Sandler, PC, Roseland, NJ, Margaret E. Ives, Esq., Phoebe Fischer–Groban, Esq., Vanessa A. Arslanian, Esq., Choate, Hall & Steward, LLP, Boston, MA, for the Hetero Defendants.
Kegan A. Brown, Esq., Daniel G. Brown, Esq. (argued), Roger J. Chin, Esq., Latham & Watkins, LLP, New York, NY, for the Sandoz Defendants.
REDACTED OPINION
SIMANDLE, Chief Judge:
| I. | INTRODUCTION | 468 |
| II. | BACKGROUND | 470 |
| A. | Factual and Procedural Background | 470 |
| III. | PRELIMINARY ISSUES | 472 |
| A. | Otsuka's Motions to Amend | 472 |
| B. | Informal Applications to Strike | 474 |
| IV. | STANDARD OF REVIEW APPLICABLE TO MOTIONS FOR TEMPORARY RESTRAINING ORDER | 475 |
| V. | DISCUSSION | 475 |
| A. | Likelihood of Success | 475 |
| 1. | Otsuka Has Not Demonstrated a Likelihood of Success on its Induced Infringement Claims | 476 |
| a. | Standard for Induced Infringement | 477 |
| i. | Claim Construction: Claim 1 of the '350 Patent Discloses a Composition, Namely a Tablet, Comprised of a Single Dosage that Contains At Least Two Active Ingredients | 478 |
| ii. | Otsuka Has Not Demonstrated That Defendants' Proposed ANDA Products Directly Infringe Construed Claim 1 of the '350 Patent | 483 |
| iii. | Otsuka Has Not Shown that Defendants Actively and Purposefully Encouraged Infringement | 484 |
| a. | Defendants' “Carve Out” of the Relevant Indication Significantly Diminishes Any Suggestion of Sufficiently Intentional Action | 485 |
